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Onvansertib in Combination With Either Low-dose Cytarabine or Decitabine in Adult Patients With Acute Myeloid Leukemia (AML) | Clinical Trials | Clareo Health

COMPLETEDPHASE1/PHASE2

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

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)

NCT03303339•Cardiff Oncology

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Disease Status and Prior Therapy:
•1. Histologically confirmed AML with \>20% blasts
•2. 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.
•3. Phase 2:
•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
•2. Age ≥18 years
•3. ECOG performance status ≤2
•4. Participants must be willing and able to review, understand, and provide written consent before starting any study-specific procedures or therapy.
+3 more criteria

Exclusion Criteria

•1. Treatment-related AML or acute promyelocytic leukemia (APL)
•2. Active malignancies within 12 months with the exception of those with a negligible risk of metastasis or death
•3. Clinical evidence of active central nervous system leukemia at the time of screening
•4. Alanine aminotransferase and/or aspartate aminotransferase ≥2.5 x upper limit of normal (ULN)
•5. Total bilirubin \> 2.0 mg/dL (or \> 3.0 mg/dL in participants with documented Gilbert syndrome)
•6. Serum creatinine ≥2.0 mg/dL
•7. New York Heart Association Class III or IV heart disease, active ischemia or any other uncontrolled cardiac condition, or hypertensive or metabolic condition
•8. Myocardial infarction in the previous 12 weeks (from the start of treatment)
•9. Resting left ventricular ejection fraction \<50% at the time of screening
•10. 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.
+4 more criteria

Locations (9)

University of California Los Angeles

Los Angeles, California, United States

Yale University

New Haven, Connecticut, United States

University of Kansas Cancer Center

Westwood, Kansas, United States

Allina Health Virginia Piper Cancer Institute

Minneapolis, Minnesota, United States

Roswell Park Cancer Institute

Buffalo, New York, United States

University of Texas Southwestern Medical Center

Dallas, Texas, United States

MD Anderson Cancer Center

Houston, Texas, United States

Virginia Cancer Specialists - Fairfax Office

Fairfax, Virginia, United States

Seattle Cancer Care Alliance

Seattle, Washington, United States

Key Dates

Start Date

November 17, 2017

Primary Completion Date

November 17, 2021

Completion Date

November 17, 2021

Last Updated

February 27, 2023

Enrollment

ACTUAL participants

Conditions

Acute Myeloid Leukemia

Interventions

Onvansertib

DRUG

Cytarabine

DRUG

Decitabine

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 27, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Phase I Study of HC-7366 for Acute Myeloid Leukemia

VAC Regimen for AML Patients Who Failed to Response to VA Regimen

A Study of Revumenib in R/R Leukemias Including Those With an MLL/KMT2A Gene Rearrangement or NPM1 Mutation

Testing the Anti-cancer Drug, Cirtuvivint, and Its Combination With ASTX727 to Improve Outcomes in Patients With Acute Myeloid Leukemia and Myelodysplastic Syndromes

Phase III Study of Induction and Consolidation Chemotherapy With Venetoclax in Patients With Newly Diagnosed AML or MDS-EB-2

A Study of CBX-250 in Participants With Relapsed or Refractory Myeloid Leukemias