The PLATINUM Trial: Optimizing Chemotherapy for the Second-Line Treatment of Metastatic BRCA1/2 o… (NCT06115499) | Clinical Trial Compass
Active — Not RecruitingPhase 2/3
The PLATINUM Trial: Optimizing Chemotherapy for the Second-Line Treatment of Metastatic BRCA1/2 or PALB2-Associated Metastatic Pancreatic Cancer
United States10 participantsStarted 2024-08-13
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Metastatic pancreatic adenocarcinoma. Adenosquamous carcinoma, squamous carcinoma, acinar cell carcinoma, and carcinoma not otherwise specified are also acceptable
* BRCA1/2 or PALB2 mutation (somatic or germline) identified on any Clinical Laboratory Improvement Amendments (CLIA)-certified gene panel. Mutations must be considered pathogenic or likely pathogenic by a reference database such as ClinVar or OncoKb.org. (Submission of mutation report will be required)
* Measurable disease
* Potential trial participants should have recovered from clinically significant adverse events of their most recent therapy/intervention prior to enrollment
* Clinical or radiographic progression on first-line FOLFIRINOX (or nanoliposomal irinotecan, fluorouracil, leucovorin, and oxaliplatin \[NALIRIFOX\]) for metastatic disease
* Patients whose front-line chemotherapy was required to be simplified due to toxicity associated with any of the constituent components of FOLFIRINOX/NALIRIFOX (e.g. simplified to leucovorin calcium, fluorouracil, and oxaliplatin \[FOLFOX\], leucovorin calcium, fluorouracil, and irinotecan \[FOLFIRI\], fluorouracil \[5-FU\] \[including capecitabine\]) will be eligible
* Patients with progressive disease while on maintenance PARP inhibitor treatment after FOLFIRINOX (or NALIRIFOX), irrespective of how long ago they received FOLFIRINOX/NALIRIFOX, will also be eligible
* Patients who develop metastatic disease during or within 6 months after …
What they're measuring
1
Overall response rate (ORR) (Phase II)
Timeframe: Up to 12 months
2
Overall Survival (OS) (Phase III)
Timeframe: From the date of randomization to the date of death due to all causes, assessed up to 5 years