Acute Myeloid LeukemiaPhase 1/2NCT03303339

Onvansertib in Combination With Either Low-dose Cytarabine or Decitabine in Adult Patients With Acute Myeloid Leukemia (AML)

A Phase 1/2 study testing Onvansertib, Cytarabine and Decitabine in people with Acute Myeloid Leukemia, run by Cardiff Oncology at 9 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Acute Myeloid Leukemia
What is being tested?: Onvansertib, Cytarabine and Decitabine
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 72 participants
Where: 9 sitesUnited States
Study dates: 17 Nov 2017to 17 Nov 2021
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Disease Status and Prior Therapy:
Histologically confirmed AML with >20% blasts
Phase 1b: Participants with AML who are refractory to or have relapsed after initial treatment for their disease, with no more than three prior lines of therapy. Participants who have received prior treatment with cytarabine or decitabine are not excluded.
Phase 2:
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

Show all 13Show fewer

Participants with newly diagnosed, untreated AML ineligible for, or who have refused, standard intensive induction therapy
Age ≥18 years
ECOG performance status ≤2
Participants must be willing and able to review, understand, and provide written consent before starting any study-specific procedures or therapy.
All men and women must agree to practice effective contraception during the entire study period and after discontinuing study drug, unless documentation of infertility exists
Sexually active, fertile women must use two effective forms of contraception (abstinence, intrauterine device, oral contraceptive, or double barrier device) from the time of informed consent and until at least 6 months after discontinuing study drug
Sexually active men and their sexual partners must use effective contraceptive methods from the time of participant informed consent and until at least 3 months after discontinuing study drug

Who cannot join

Treatment-related AML or acute promyelocytic leukemia (APL)
Active malignancies within 12 months with the exception of those with a negligible risk of metastasis or death
Clinical evidence of active central nervous system leukemia at the time of screening
Alanine aminotransferase and/or aspartate aminotransferase ≥2.5 x upper limit of normal (ULN)
Total bilirubin > 2.0 mg/dL (or > 3.0 mg/dL in participants with documented Gilbert syndrome)
Serum creatinine ≥2.0 mg/dL

Show all 14Show fewer

New York Heart Association Class III or IV heart disease, active ischemia or any other uncontrolled cardiac condition, or hypertensive or metabolic condition
Myocardial infarction in the previous 12 weeks (from the start of treatment)
Resting left ventricular ejection fraction <50% at the time of screening
QT (Interval from the beginning of the QRS complex to the end of the T wave on an electrocardiogram) interval with Fridericia's correction [QTcF] >450 milliseconds. The QTcF should be calculated as the arithmetic mean of the QTcF on triplicate ECGs. In the case of potentially correctible causes of QT prolongation (e.g., medications, hypokalemia), the triplicate ECG may be repeated once during screening and that result may be used to determine eligibility.
Active and uncontrolled disease (other than AML) or infection as judged by the treating physician
Treatment with systemic therapy for the primary disease within 14 days (except for hydroxyurea or isolated doses of cytarabine or decitabine for white blood cell control)
Grade 2 or greater toxicities from prior therapy, except for Grade 2 toxicities that are not expected to resolve and that in the judgment of the Investigator do not pose a significant safety risk to subject participation.
Participants with any other medical condition, including mental illness or substance abuse, deemed by the Investigator to be likely to interfere with the participant's ability to sign the informed consent form or his/her ability to cooperate and participate in the study, or to interfere with the interpretation of the results.

Trial locations and contacts

9 sites in 1 country.

City, postcode or hospital

9 sites in 1 country

United States9 sites

Roswell Park Cancer Institute
Buffalo, New York, 14263
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Virginia Cancer Specialists - Fairfax Office
Fairfax, Virginia, 22031
MD Anderson Cancer Center
Houston, Texas, 77030
University of California Los Angeles
Los Angeles, California, 90095
Allina Health Virginia Piper Cancer Institute
Minneapolis, Minnesota, 55407
Yale University
New Haven, Connecticut, 06510
Seattle Cancer Care Alliance
Seattle, Washington, 98109
University of Kansas Cancer Center
Westwood, Kansas, 66205

Other trials in United States

About this study

Official title: A Phase 1b/2 Study of PCM-075 (Onvansertib) in Combination With Either Low-Dose Cytarabine or Decitabine in Subjects With Acute Myeloid Leukemia (AML)

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.

Conditions: Acute Myeloid Leukemia
Being tested: Onvansertib, Cytarabine, Decitabine
Keywords: PLK1, PLK Inhibitor, Onvansertib
Medical subject headings: Leukemia, Myeloid, Acute

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

OnvansertibDrug
Onvansertib orally
CytarabineDrug
subcutaneously
DecitabineDrug
intravenously

Study groups in NCT03303339
Study group	Role	What they receive
Phase 1b: Onvansertib + low-dose cytarabine	Experimental	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. Receives: Drug: Onvansertib; Drug: Cytarabine
Phase 1b: Onvansertib + decitabine	Experimental	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. Receives: Drug: Onvansertib; Drug: Decitabine
Phase 2: Onvansertib + decitabine	Experimental	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. Receives: Drug: Onvansertib; Drug: Decitabine

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline up to 30 days after last dose of study drug (up to 27 months)

Secondary outcomes (9)

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 Months
Pharmacokinetic Parameter: Maximum Observed Plasma Concentration (Cmax) for Onvansertib
Measured: Cycle 1: Days 1 and 5
Pharmacokinetic Parameter: Time to Reach the Maximum Observed Plasma Concentration (Tmax) for Onvansertib
Measured: Cycle 1: Days 1 and 5
Pharmacokinetic Parameter: Area Under the Curve Over the First 24 Hours AUC(0-24) for Onvansertib
Measured: Cycle 1: Days 1 and 5
Pharmacokinetic Parameter: Plasma Terminal Elimination Half-life (t1/2) for Onvansertib
Measured: Cycle 1: Days 1 and 5

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Nov 201717 Nov 2021

First posted6 Oct 2017
Study start17 Nov 2017
Primary completion17 Nov 2021
Study completion17 Nov 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 72 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03303339
Sponsor's protocol ID: TROV-052
Other IDs: U1111-1201-6416
Status last verified: Dec 2022
First submitted: 6 Sep 2017
Last updated: 27 Feb 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Hagege A, Ambrosetti D, Boyer J, Bozec A, Doyen J, Chamorey E, He X, Bourget I, Rousset J, Saada E, Rastoin O, Parola J, Luciano F, Cao Y, Pages G, Dufies M. The Polo-like kinase 1 inhibitor onvansertib represents a relevant treatment for head and neck squamous cell carcinoma resistant to cisplatin and radiotherapy. Theranostics. 2021 Sep 21;11(19):9571-9586. doi: 10.7150/thno.61711. eCollection 2021.
PubMed 34646387

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
A Long-term Follow-up Study of Patients With ARD103 CAR-T Cell Therapies
Acute Myeloid Leukemia, in Relapse, Acute Myeloid Leukemia, in Relapsed or Refractory
RecruitingPhase 2
MYELOMATCH: A Screening Study to Assign People With Myeloid Cancer to a Treatment Study or Standard of Care Treatment Within myeloMATCH (MyeloMATCH Screening Trial)
Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm
RecruitingPhase 1
225Ac-DOTA-Anti-CD38 Daratumumab Monoclonal Antibody With Fludarabine, Melphalan and Total Marrow and Lymphoid Irradiation as Conditioning Treatment for Donor Stem Cell Transplant in Patients With High-Risk Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia and Myelodysplastic Syndrome
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
RecruitingPhase 2
Testing the Addition of Venetoclax or Gemtuzumab Ozogamicin (GO) to Usual Treatment Regimen (Cytarabine and Daunorubicin, "7+3") for Core Binding Factor Acute Myeloid Leukemia (CBF-AML) to Improve Response (A MYELOMATCH Treatment Trial)
Core Binding Factor Acute Myeloid Leukemia
RecruitingPhase 1/2
Phase I/II Trial: Engineered Donor Graft (Orca Q) for Pediatric Hematopoietic Cell Transplant (HCT)
Acute Myeloid Leukemia, Acute Lymphoid Leukemia

All Acute Myeloid Leukemia trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1b/2 Study of PCM-075 (Onvansertib) in Combination With Either Low-Dose Cytarabine or Decitabine in Subjects With Acute Myeloid Leukemia (AML)
ClinicalTrials.gov ID: NCT03303339
Acronym / sponsor ID: TROV-052
Conditions: Acute Myeloid Leukemia
Keywords: PLK1, PLK Inhibitor, Onvansertib
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 72 participants (actual)
Lead sponsor: Cardiff OncologyIndustry (pharma, biotech, devices)
Study start: 17 Nov 2017 (actual)
Primary completion: 17 Nov 2021 (actual)
Study completion: 17 Nov 2021 (actual)
First posted: 6 Oct 2017 (actual)
Results: Posted 27 Feb 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Phase 1b: Onvansertib + low-dose cytarabine	Experimental	Drug: Onvansertib, Drug: CytarabineOnvansertib, 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.
Phase 1b: Onvansertib + decitabine	Experimental	Drug: Onvansertib, Drug: DecitabineOnvansertib 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.
Phase 2: Onvansertib + decitabine	Experimental	Drug: Onvansertib, Drug: DecitabineOnvansertib 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (13 listed)

Disease Status and Prior Therapy:
OR
Age ≥18 years
ECOG performance status ≤2
Participants must be willing and able to review, understand, and provide written consent before starting any study-specific procedures or therapy.

Key exclusion criteria (14 listed)

Treatment-related AML or acute promyelocytic leukemia (APL)
Active malignancies within 12 months with the exception of those with a negligible risk of metastasis or death
Clinical evidence of active central nervous system leukemia at the time of screening
Alanine aminotransferase and/or aspartate aminotransferase ≥2.5 x upper limit of normal (ULN)
Total bilirubin > 2.0 mg/dL (or > 3.0 mg/dL in participants with documented Gilbert syndrome)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
OnvansertibOnvansertib orally	Drug	Phase 1b: Onvansertib + decitabine, Phase 1b: Onvansertib + low-dose cytarabine, Phase 2: Onvansertib + decitabine
Cytarabinesubcutaneously	Drug	Phase 1b: Onvansertib + low-dose cytarabine
Decitabineintravenously	Drug	Phase 1b: Onvansertib + decitabine, Phase 2: Onvansertib + decitabine

Primary outcome

Number of Participants Who Experienced Dose Limiting Toxicities (DLT)
Time frame: Up to Day 28 of Cycle 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).
Number of Participants With Change From Baseline in Eastern Co-operative Oncology Group (ECOG) Performance Status
Time frame: Baseline and end of study (approximately up to up to 27 months)
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.
Phase 2: Number of Participants Who Achieved a Complete Response (CR)
Time frame: Up to 27 months
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.
Number of Participants With Adverse Events (AEs)
Time frame: Baseline up to 30 days after last dose of study drug (up to 27 months)
Any clinically significant change in electrocardiogram (ECG), physical examination findings, body weight, vital signs, and laboratory parameters were recorded as Adverse Events.

9 secondary outcomes

Phase 2: Number of Participants Who Achieved a Morphologic Leukemia-free (MLF) State
Time frame: Up to 27 months
Phase 2: Number of Participants With Partial Response (PR)
Time frame: Up to 27 months
Phase 2: Duration of Response (DOR)
Time frame: Up to 27 months
Phase 2: Event-free Survival (EFS)
Time frame: 12 Months
Phase 2: Overall Survival (OS)
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

Results and safety

Results posted to the registry on 27 Feb 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Phase 1b: Onvansertib 12 mg/m^2 + Low-dose Cytarabine	3	0
Phase 1b: Onvansertib 18 mg/m^2 + Low-dose Cytarabine	3	1
Phase 1b: Onvansertib 27 mg/m^2 + Low-dose Cytarabine	3	1
Phase 1b: Onvansertib 40 mg/m^2 + Low-dose Cytarabine	3	2
Phase 1b: Onvansertib 60 mg/m^2 + Low-dose Cytarabine	5	0
Phase 1b: Onvansertib 12 mg/m^2 + Decitabine	4	1
Phase 1b: Onvansertib 18 mg/m^2 + Decitabine	3	0
Phase 1b: Onvansertib 27 mg/m^2 + Decitabine	3	1
Phase 1b: Onvansertib 40 mg/m^2 + Decitabine	4	0
Phase 1b: Onvansertib 60 mg/m^2 + Decitabine	3	0
Phase 1b: Onvansertib 90 mg/m^2 + Decitabine	6	1
Phase 2: Onvansertib 60 mg/m^2 + Decitabine	32	4

Primary outcome: Number of Participants Who Experienced Dose Limiting Toxicities (DLT)

Time frame: Up to Day 28 of Cycle 1. Count of participants. Unit: Participants

Measure	Phase 1b: Onvansertib 12 mg/m^2 + Low-dose Cytarabine n = 3	Phase 1b: Onvansertib 18 mg/m^2 + Low-dose Cytarabine n = 3	Phase 1b: Onvansertib 27 mg/m^2 + Low-dose Cytarabine n = 3	Phase 1b: Onvansertib 40 mg/m^2 + Low-dose Cytarabine n = 3	Phase 1b: Onvansertib 60 mg/m^2 + Low-dose Cytarabine n = 5	Phase 1b: Onvansertib 12 mg/m^2 + Decitabine n = 4	Phase 1b: Onvansertib 18 mg/m^2 + Decitabine n = 3	Phase 1b: Onvansertib 27 mg/m^2 + Decitabine n = 3	Phase 1b: Onvansertib 40 mg/m^2 + Decitabine n = 4	Phase 1b: Onvansertib 60 mg/m^2 + Decitabine n = 3	Phase 1b: Onvansertib 90 mg/m^2 + Decitabine n = 6
Value	0	0	0	0	0	0	0	0	0	0	2

Phase 1b: Onvansertib 12 mg/m^2 + Low-dose Cytarabine vs Phase 1b: Onvansertib 18 mg/m^2 + Low-dose Cytarabine vs Phase 1b: Onvansertib 27 mg/m^2 + Low-dose Cytarabine vs Phase 1b: Onvansertib 40 mg/m^2 + Low-dose Cytarabine vs Phase 1b: Onvansertib 60 mg/m^2 + Low-dose Cytarabine vs Phase 1b: Onvansertib 12 mg/m^2 + Decitabine vs Phase 1b: Onvansertib 18 mg/m^2 + Decitabine vs Phase 1b: Onvansertib 27 mg/m^2 + Decitabine vs Phase 1b: Onvansertib 40 mg/m^2 + Decitabine vs Phase 1b: Onvansertib 60 mg/m^2 + Decitabine vs Phase 1b: Onvansertib 90 mg/m^2 + Decitabine: Maximum Tolerated Dose: 60

Population analysed: The safety analysis set was comprised of all subjects who received at least one dose of onvansertib.

Primary outcome: Number of Participants With Change From Baseline in Eastern Co-operative Oncology Group (ECOG) Performance Status

Time frame: Baseline and end of study (approximately up to up to 27 months). Count of participants. Unit: Participants

Measure	Phase 1b: Onvansertib + Low-dose Cytarabine n = 17	Phase 1b: Onvansertib + Decitabine n = 23	Phase 2: Onvansertib + Decitabine n = 32
Value	11	14	22

Population analysed: Per SAP It was pre-planned to report this data by treatment type instead of by dose.

Primary outcome: Phase 2: Number of Participants Who Achieved a Complete Response (CR)

Time frame: Up to 27 months. Count of participants. Unit: Participants

Measure	Phase 2: Onvansertib + Decitabine n = 32
Value	3

Population analysed: Only participants in Phase 2 were included in this analysis.

Primary outcome: Number of Participants With Adverse Events (AEs)

Time frame: Baseline up to 30 days after last dose of study drug (up to 27 months). Count of participants. Unit: Participants

Measure	Phase 1b: Onvansertib 12 mg/m^2 + Low-dose Cytarabine n = 3	Phase 1b: Onvansertib 18 mg/m^2 + Low-dose Cytarabine n = 3	Phase 1b: Onvansertib 27 mg/m^2 + Low-dose Cytarabine n = 3	Phase 1b: Onvansertib 40 mg/m^2 + Low-dose Cytarabine n = 3	Phase 1b: Onvansertib 60 mg/m^2 + Low-dose Cytarabine n = 5	Phase 1b: Onvansertib 12 mg/m^2 + Decitabine n = 4	Phase 1b: Onvansertib 18 mg/m^2 + Decitabine n = 3	Phase 1b: Onvansertib 27 mg/m^2 + Decitabine n = 3	Phase 1b: Onvansertib 40 mg/m^2 + Decitabine n = 4	Phase 1b: Onvansertib 60 mg/m^2 + Decitabine n = 3	Phase 1b: Onvansertib 90 mg/m^2 + Decitabine n = 6	Phase 2: Onvansertib 60 mg/m^2 + Decitabine n = 32
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

Population analysed: The safety analysis set was comprised of all subjects who received at least one dose of onvansertib.

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: 27 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Phase 1b: Onvansertib 12 mg/m^2 + Low-dose Cytarabine	2 of 3 (66.7%)	3 of 3 (100%)	2 of 3
Phase 1b: Onvansertib 18 mg/m^2 + Low-dose Cytarabine	3 of 3 (100%)	3 of 3 (100%)	2 of 3
Phase 1b: Onvansertib 27 mg/m^2 + Low-dose Cytarabine	1 of 3 (33.3%)	3 of 3 (100%)	2 of 3
Phase 1b: Onvansertib 40 mg/m^2 + Low-dose Cytarabine	2 of 3 (66.7%)	3 of 3 (100%)	1 of 3
Phase 1b: Onvansertib 60 mg/m^2 + Low-dose Cytarabine	3 of 5 (60%)	5 of 5 (100%)	4 of 5
Phase 1b: Onvansertib 12 mg/m^2 + Decitabine	2 of 4 (50%)	4 of 4 (100%)	2 of 4
Phase 1b: Onvansertib 18 mg/m^2 + Decitabine	3 of 3 (100%)	3 of 3 (100%)	2 of 3
Phase 1b: Onvansertib 27 mg/m^2 + Decitabine	3 of 3 (100%)	3 of 3 (100%)	2 of 3
Phase 1b: Onvansertib 40 mg/m^2 + Decitabine	4 of 4 (100%)	4 of 4 (100%)	3 of 4
Phase 1b: Onvansertib 60 mg/m^2 + Decitabine	2 of 3 (66.7%)	3 of 3 (100%)	3 of 3
Phase 1b: Onvansertib 90 mg/m^2 + Decitabine	5 of 6 (83.3%)	6 of 6 (100%)	4 of 6
Phase 2: Onvansertib 60 mg/m^2 + Decitabine	27 of 32 (84.4%)	32 of 32 (100%)	24 of 32

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 34646387Hagege A, Ambrosetti D, Boyer J, Bozec A, Doyen J, Chamorey E, He X, Bourget I, Rousset J, Saada E, Rastoin O, Parola J, Luciano F, Cao Y, Pages G, Dufies M. The Polo-like kinase 1 inhibitor onvansertib represents a relevant treatment for head and neck squamous cell carcinoma resistant to cisplatin and radiotherapy. Theranostics. 2021 Sep 21;11(19):9571-9586. doi: 10.7150/thno.61711. eCollection 2021.
Individual participant dataSharing planned: Undecided

Related trials for Acute Myeloid Leukemia

RecruitingObservational study
A Long-term Follow-up Study of Patients With ARD103 CAR-T Cell Therapies
Acute Myeloid Leukemia, in Relapse, Acute Myeloid Leukemia, in Relapsed or Refractory
RecruitingPhase 2
MYELOMATCH: A Screening Study to Assign People With Myeloid Cancer to a Treatment Study or Standard of Care Treatment Within myeloMATCH (MyeloMATCH Screening Trial)
Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm
RecruitingPhase 1
225Ac-DOTA-Anti-CD38 Daratumumab Monoclonal Antibody With Fludarabine, Melphalan and Total Marrow and Lymphoid Irradiation as Conditioning Treatment for Donor Stem Cell Transplant in Patients With High-Risk Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia and Myelodysplastic Syndrome
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
RecruitingPhase 2
Testing the Addition of Venetoclax or Gemtuzumab Ozogamicin (GO) to Usual Treatment Regimen (Cytarabine and Daunorubicin, "7+3") for Core Binding Factor Acute Myeloid Leukemia (CBF-AML) to Improve Response (A MYELOMATCH Treatment Trial)
Core Binding Factor Acute Myeloid Leukemia
RecruitingPhase 1/2
Phase I/II Trial: Engineered Donor Graft (Orca Q) for Pediatric Hematopoietic Cell Transplant (HCT)
Acute Myeloid Leukemia, Acute Lymphoid Leukemia

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

9 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Onvansertib, Cytarabine and Decitabine in people with Acute Myeloid Leukemia, run by Cardiff Oncology at 9 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Who Experienced Dose Limiting Toxicities (DLT) (time frame: Up to Day 28 of Cycle 1). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03303339, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2023.