Trial Search Results

Study of Azacitidine With or Without Birinapant in Subjects With MDS or CMMoL

We hope to learn if taking birinapant at the same time as the standard anticancer treatment azacitidine helps cancer patients.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

TetraLogic Pharmaceuticals

Stanford Investigator(s):

Intervention(s):

  • Drug: birinapant
  • Drug: Azacitidine
  • Drug: Placebo

Phase:

Phase 2

Eligibility


key Inclusion Criteria:

   - Morphologically confirmed diagnosis of MDS/CMMoL according to FAB or WHO
   classification, including RAEB-t and MDS/MPN

   - International prognostic score-revised (IPSS-R) of >3.5 (Intermediate, High or Very
   High)

   - Previously untreated with hypomethylating agents for MDS/CMMoL

   - Performance status of 0, 1 or 2 by the ECOG scale

   - Adequate renal and liver function

   - Female subjects of childbearing potential must have a negative serum pregnancy test at
   screening within 96 hours prior to the first study dose.

   - Female subjects of childbearing potential and male subjects with partners of
   childbearing potential should ensure use of a highly effective method of birth control
   as defined by the investigator, for example, those which result in a low failure rate
   (i.e., less than 1% per year) when used consistently and correctly during the study
   and for a period of 3 months following the last dose of any drug administered during
   the study.

Key Exclusion Criteria:

   - Relapsed or refractory to hypomethylating agents

   - Acute myeloid leukemia (AML), except those patients with RAEB-t who are not candidates
   for intensive AML therapy.

   - Participated in any interventional study within 4 weeks of randomization or 5 half
   lives (whichever is longer).

   - Received any hematopoietic growth factors within 14 days prior to screening.

   - Prior malignancy or secondary malignancy within the prior 2 years (except in situ
   cervical cancer, squamous cell carcinoma or basal cell carcinoma of the skin).

   - known diagnosis of human immunodeficiency virus or chronic active Hep B or C.

   - Uncontrolled hypertension

   - Impaired cardiac function, uncontrolled cardiac arrhythmias despite medications, or
   clinically significant cardiac disease

   - 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.

   - Known allergy or hypersensitivity to any of the formulation components

   - Any concurrent disease and/or medical condition that, in the opinion of the
   Investigator, would prevent the subject's participation.

   - History of cranial nerve palsy.

   - Being treated with anti-TNF therapies or has been treated with an anti-TNF therapy
   within 5 half-lives of randomization.

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
CCTO
650-498-7061
Not Recruiting