A Phase 1/2 interventional study of Onvansertib and Cytarabine in Acute Myeloid Leukemia, sponsored by Cardiff Oncology. Completed at 9 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-02-27.
Sponsored by Cardiff Oncology · Phase 1/2, Interventional, and Treatment
The purpose of the phase 1b/2 study is to determine whether Onvansertib given orally daily for 5 consecutive days every 28 days is safe and tolerable in adult patients who have relapsed/refractory Acute Myeloid Leukemia (AML), or are ineligible for intensive induction therapy, and to determine the maximum tolerated dose and recommended phase 2 dose of Onvansertib in combination with decitabine or Onvansertib in combination with low-dose cytarabine. In the phase 2 portion of the study, Onvansertib in combination with decitabine will be studied to provide further data on the safety profile of the combination and to preliminarily assess the activity of the chosen combination in patients with untreated AML who are not candidates for aggressive induction therapy, or who have received one prior treatment for their AML.
3,667 studies on the registry are indexed under Leukemia, Myeloid, Acute; 816 are open to participants now.
This study's enrollment of 72 is above the median of 40 across 3,005 interventional studies indexed under Leukemia, Myeloid, Acute.
Browse Leukemia, Myeloid, Acute studies →Cardiff Oncology is the lead sponsor of 7 studies on the registry; none are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Disease Status and Prior Therapy:
i. Participants with AML who are refractory to, or have relapsed after, initial treatment for their disease, with no more than one prior line of therapy, and are judged not to be candidates for re-induction therapy that includes hematopoietic cell transplantation. Participants who have received prior cytarabine or decitabine are not excluded.
OR
ii. Participants with newly diagnosed, untreated AML ineligible for, or who have refused, standard intensive induction therapy
All men and women must agree to practice effective during the entire study period and after discontinuing study drug, unless documentation of infertility exists
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.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
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.
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.
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.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
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.
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.
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.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
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.
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.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
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.
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.
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.
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.
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.
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.
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.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Onvansertib, administered in escalating doses orally Day 1 through Day 5 every 28 days (1 cycle) in combination with cytarabine, which will be administered in all cohorts as 20 mg/m\^2 subcutaneously, once daily on Day 1 through Day 10 every 28 days (1 cycle). Onvansertib administration, in combination with cytarabine, will be initiated at a starting dose of 12 mg/m\^2 orally, daily for 5 days. Onvansertib dose will be escalated in successive cohorts until the recommended phase 2 dose is achieved.
Drug: Onvansertib · Drug: Cytarabine
Onvansertib will be administered in escalating doses orally, Day 1 through Day 5 every 28 days (1 cycle) in combination with decitabine, administered consistently in all cohorts as 20 mg/m\^2 intravenously over 1 hour on Day 1 through Day 5 every 28 days (1 cycle). Onvansertib administration, in combination with decitabine, will be initiated at a starting dose of 12 mg/m\^2 orally, daily for 5 days (Day 1 through Day 5). Onvansertib dose will be escalated in successive cohorts until the recommended phase 2 dose is achieved.
Drug: Onvansertib · Drug: Decitabine
Onvansertib recommended phase 2 dose, orally Day 1 through Day 5 every 28 days (1 cycle) and decitabine, administered consistently as 20 mg/m\^2 intravenously over 1 hour on Day 1 through Day 5 every 28 days (1 cycle), with treatment modifications or delays based on return of hematopoietic function to baseline or Grade ≤1 toxicity for optimal subject management.
Drug: Onvansertib · Drug: Decitabine
Onvansertib orally
subcutaneously
intravenously
Number of Participants Who Experienced Dose Limiting Toxicities (DLT)
Dose-limiting toxicities were defined as events related to onvansertib that were considered an adverse reaction or suspected adverse reaction during the first cycle of therapy and that fulfilled one of the following: Hematologic (persistent pancytopenia resistant to current standards of care that continues for ≥42 days and is not related to leukemic infiltration or another cause unrelated to study therapy) or Non-Hematologic (any Grade 3 abnormalities that persist \>7 days without decreasing in severity despite standards of care, are clinically significant, or that are Grade 4 and symptomatic).
Time frame: Up to Day 28 of Cycle 1
Number of Participants With Change From Baseline in Eastern Co-operative Oncology Group (ECOG) Performance Status
ECOG performance status was determined using 6-point scale from 0-5, with 0 meaning a participant was fully active/able to carry on all pre-disease activities without restriction and 5 meaning the participant was deceased.
Time frame: Baseline and end of study (approximately up to up to 27 months)
Phase 2: Number of Participants Who Achieved a Complete Response (CR)
Complete Response also includes Complete Response with Incomplete Blood Count Recovery (CRi). Complete response is defined by the following criteria: Morphologic leukemia-free state plus: * Subject is independent of transfusions * Absolute neutrophil count of \>1000/mm3 * Platelets of ≥100,000/mm3 Complete response with incomplete blood count recovery meets all criteria for CR except for either neutropenia (ANC \<1000/mm3) or thrombocytopenia (\<100,000/mm3) but must include transfusion independence.
Time frame: Up to 27 months
Number of Participants With Adverse Events (AEs)
Any clinically significant change in electrocardiogram (ECG), physical examination findings, body weight, vital signs, and laboratory parameters were recorded as Adverse Events.
Time frame: Baseline up to 30 days after last dose of study drug (up to 27 months)
Phase 2: Number of Participants Who Achieved a Morphologic Leukemia-free (MLF) State
Defined as bone marrow (BM) \<5% blasts in an aspirate with spicules and no blasts with Auer rods or persistence of extramedullary disease.
Time frame: Up to 27 months
Phase 2: Number of Participants With Partial Response (PR)
PR criteria includes all of the hematologic values for a CR but with a decrease of at least 50% in the percentage of blasts to 5% to 25% in the bone marrow aspirate and a normalization of blood counts.
Time frame: Up to 27 months
Phase 2: Duration of Response (DOR)
Duration of Response (DOR) is the time (in months) from the first response of CR, CRi or PR until recurrence of or progression of disease (or death). MLF State is also included as a response when calculating DOR. Responding subjects without death or progression will be censored at the date of their last evaluable disease assessment.
Time frame: Up to 27 months
Phase 2: Event-free Survival (EFS)
EFS is defined as the time from enrollment until disease progression or death from any cause and reported as the proportion of participants event free at 12 months.
Time frame: 12 Months
Phase 2: Overall Survival (OS)
OS is defined as the time from enrollment until death from any cause and reported as the proportion of participants alive at 12 months.
Time frame: 12 Months
Pharmacokinetic Parameter: Maximum Observed Plasma Concentration (Cmax) for Onvansertib
Time frame: Cycle 1: Days 1 and 5
Pharmacokinetic Parameter: Time to Reach the Maximum Observed Plasma Concentration (Tmax) for Onvansertib
Time frame: Cycle 1: Days 1 and 5
Pharmacokinetic Parameter: Area Under the Curve Over the First 24 Hours AUC(0-24) for Onvansertib
Time frame: Cycle 1: Days 1 and 5
Pharmacokinetic Parameter: Plasma Terminal Elimination Half-life (t1/2) for Onvansertib
Time frame: Cycle 1: Days 1 and 5
72 participants were enrolled across 8 sites in the United States.
| Milestone | Phase 1b: Onvansertib 12 mg/m^2 + Low-dose Cytarabine | Phase 1b: Onvansertib 18 mg/m^2 + Low-dose Cytarabine | Phase 1b: Onvansertib 27 mg/m^2 + Low-dose Cytarabine | Phase 1b: Onvansertib 40 mg/m^2 + Low-dose Cytarabine | Phase 1b: Onvansertib 60 mg/m^2 + Low-dose Cytarabine | Phase 1b: Onvansertib 12 mg/m^2 + Decitabine | Phase 1b: Onvansertib 18 mg/m^2 + Decitabine | Phase 1b: Onvansertib 27 mg/m^2 + Decitabine | Phase 1b: Onvansertib 40 mg/m^2 + Decitabine | Phase 1b: Onvansertib 60 mg/m^2 + Decitabine | Phase 1b: Onvansertib 90 mg/m^2 + Decitabine | Phase 2: Onvansertib 60 mg/m^2 + Decitabine |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Started | 3 | 3 | 3 | 3 | 5 | 4 | 3 | 3 | 4 | 3 | 6 | 32 |
| Completed | 0 | 1 | 1 | 2 | 0 | 1 | 0 | 1 | 0 | 0 | 1 | 4 |
| Not completed | 3 | 2 | 2 | 1 | 5 | 3 | 3 | 2 | 4 | 3 | 5 | 28 |
| Withdrew: Death | 2 | 2 | 2 | 1 | 4 | 2 | 2 | 2 | 3 | 3 | 4 | 24 |
| Withdrew: Study terminated by sponsor | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 1 |
| Withdrew: Withdrawal by subject | 1 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 2 |
| Withdrew: Physician decision | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Safety/non-compliance | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
Dose-limiting toxicities were defined as events related to onvansertib that were considered an adverse reaction or suspected adverse reaction during the first cycle of therapy and that fulfilled one of the following: Hematologic (persistent pancytopenia resistant to current standards of care that continues for ≥42 days and is not related to leukemic infiltration or another cause unrelated to study therapy) or Non-Hematologic (any Grade 3 abnormalities that persist \>7 days without decreasing in severity despite standards of care, are clinically significant, or that are Grade 4 and symptomatic).
| Participants | Phase 1b: Onvansertib 12 mg/m^2 + Low-dose Cytarabine | Phase 1b: Onvansertib 18 mg/m^2 + Low-dose Cytarabine | Phase 1b: Onvansertib 27 mg/m^2 + Low-dose Cytarabine | Phase 1b: Onvansertib 40 mg/m^2 + Low-dose Cytarabine | Phase 1b: Onvansertib 60 mg/m^2 + Low-dose Cytarabine | Phase 1b: Onvansertib 12 mg/m^2 + Decitabine | Phase 1b: Onvansertib 18 mg/m^2 + Decitabine | Phase 1b: Onvansertib 27 mg/m^2 + Decitabine | Phase 1b: Onvansertib 40 mg/m^2 + Decitabine | Phase 1b: Onvansertib 60 mg/m^2 + Decitabine | Phase 1b: Onvansertib 90 mg/m^2 + Decitabine |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Number of Participants Who Experienced Dose Limiting Toxicities (DLT) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 |
ECOG performance status was determined using 6-point scale from 0-5, with 0 meaning a participant was fully active/able to carry on all pre-disease activities without restriction and 5 meaning the participant was deceased.
| Participants | Phase 1b: Onvansertib + Low-dose Cytarabine | Phase 1b: Onvansertib + Decitabine | Phase 2: Onvansertib + Decitabine |
|---|---|---|---|
| Number of Participants With Change From Baseline in Eastern Co-operative Oncology Group (ECOG) Performance Status | 11 | 14 | 22 |
Complete Response also includes Complete Response with Incomplete Blood Count Recovery (CRi). Complete response is defined by the following criteria: Morphologic leukemia-free state plus: * Subject is independent of transfusions * Absolute neutrophil count of \>1000/mm3 * Platelets of ≥100,000/mm3 Complete response with incomplete blood count recovery meets all criteria for CR except for either neutropenia (ANC \<1000/mm3) or thrombocytopenia (\<100,000/mm3) but must include transfusion independence.
| Participants | Phase 2: Onvansertib + Decitabine |
|---|---|
| Phase 2: Number of Participants Who Achieved a Complete Response (CR) | 3 |
Any clinically significant change in electrocardiogram (ECG), physical examination findings, body weight, vital signs, and laboratory parameters were recorded as Adverse Events.
| Participants | Phase 1b: Onvansertib 12 mg/m^2 + Low-dose Cytarabine | Phase 1b: Onvansertib 18 mg/m^2 + Low-dose Cytarabine | Phase 1b: Onvansertib 27 mg/m^2 + Low-dose Cytarabine | Phase 1b: Onvansertib 40 mg/m^2 + Low-dose Cytarabine | Phase 1b: Onvansertib 60 mg/m^2 + Low-dose Cytarabine | Phase 1b: Onvansertib 12 mg/m^2 + Decitabine | Phase 1b: Onvansertib 18 mg/m^2 + Decitabine | Phase 1b: Onvansertib 27 mg/m^2 + Decitabine | Phase 1b: Onvansertib 40 mg/m^2 + Decitabine | Phase 1b: Onvansertib 60 mg/m^2 + Decitabine | Phase 1b: Onvansertib 90 mg/m^2 + Decitabine | Phase 2: Onvansertib 60 mg/m^2 + Decitabine |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Any Adverse Events | 3 | 3 | 3 | 3 | 5 | 4 | 3 | 3 | 4 | 3 | 6 | 32 |
| Any Serious Adverse Events | 2 | 3 | 1 | 2 | 3 | 2 | 3 | 3 | 4 | 2 | 5 | 27 |
| Any Treatment-Related Serious Adverse Events | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 1 | 3 | 5 |
Defined as bone marrow (BM) \<5% blasts in an aspirate with spicules and no blasts with Auer rods or persistence of extramedullary disease.
| Participants | Phase 2: Onvansertib + Decitabine |
|---|---|
| Phase 2: Number of Participants Who Achieved a Morphologic Leukemia-free (MLF) State | 1 |
PR criteria includes all of the hematologic values for a CR but with a decrease of at least 50% in the percentage of blasts to 5% to 25% in the bone marrow aspirate and a normalization of blood counts.
| Participants | Phase 2: Onvansertib + Decitabine |
|---|---|
| Phase 2: Number of Participants With Partial Response (PR) | 0 |
Duration of Response (DOR) is the time (in months) from the first response of CR, CRi or PR until recurrence of or progression of disease (or death). MLF State is also included as a response when calculating DOR. Responding subjects without death or progression will be censored at the date of their last evaluable disease assessment.
| months | Phase 2: Onvansertib + Decitabine |
|---|---|
| Phase 2: Duration of Response (DOR) | 5.2 (0.0 to 9.1) |
EFS is defined as the time from enrollment until disease progression or death from any cause and reported as the proportion of participants event free at 12 months.
| Proportion of Participants | Phase 2: Onvansertib + Decitabine |
|---|---|
| Phase 2: Event-free Survival (EFS) | 0.1 (0.0 to 0.2) |
OS is defined as the time from enrollment until death from any cause and reported as the proportion of participants alive at 12 months.
| Proportion of Participants | Phase 2: Onvansertib + Decitabine |
|---|---|
| Phase 2: Overall Survival (OS) | 0.2 (0.1 to 0.4) |
| ng/mL | Phase 1b: Onvansertib 12 mg/m^2 + Low-dose Cytarabine | Phase 1b: Onvansertib 18 mg/m^2 + Low-dose Cytarabine | Phase 1b: Onvansertib 27 mg/m^2 + Low-dose Cytarabine | Phase 1b: Onvansertib 40 mg/m^2 + Low-dose Cytarabine | Phase 1b: Onvansertib 60 mg/m^2 + Low-dose Cytarabine | Phase 1b: Onvansertib 12 mg/m^2 + Decitabine | Phase 1b: Onvansertib 18 mg/m^2 + Decitabine | Phase 1b: Onvansertib 27 mg/m^2 + Decitabine | Phase 1b: Onvansertib 40 mg/m^2 + Decitabine | Phase 1b: Onvansertib 60 mg/m^2 + Decitabine | Phase 1b: Onvansertib 90 mg/m^2 + Decitabine | Phase 2: Onvansertib 60 mg/m^2 + Decitabine |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Cycle 1 Day 1 | 92.57 ± 5.66 | 69.56 ± 28.73 | 251.16 ± 85.37 | 256.11 ± 24.96 | 626.18 ± 61.37 | 80.15 ± 21.33 | 129.18 ± 93.78 | 309.86 ± 72.47 | 410.42 ± 26.38 | 724.76 ± 57.33 | 737.21 ± 43.06 | 515.63 ± 43.47 |
| Cycle 1 Day 5 | 139.22 ± 55.12 | 103.27 ± 43.01 | 298.63 ± 66.58 | 339.52 ± 31.25 | 857.29 ± 38.54 | 146.10 ± 56.75 | 197.67 ± 85.14 | 398.38 ± 32.95 | 496.24 ± 52.72 | 955.59 ± 54.78 | 1137.16 ± 61.56 | 861.86 ± 46.68 |
| Hours | Phase 1b: Onvansertib 12 mg/m^2 + Low-dose Cytarabine | Phase 1b: Onvansertib 18 mg/m^2 + Low-dose Cytarabine | Phase 1b: Onvansertib 27 mg/m^2 + Low-dose Cytarabine | Phase 1b: Onvansertib 40 mg/m^2 + Low-dose Cytarabine | Phase 1b: Onvansertib 60 mg/m^2 + Low-dose Cytarabine | Phase 1b: Onvansertib 12 mg/m^2 + Decitabine | Phase 1b: Onvansertib 18 mg/m^2 + Decitabine | Phase 1b: Onvansertib 27 mg/m^2 + Decitabine | Phase 1b: Onvansertib 40 mg/m^2 + Decitabine | Phase 1b: Onvansertib 60 mg/m^2 + Decitabine | Phase 1b: Onvansertib 90 mg/m^2 + Decitabine | Phase 2: Onvansertib 60 mg/m^2 + Decitabine |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Cycle 1 Day 1 | 1.961 ± 81.664 | 2.548 ± 96.282 | 2.301 ± 84.217 | 1.384 ± 103.829 | 2.071 ± 39.570 | 3.102 ± 31.792 | 2.365 ± 78.396 | 1.288 ± 41.249 | 1.373 ± 49.676 | 2.893 ± 135.893 | 2.435 ± 53.682 | 2.725 ± 69.661 |
| Cycle 1 Day 5 | 1.844 ± 62.646 | 2.892 ± 37.244 | 2.267 ± 82.486 | 1.474 ± 67.999 | 2.148 ± 55.159 | 2.438 ± 24.524 | 1.583 ± 96.305 | 3.145 ± 33.877 | 3.161 ± 41.350 | 3.161 ± 41.350 | 3.189 ± 29.775 | 2.665 ± 51.333 |
| h*ng/mL | Phase 1b: Onvansertib 12 mg/m^2 + Low-dose Cytarabine | Phase 1b: Onvansertib 18 mg/m^2 + Low-dose Cytarabine | Phase 1b: Onvansertib 27 mg/m^2 + Low-dose Cytarabine | Phase 1b: Onvansertib 40 mg/m^2 + Low-dose Cytarabine | Phase 1b: Onvansertib 60 mg/m^2 + Low-dose Cytarabine | Phase 1b: Onvansertib 12 mg/m^2 + Decitabine | Phase 1b: Onvansertib 18 mg/m^2 + Decitabine | Phase 1b: Onvansertib 27 mg/m^2 + Decitabine | Phase 1b: Onvansertib 40 mg/m^2 + Decitabine | Phase 1b: Onvansertib 60 mg/m^2 + Decitabine | Phase 1b: Onvansertib 90 mg/m^2 + Decitabine | Phase 2: Onvansertib 60 mg/m^2 + Decitabine |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Cycle 1 Day 1 | 1197.93 ± 23.42 | 772.68 ± 26.21 | 2534.22 ± 31.05 | 2761.11 ± 36.97 | 5386.69 ± 59.16 | 1099.43 ± 29.81 | 2789.81 ± 25.30 | 3257.57 ± 53.53 | 4084.18 ± 27.94 | 9599.19 ± 25.01 | 9087.77 ± 57.43 | 6280.28 ± 46.85 |
| Cycle 1 Day 5 | 1868.69 ± 70.99 | 3626.44 ± 5.33 | 5343.01 ± 2.11 | 7415.04 ± 64.35 | 19470.17 ± 17.10 | 1868.69 ± 70.99 | 3626.44 ± 5.33 | 5343.01 ± 2.11 | 7415.04 ± 64.35 | 19470.17 ± 17.10 | 12981.17 ± 56.18 | 11767.29 ± 39.78 |
| Hours | Phase 1b: Onvansertib 12 mg/m^2 + Low-dose Cytarabine | Phase 1b: Onvansertib 18 mg/m^2 + Low-dose Cytarabine | Phase 1b: Onvansertib 27 mg/m^2 + Low-dose Cytarabine | Phase 1b: Onvansertib 40 mg/m^2 + Low-dose Cytarabine | Phase 1b: Onvansertib 60 mg/m^2 + Low-dose Cytarabine | Phase 1b: Onvansertib 12 mg/m^2 + Decitabine | Phase 1b: Onvansertib 18 mg/m^2 + Decitabine | Phase 1b: Onvansertib 27 mg/m^2 + Decitabine | Phase 1b: Onvansertib 40 mg/m^2 + Decitabine | Phase 1b: Onvansertib 60 mg/m^2 + Decitabine | Phase 1b: Onvansertib 90 mg/m^2 + Decitabine | Phase 2: Onvansertib 60 mg/m^2 + Decitabine |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Cycle 1 Day 1 | 11.294 ± 11.098 | 7.993 ± NA | 12.197 ± 71.258 | 11.747 ± 63.901 | 7.309 ± 99.539 | 16.960 ± 54.430 | 13.795 ± 28.866 | 9.394 ± 20.598 | 11.389 ± 39.530 | 12.917 ± 41.715 | 12.633 ± 50.655 | 11.904 ± 29.602 |
| Cycle 1 Day 5 | 16.413 ± 28.186 | 12.561 ± 38.983 | 12.246 ± 38.286 | 7.321 ± 8.094 | 14.484 ± 32.002 | 13.282 ± 39.361 | 9.082 ± 25.356 | 10.713 ± 23.782 | 16.337 ± 27.365 | 44.018 ± NA | 12.378 ± 10.948 | 14.060 ± 28.874 |
Collected over 27 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Phase 1b: Onvansertib 12 mg/m^2 + Low-dose Cytarabine | 2/3 (66.7%) | 2/3 (66.7%) | 3/3 (100%) |
| Phase 1b: Onvansertib 18 mg/m^2 + Low-dose Cytarabine | 2/3 (66.7%) | 3/3 (100%) | 3/3 (100%) |
| Phase 1b: Onvansertib 27 mg/m^2 + Low-dose Cytarabine | 2/3 (66.7%) | 1/3 (33.3%) | 3/3 (100%) |
| Phase 1b: Onvansertib 40 mg/m^2 + Low-dose Cytarabine | 1/3 (33.3%) | 2/3 (66.7%) | 3/3 (100%) |
| Phase 1b: Onvansertib 60 mg/m^2 + Low-dose Cytarabine | 4/5 (80%) | 3/5 (60%) | 5/5 (100%) |
| Phase 1b: Onvansertib 12 mg/m^2 + Decitabine | 2/4 (50%) | 2/4 (50%) | 4/4 (100%) |
| Phase 1b: Onvansertib 18 mg/m^2 + Decitabine | 2/3 (66.7%) | 3/3 (100%) | 3/3 (100%) |
| Phase 1b: Onvansertib 27 mg/m^2 + Decitabine | 2/3 (66.7%) | 3/3 (100%) | 3/3 (100%) |
| Phase 1b: Onvansertib 40 mg/m^2 + Decitabine | 3/4 (75%) | 4/4 (100%) | 4/4 (100%) |
| Phase 1b: Onvansertib 60 mg/m^2 + Decitabine | 3/3 (100%) | 2/3 (66.7%) | 3/3 (100%) |
| Phase 1b: Onvansertib 90 mg/m^2 + Decitabine | 4/6 (66.7%) | 5/6 (83.3%) | 6/6 (100%) |
| Phase 2: Onvansertib 60 mg/m^2 + Decitabine | 24/32 (75%) | 27/32 (84.4%) | 32/32 (100%) |
| Event | Phase 1b: Onvansertib 12 mg/m^2 + Low-dose Cytarabine | Phase 1b: Onvansertib 18 mg/m^2 + Low-dose Cytarabine | Phase 1b: Onvansertib 27 mg/m^2 + Low-dose Cytarabine | Phase 1b: Onvansertib 40 mg/m^2 + Low-dose Cytarabine | Phase 1b: Onvansertib 60 mg/m^2 + Low-dose Cytarabine | Phase 1b: Onvansertib 12 mg/m^2 + Decitabine | Phase 1b: Onvansertib 18 mg/m^2 + Decitabine | Phase 1b: Onvansertib 27 mg/m^2 + Decitabine | Phase 1b: Onvansertib 40 mg/m^2 + Decitabine | Phase 1b: Onvansertib 60 mg/m^2 + Decitabine | Phase 1b: Onvansertib 90 mg/m^2 + Decitabine | Phase 2: Onvansertib 60 mg/m^2 + Decitabine |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Febrile neutropeniaBlood and lymphatic system disorders | 1/3 | 1/3 | 0/3 | 0/3 | 2/5 | 1/4 | 1/3 | 2/3 | 2/4 | 1/3 | 5/6 | 8/32 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 0/3 | 0/3 | 0/3 | 0/3 | 0/5 | 0/4 | 0/3 | 2/3 | 0/4 | 0/3 | 0/6 | 4/32 |
| Lung infectionInfections and infestations | 0/3 | 1/3 | 0/3 | 0/3 | 1/5 | 1/4 | 0/3 | 0/3 | 0/4 | 1/3 | 1/6 | 4/32 |
| PneumoniaInfections and infestations | 0/3 | 0/3 | 1/3 | 1/3 | 0/5 | 0/4 | 0/3 | 0/3 | 1/4 | 0/3 | 1/6 | 2/32 |
| Septic shockInfections and infestations | 1/3 | 0/3 | 0/3 | 0/3 | 0/5 | 0/4 | 0/3 | 0/3 | 0/4 | 0/3 | 0/6 | 1/32 |
| AstheniaGeneral disorders | 1/3 | 0/3 | 0/3 | 0/3 | 1/5 | 0/4 | 0/3 | 0/3 | 0/4 | 0/3 | 0/6 | 0/32 |
| Oedema peripheralGeneral disorders | 0/3 | 1/3 | 0/3 | 0/3 | 0/5 | 0/4 | 0/3 | 0/3 | 0/4 | 0/3 | 0/6 | 0/32 |
| PyrexiaGeneral disorders | 1/3 | 0/3 | 0/3 | 0/3 | 0/5 | 0/4 | 0/3 | 0/3 | 0/4 | 0/3 | 0/6 | 1/32 |
| Neutrophil count decreasedInvestigations | 0/3 | 0/3 | 0/3 | 1/3 | 0/5 | 0/4 | 0/3 | 0/3 | 0/4 | 0/3 | 0/6 | 0/32 |
| Urine output decreasedInvestigations | 0/3 | 1/3 | 0/3 | 0/3 | 0/5 | 0/4 | 0/3 | 0/3 | 0/4 | 0/3 | 0/6 | 0/32 |
| Event | Phase 1b: Onvansertib 12 mg/m^2 + Low-dose Cytarabine | Phase 1b: Onvansertib 18 mg/m^2 + Low-dose Cytarabine | Phase 1b: Onvansertib 27 mg/m^2 + Low-dose Cytarabine | Phase 1b: Onvansertib 40 mg/m^2 + Low-dose Cytarabine | Phase 1b: Onvansertib 60 mg/m^2 + Low-dose Cytarabine | Phase 1b: Onvansertib 12 mg/m^2 + Decitabine | Phase 1b: Onvansertib 18 mg/m^2 + Decitabine | Phase 1b: Onvansertib 27 mg/m^2 + Decitabine | Phase 1b: Onvansertib 40 mg/m^2 + Decitabine | Phase 1b: Onvansertib 60 mg/m^2 + Decitabine | Phase 1b: Onvansertib 90 mg/m^2 + Decitabine | Phase 2: Onvansertib 60 mg/m^2 + Decitabine |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| ConstipationGastrointestinal disorders | 0/3 | 3/3 | 1/3 | 1/3 | 0/5 | 1/4 | 0/3 | 0/3 | 1/4 | 0/3 | 0/6 | 1/32 |
| Febrile neutropeniaBlood and lymphatic system disorders | 1/3 | 1/3 | 0/3 | 0/3 | 2/5 | 1/4 | 1/3 | 2/3 | 3/4 | 1/3 | 5/6 | 12/32 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 1/3 | 2/3 | 0/3 | 2/3 | 0/5 | 1/4 | 0/3 | 0/3 | 3/4 | 1/3 | 1/6 | 5/32 |
| FatigueGeneral disorders | 1/3 | 2/3 | 2/3 | 2/3 | 1/5 | 1/4 | 0/3 | 1/3 | 1/4 | 2/3 | 3/6 | 8/32 |
| Oedema peripheralGeneral disorders | 0/3 | 2/3 | 0/3 | 0/3 | 2/5 | 1/4 | 0/3 | 0/3 | 1/4 | 1/3 | 1/6 | 6/32 |
| PyrexiaGeneral disorders | 1/3 | 2/3 | 0/3 | 1/3 | 0/5 | 0/4 | 0/3 | 0/3 | 1/4 | 1/3 | 0/6 | 2/32 |
| DiarrhoeaGastrointestinal disorders | 1/3 | 0/3 | 2/3 | 2/3 | 1/5 | 0/4 | 0/3 | 0/3 | 0/4 | 1/3 | 2/6 | 9/32 |
| NauseaGastrointestinal disorders | 2/3 | 2/3 | 1/3 | 0/3 | 0/5 | 2/4 | 0/3 | 0/3 | 2/4 | 1/3 | 4/6 | 7/32 |
| StomatitisGastrointestinal disorders | 0/3 | 0/3 | 0/3 | 1/3 | 1/5 | 0/4 | 0/3 | 1/3 | 1/4 | 2/3 | 3/6 | 9/32 |
| HeadacheNervous system disorders | 0/3 | 2/3 | 1/3 | 0/3 | 0/5 | 0/4 | 0/3 | 0/3 | 1/4 | 1/3 | 0/6 | 3/32 |
| Age, Categorical(Participants) | Phase 1b: Onvansertib 12 mg/m^2 + Low-dose Cytarabine | Phase 1b: Onvansertib 18 mg/m^2 + Low-dose Cytarabine | Phase 1b: Onvansertib 27 mg/m^2 + Low-dose Cytarabine | Phase 1b: Onvansertib 40 mg/m^2 + Low-dose Cytarabine | Phase 1b: Onvansertib 60 mg/m^2 + Low-dose Cytarabine | Phase 1b: Onvansertib 12 mg/m^2 + Decitabine | Phase 1b: Onvansertib 18 mg/m^2 + Decitabine | Phase 1b: Onvansertib 27 mg/m^2 + Decitabine | Phase 1b: Onvansertib 40 mg/m^2 + Decitabine | Phase 1b: Onvansertib 60 mg/m^2 + Decitabine | Phase 1b: Onvansertib 90 mg/m^2 + Decitabine | Phase 2: Onvansertib 60 mg/m^2 + Decitabine | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 0 | 2 | 1 | 1 | 0 | 3 | 1 | 1 | 1 | 2 | 2 | 4 | 18 |
| >=65 years | 3 | 1 | 2 | 2 | 5 | 1 | 2 | 2 | 3 | 1 | 4 | 28 | 54 |
| Sex: Female, Male(Participants) | Phase 1b: Onvansertib 12 mg/m^2 + Low-dose Cytarabine | Phase 1b: Onvansertib 18 mg/m^2 + Low-dose Cytarabine | Phase 1b: Onvansertib 27 mg/m^2 + Low-dose Cytarabine | Phase 1b: Onvansertib 40 mg/m^2 + Low-dose Cytarabine | Phase 1b: Onvansertib 60 mg/m^2 + Low-dose Cytarabine | Phase 1b: Onvansertib 12 mg/m^2 + Decitabine | Phase 1b: Onvansertib 18 mg/m^2 + Decitabine | Phase 1b: Onvansertib 27 mg/m^2 + Decitabine | Phase 1b: Onvansertib 40 mg/m^2 + Decitabine | Phase 1b: Onvansertib 60 mg/m^2 + Decitabine | Phase 1b: Onvansertib 90 mg/m^2 + Decitabine | Phase 2: Onvansertib 60 mg/m^2 + Decitabine | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Female | 0 | 1 | 1 | 0 | 2 | 1 | 1 | 1 | 1 | 1 | 3 | 13 | 25 |
| Male | 3 | 2 | 2 | 3 | 3 | 3 | 2 | 2 | 3 | 2 | 3 | 19 | 47 |
| Ethnicity (NIH/OMB)(Participants) | Phase 1b: Onvansertib 12 mg/m^2 + Low-dose Cytarabine | Phase 1b: Onvansertib 18 mg/m^2 + Low-dose Cytarabine | Phase 1b: Onvansertib 27 mg/m^2 + Low-dose Cytarabine | Phase 1b: Onvansertib 40 mg/m^2 + Low-dose Cytarabine | Phase 1b: Onvansertib 60 mg/m^2 + Low-dose Cytarabine | Phase 1b: Onvansertib 12 mg/m^2 + Decitabine | Phase 1b: Onvansertib 18 mg/m^2 + Decitabine | Phase 1b: Onvansertib 27 mg/m^2 + Decitabine | Phase 1b: Onvansertib 40 mg/m^2 + Decitabine | Phase 1b: Onvansertib 60 mg/m^2 + Decitabine | Phase 1b: Onvansertib 90 mg/m^2 + Decitabine | Phase 2: Onvansertib 60 mg/m^2 + Decitabine | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Hispanic or Latino | 0 | 2 | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 5 |
| Not Hispanic or Latino | 3 | 1 | 3 | 3 | 4 | 4 | 3 | 1 | 4 | 1 | 6 | 30 | 63 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 2 | 0 | 1 | 4 |
| Race (NIH/OMB)(Participants) | Phase 1b: Onvansertib 12 mg/m^2 + Low-dose Cytarabine | Phase 1b: Onvansertib 18 mg/m^2 + Low-dose Cytarabine | Phase 1b: Onvansertib 27 mg/m^2 + Low-dose Cytarabine | Phase 1b: Onvansertib 40 mg/m^2 + Low-dose Cytarabine | Phase 1b: Onvansertib 60 mg/m^2 + Low-dose Cytarabine | Phase 1b: Onvansertib 12 mg/m^2 + Decitabine | Phase 1b: Onvansertib 18 mg/m^2 + Decitabine | Phase 1b: Onvansertib 27 mg/m^2 + Decitabine | Phase 1b: Onvansertib 40 mg/m^2 + Decitabine | Phase 1b: Onvansertib 60 mg/m^2 + Decitabine | Phase 1b: Onvansertib 90 mg/m^2 + Decitabine | Phase 2: Onvansertib 60 mg/m^2 + Decitabine | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 3 | 6 |
| White | 2 | 2 | 3 | 3 | 4 | 4 | 3 | 1 | 4 | 2 | 5 | 29 | 62 |
| More than one race | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 3 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided
Ran from Nov 2017 to primary completion in Nov 2021, 48 months.
Results were first posted in Feb 2023, 1 year 3 months after primary completion.
Of 92 industry-sponsored phase 1/2 interventional studies under Leukemia, Myeloid, Acute, half reached primary completion within 73 months of starting (the median), counting those still running; a quarter within 45 and three quarters within 91. This study's 48 months is below that.
Counting every sponsor, half of 226 studies reached it within 73 months; a quarter within 48 and three quarters within 106.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
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Cardiff Oncology