MedTrace Logo

Birinapant With 5-azacitidine in MDS Subjects Who Are Naïve, Have Relapsed or Are Refractory to 5-azacitidine Therapy

NCT01828346 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2016-04-21

No results posted yet for this study

Summary

This is a dose escalation followed by dose expansion study of TL32711 in combination with 5-Azacitidine in subjects with Myelodysplastic syndrome who are naïve, have relapsed or have failed prior 5-azacitidine therapy. Pre-clinical and mechanistic studies support that 5-Azacitidine may modulate pathways that enable birinapant-mediated anti-tumor activity.

Conditions

Interventions

DRUG

Birinapant

Dose escalation part: (Drug escalation dose levels) * Dose Level (1) - 13mg/m2 (twice a week for 3 of 4 weeks) * Dose Level (-1) - 11 mg/m2 (twice a week for 3 of 4 weeks) * Dose Level (2) - 13mg/m2 (twice weekly x 4 weeks) * Dose Level (3a) - 17mg/m2 (twice weekly × 4 weeks)OR * Dose Level (3b) - 17mg/m2 (twice a week for 3 of 4 weeks)

DRUG

5-Azacitidine

Dose Level (0) - 75mg/m2 daily

Sponsors & Collaborators

  • TetraLogic Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Gautam Borthakur, MD · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2015-06-30
Completion
2015-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01828346 on ClinicalTrials.gov