Clinical trial NCT02147873 (phase 2, status: terminated)
Conditions: myelodysplastic syndrome (mds), chronic myelomonocytic leukemia (cmml)
ICD codes: D46.Z, D46.9, C94.6, D46.C, C92.51, C92.52, C93.11, C93.12, C93.31, C93.32, C92.50
Drugs: birinapant, azacitidine, placebo
SMILES: CC[C@H](NC(=O)[C@H](C)NC)C(=O)N1C[C@@H](O)C[C@H]1CC1=C(NC2=CC(F)=CC=C12)C1=C(C[C@@H]2C[C@H](O)CN2C(=O)[C@H](CC)NC(=O)[C@H](C)NC)C2=CC=C(F)C=C2N1, NC1=CC=CC2=C1CN(C1CCC(=O)NC1=O)C2=O, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Reason stopped: 
    study terminated due to lack of efficacy
  
Eligibility criteria:

        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.