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

Completed · Phase 1/Phase 2

Conditions studied: Myelodysplastic Syndrome

In brief

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.

Key facts

Study ID

NCT01828346

Run by

TetraLogic Pharmaceuticals

People needed

21

Starts

2013-06-01

Expected to finish

2015-11-01

Last updated by the study team

2016-04-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Palo Verde Hematology Oncology — Glendale, Arizona, United States
• Mayo Clinic Scottsdale — Scottsdale, Arizona, United States
• California Cancer Associates for Research and Excellence — Fresno, California, United States
• Mayo Clinic Jacksonville — Jacksonville, Florida, United States
• Roswell Park Cancer Institute — Buffalo, New York, United States
• University of Pennsylvania, Abramson Cancer Center — Philadelphia, Pennsylvania, United States
• The University of Texas M.D. Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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