deltatrials
Terminated PHASE1/PHASE2 INTERVENTIONAL 2-arm NCT02540356

Phase 1/2a Two-Arm Dose-Escalation Study of BAX69 in Subjects With Malignant Ascites of Ovarian Cancer

A Phase 1/2a, Open-Label, Parallel, Two-Arm Dose-Escalation Study to Assess the Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of BAX69 in Subjects With Refractory Ovarian Cancer With Malignant Ascites

Sponsor: Baxalta now part of Shire

Updated 12 times since 2017 Last updated: Dec 22, 2020 Started: Nov 2, 2015 Primary completion: May 26, 2016 Completion: May 26, 2016
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

This trial was terminated. No reason was provided.

A PHASE1/PHASE2 clinical study on Refractory Ovarian Cancer With Recurrent Symptomatic Malignant Ascites, this trial is terminated or withdrawn. The trial is conducted by Baxalta now part of Shire and has accumulated 12 data snapshots since 2015. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshotTerminated~Feb 2017 – ~Jul 2017 · 5 months · monthly snapshotTerminated~Jul 2017 – ~Nov 2017 · 4 months · monthly snapshotTerminated~Nov 2017 – ~Jun 2018 · 7 months · monthly snapshotTerminated~Jun 2018 – ~Jun 2019 · 12 months · monthly snapshotTerminated~Jun 2019 – ~Jan 2021 · 19 months · monthly snapshotTerminated~Jan 2021 – ~Feb 2021 · 31 days · monthly snapshotTerminated~Feb 2021 – ~Dec 2021 · 10 months · monthly snapshotTerminated~Dec 2021 – ~Jul 2024 · 31 months · monthly snapshotTerminated~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotTerminated~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshotTerminated~Sep 2025 – present · 10 months · monthly snapshotTerminated

Change History

12 versions recorded
  1. Sep 2025 — Present [monthly]

    Terminated PHASE1/PHASE2

  2. Sep 2024 — Sep 2025 [monthly]

    Terminated PHASE1/PHASE2

  3. Jul 2024 — Sep 2024 [monthly]

    Terminated PHASE1/PHASE2

    Phase: PHASE1_PHASE2PHASE1/PHASE2

  4. Dec 2021 — Jul 2024 [monthly]

    Terminated PHASE1_PHASE2

  5. Feb 2021 — Dec 2021 [monthly]

    Terminated PHASE1_PHASE2

Show 7 earlier versions
  1. Jan 2021 — Feb 2021 [monthly]

    Terminated PHASE1_PHASE2

  2. Jun 2019 — Jan 2021 [monthly]

    Terminated PHASE1_PHASE2

  3. Jun 2018 — Jun 2019 [monthly]

    Terminated PHASE1_PHASE2

  4. Nov 2017 — Jun 2018 [monthly]

    Terminated PHASE1_PHASE2

  5. Jul 2017 — Nov 2017 [monthly]

    Terminated PHASE1_PHASE2

  6. Feb 2017 — Jul 2017 [monthly]

    Terminated PHASE1_PHASE2

  7. Jan 2017 — Feb 2017 [monthly]

    Terminated PHASE1_PHASE2

    First recorded

Nov 2015

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Baxalta now part of Shire
Data source: Takeda

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