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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Cardiff Oncology
Study ID
NCT03303339
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Onvansertib — DRUG
    Onvansertib orally
  • Cytarabine — DRUG
    subcutaneously
  • Decitabine — DRUG
    intravenously

Study Details

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.

Key Dates

Start date
Nov 17, 2017
Status verified
Dec 2022
Primary completion
Nov 17, 2021
Completion
Nov 17, 2021

Study Design

Enrollment
72 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1b: Onvansertib + low-dose cytarabine
    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.
  • Experimental: Phase 1b: Onvansertib + decitabine
    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.
  • Experimental: Phase 2: Onvansertib + 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.

Primary Outcome Measure

Number of Participants Who Experienced Dose Limiting Toxicities (DLT) [ Time Frame: Up to Day 28 of Cycle 1 ]

Locations (9)

FacilityCityStateZIPSite coordinators
University of California Los AngelesLos AngelesCalifornia90095-
Yale UniversityNew HavenConnecticut06510-
University of Kansas Cancer CenterWestwoodKansas66205-
Allina Health Virginia Piper Cancer InstituteMinneapolisMinnesota55407-
Roswell Park Cancer InstituteBuffaloNew York14263-
University of Texas Southwestern Medical CenterDallasTexas75390-
MD Anderson Cancer CenterHoustonTexas77030-
Virginia Cancer Specialists - Fairfax OfficeFairfaxVirginia22031-
Seattle Cancer Care AllianceSeattleWashington98109-

Find similar trials in Los Angeles, CA

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
University of California Los Angeles· Los Angeles, CAYale University· New Haven, CTUniversity of Kansas Cancer Center· Westwood, KSAllina Health Virginia Piper Cancer Institute· Minneapolis, MNRoswell Park Cancer Institute· Buffalo, NYUniversity of Texas Southwestern Medical Center· Dallas, TX

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