The PLATINUM Trial: Optimizing Chemotherapy for the Second-Line Treatment of Metastatic BRCA1/2 or PALB2-Associated Metastatic Pancreatic Cancer

StatusActive, Not Recruiting
PhasePhase 2/3
Started

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Record History

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  1. Primary completion moved earlier from Jan 15, 2029 to Dec 1, 2027 Show 5 more changesShow less
    • Study completion moved earlier from Dec 9, 2029 to Jan 1, 2028
    • Eligibility criteria revised
    • Secondary endpoints: details revised at 1 of 2 entries
    • Study description revised
    • Site details revised at 35 of 345 sites
  2. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 100 to confirmed 10
    • Study sites: 344 to 345
    v14
  3. Study sites: 342 to 344v13
  4. Site details revised at 47 of 342 sitesv12
  5. Study sites: 309 to 342v11
Show 9 earlier versionsHide 9 earlier versions
  1. Study sites: 278 to 309v10
  2. Start date: Dec 6, 2023 to Aug 13, 2024
    • Site contacts updated at 263 of 278 sites
    v9
  3. Study sites: 272 to 278v8
  4. Study sites: 229 to 272v7
  5. Study sites: 198 to 229v6
  6. Study sites: 185 to 198v5
  7. Study sites: 126 to 185v4
  8. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 126
    • Start date changed from estimate of Apr 9, 2024 to Dec 6, 2023
    v3
  9. Re-verified, no change to tracked fieldsv2
  1. Study First Submitted
  • 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.
This phase II/III trial compares the effect of the 3-drug chemotherapy combination of nab-paclitaxel, gemcitabine, plus cisplatin versus the 2-drug chemotherapy combination of nab-paclitaxel plus gemcitabine for the treatment of patients with pancreatic cancer that has spread to other places in the body (metastatic) and a known genetic mutation in the BRCA1, BRCA2, or PALB2 gene.
Trial Details
NCT Number NCT06115499
Lead Sponsor Alliance for Clinical Trials in Oncology
Collaborators: National Cancer Institute (NCI)
Conditions
(from sponsor)		 Pancreatic Acinar Cell Carcinoma, Pancreatic Adenocarcinoma, Pancreatic Adenosquamous Carcinoma, Pancreatic Carcinoma, Pancreatic Ductal Adenocarcinoma, Pancreatic Squamous Cell Carcinoma, Stage IV Pancreatic Cancer AJCC v8
Related terms Pancreatic Neoplasms
Enrollment 10 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov