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CompletedNCT02116777Updated Mar 26, 2021Results posted

Talazoparib and Temozolomide in Treating Younger Patients With Refractory or Recurrent Malignancies

A Phase 1/2 interventional study of Laboratory Biomarker Analysis and Pharmacological Study in Adult Solid Neoplasm, Childhood Solid Neoplasm and Recurrent Childhood Central Nervous System Neoplasm, sponsored by National Cancer Institute (NCI). Completed at 22 sites in United States. Open to participants aged 13 Months to 30 Years. Per ClinicalTrials.gov, last updated 2021-03-26.

Sponsored by National Cancer Institute (NCI) · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
13 Months to 30 Years
Sex
All
01

Study summary

This phase I/II trial studies the side effects and best dose of talazoparib and temozolomide and to see how well they work in treating younger patients with tumors that have not responded to previous treatment (refractory) or have come back (recurrent). Talazoparib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving talazoparib together with temozolomide may work better in treating younger patients with refractory or recurrent malignancies.

Read the detailed description

PRIMARY OBJECTIVES:

I. To estimate the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of temozolomide when combined with a dose of talazoparib (BMN 673) given once daily for 5 days after a one day dose of BMN 673 administered orally (either once daily or twice daily), every 28 days to children with refractory or recurrent solid tumors. (Phase I) II. To define and describe the toxicities of BMN 673 given with temozolomide administered on this schedule. (Phase I) III. To characterize the pharmacokinetics of BMN 673 and temozolomide when given in combination to children with refractory or recurrent cancer. (Phase I) IV. To define the antitumor activity of BMN 673 when given with temozolomide in recurrent/refractory Ewing sarcoma.(Phase II)

SECONDARY OBJECTIVES:

I. To preliminarily define the antitumor activity of BMN 673 and temozolomide in pediatric patients with recurrent or refractory solid tumors within the confines of a phase I study.

II. To explore possible predictive biomarkers in archival tumor tissue from Ewing sarcoma patients in Phase II.

OUTLINE: This is a phase I, dose-escalation study followed by a phase II study.

Patients receive talazoparib orally (PO) once daily (QD) or twice daily (BID) on days 1-6 and temozolomide PO QD on days 2-6. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 30 days.

02

Conditions studied

  • Adult Solid Neoplasm
  • Childhood Solid Neoplasm
  • Recurrent Childhood Central Nervous System Neoplasm
  • Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor
  • Recurrent Malignant Solid Neoplasm
  • Refractory Central Nervous System Neoplasm
03

In context

Central Nervous System Neoplasms

699 studies on the registry are indexed under Central Nervous System Neoplasms; 66 are open to participants now.

This study's enrollment of 40 is above the median of 35 across 487 interventional studies indexed under Central Nervous System Neoplasms.

Browse Central Nervous System Neoplasms studies →

Lead sponsor

National Cancer Institute (NCI) is the lead sponsor of 3,556 studies on the registry; 336 are open to participants now.

Of its 411 completed or terminated interventional studies of FDA-regulated products, 373 (91%) have results posted.

Browse National Cancer Institute (NCI) studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
13 Months to 30 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age:

    • Phase 1 (Part A)

      • Patients must be > than 12 months and =\< 21 years of age at the time of study enrollment

    • Phase 2 (Part B)

      • Patients must be > than 12 months and =\< 30 years of age at the time of study enrollment

  • Body surface area (for Parts A and B):

    • Patients must have a body surface area (BSA) of >= 0.42 m\^2 at the time of study enrollment

  • Diagnosis:

    • Phase 1 (Part A)

      • Solid tumors (Part A1): patients with solid tumors including central nervous system (CNS) tumors without bone marrow involvement are eligible; patients must have had histologic verification of at original diagnosis or relapse except in patients with intrinsic brain stem tumors, optic pathway gliomas, or patients with pineal tumors and elevations of cerebrospinal fluid (CSF) or serum tumor markers including alpha-fetoprotein or beta-human chorionic gonadotropin (HCG)
      • Ewing sarcoma or peripheral primitive neuroectodermal tumor (PNET) (Part A2): patients with relapsed or refractory Ewing sarcoma or peripheral PNET without bone marrow involvement will be eligible for Part A2 if there are no available slots on Part A1; these patients will be enrolled at one dose level below the dose level at which patients on Part A1 are actively enrolling, or at the starting dose level (dose level 1) if dose escalation has not yet occurred; patients must have had histologic verification of malignancy at original diagnosis or relapse

    • Phase 2 (Part B)

      • Ewing sarcoma or peripheral PNET: patients with relapsed or refractory Ewing sarcoma or peripheral PNET are eligible; patients must have had histologic verification of malignancy at original diagnosis or relapse
    • Phase 2 (Part C)

  • Disease status:

    • Phase 1 (Part A):

      • Patients must have either measurable or evaluable disease

    • Phase 2 (Part B):

      • Ewing sarcoma or peripheral PNET: patients must have
  • Therapeutic options: patient's current disease state must be one for which there is no known curative therapy or therapy proven to prolong survival with an acceptable quality of life
  • >= 50% for patients > 16 years of age and Lansky >= 50 for patients =\< 16 years of age; Note: neurologic deficits in patients with CNS tumors must have been relatively stable for at least 7 days prior to study enrollment; patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score
  • Patients who have received prior therapy with a temozolomide-based regimen are eligible; Note: patients who have progressed on a poly adenosine diphosphate ribose polymerase (PARP) inhibitor and temozolomide regimen are not eligible for Part A of the study

  • Patients must have fully recovered from the acute toxic effects of all prior anti-cancer chemotherapy

    • Myelosuppressive chemotherapy:

      • Solid tumors (Part A and Part B): at least 21 days after the last dose of myelosuppressive chemotherapy (42 days if prior nitrosourea)
    • Hematopoietic growth factors: at least 14 days after the last dose of a long-acting growth factor (e.g. Neulasta) or 7 days for short-acting growth factor; for agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur; the duration of this interval must be discussed with the study chair
    • Biologic (anti-neoplastic agent): at least 7 days after the last dose of a biologic agent; for agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur; the duration of this interval must be discussed with the study chair
    • Immunotherapy: at least 42 days after the completion of any type of immunotherapy, e.g. tumor vaccines
    • Monoclonal antibodies: at least 3 half-lives of the antibody after the last dose of a monoclonal antibody
    • Radiation therapy (XRT): at least 14 days after local palliative XRT (small port); at least 42 days must have elapsed if other substantial bone marrow (BM) radiation; patients with prior total body irradiation (TBI), craniospinal XRT and/or >= 50% radiation of the pelvis are not eligible
    • Stem cell infusion without TBI: no evidence of active graft vs. host disease and at least 84 days must have elapsed after transplant or stem cell infusion

  • PARP inhibitor exposure:

    • Part A: Patients who have received prior therapy with a PARP inhibitor, with the exception of BMN 673, are eligible; however, patients who have progressed on a PARP inhibitor and temozolomide regimen are not eligible
    • Part B: Patients who have previously been exposed to a PARP inhibitor are not eligible
  • For patients with solid tumors without known bone marrow involvement: peripheral (ANC) >= 1000/mm\^3
  • For patients with solid tumors without known bone marrow involvement: count >= 100,000/mm\^3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment)
  • For patients with solid tumors without known bone marrow involvement: >= 8.0 g/dL (may receive red blood cell [RBC] transfusions)
  • All patients enrolled on Part A of the study must be evaluable for hematologic toxicity
  • Patients on Part B of the study with known bone marrow disease will be eligible for the study provided they meet the blood counts (may receive transfusions provided they are not known to be refractory to red cell or platelet transfusions); these patients will not be evaluable for hematologic toxicity

  • or radioisotope (GFR) >= 70 ml/min/1.73 m\^2 or a maximum serum creatinine (mg/dL) based on age/gender as follows:

    • 1 to \< 2 years: 0.6
    • 2 to \< 6 years: 0.8
    • 6 to \< 10 years: 1
    • 10 to \< 13 years: 1.2
    • 13 to \< 16 years: 1.5 for males, 1.4 for females
    • >= 16 years: 1.7 for males, 1.4 for females
  • Patients on Part A and Part B: (sum of conjugated + unconjugated) =\< 1.5 x (ULN) for age
  • Patients on Part A and Part B: serum glutamate pyruvate transaminase () (alanine aminotransferase [ALT]) =\< 110 U/L; for the purpose of this study, the ULN for SGPT is 45 U/L
  • Patients on Part A and Part B: serum albumin >= 2 g/dL
  • All patients and/or their parents or legally authorized representatives must sign a written ; assent, when appropriate, will be obtained according to institutional guidelines
  • For patients enrolling on Part B: tissue blocks or slides must be sent; if tissue blocks or slides are unavailable, the Study Chair must be notified prior to enrollment

Exclusion criteria

Exclusion Criteria:

  • Pregnant or breast-feeding women will not be entered on this study; pregnancy tests must be obtained in girls who are post-menarchal; males or females of may not participate unless they have agreed to use an effective method
  • Patients receiving who have not been on a stable or decreasing dose of corticosteroid for at least 7 days prior to enrollment are not eligible
  • Patients who are currently receiving another drug are not eligible
  • Patients who are currently receiving other anti-cancer agents are not eligible (except leukemia patients receiving hydroxyurea, which may be continued until 24 hours prior to start of protocol therapy); patients with acute lymphoblastic leukemia may receive intrathecal therapy
  • Patients who are receiving cyclosporine, tacrolimus or other agents to prevent post bone marrow transplant are not eligible for this trial
  • Patients must be able to swallow capsules whole
  • Patients who have an uncontrolled infection are not eligible
  • Patients who have received a prior solid organ transplantation are not eligible
  • Patients with prior TBI, craniospinal XRT and/or those with >= 50% radiation of the pelvis are not eligible
  • Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible
  • Patients with known to temozolomide or dacarbazine are not eligible
  • Phase 1 (Part A): patients who have progressed on a PARP inhibitor and temozolomide regimen are not eligible
  • Phase 2 (Part B): patients who have previously been exposed to a PARP inhibitor are not eligible
  • Phase 1 (Part A): patients with known bone marrow involvement are not eligible
Terms in these criteria, in plain language(20)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Measurable disease

The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.

The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.

Karnofsky performance status (KPS)

A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.

Studies often ask for 60 or 70 and above. Your doctor gives the score.

Absolute neutrophil count (ANC)

The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.

It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Reproductive potential

Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.

Criteria about it usually ask for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

GVHD (graft-versus-host disease)

After a transplant from a donor, the donor’s immune cells attack the recipient’s body, often the skin, gut or liver.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    Treatment (talazoparib, temozolomide): Phase 1

    (Part A): Patients receive talazoparib PO QD or BID on days 1-6 and temozolomide PO QD on days 2-6. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.

    Other: Laboratory Biomarker Analysis · Other: Pharmacological Study · Drug: Talazoparib · Drug: Temozolomide

  • Experimental
    Treatment (talazoparib, temozolomide): Phase 2

    (Part B): Relapse/Refractory EWS or PNET Patients receive MTD from Phase 1 portion of study. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.

    Other: Laboratory Biomarker Analysis · Other: Pharmacological Study · Drug: Talazoparib · Drug: Temozolomide

Interventions

  • OtherLaboratory Biomarker Analysis

    Correlative studies

  • OtherPharmacological Study

    Correlative studies

  • DrugTalazoparib

    Given PO

    Also known as: BMN 673, BMN-673

  • DrugTemozolomide

    Given PO

    Also known as: CCRG-81045, Imidazo[5,1-d]-1,2,3,5-tetrazine-8-carboxamide, 3, 4-dihydro-3-methyl-4-oxo-, M & B 39831, M and B 39831, Methazolastone, RP-46161, SCH 52365, Temcad, Temodal, Temodar, Temomedac, TMZ

06

What researchers measure

Primary outcomes

  1. The Number of Participants With Dose Limiting Toxicities to Determine the Maximum Tolerated Dose of Temozolomide and Talazoparib Combination Therapy

    The Maximum Tolerated Dose (MTD) reflects the highest dose of Talazoparib (BMN 673) when combined with a dose of temozolomide that did not cause a Grade 3 or higher toxicity in children with refractory or recurrent solid tumors.

    Time frame: 28 days

  2. All Cycle 1 Toxicities >=Grade 3

    The number of patients with at least one toxicity (DLT or non-DLT) in cycle 1 that is at least possibly attributable to study agent

    Time frame: Up to 28 days

  3. T Max of Talazoparib

    Median with minimum and maximum for the time at which the maximum (peak) serum concentration occurs.

    Time frame: Cycle 1 Day 1 pre-dose, and 1, 2, 4, 8 and 24 hours after the first talazoparib dose.

  4. C Max of Talazoparib

    Median with minimum and maximum for the time at which the maximum (peak) serum concentration occurs.

    Time frame: Cycle 1 Day 1 pre-dose, and 1, 2, 4, 8 and 24 hours after the first talazoparib dose.

  5. AUC of Talazoparib

    Median with minimum and maximum for the area under the drug concentration over time curve.

    Time frame: Cycle 1 Day 1 pre-dose, and 1, 2, 4 and 8 hours after the first talazoparib dose

  6. Accumulation Half-life of Talazoparib in Combination With Temozolomide.

    Median with minimum and maximum for the time required for the serum concentration to fall to 50% of its starting dose.

    Time frame: Cycle 1 Day 1 pre-dose, and 1, 2, 4 and 8 hours after the first talazoparib dose. Day 5 or 6 pre-dose, and 1, 2, 4 and 8 hours after the talazoparib dose

  7. T Max of Talazoparib in Combination With Temozolomide

    Median with minimum and maximum for the time at which the maximum (peak) serum concentration occurs.

    Time frame: Cycle 1 Day 5 or 6 pre-dose, and 1, 2, 4 and 8 hours after the talazoparib dose

  8. C Max of Talazoparib in Combination With Temozolomide

    Median with minimum and maximum for the time at which the maximum (peak) serum concentration occurs.

    Time frame: Cycle 1 Day 5 or 6 pre-dose, and 1, 2, 4 and 8 hours after the talazoparib dose

  9. AUC of Talazoparib in Combination With Temozolomide

    Median with minimum and maximum area under the drug concentration over time curve

    Time frame: Cycle 1 Day 5 or 6 pre-dose, and 1, 2, 4 and 8 hours after the talazoparib dose

  10. Clearance of Talazoparib in Combination With Temozolomide

    Median with minimum and maximum for the rate of elimination of the drug.

    Time frame: Cycle 1 Day 5 or 6 pre-dose, and 1, 2, 4 and 8 hours after the talazoparib dose

  11. Accumulation Ratio of Talazoparib in Combination With Temozolomide

    Median with minimum and maximum of the accumulation ratio.

    Time frame: Cycle 1 Day 1 pre-dose, and 1, 2, 4 and 8 hours after the first talazoparib dose. Day 5 or 6 pre-dose, and 1, 2, 4 and 8 hours after the talazoparib dose

  12. Half-life of Temozolomide in Combination With Talazoparib

    Median with minimum and maximum for the time required for the serum concentration to fall to 50% of its starting dose.

    Time frame: Cycle 1 Day 5 or 6 pre-dose, and 1, 2, 4 and 8 hours after the temozolomide dose

  13. T Max of Temozolomide in Combination With Talazoparib

    Median with minimum and maximum for the time at which the maximum (peak) serum concentration occurs.

    Time frame: Cycle 1 Day 5 or 6 pre-dose, and 1, 2, 4 and 8 hours after the temozolomide dose

  14. C Max of Temozolomide in Combination With Talazoparib

    Median with minimum and maximum for the maximum (peak) serum concentration.

    Time frame: Cycle 1 Day 5 or 6 pre-dose, and 1, 2, 4 and 8 hours after the temozolomide dose

  15. AUC of Temozolomide in Combination With Talazoparib

    Median with minimum and maximum for the area under the drug concentration over time curve.

    Time frame: Cycle 1 Day 5 or 6 pre-dose, and 1, 2, 4 and 8 hours after the temozolomide dose.

  16. Clearance of Temozolomide in Combination With Talazoparib

    Median with minimum and maximum for the rate of elimination of the drug.

    Time frame: Cycle 1 Day 5 or 6 pre-dose, and 1, 2, 4 and 8 hours after the temozolomide dose

  17. Number of Ewing/Peripheral PNET Participants in Phase 2 With Complete Response (CR) or Partial Response (PR)

    Frequency of Ewing sarcoma and peripheral PNET participants with Complete Response (CR) or Partial Response (PR) per the Response Evaluation Criteria In Solid Tumors (RECIST)

    Time frame: Up to 24 months

Secondary outcomes

  1. Number of Solid Tumor Patients With Complete Response (CR) or Partial Response (PR)

    Frequency of solid tumor participants with Complete Response (CR) or Partial Response (PR) per the Response Evaluation Criteria In Solid Tumors (RECIST)

    Time frame: Up to 24 months

07

Results

Posted Mar 26, 2021

Participant flow

Participant flow — Overall Study
Milestone400 mcg/m²/Dose BMN 673 QD+20mg/m²/Dose TEM,Max 800 mcg/Day400 mcg/m²/Dose BMN 673 BID+20mg/m²/Dose TEM,Max 800 mcg/Day600 mcg/m²/Dose BMN 673 BID+20mg/m²/Dose TEM,Max 1000 mcg/Day600 mcg/m²/Dose BMN 673 BID+30mg/m²/Dose TEM, Max 1000 mcg/Day600 mcg/m²/Dose BMN 673 BID+40mg/m²/Dose TEM, Max 1000 mcg/Day600 mcg/m²/doseBMN 673 BID+55mg/m²/Dose TEM, Max 1000 mcg/Day600 mcg/m²/Dose BMN 673 BID+30mg/m²/Dose TEM,Max 1000 mcg/Day
Started33313639
Completed0000000
Not completed33313639
Withdrew: Adverse event0000220
Withdrew: Death0001000
Withdrew: Lack of efficacy3338419
Withdrew: Physician decision0002000
Withdrew: Protocol violation0001000
Withdrew: Withdrawal by subject0001000

Outcome measures

PrimaryThe Number of Participants With Dose Limiting Toxicities to Determine the Maximum Tolerated Dose of Temozolomide and Talazoparib Combination Therapy

The Maximum Tolerated Dose (MTD) reflects the highest dose of Talazoparib (BMN 673) when combined with a dose of temozolomide that did not cause a Grade 3 or higher toxicity in children with refractory or recurrent solid tumors.

Time frame:
28 days
Reported as:
Count of participants · Participants
The Number of Participants With Dose Limiting Toxicities to Determine the Maximum Tolerated Dose of Temozolomide and Talazoparib Combination Therapy
Participants400 mcg/m²/Dose BMN 673 QD+20mg/m²/Dose TEM,Max 800 mcg/Day400 mcg/m²/Dose BMN 673 BID+20mg/m²/Dose TEM,Max 800 mcg/Day600 mcg/m²/Dose BMN 673 BID+20mg/m²/Dose TEM,Max 1000 mcg/Day600 mcg/m²/Dose BMN 673 BID+30mg/m²/Dose TEM, Max 1000 mcg/Day600 mcg/m²/Dose BMN 673 BID+40mg/m²/Dose TEM, Max 1000 mcg/Day600 mcg/m²/doseBMN 673 BID+55mg/m²/Dose TEM, Max 1000 mcg/Day600 mcg/m²/Dose BMN 673 BID+30 mg/m²/Dose TEM,Max 1000 mcg/Day
The Number of Participants With Dose Limiting Toxicities to Determine the Maximum Tolerated Dose of Temozolomide and Talazoparib Combination Therapy0012220
Statistical analysis
  • 400 mcg/m²/Dose BMN 673 QD+20mg/m²/Dose TEM,Max 800 mcg/Day vs 400 mcg/m²/Dose BMN 673 BID+20mg/m²/Dose TEM,Max 800 mcg/Day vs 600 mcg/m²/Dose BMN 673 BID+20mg/m²/Dose TEM,Max 1000 mcg/Day vs 600 mcg/m²/Dose BMN 673 BID+30mg/m²/Dose TEM, Max 1000 mcg/Day vs 600 mcg/m²/Dose BMN 673 BID+40mg/m²/Dose TEM, Max 1000 mcg/Day vs 600 mcg/m²/doseBMN 673 BID+55mg/m²/Dose TEM, Max 1000 mcg/Day vs 600 mcg/m²/Dose BMN 673 BID+30 mg/m²/Dose TEM,Max 1000 mcg/Day · Maximum tolerate dose level: 4Maximum Tolerate Dose Level is Dose Level 4 (600 mcg/m²/dose +30 mg/m2/dose (BMN 673) BID + 30 mg/m²/dose (TEM), Max 1000 mcg/day). MTD determined by using the Rolling-6 Design.
PrimaryAll Cycle 1 Toxicities >=Grade 3

The number of patients with at least one toxicity (DLT or non-DLT) in cycle 1 that is at least possibly attributable to study agent

Time frame:
Up to 28 days
Reported as:
Count of participants · Participants
All Cycle 1 Toxicities >=Grade 3
Participants400 mcg/m²/Dose BMN 673 QD+20mg/m²/Dose TEM,Max 800 mcg/Day400 mcg/m²/Dose BMN 673 BID+20mg/m²/Dose TEM,Max 800 mcg/Day600 mcg/m²/Dose BMN 673 BID+20mg/m²/Dose TEM,Max 1000 mcg/Day600 mcg/m²/Dose BMN 673 BID+30mg/m²/Dose TEM, Max 1000 mcg/Day600 mcg/m²/Dose BMN 673 BID+40mg/m²/Dose TEM, Max 1000 mcg/Day600 mcg/m²/doseBMN 673 BID+55mg/m²/Dose TEM, Max 1000 mcg/Day600 mcg/m²/Dose BMN 673 BID+30mg/m²/Dose TEM,Max 1000 mcg/Day
All Cycle 1 Toxicities >=Grade 30027535
PrimaryT Max of Talazoparib

Median with minimum and maximum for the time at which the maximum (peak) serum concentration occurs.

Time frame:
Cycle 1 Day 1 pre-dose, and 1, 2, 4, 8 and 24 hours after the first talazoparib dose.
Reported as:
Median · Hours
T Max of Talazoparib
HoursTreatment (Talazoparib, Temozolomide): Phase 1
T Max of Talazoparib2 (1 to 24)
PrimaryC Max of Talazoparib

Median with minimum and maximum for the time at which the maximum (peak) serum concentration occurs.

Time frame:
Cycle 1 Day 1 pre-dose, and 1, 2, 4, 8 and 24 hours after the first talazoparib dose.
Reported as:
Median · ng/mL
C Max of Talazoparib
ng/mLTreatment (Talazoparib, Temozolomide): Phase 1
C Max of Talazoparib4670 (708 to 19300)
PrimaryAUC of Talazoparib

Median with minimum and maximum for the area under the drug concentration over time curve.

Time frame:
Cycle 1 Day 1 pre-dose, and 1, 2, 4 and 8 hours after the first talazoparib dose
Reported as:
Median · h•µg/L
AUC of Talazoparib
h•µg/LTreatment (Talazoparib, Temozolomide): Phase 1
AUC of Talazoparib17.55 (2.15 to 63.14)
PrimaryAccumulation Half-life of Talazoparib in Combination With Temozolomide.

Median with minimum and maximum for the time required for the serum concentration to fall to 50% of its starting dose.

Time frame:
Cycle 1 Day 1 pre-dose, and 1, 2, 4 and 8 hours after the first talazoparib dose. Day 5 or 6 pre-dose, and 1, 2, 4 and 8 hours after the talazoparib dose
Reported as:
Median · Hours
Accumulation Half-life of Talazoparib in Combination With Temozolomide.
HoursTreatment (Talazoparib, Temozolomide): Phase 1
Accumulation Half-life of Talazoparib in Combination With Temozolomide.46.8 (18.20 to 253.27)
PrimaryT Max of Talazoparib in Combination With Temozolomide

Median with minimum and maximum for the time at which the maximum (peak) serum concentration occurs.

Time frame:
Cycle 1 Day 5 or 6 pre-dose, and 1, 2, 4 and 8 hours after the talazoparib dose
Reported as:
Median · Hours
T Max of Talazoparib in Combination With Temozolomide
HoursTreatment (Talazoparib, Temozolomide): Phase 1
T Max of Talazoparib in Combination With Temozolomide1.04 (1 to 8)
PrimaryC Max of Talazoparib in Combination With Temozolomide

Median with minimum and maximum for the time at which the maximum (peak) serum concentration occurs.

Time frame:
Cycle 1 Day 5 or 6 pre-dose, and 1, 2, 4 and 8 hours after the talazoparib dose
Reported as:
Median · pg/ml
C Max of Talazoparib in Combination With Temozolomide
pg/mlTreatment (Talazoparib, Temozolomide): Phase 1
C Max of Talazoparib in Combination With Temozolomide16450 (7070 to 56300)
PrimaryAUC of Talazoparib in Combination With Temozolomide

Median with minimum and maximum area under the drug concentration over time curve

Time frame:
Cycle 1 Day 5 or 6 pre-dose, and 1, 2, 4 and 8 hours after the talazoparib dose
Reported as:
Median · h•µg/L
AUC of Talazoparib in Combination With Temozolomide
h•µg/LTreatment (Talazoparib, Temozolomide): Phase 1
AUC of Talazoparib in Combination With Temozolomide82.08 (41.92 to 226.70)
PrimaryAUC of Talazoparib in Combination With Temozolomide

Median with minimum and maximum area under the drug concentration over time curve

Time frame:
Cycle 1 Day 5 or 6 pre-dose, and 1, 2, 4 and 8 hours after the talazoparib dose
Reported as:
Median · h•µg/L
AUC of Talazoparib in Combination With Temozolomide
h•µg/LTreatment (Talazoparib, Temozolomide): Phase 1
AUC of Talazoparib in Combination With Temozolomide173.08 (83.61 to 456.28)
PrimaryClearance of Talazoparib in Combination With Temozolomide

Median with minimum and maximum for the rate of elimination of the drug.

Time frame:
Cycle 1 Day 5 or 6 pre-dose, and 1, 2, 4 and 8 hours after the talazoparib dose
Reported as:
Median · L/hr/m²
Clearance of Talazoparib in Combination With Temozolomide
L/hr/m²Treatment (Talazoparib, Temozolomide): Phase 1
Clearance of Talazoparib in Combination With Temozolomide3.08 (1.34 to 6.19)
PrimaryAccumulation Ratio of Talazoparib in Combination With Temozolomide

Median with minimum and maximum of the accumulation ratio.

Time frame:
Cycle 1 Day 1 pre-dose, and 1, 2, 4 and 8 hours after the first talazoparib dose. Day 5 or 6 pre-dose, and 1, 2, 4 and 8 hours after the talazoparib dose
Reported as:
Median · Ratio
Accumulation Ratio of Talazoparib in Combination With Temozolomide
RatioTreatment (Talazoparib, Temozolomide): Phase 1
Accumulation Ratio of Talazoparib in Combination With Temozolomide3.34 (1.67 to 15.73)
PrimaryHalf-life of Temozolomide in Combination With Talazoparib

Median with minimum and maximum for the time required for the serum concentration to fall to 50% of its starting dose.

Time frame:
Cycle 1 Day 5 or 6 pre-dose, and 1, 2, 4 and 8 hours after the temozolomide dose
Reported as:
Median · Hours
Half-life of Temozolomide in Combination With Talazoparib
HoursTreatment (Talazoparib, Temozolomide): Phase 1
Half-life of Temozolomide in Combination With Talazoparib1.74 (1.33 to 4.92)
PrimaryT Max of Temozolomide in Combination With Talazoparib

Median with minimum and maximum for the time at which the maximum (peak) serum concentration occurs.

Time frame:
Cycle 1 Day 5 or 6 pre-dose, and 1, 2, 4 and 8 hours after the temozolomide dose
Reported as:
Median · Hours
T Max of Temozolomide in Combination With Talazoparib
HoursTreatment (Talazoparib, Temozolomide): Phase 1
T Max of Temozolomide in Combination With Talazoparib1.03 (1 to 4)
PrimaryC Max of Temozolomide in Combination With Talazoparib

Median with minimum and maximum for the maximum (peak) serum concentration.

Time frame:
Cycle 1 Day 5 or 6 pre-dose, and 1, 2, 4 and 8 hours after the temozolomide dose
Reported as:
Median · ng/mL
C Max of Temozolomide in Combination With Talazoparib
ng/mLTreatment (Talazoparib, Temozolomide): Phase 1
C Max of Temozolomide in Combination With Talazoparib1234.1 (346.56 to 6593.17)
PrimaryAUC of Temozolomide in Combination With Talazoparib

Median with minimum and maximum for the area under the drug concentration over time curve.

Time frame:
Cycle 1 Day 5 or 6 pre-dose, and 1, 2, 4 and 8 hours after the temozolomide dose.
Reported as:
Median · h•µg/L
AUC of Temozolomide in Combination With Talazoparib
h•µg/LTreatment (Talazoparib, Temozolomide): Phase 1
AUC of Temozolomide in Combination With Talazoparib4352.16 (1174.08 to 21653.96)
PrimaryClearance of Temozolomide in Combination With Talazoparib

Median with minimum and maximum for the rate of elimination of the drug.

Time frame:
Cycle 1 Day 5 or 6 pre-dose, and 1, 2, 4 and 8 hours after the temozolomide dose
Reported as:
Median · L/hr/m²
Clearance of Temozolomide in Combination With Talazoparib
L/hr/m²Treatment (Talazoparib, Temozolomide): Phase 1
Clearance of Temozolomide in Combination With Talazoparib6.49 (2.59 to 30.08)
PrimaryNumber of Ewing/Peripheral PNET Participants in Phase 2 With Complete Response (CR) or Partial Response (PR)

Frequency of Ewing sarcoma and peripheral PNET participants with Complete Response (CR) or Partial Response (PR) per the Response Evaluation Criteria In Solid Tumors (RECIST)

Time frame:
Up to 24 months
Reported as:
Count of participants · Participants
Number of Ewing/Peripheral PNET Participants in Phase 2 With Complete Response (CR) or Partial Response (PR)
ParticipantsTreatment (Talazoparib, Temozolomide): Phase 2
Number of Ewing/Peripheral PNET Participants in Phase 2 With Complete Response (CR) or Partial Response (PR)0
SecondaryNumber of Solid Tumor Patients With Complete Response (CR) or Partial Response (PR)

Frequency of solid tumor participants with Complete Response (CR) or Partial Response (PR) per the Response Evaluation Criteria In Solid Tumors (RECIST)

Time frame:
Up to 24 months
Reported as:
Count of participants · Participants
Number of Solid Tumor Patients With Complete Response (CR) or Partial Response (PR)
ParticipantsTreatment (Talazoparib, Temozolomide): Phase 1
Number of Solid Tumor Patients With Complete Response (CR) or Partial Response (PR)1

Adverse events

Collected over Up to 24 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
400 mcg/m²/Dose BMN 673 QD+20mg/m²/Dose TEM,Max 800 mcg/Day0/3 (0%)2/3 (66.7%)3/3 (100%)
400 mcg/m²/Dose BMN 673 BID+20mg/m²/Dose TEM,Max 800 mcg/Day0/3 (0%)2/3 (66.7%)3/3 (100%)
600 mcg/m²/Dose BMN 673 BID+20mg/m²/Dose TEM,Max 1000 mcg/Day0/3 (0%)2/3 (66.7%)3/3 (100%)
600 mcg/m²/Dose BMN 673 BID+30mg/m²/Dose TEM, Max 1000 mcg/Day2/13 (15.4%)11/13 (84.6%)13/13 (100%)
600 mcg/m²/Dose BMN 673 BID+40mg/m²/Dose TEM, Max 1000 mcg/Day1/6 (16.7%)6/6 (100%)6/6 (100%)
600 mcg/m²/doseBMN 673 BID+55mg/m²/Dose TEM, Max 1000 mcg/Day0/3 (0%)3/3 (100%)3/3 (100%)
600 mcg/m²/Dose BMN 673 BID+30mg/m²/Dose TEM,Max 1000 mcg/Day0/9 (0%)8/9 (88.9%)9/9 (100%)
Most frequent serious events
Showing 10 of 72
Most frequent serious events
Event400 mcg/m²/Dose BMN 673 QD+20mg/m²/Dose TEM,Max 800 mcg/Day400 mcg/m²/Dose BMN 673 BID+20mg/m²/Dose TEM,Max 800 mcg/Day600 mcg/m²/Dose BMN 673 BID+20mg/m²/Dose TEM,Max 1000 mcg/Day600 mcg/m²/Dose BMN 673 BID+30mg/m²/Dose TEM, Max 1000 mcg/Day600 mcg/m²/Dose BMN 673 BID+40mg/m²/Dose TEM, Max 1000 mcg/Day600 mcg/m²/doseBMN 673 BID+55mg/m²/Dose TEM, Max 1000 mcg/Day600 mcg/m²/Dose BMN 673 BID+30mg/m²/Dose TEM,Max 1000 mcg/Day
Neutrophil count decreasedInvestigations0/30/31/38/135/63/35/9
AnemiaBlood and lymphatic system disorders0/30/30/33/131/62/35/9
Lymphocyte count decreasedInvestigations0/32/30/34/132/62/36/9
Platelet count decreasedInvestigations0/30/30/34/133/62/35/9
White blood cell decreasedInvestigations0/30/30/33/132/62/35/9
AnorexiaMetabolism and nutrition disorders1/30/30/31/131/61/31/9
AtaxiaNervous system disorders0/30/31/30/130/60/30/9
Catheter related infectionInfections and infestations0/30/30/30/131/61/30/9
DysphagiaGastrointestinal disorders0/30/31/31/130/60/30/9
DysphasiaNervous system disorders0/30/31/30/130/60/30/9
Most frequent other events
Showing 10 of 257
Most frequent other events
Event400 mcg/m²/Dose BMN 673 QD+20mg/m²/Dose TEM,Max 800 mcg/Day400 mcg/m²/Dose BMN 673 BID+20mg/m²/Dose TEM,Max 800 mcg/Day600 mcg/m²/Dose BMN 673 BID+20mg/m²/Dose TEM,Max 1000 mcg/Day600 mcg/m²/Dose BMN 673 BID+30mg/m²/Dose TEM, Max 1000 mcg/Day600 mcg/m²/Dose BMN 673 BID+40mg/m²/Dose TEM, Max 1000 mcg/Day600 mcg/m²/doseBMN 673 BID+55mg/m²/Dose TEM, Max 1000 mcg/Day600 mcg/m²/Dose BMN 673 BID+30mg/m²/Dose TEM,Max 1000 mcg/Day
AnemiaBlood and lymphatic system disorders2/32/32/312/136/63/38/9
FatigueGeneral disorders3/31/30/310/135/63/36/9
HeadacheNervous system disorders3/31/31/33/130/63/35/9
NauseaGastrointestinal disorders1/31/33/36/134/62/37/9
Sinus tachycardiaCardiac disorders0/31/31/35/132/63/33/9
VomitingGastrointestinal disorders0/31/31/35/134/63/33/9
White blood cell decreasedInvestigations1/32/32/310/135/63/37/9
Alkaline phosphatase increasedInvestigations1/31/31/32/131/61/37/9
Lymphocyte count decreasedInvestigations1/32/32/310/134/61/34/9
Platelet count decreasedInvestigations2/31/31/39/134/62/35/9

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)400 mcg/m²/Dose BMN 673 QD+20mg/m²/Dose TEM,Max 800 mcg/Day400 mcg/m²/Dose BMN 673 BID+20mg/m²/Dose TEM,Max 800 mcg/Day600 mcg/m²/Dose BMN 673 BID+20mg/m²/Dose TEM,Max 1000 mcg/Day600 mcg/m²/Dose BMN 673 BID+30mg/m²/Dose TEM, Max 1000 mcg/Day600 mcg/m²/Dose BMN 673 BID+40mg/m²/Dose TEM, Max 1000 mcg/Day600 mcg/m²/doseBMN 673 BID+55mg/m²/Dose TEM, Max 1000 mcg/Day600 mcg/m²/Dose BMN 673 BID+30mg/m²/Dose TEM,Max 1000 mcg/DayTotal
<=18 years2231253330
Between 18 and 65 years110110610
>=65 years00000000
Age, Continuous
Age, Continuous(Years)400 mcg/m²/Dose BMN 673 QD+20mg/m²/Dose TEM,Max 800 mcg/Day400 mcg/m²/Dose BMN 673 BID+20mg/m²/Dose TEM,Max 800 mcg/Day600 mcg/m²/Dose BMN 673 BID+20mg/m²/Dose TEM,Max 1000 mcg/Day600 mcg/m²/Dose BMN 673 BID+30mg/m²/Dose TEM, Max 1000 mcg/Day600 mcg/m²/Dose BMN 673 BID+40mg/m²/Dose TEM, Max 1000 mcg/Day600 mcg/m²/doseBMN 673 BID+55mg/m²/Dose TEM, Max 1000 mcg/Day600 mcg/m²/Dose BMN 673 BID+30mg/m²/Dose TEM,Max 1000 mcg/DayTotal
Median18 (16 to 19)16 (7 to 19)14 (13 to 14)13 (5 to 19)13.5 (4 to 20)12 (6 to 15)22 (16 to 25)15.5 (4 to 25)
Sex: Female, Male
Sex: Female, Male(Participants)400 mcg/m²/Dose BMN 673 QD+20mg/m²/Dose TEM,Max 800 mcg/Day400 mcg/m²/Dose BMN 673 BID+20mg/m²/Dose TEM,Max 800 mcg/Day600 mcg/m²/Dose BMN 673 BID+20mg/m²/Dose TEM,Max 1000 mcg/Day600 mcg/m²/Dose BMN 673 BID+30mg/m²/Dose TEM, Max 1000 mcg/Day600 mcg/m²/Dose BMN 673 BID+40mg/m²/Dose TEM, Max 1000 mcg/Day600 mcg/m²/doseBMN 673 BID+55mg/m²/Dose TEM, Max 1000 mcg/Day600 mcg/m²/Dose BMN 673 BID+30mg/m²/Dose TEM,Max 1000 mcg/DayTotal
Female111342416
Male2221021524
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)400 mcg/m²/Dose BMN 673 QD+20mg/m²/Dose TEM,Max 800 mcg/Day400 mcg/m²/Dose BMN 673 BID+20mg/m²/Dose TEM,Max 800 mcg/Day600 mcg/m²/Dose BMN 673 BID+20mg/m²/Dose TEM,Max 1000 mcg/Day600 mcg/m²/Dose BMN 673 BID+30mg/m²/Dose TEM, Max 1000 mcg/Day600 mcg/m²/Dose BMN 673 BID+40mg/m²/Dose TEM, Max 1000 mcg/Day600 mcg/m²/doseBMN 673 BID+55mg/m²/Dose TEM, Max 1000 mcg/Day600 mcg/m²/Dose BMN 673 BID+30mg/m²/Dose TEM,Max 1000 mcg/DayTotal
Hispanic or Latino02120016
Not Hispanic or Latino3121162732
Unknown or Not Reported00000112
Race (NIH/OMB)
Race (NIH/OMB)(Participants)400 mcg/m²/Dose BMN 673 QD+20mg/m²/Dose TEM,Max 800 mcg/Day400 mcg/m²/Dose BMN 673 BID+20mg/m²/Dose TEM,Max 800 mcg/Day600 mcg/m²/Dose BMN 673 BID+20mg/m²/Dose TEM,Max 1000 mcg/Day600 mcg/m²/Dose BMN 673 BID+30mg/m²/Dose TEM, Max 1000 mcg/Day600 mcg/m²/Dose BMN 673 BID+40mg/m²/Dose TEM, Max 1000 mcg/Day600 mcg/m²/doseBMN 673 BID+55mg/m²/Dose TEM, Max 1000 mcg/Day600 mcg/m²/Dose BMN 673 BID+30mg/m²/Dose TEM,Max 1000 mcg/DayTotal
American Indian or Alaska Native00000000
Asian00110002
Native Hawaiian or Other Pacific Islander00000000
Black or African American10021004
White232752829
More than one race00000000
Unknown or Not Reported00030115
08

Study locations

22 sites
  • Children's Hospital of Alabama
    Birmingham, Alabama 35233, United States
  • Children's Hospital Los Angeles
    Los Angeles, California 90027, United States
  • Children's Hospital of Orange County
    Orange, California 92868, United States
  • UCSF Medical Center-Parnassus
    San Francisco, California 94143, United States
  • UCSF Medical Center-Mission Bay
    San Francisco, California 94158, United States
  • Children's Hospital Colorado
    Aurora, Colorado 80045, United States
  • Children's National Medical Center
    Washington, District of Columbia 20010, United States
  • Children's Healthcare of Atlanta - Egleston
    Atlanta, Georgia 30322, United States
  • Lurie Children's Hospital-Chicago
    Chicago, Illinois 60611, United States
  • Riley Hospital for Children
    Indianapolis, Indiana 46202, United States
  • C S Mott Children's Hospital
    Ann Arbor, Michigan 48109, United States
  • University of Minnesota/Masonic Cancer Center
    Minneapolis, Minnesota 55455, United States
  • Washington University School of Medicine
    Saint Louis, Missouri 63110, United States
  • NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
    New York, New York 10032, United States
  • Cincinnati Children's Hospital Medical Center
    Cincinnati, Ohio 45229, United States
  • Oregon Health and Science University
    Portland, Oregon 97239, United States
  • Children's Hospital of Philadelphia
    Philadelphia, Pennsylvania 19104, United States
  • Children's Hospital of Pittsburgh of UPMC
    Pittsburgh, Pennsylvania 15224, United States
  • St. Jude Children's Research Hospital
    Memphis, Tennessee 38105, United States
  • Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
    Houston, Texas 77030, United States
  • Seattle Children's Hospital
    Seattle, Washington 98105, United States
  • Children's Hospital of Wisconsin
    Milwaukee, Wisconsin 53226, United States
09

References and documents

Publications

  • Schafer ES, Rau RE, Berg SL, Liu X, Minard CG, Bishop AJR, Romero JC, Hicks MJ, Nelson MD Jr, Voss S, Reid JM, Fox E, Weigel BJ, Blaney SM. Phase 1/2 trial of talazoparib in combination with temozolomide in children and adolescents with refractory/recurrent solid tumors including Ewing sarcoma: A Children's Oncology Group Phase 1 Consortium study (ADVL1411). Pediatr Blood Cancer. 2020 Feb;67(2):e28073. doi: 10.1002/pbc.28073. Epub 2019 Nov 14. PubMed 31724813 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 26, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02116777
Lead sponsor
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Apr 17, 2014
Start date
May 16, 2014
Primary completion
Dec 31, 2018
Completion
Dec 31, 2018
Results posted
Mar 26, 2021
Last update
Mar 26, 2021

Study contacts

Eric S Schafer
principal investigator · COG Phase I Consortium

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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