Status:
COMPLETED
Birinapant With 5-azacitidine in MDS Subjects Who Are Naïve, Have Relapsed or Are Refractory to 5-azacitidine Therapy
Lead Sponsor:
TetraLogic Pharmaceuticals
Conditions:
Myelodysplastic Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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-az...
Detailed Description
This is a Phase 1b/2a, open-label, non-randomized study in male and female subjects with MDS who are naïve, refractory or have relapsed to 5-Azacitidine therapy. Primary Objective is to determine the...
Eligibility Criteria
Inclusion
- Men or women more than 18 years of age.
- Patients with high-risk Myelodysplastic Syndrome
- Performance status of greater or equal to 2 by the Eastern Cooperative Oncology Group (ECOG) scale.
- Subjects with high-risk MDS who are naïve to 5-Azacitidine or have previously received 5-AZA or decitabine as first-line cytotoxic therapy. Subjects with prior 5-Azacitidine therapy were evaluated to be either refractory or relapsed as determined by the Investigator, according to IWG response criteria.Subjects with relapsed or refractory disease may have only received prior 5-Azacitidine or decitabine.
- Hydroxyurea for patients with rapidly proliferative disease can be used up to 24 hours prior to therapy but not concomitantly with 5-Azacitidine.
- Adequate liver, pancreatic and renal function.
- Women of childbearing potential must have a negative serum pregnancy test at screening within 48 hours prior to the first dose
- Women of childbearing potential must agree to use 2 methods of adequate contraception
Exclusion
- Subjects with life-threatening toxicity or non tolerability to prior 5-Azacitidine therapy.
- Subjects with hypoplastic Myelodysplastic syndrome.
- Subjects with \>30% bone marrow blast cells.
- Subjects with malignant hepatic tumors or secondary malignancy within 2 years
- Known diagnosis of human immunodeficiency virus or chronic active Hepatitis B or C.
- Uncontrolled hypertension
- Impaired cardiac function, uncontrolled cardiac arrhythmias despite medications,
- QT interval corrected for heart rate (QTcB) more than 480 msec
- Lack of recovery of prior adverse events to Grade ≤1 severity (National Cancer Institute Common Terminology Criteria for Adverse Events version 4) (except alopecia) due to therapy administered prior to the initiation of study drug dosing.
- Nursing or pregnant women.
- Known allergy to any of the formulation components of birinapant.
- Known or suspected hypersensitivity to 5-Azacitidine or mannitol.
- Any concurrent disease and/or medical condition that, in the opinion of the Investigator, would prevent the subject's participation.
- History of Bell's Palsy.
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2015
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT01828346
Start Date
June 1 2013
End Date
November 1 2015
Last Update
April 21 2016
Active Locations (7)
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1
Palo Verde Hematology Oncology
Glendale, Arizona, United States, 85304
2
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States, 85259
3
California Cancer Associates for Research and Excellence
Fresno, California, United States, 93720
4
Mayo Clinic Jacksonville
Jacksonville, Florida, United States, 32224