A Phase 1/2 interventional study of Bendamustine Hydrochloride and Pharmacological Study in Adult B Acute Lymphoblastic Leukemia, Adult Nasal Type Extranodal NK/T-Cell Lymphoma and Adult Solid Neoplasm, sponsored by National Cancer Institute (NCI). Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-12-16.
Sponsored by National Cancer Institute (NCI) · Phase 1/2, Interventional, and Treatment
Among 112 studies in Burkitt Lymphoma by National Cancer Institute (NCI) — 9 open to participants now, 17 under way, 4 of them phase 3. Burkitt Lymphoma · National Cancer Institute (NCI).
Among the 112 studies in Burkitt Lymphoma by National Cancer Institute (NCI), this one is the 51st largest by enrollment of the 100 interventional ones that give a count, is one of 2 that started in 2011, is one of 7 in phase 1/2, and was the 84th registered.
976 studies on the registry are indexed under Burkitt Lymphoma; 159 are open to participants now.
Browse Burkitt Lymphoma studies →9 of the 112 studies in Burkitt Lymphoma by National Cancer Institute (NCI) are open now, in 4 countries. Recruiting first, the newest first:
National Cancer Institute (NCI) · Sites in United States
Ages 18+
National Cancer Institute (NCI) · Sites in United States, Puerto Rico
Ages up to 365 days
National Cancer Institute (NCI) · Sites in United States, Australia, Canada and 1 more country
Ages 366 days–46 yrs
National Cancer Institute (NCI) · Sites in United States
Ages 18–120
National Cancer Institute (NCI) · Sites in United States
Ages 3–39
By country, each count listing its studies:
Of the 128 Burkitt Lymphoma studies recruiting now, 38 (30%) set no upper age limit and 77 (60%) stop at 75 or younger; 75 take children under 18; 2 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
112 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 74 · Phase 2 35 · Phase 3 7
First in 1989; this study’s year is marked. 2 started in 2011.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 43 is above the median of 36 across 765 interventional studies indexed under Burkitt Lymphoma.
Median enrollment 44 across the 100 interventional studies, 2,500 across the 2 observational. Of the 95 that completed or were terminated, 16 (17%) have results posted.
This tab as a report to print or save as PDF → With an account.
National Cancer Institute (NCI) is the lead sponsor of 3,556 studies on the registry; 336 are open to participants now.
Of its 412 completed or terminated interventional studies of FDA-regulated products, 374 (91%) have results posted.
4 of the studies in Burkitt Lymphoma by National Cancer Institute (NCI) that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03914625Phase 3National Cancer Institute (NCI)A Study to Investigate Blinatumomab in Combination With Chemotherapy in Patients With Newly Diagnosed B-Lymphoblastic Leukemia | 2027-09-30 |
| NCT03739814National Cancer Institute (NCI)Inotuzumab Ozogamicin and Blinatumomab With or Without Ponatinib in Treating Patients With Newly Diagnosed, Recurrent, or Refractory CD22-Positive B-Lineage Acute Lymphoblastic Leukemia | 2027-02-01 |
| NCT05442515National Cancer Institute (NCI)CD19/CD22 Bicistronic Chimeric Antigen Receptor (CAR) T Cells in Children and Young Adults With Recurrent or Refractory B Cell Malignancies | 2027-07-01 |
| NCT03223610National Cancer Institute (NCI)Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Revlimid (ViPOR) in Relapsed/Refractory B-cell Lymphoma | 2027-08-12 |
Add all 4 to your calendar (.ics) → With an account.
Among the 112 studies in Burkitt Lymphoma by National Cancer Institute (NCI), from their registry updates:
This tab as a report to print or save as PDF → With an account.
This phase I/II trial studies the side effects and the best dose of veliparib when given together with bendamustine hydrochloride and rituximab and to see how well they work in treating patients with lymphoma, multiple myeloma, or solid tumors that have come back or have not responded to treatment. Veliparib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as bendamustine hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some find cancer cells and help kill them or carry cancer-killing substances to them. Others interfere with the ability of cancer cells to grow and spread. Giving veliparib together with bendamustine hydrochloride and rituximab may kill more cancer cells.
PRIMARY OBJECTIVES:
I. To determine the maximum-tolerated dose (MTD) of ABT-888 (veliparib) in combination with bendamustine (bendamustine hydrochloride) in patients with solid tumors, lymphoma, or multiple myeloma. (Phase Ib) II. To establish the safety of ABT-888 in combination with bendamustine and rituximab in an expansion cohort of patients with non-Hodgkin lymphoma (NHL). (Phase Ib) III. To assess the toxicity profile of this regimen in the above patients. (Phase Ib) IV. To determine the complete response (CR) rate in patients with indolent NHL or mantle cell lymphoma (MCL) treated with ABT-888 + bendamustine + rituximab. (Phase IIa)
SECONDARY OBJECTIVES:
I. To assess response rates and survival parameters of patients treated with ABT-888 + bendamustine +/- rituximab. (Phase Ib) II. To assess pharmacokinetic parameters of ABT-888 in this regimen. (Phase Ib) III. To assess progression-free survival, overall survival, and duration of remission of patients with indolent NHL and MCL treated with ABT-888 + bendamustine + rituximab. (Phase IIa)
OUTLINE: This is a phase I, dose-escalation study of veliparib followed by a phase II study.
Patients receive veliparib orally (PO) twice daily (BID) on days 1-7 and bendamustine hydrochloride intravenously (IV) over 30-60 minutes on days 1-2. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Once the maximum-tolerated dose is determined, a cohort of patients receives veliparib and bendamustine hydrochloride as above and rituximab IV on day 1. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 30 days.
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.
Exclusion Criteria:
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.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
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.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
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.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
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.
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.
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).
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.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
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.
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.
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.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
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.
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.
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.
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.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CD4 count
The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients receive veliparib PO BID on days 1-7 and bendamustine hydrochloride IV over 30-60 minutes on days 1-2. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Once the maximum-tolerated dose is determined, a cohort of patients receives veliparib and bendamustine hydrochloride as above and rituximab IV on day 1. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Drug: Bendamustine Hydrochloride · Other: Pharmacological Study · Biological: Rituximab · Drug: Veliparib
Given IV
Also known as: Bendamustin Hydrochloride, Cytostasan Hydrochloride, Levact, Ribomustin, SyB L-0501, Treanda
Correlative studies
Given IV
Also known as: BI 695500, C2B8 Monoclonal Antibody, Chimeric Anti-CD20 Antibody, IDEC-102, IDEC-C2B8, IDEC-C2B8 Monoclonal Antibody, MabThera, Monoclonal Antibody IDEC-C2B8, PF-05280586, Rituxan, Rituximab Biosimilar BI 695500, Rituximab Biosimilar PF-05280586, Rituximab Biosimilar RTXM83, RTXM83
Given PO
Also known as: ABT-888, PARP-1 inhibitor ABT-888
Maximum Tolerated Dose of Veliparib When Combined With Bendamustine Hydrochloride
Maximum Tolerated Dose (MTD) reflects the highest dose of Veliparib when combined with Bendamustine Hydrochloride that did not cause a DLT. The maximum tolerated dose (MTD) was defined as the highest dose level at which 33% of patients experienced DLT.
Time frame: 28 days
Response Rate
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI and/or CT: Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for a Partial Response nor sufficient increase to qualify for Progression of Disease (POD); POD, 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Complete Response (CR), Disappearance of all target lesions.
Time frame: 2 years
Number of Participants With Adverse Events
Adverse events assessed by NCI CTCAE version 4.0 (Phase Ib) See adverse events section.
Time frame: 2 years
Complete Response (CR) to Study Treatment (Phase IIa)
Summary statistics will be used for CR. Responses will be evaluated by the International Uniform Response Criteria for Multiple Myeloma.
Time frame: 2 years
Duration of Remission (Phase IIa)
Time frame: From the first documented response to the first documented progression or death, assessed up to 30 days post-treatment
Overall Survival (Phase IIa)
Kaplan-Meier estimates will be calculated and log-rank tests will be employed when certain comparisons are needed.
Time frame: Up to 30 days post-treatment
Pharmacokinetic Parameters of Veliparib (Phase Ib)
Area Under the Curve from time zero to 12 hours following Veliparib administration
Time frame: From time zero to 12 hours on day 2 of course 1
Progression-free Survival Using RECIST Version 1.1 (Phase IIa)
Kaplan-Meier estimates will be calculated and log-rank tests will be employed when certain comparisons are needed. Changes in the largest diameter (unidimensional measurement) of the tumor lesions and the shortest diameter in the case of malignant lymph nodes are used in the RECIST criteria.
Time frame: 2 years
Participants With Dose Limiting Toxicities
Time frame: 28 days
| Milestone | Dose Level 1-Bendamustine 70 mg/m2, ABT-888 50 mg | Dose Level 2: Bendamustine 90 mg/m2, ABT-888 50 mg | Dose Level 3: Bendamustine 90 mg/m2, ABT-888 100 mg BID | Dose Level 4: Bendamustine 90 mg/m2, ABT-888 150 mg BID | Dose Level 5: Bendamustine 90 mg/m2, ABT-888 200 mg BID | Dose Level 6: Bendamustine 90 mg/m2, ABT-888 300 mg BID | Dose Level 7: Bendamustine 90 mg/m2, ABT-888 400 mg BID |
|---|---|---|---|---|---|---|---|
| Started | 3 | 3 | 6 | 4 | 5 | 15 | 7 |
| Completed | 1 | 1 | 1 | 1 | 1 | 7 | 0 |
| Not completed | 2 | 2 | 5 | 3 | 4 | 8 | 7 |
| Withdrew: Other | 1 | 0 | 0 | 0 | 0 | 1 | 0 |
| Withdrew: Progressive disease | 1 | 1 | 3 | 1 | 3 | 2 | 3 |
| Withdrew: Death | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Adverse event | 0 | 0 | 1 | 1 | 0 | 3 | 1 |
| Withdrew: Withdrawal by subject | 0 | 0 | 1 | 0 | 1 | 1 | 3 |
| Withdrew: Not treated | 0 | 0 | 0 | 1 | 0 | 1 | 0 |
Maximum Tolerated Dose (MTD) reflects the highest dose of Veliparib when combined with Bendamustine Hydrochloride that did not cause a DLT. The maximum tolerated dose (MTD) was defined as the highest dose level at which 33% of patients experienced DLT.
| mg | All Study Participants |
|---|---|
| Maximum Tolerated Dose of Veliparib When Combined With Bendamustine Hydrochloride | 300 |
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI and/or CT: Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for a Partial Response nor sufficient increase to qualify for Progression of Disease (POD); POD, 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Complete Response (CR), Disappearance of all target lesions.
| Participants | Dose Level 1-Bendamustine 70 mg/m2, ABT-888 50 mg | Dose Level 2: Bendamustine 90 mg/m2, ABT-888 50 mg | Dose Level 3: Bendamustine 90 mg/m2, ABT-888 100 mg BID | Dose Level 4: Bendamustine 90 mg/m2, ABT-888 150 mg BID | Dose Level 5: Bendamustine 90 mg/m2, ABT-888 200 mg BID | Dose Level 6: Bendamustine 90 mg/m2, ABT-888 300 mg BID | Dose Level 7: Bendamustine 90 mg/m2, ABT-888 400 mg BID |
|---|---|---|---|---|---|---|---|
| Complete Response | 0 | 0 | 1 | 0 | 0 | 4 | 0 |
| Partial Response | 1 | 1 | 0 | 0 | 1 | 4 | 0 |
| Stable Disease | 1 | 2 | 2 | 2 | 0 | 5 | 0 |
| Progression of Disease | 1 | 0 | 2 | 0 | 2 | 1 | 2 |
Adverse events assessed by NCI CTCAE version 4.0 (Phase Ib) See adverse events section.
| participants | Dose Level 1-Bendamustine 70 mg/m2, ABT-888 50 mg | Dose Level 2: Bendamustine 90 mg/m2, ABT-888 50 mg | Dose Level 3: Bendamustine 90 mg/m2, ABT-888 100 mg BID | Dose Level 4: Bendamustine 90 mg/m2, ABT-888 150 mg BID | Dose Level 5: Bendamustine 90 mg/m2, ABT-888 200 mg BID | Dose Level 6: Bendamustine 90 mg/m2, ABT-888 300 mg BID | Dose Level 7: Bendamustine 90 mg/m2, ABT-888 400 mg BID |
|---|---|---|---|---|---|---|---|
| Number of Participants With Adverse Events | 3 | 3 | 4 | 2 | 2 | 5 | 3 |
Summary statistics will be used for CR. Responses will be evaluated by the International Uniform Response Criteria for Multiple Myeloma.
| Participants | All Study Participants |
|---|---|
| Complete Response (CR) to Study Treatment (Phase IIa) | 5 |
No measurements were reported for this outcome.
Kaplan-Meier estimates will be calculated and log-rank tests will be employed when certain comparisons are needed.
No measurements were reported for this outcome.
Area Under the Curve from time zero to 12 hours following Veliparib administration
| μg*h/mL | Dose Level 1-Bendamustine 70 mg/m2, ABT-888 50 mg | Dose Level 2: Bendamustine 90 mg/m2, ABT-888 50 mg | Dose Level 3: Bendamustine 90 mg/m2, ABT-888 100 mg BID | Dose Level 4: Bendamustine 90 mg/m2, ABT-888 150 mg BID | Dose Level 5: Bendamustine 90 mg/m2, ABT-888 200 mg BID | Dose Level 6: Bendamustine 90 mg/m2, ABT-888 300 mg BID | Dose Level 7: Bendamustine 90 mg/m2, ABT-888 400 mg BID |
|---|---|---|---|---|---|---|---|
| Pharmacokinetic Parameters of Veliparib (Phase Ib) | 1.79 ± 0.41 | 3.58 ± 0.93 | 7.93 ± 1.90 | 12.6 ± 3.8 | 16.9 ± 11.1 | 19.0 ± 10.5 | 25.0 ± 14.6 |
Kaplan-Meier estimates will be calculated and log-rank tests will be employed when certain comparisons are needed. Changes in the largest diameter (unidimensional measurement) of the tumor lesions and the shortest diameter in the case of malignant lymph nodes are used in the RECIST criteria.
| Months | All Study Participants |
|---|---|
| Progression-free Survival Using RECIST Version 1.1 (Phase IIa) | 14.2 (2 to 20.1) |
| participants | Dose Level 1-Bendamustine 70 mg/m2, ABT-888 50 mg | Dose Level 2: Bendamustine 90 mg/m2, ABT-888 50 mg | Dose Level 3: Bendamustine 90 mg/m2, ABT-888 100 mg BID | Dose Level 4: Bendamustine 90 mg/m2, ABT-888 150 mg BID | Dose Level 5: Bendamustine 90 mg/m2, ABT-888 200 mg BID | Dose Level 6: Bendamustine 90 mg/m2, ABT-888 300 mg BID | Dose Level 7: Bendamustine 90 mg/m2, ABT-888 400 mg BID |
|---|---|---|---|---|---|---|---|
| Participants With Dose Limiting Toxicities | 0 | 0 | 1 | 0 | 0 | 1 | 2 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Dose Level 1: Bendamustine 70 mg/m2, ABT-888 50 mg | 0/3 (0%) | 1/3 (33.3%) | 2/3 (66.7%) |
| Dose Level 2: Bendamustine 90 mg/m2, ABT-888 50 mg | 1/3 (33.3%) | 3/3 (100%) | 1/3 (33.3%) |
| Dose Level 3: Bendamustine 90 mg/m2, ABT-888 100 mg BID | 0/6 (0%) | 3/6 (50%) | 1/6 (16.7%) |
| Dose Level 4: Bendamustine 90 mg/m2, ABT-888 150 mg BID | 0/4 (0%) | 2/4 (50%) | 0/4 (0%) |
| Dose Level 5: Bendamustine 90 mg/m2, ABT-888 200 mg BID | 0/5 (0%) | 2/5 (40%) | 0/5 (0%) |
| Dose Level 6: Bendamustine 90 mg/m2, ABT-888 300 mg BID | 0/15 (0%) | 5/15 (33.3%) | 0/15 (0%) |
| Dose Level 7: Bendamustine 90 mg/m2, ABT-888 400 mg BID | 0/7 (0%) | 3/7 (42.9%) | 0/7 (0%) |
| Event | Dose Level 1: Bendamustine 70 mg/m2, ABT-888 50 mg | Dose Level 2: Bendamustine 90 mg/m2, ABT-888 50 mg | Dose Level 3: Bendamustine 90 mg/m2, ABT-888 100 mg BID | Dose Level 4: Bendamustine 90 mg/m2, ABT-888 150 mg BID | Dose Level 5: Bendamustine 90 mg/m2, ABT-888 200 mg BID | Dose Level 6: Bendamustine 90 mg/m2, ABT-888 300 mg BID | Dose Level 7: Bendamustine 90 mg/m2, ABT-888 400 mg BID |
|---|---|---|---|---|---|---|---|
| HematuriaRenal and urinary disorders | 1/3 | 1/3 | 0/6 | 0/4 | 0/5 | 0/15 | 0/7 |
| AnemiaBlood and lymphatic system disorders | 0/3 | 1/3 | 1/6 | 0/4 | 0/5 | 0/15 | 0/7 |
| Back painMusculoskeletal and connective tissue disorders | 0/3 | 1/3 | 0/6 | 0/4 | 0/5 | 0/15 | 0/7 |
| SepsisInfections and infestations | 0/3 | 1/3 | 0/6 | 0/4 | 0/5 | 1/15 | 1/7 |
| Abdominal painMusculoskeletal and connective tissue disorders | 0/3 | 1/3 | 0/6 | 1/4 | 0/5 | 0/15 | 0/7 |
| Duodenal hemorrhageGastrointestinal disorders | 0/3 | 1/3 | 0/6 | 0/4 | 0/5 | 0/15 | 0/7 |
| Gastric hemorrhageGastrointestinal disorders | 0/3 | 1/3 | 0/6 | 0/4 | 0/5 | 0/15 | 0/7 |
| Lung InfectionInfections and infestations | 0/3 | 0/3 | 1/6 | 1/4 | 0/5 | 0/15 | 0/7 |
| Abdominal InfectionInfections and infestations | 0/3 | 0/3 | 0/6 | 1/4 | 0/5 | 0/15 | 0/7 |
| FatigueGeneral disorders | 0/3 | 0/3 | 0/6 | 0/4 | 1/5 | 0/15 | 0/7 |
| Event | Dose Level 1: Bendamustine 70 mg/m2, ABT-888 50 mg | Dose Level 2: Bendamustine 90 mg/m2, ABT-888 50 mg | Dose Level 3: Bendamustine 90 mg/m2, ABT-888 100 mg BID | Dose Level 4: Bendamustine 90 mg/m2, ABT-888 150 mg BID | Dose Level 5: Bendamustine 90 mg/m2, ABT-888 200 mg BID | Dose Level 6: Bendamustine 90 mg/m2, ABT-888 300 mg BID | Dose Level 7: Bendamustine 90 mg/m2, ABT-888 400 mg BID |
|---|---|---|---|---|---|---|---|
| Lymphocyte count decreasedInvestigations | 2/3 | 1/3 | 1/6 | 0/4 | 0/5 | 0/15 | 0/7 |
| AnemiaBlood and lymphatic system disorders | 1/3 | 1/3 | 0/6 | 0/4 | 0/5 | 0/15 | 0/7 |
| DiarrheaGastrointestinal disorders | 1/3 | 0/3 | 0/6 | 0/4 | 0/5 | 0/15 | 0/7 |
| FatigueGeneral disorders | 1/3 | 0/3 | 0/6 | 0/4 | 0/5 | 0/15 | 0/7 |
| HematuriaRenal and urinary disorders | 1/3 | 0/3 | 0/6 | 0/4 | 0/5 | 0/15 | 0/7 |
| HypoalbuminemiaMetabolism and nutrition disorders | 0/3 | 1/3 | 0/6 | 0/4 | 0/5 | 0/15 | 0/7 |
| HypocalcemiaMetabolism and nutrition disorders | 1/3 | 0/3 | 0/6 | 0/4 | 0/5 | 0/15 | 0/7 |
| HypophosphatemiaMetabolism and nutrition disorders | 1/3 | 0/3 | 0/6 | 0/4 | 0/5 | 0/15 | 0/7 |
| NauseaGastrointestinal disorders | 0/3 | 1/3 | 0/6 | 0/4 | 0/5 | 0/15 | 0/7 |
| Platelet count decreasedInvestigations | 1/3 | 0/3 | 0/6 | 0/4 | 0/5 | 0/15 | 0/7 |
| Age, Categorical(Participants) | Dose Level 1: Bendamustine 70 mg/m2, ABT-888 50 mg | Dose Level 2: Bendamustine 90 mg/m2, ABT-888 50 mg | Dose Level 3: Bendamustine 90 mg/m2, ABT-888 100 mg BID | Dose Level 4: Bendamustine 90 mg/m2, ABT-888 150 mg BID | Dose Level 5: Bendamustine 90 mg/m2, ABT-888 200 mg BID | Dose Level 6: Bendamustine 90 mg/m2, ABT-888 300 mg BID | Dose Level 7: Bendamustine 90 mg/m2, ABT-888 400 mg BID | Total |
|---|---|---|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 1 | 1 | 4 | 4 | 1 | 8 | 3 | 22 |
| >=65 years | 2 | 2 | 2 | 0 | 4 | 7 | 4 | 21 |
| Sex: Female, Male(Participants) | Dose Level 1: Bendamustine 70 mg/m2, ABT-888 50 mg | Dose Level 2: Bendamustine 90 mg/m2, ABT-888 50 mg | Dose Level 3: Bendamustine 90 mg/m2, ABT-888 100 mg BID | Dose Level 4: Bendamustine 90 mg/m2, ABT-888 150 mg BID | Dose Level 5: Bendamustine 90 mg/m2, ABT-888 200 mg BID | Dose Level 6: Bendamustine 90 mg/m2, ABT-888 300 mg BID | Dose Level 7: Bendamustine 90 mg/m2, ABT-888 400 mg BID | Total |
|---|---|---|---|---|---|---|---|---|
| Female | 1 | 2 | 5 | 2 | 2 | 8 | 6 | 26 |
| Male | 2 | 1 | 1 | 2 | 3 | 7 | 1 | 17 |
| Region of Enrollment(participants) | Dose Level 1: Bendamustine 70 mg/m2, ABT-888 50 mg | Dose Level 2: Bendamustine 90 mg/m2, ABT-888 50 mg | Dose Level 3: Bendamustine 90 mg/m2, ABT-888 100 mg BID | Dose Level 4: Bendamustine 90 mg/m2, ABT-888 150 mg BID | Dose Level 5: Bendamustine 90 mg/m2, ABT-888 200 mg BID | Dose Level 6: Bendamustine 90 mg/m2, ABT-888 300 mg BID | Dose Level 7: Bendamustine 90 mg/m2, ABT-888 400 mg BID | Total |
|---|---|---|---|---|---|---|---|---|
| United States | 3 | 3 | 6 | 4 | 5 | 15 | 7 | 43 |
The record gives a start of Jul 2011, a primary completion of Apr 2015 and a completion of Apr 2015. It does not say whether these dates are actual or estimated.
Results were first posted in Dec 2019, 4 years 8 months after primary completion.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: Veliparib
National Cancer Institute (NCI) →