deltatrials
Completed PHASE1/PHASE2 INTERVENTIONAL 1-arm NCT01828346

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

A Phase 1b/2a, Open-label, Non-randomized Study of Birinapant in Combination With 5-azacitidine in Subjects With Myelodysplastic Syndrome Who Are Naïve, Refractory or Have Relapsed to 5-azacitidine Therapy

Sponsor: TetraLogic Pharmaceuticals

Updated 6 times since 2017 Last updated: Apr 19, 2016 Started: Jun 30, 2013 Primary completion: Jun 30, 2015 Completion: Nov 30, 2015
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT01828346, this PHASE1/PHASE2 trial focuses on Myelodysplastic Syndrome and remains completed. Sponsored by TetraLogic Pharmaceuticals, it has been updated 6 times since 2013, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshotCompleted~Feb 2017 – ~Jun 2018 · 16 months · monthly snapshotCompleted~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotCompleted~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 22 months · monthly snapshotCompleted

Change History

6 versions recorded
  1. Sep 2024 — Present [monthly]

    Completed PHASE1/PHASE2

  2. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE1/PHASE2

    Phase: PHASE1_PHASE2PHASE1/PHASE2

  3. Jan 2021 — Jul 2024 [monthly]

    Completed PHASE1_PHASE2

  4. Jun 2018 — Jan 2021 [monthly]

    Completed PHASE1_PHASE2

  5. Feb 2017 — Jun 2018 [monthly]

    Completed PHASE1_PHASE2

Show 1 earlier version
  1. Jan 2017 — Feb 2017 [monthly]

    Completed PHASE1_PHASE2

    First recorded

Jun 2013

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • TetraLogic Pharmaceuticals
Data source: TetraLogic Pharmaceuticals

For direct contact, visit the study record on ClinicalTrials.gov .