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DNA Methyltransferase Inhibitor
Decitabine for Acute Myeloid Leukemia (1565GCC Trial)
Phase 1 & 2
Waitlist Available
Led By Maria Baer, MD
Research Sponsored by University of Maryland, Baltimore
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up cycle length = 28 days
Awards & highlights
1565GCC Trial Summary
This trial is exploring whether a new experimental drug, talazoparib, when given with the already-used decitabine, is more successful in treating AML than decitabine given alone. There are two parts to the study, with the first part aiming to find the best doses of decitabine and talazoparib to use when given together, enrolling anywhere from 2-36 people. Part two of the study then looks at how well the drugs work together to treat AML on a larger scale, with 79-135 people. The trial is being conducted at multiple centers with up to 171 people globally
1565GCC Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ cycle length = 28 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~cycle length = 28 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Phase 1 - Dose Finding
1565GCC Trial Design
5Treatment groups
Experimental Treatment
Active Control
Group I: Phase 2: Decitabine and Talazoparib ComboExperimental Treatment2 Interventions
Phase 2:
Recommended Phase 2 Dose (RP2D) The MTD of the combination of decitabine with a dose of talazoparib of at least 0.25 mg is defined as the maximal tolerated dose of decitabine studied - and for that dose level, combined with the maximum dose of talazoparib for which the incidence of DLT was less than 33% in 6 participants treated and this will be chosen as the recommended Phase 2 dose (RP2D). Among potential combined dose levels at MTD, available pharmacodynamic data (PARP trapping) will also be considered in the choice of RP2D, as will any significant indications of differences in clinical efficacy
Group II: Phase 1: Decitabine and Talazoparib ComboExperimental Treatment2 Interventions
Phase 1:
Decitabine by IV daily for 5 days every 28 days. Talazoparib orally daily days 1-28.
The 'outer layer' of this nested dose escalation trial will escalate the dose of the two drugs by sequentially going through dose levels 1-6 in the table found in the protocol. The standard algorithm of the 3+3 design will be applied.
Group III: Phase 2 Arm AActive Control2 Interventions
Adult patients with AML who are thought not to be likely to tolerate or respond to standard chemotherapy
Group IV: Phase 2 Arm BActive Control2 Interventions
Adult patients with AML that has not responded to previous treatment or has come back after responding to previous treatment
Group V: Phase 2 Arm CActive Control2 Interventions
Adult patients previously treated with a DNA methyltransferase inhibitor (decitabine, azacitidine or guadecitabine)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Decitabine
2004
Completed Phase 3
~1680
talazoparib
2016
Completed Phase 3
~480
Find a Location
Who is running the clinical trial?
University of Maryland, BaltimoreLead Sponsor
688 Previous Clinical Trials
374,631 Total Patients Enrolled
PfizerIndustry Sponsor
4,570 Previous Clinical Trials
10,910,415 Total Patients Enrolled
Van Andel Research InstituteOTHER
27 Previous Clinical Trials
5,372 Total Patients Enrolled
Frequently Asked Questions
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