deltatrials
Active Not Recruiting PHASE1/PHASE2 INTERVENTIONAL 1-arm NCT04742101

Phase I/II Trial of S65487 Plus Azacitidine in Acute Myeloid Leukemia

Phase I / II, Open Label, Dose Escalation Part (Phase I) Followed by Non-comparative Expansion Part (Phase II), Multi-centre Study, Evaluating Safety, Pharmacokinetics and Efficacy of S65487, a Bcl2 Inhibitor Combined With Azacitidine in Adult Patients With Previously Untreated Acute Myeloid Leukemia Not Eligible for Intensive Treatment

Sponsor: ADIR, a Servier Group company

Conditions Acute Myeloid Leukemia
Interventions S65487 and azacitidine
Updated 14 times since 2021 Last updated: Apr 8, 2025 Started: Mar 10, 2021 Primary completion: Dec 30, 2025 Completion: Dec 30, 2025
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE1/PHASE2 clinical study on Acute Myeloid Leukemia, this trial is ongoing. The trial is conducted by ADIR, a Servier Group company and has accumulated 14 data snapshots since 2021. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.

Status Flow

~Mar 2021 – ~Jun 2021 · 3 months · monthly snapshot~Jun 2021 – ~May 2022 · 11 months · monthly snapshot~May 2022 – ~Jan 2023 · 8 months · monthly snapshot~Jan 2023 – ~Apr 2023 · 3 months · monthly snapshot~Apr 2023 – ~Jun 2023 · 2 months · monthly snapshot~Jun 2023 – ~Jul 2023 · 30 days · monthly snapshot~Jul 2023 – ~Aug 2023 · 31 days · monthly snapshot~Aug 2023 – ~Apr 2024 · 8 months · monthly snapshot~Apr 2024 – ~Jul 2024 · 3 months · monthly snapshot~Jul 2024 – ~Aug 2024 · 31 days · monthly snapshot~Aug 2024 – ~Sep 2024 · 31 days · monthly snapshot~Sep 2024 – ~May 2025 · 8 months · monthly snapshot~May 2025 – ~Sep 2025 · 4 months · monthly snapshot~Sep 2025 – present · 11 months · monthly snapshot

Change History

14 versions recorded

  1. Sep 2025 — Present [monthly]

    Active Not Recruiting PHASE1/PHASE2

  2. May 2025 — Sep 2025 [monthly]

    Active Not Recruiting PHASE1/PHASE2

  3. Sep 2024 — May 2025 [monthly]

    Active Not Recruiting PHASE1/PHASE2

  4. Aug 2024 — Sep 2024 [monthly]

    Active Not Recruiting PHASE1/PHASE2

  5. Jul 2024 — Aug 2024 [monthly]

    Active Not Recruiting PHASE1/PHASE2

    Status: Recruiting → Active Not Recruiting · Phase: PHASE1_PHASE2 → PHASE1/PHASE2

▶ Show 9 earlier versions

  1. Apr 2024 — Jul 2024 [monthly]

    Recruiting PHASE1_PHASE2

  2. Aug 2023 — Apr 2024 [monthly]

    Recruiting PHASE1_PHASE2

  3. Jul 2023 — Aug 2023 [monthly]

    Recruiting PHASE1_PHASE2

  4. Jun 2023 — Jul 2023 [monthly]

    Recruiting PHASE1_PHASE2

  5. Apr 2023 — Jun 2023 [monthly]

    Recruiting PHASE1_PHASE2

  6. Jan 2023 — Apr 2023 [monthly]

    Recruiting PHASE1_PHASE2

  7. May 2022 — Jan 2023 [monthly]

    Recruiting PHASE1_PHASE2

  8. Jun 2021 — May 2022 [monthly]

    Recruiting PHASE1_PHASE2

    Status: Not Yet Recruiting → Recruiting

  9. Mar 2021 — Jun 2021 [monthly]

    Not Yet Recruiting PHASE1_PHASE2

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • ADIR, a Servier Group company
  • Institut de Recherches Internationales Servier
Data source: Servier

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

Study Locations