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Maintenance With Olaparib or Selumetinib + Durvaluma for m-PDAC Guided by BRCAness and KRAS Status.

Study acronym: MAZEPPA
StatusActive, Not Recruiting
PhasePhase 2
Started
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Record History

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  1. Primary completion date: Jul 12, 2023 to Jun 15, 2023
    • Study completion date: Dec 2024 to Dec 2025
    • Study title shortened, about 2 words
    v8
  2. Trial status: Recruiting to Active, Not Recruiting
    • Primary completion date changed from estimate of Sep 2023 to Jul 12, 2023
    • Site details revised at 29 of 29 sites
    • Study title shortened, about 9 words
    v7
  3. Primary completion date: Dec 2022 to Sep 2023
    • Study completion date: Dec 2023 to Dec 2024
    v6
  4. Start date changed from estimate of Nov 25, 2020 to Dec 7, 2020
    • Site details revised at 5 of 29 sites
    v5
  5. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Sep 19, 2020 to Nov 25, 2020
    • Site details revised at 29 of 29 sites
    v4
Show 2 earlier versionsHide 2 earlier versions
  1. Start date: Aug 19, 2020 to Sep 19, 2020v3
  2. Start date: May 2020 to Aug 19, 2020v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
MAZEPPA is open-label, phase II study to assess the efficacy of a genomic-driven maintenance therapy in terms of PFS in Pancreatic ductal adenocarcinoma (PDAC) patients with disease controlled after 4 months of mFOLFIRINOX chemotherapy as following: Patients with a BRCAness somatic profile: olaparib Arm A. Patients with no BRCAness profile and with KRAS mutation randomization between durvalumab plus selumetinib Arm B, versus FOLFIRI Arm C.
Trial Details
NCT Number NCT04348045
Lead Sponsor GERCOR - Multidisciplinary Oncology Cooperative Group
Collaborators: AstraZeneca
Conditions
(from sponsor)		 Metastatic Pancreatic Adenocarcinoma
Enrollment 307 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov