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A022106

Trial Overview

Official Title

PHASE II/III SECOND-LINE NABPLAGEM VS. NAB-PACLITAXEL/GEMCITABINE IN BRCA1/2 OR PALB2 MUTANT METASTATIC PANCREATIC DUCTAL ADENOCARCINOMA (PLATINUM)

Study Purpose

To evaluate and compare overall response rate (ORR) in patients with BRCA1/2 or PALB2 mutant pancreas cancer whose disease has progressed on front-line FOLFIRINOX treated with NABPLAGEM = nab-paclitaxel, gemcitabine, and cisplatin (arm 1) versus nab-paclitaxel and gemcitabine (arm 2)

Diagnosis

Pancreatic cancer

Eligibility

Histologic documentation of metastatic pancreatic adenocarcinoma, adenosquamous carcinoma, carcinoma or acinar carcinoma -Pathogenic BRCA1/2 or PALB2 mutation (somatic or germline);

 

Intervention

Arm 1: Nab-paclitaxel 100 mg/m2 + cisplatin 25 mg/m2 + gemcitabine 800 mg/m2 on days 1 and 15

Arm 2: Nab-paclitaxel 125 mg/m2 + gemcitabine 1000 mg/m2 on days 1 and 15

For more information, visit Clinicaltrials.gov

Key Participation Requirements
Trial Location(s)
Methodist Estabrook Cancer Center Methodist Jennie Edmundson Hospital
Enrollment Status
Recruiting
Phase
Phase II
Methodist Health System Trial Code
A022106