Efficacy and Safety of PARPi to Treat Pancreatic Cancer

Sponsor
Sheba Medical Center
Study ID
NCT02511223
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • OLAPARIB — DRUG
    Olaparib 300 (mg) twice a day per os given every day until disease progression or toxicity

Study Details

This is an open label, single arm, phase II trial of Olaparib for (PDAC) pancreatic ductal adenocarcinoma patients with BRCAness (breast cancer gene). All study subjects will receive Olaparib in a dose of 300 mg p.o twice daily. Treatment will continue until progression, intolerable toxicity or as per patient preference. Primary objective: To determine the efficacy of Olaparib monotherapy in stage IV pancreatic ductal adenocarcinoma (PDAC)with (BRCAness) BRCA -Breast Cancer susceptibility gene.

Key Dates

Start date
Jul 31, 2016
Status verified
Mar 2017
Primary completion
Apr 18, 2021
Completion
Apr 18, 2021

Study Design

Enrollment
24 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Single Arm
    Only one Arm,All patients will receive Olaparib 300 (mg) milligram bid p.o till disease progression

Primary Outcome Measure

Objective Response Rate (ORR) by using RECIST 1.1 [ Time Frame: approximately- 24 months ]

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