deltatrials
Active Not Recruiting PHASE2 NCT01585805

Gemcitabine Hydrochloride and Cisplatin With or Without Veliparib or Veliparib Alone in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer

A Randomized Phase II Study of Gemcitabine, Cisplatin +/- Veliparib in Patients With Pancreas Adenocarcinoma and a Known BRCA/ PALB2 Mutation (Part I) and a Phase II Single Arm Study of Single-Agent Veliparib in Previously Treated Pancreas Adenocarcinoma (Part II)

Sponsor: National Cancer Institute (NCI)

Conditions Locally Advanced Pancreatic Adenocarcinoma Metastatic Pancreatic Adenocarcinoma Stage III Pancreatic Cancer AJCC v8 Stage IV Pancreatic Cancer AJCC v8
Interventions Biopsy Biospecimen Collection Cisplatin Computed Tomography Gemcitabine Gemcitabine Hydrochloride Magnetic Resonance Imaging Veliparib
Updated 44 times since 2017 Last updated: Mar 8, 2025 Started: May 15, 2012 Primary completion: Dec 31, 2024 Completion: Mar 6, 2026

Listed as NCT01585805, this PHASE2 trial focuses on Locally Advanced Pancreatic Adenocarcinoma and Metastatic Pancreatic Adenocarcinoma and remains ongoing. Sponsored by National Cancer Institute (NCI), it has been updated 44 times since 2012, reflecting substantial change activity. This study contributes to the evolving evidence base for cancer treatment protocols.

Change History

44 versions recorded

  1. Sep 2025 — Present [monthly]

    Active Not Recruiting PHASE2

  2. Apr 2025 — Sep 2025 [monthly]

    Active Not Recruiting PHASE2

  3. Nov 2024 — Apr 2025 [monthly]

    Active Not Recruiting PHASE2

  4. Sep 2024 — Nov 2024 [monthly]

    Active Not Recruiting PHASE2

  5. Aug 2024 — Sep 2024 [monthly]

    Active Not Recruiting PHASE2

▶ Show 39 earlier versions

  1. Jul 2024 — Aug 2024 [monthly]

    Active Not Recruiting PHASE2

  2. Apr 2024 — Jul 2024 [monthly]

    Active Not Recruiting PHASE2

  3. Mar 2024 — Apr 2024 [monthly]

    Active Not Recruiting PHASE2

  4. Jan 2024 — Mar 2024 [monthly]

    Active Not Recruiting PHASE2

  5. Dec 2023 — Jan 2024 [monthly]

    Active Not Recruiting PHASE2

  6. Sep 2023 — Dec 2023 [monthly]

    Active Not Recruiting PHASE2

  7. Aug 2023 — Sep 2023 [monthly]

    Active Not Recruiting PHASE2

  8. Mar 2023 — Aug 2023 [monthly]

    Active Not Recruiting PHASE2

  9. Jul 2022 — Mar 2023 [monthly]

    Active Not Recruiting PHASE2

  10. Jan 2022 — Jul 2022 [monthly]

    Active Not Recruiting PHASE2

  11. Oct 2021 — Jan 2022 [monthly]

    Active Not Recruiting PHASE2

  12. Sep 2021 — Oct 2021 [monthly]

    Active Not Recruiting PHASE2

  13. Jan 2021 — Sep 2021 [monthly]

    Active Not Recruiting PHASE2

  14. Jul 2020 — Jan 2021 [monthly]

    Active Not Recruiting PHASE2

  15. Jun 2020 — Jul 2020 [monthly]

    Active Not Recruiting PHASE2

  16. May 2020 — Jun 2020 [monthly]

    Active Not Recruiting PHASE2

  17. Apr 2020 — May 2020 [monthly]

    Active Not Recruiting PHASE2

  18. Mar 2020 — Apr 2020 [monthly]

    Active Not Recruiting PHASE2

  19. Feb 2020 — Mar 2020 [monthly]

    Active Not Recruiting PHASE2

  20. Jan 2020 — Feb 2020 [monthly]

    Active Not Recruiting PHASE2

  21. Dec 2019 — Jan 2020 [monthly]

    Active Not Recruiting PHASE2

  22. Nov 2019 — Dec 2019 [monthly]

    Active Not Recruiting PHASE2

  23. Oct 2019 — Nov 2019 [monthly]

    Active Not Recruiting PHASE2

  24. Aug 2019 — Oct 2019 [monthly]

    Active Not Recruiting PHASE2

  25. Jul 2019 — Aug 2019 [monthly]

    Active Not Recruiting PHASE2

  26. Jun 2019 — Jul 2019 [monthly]

    Active Not Recruiting PHASE2

  27. May 2019 — Jun 2019 [monthly]

    Active Not Recruiting PHASE2

  28. Mar 2019 — May 2019 [monthly]

    Active Not Recruiting PHASE2

    Status: Recruiting → Active Not Recruiting

  29. Jan 2019 — Mar 2019 [monthly]

    Recruiting PHASE2

  30. Sep 2018 — Jan 2019 [monthly]

    Recruiting PHASE2

  31. Aug 2018 — Sep 2018 [monthly]

    Recruiting PHASE2

  32. Jun 2018 — Aug 2018 [monthly]

    Recruiting PHASE2

  33. May 2018 — Jun 2018 [monthly]

    Recruiting PHASE2

  34. Aug 2017 — May 2018 [monthly]

    Recruiting PHASE2

  35. Jun 2017 — Aug 2017 [monthly]

    Recruiting PHASE2

  36. May 2017 — Jun 2017 [monthly]

    Recruiting PHASE2

  37. Mar 2017 — May 2017 [monthly]

    Recruiting PHASE2

  38. Feb 2017 — Mar 2017 [monthly]

    Recruiting PHASE2

  39. Jan 2017 — Feb 2017 [monthly]

    Recruiting PHASE2

    First recorded

May 2012

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • National Cancer Institute (NCI)
Data source: National Cancer Institute (NCI)

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

Study Locations

Ann Arbor, United States, Basking Ridge, United States, Chicago, United States, Commack, United States, Harrison, United States, Harvey, United States, Jerusalem, Israel, New York, United States, St Louis, United States, Tel Litwinsky, Israel and 2 more location s