Full results & analysis
Available in the Gosset platform where reported.
Trial intelligence / Profile preview
Birinapant in AML, MDS, and ALL
NCT01486784Phase 2
Key facts
- Status
- Terminated
- Start
- Nov 2011
- Primary completion
- Nov 2014
- Countries
- 1
- Sponsor
- Abramson Cancer Center
- Modality
- Small Molecules, Modified Peptides
- Drugs
- birinapant
- Conditions
- acute myeloid leukemia (AML)myelodysplastic syndrome (MDS)acute lymphoblastic leukemia (ALL)
01
Overview
Phase 2, open-label trial of birinapant in acute myeloid leukemia (AML), myelodysplastic syndrome (MDS) and acute lymphoblastic leukemia (ALL) (6 arms), sponsored by Abramson Cancer Center. Primary endpoints: The Safety of Birinapant (TL32711) and Number of Dose Limiting Toxicities Per Dosing Level. Started Nov 2011; status: terminated.
02
Design
6 arms- Study design
- Non-randomizedOpen-label
Phase 1 DL1
26mg/m2/dose IV once per week x 3 weeks of 4 week cycle
Phase 1 DL-1
17mg/m2 IV/dose once per week x 3 weeks of 4 week cycle
Phase 1 DL-1a
17mg/m2/dose IV twice per week x 3 weeks of 4 week cycle
Phase 1 DL-1b
17mg/m2/dose IV three times per week x 3 weeks of 4 week cycle
Phase 1 DL-1c
22mg/m2/dose IV twice per week x 3 weeks of 4 week cycle
Phase 1 DL-1d
17mg/m2/dose IV twice per week x 3 weeks of 4 week cycle
03
Who it enrols
Patients 18+ with relapsed/refractory AML, MDS, or ALL. Specific criteria vary by age and disease (e.g., 60+ AML failed 1 prior therapy, 18-59 AML failed 3).
04
Endpoints
Primary
The Safety of Birinapant (TL32711)
Number of Dose Limiting Toxicities Per Dosing Level
Beyond the preview
Go deeper on NCT01486784.
Full results, competitive context and analysis are in the Gosset platform.
Competitive context
Available in the Gosset platform where reported.
Bring the full picture into focus.
See how Gosset can support your research on NCT01486784.