Olaparib in PALB2 Advanced Pancreatic Cancer

Sponsor
Azienda Ospedaliero-Universitaria di Modena
Study ID
NCT06078787
Phase
PHASE2
Status
Recruiting
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Conditions

  • Advanced Pancreatic Cancer
  • Metastatic Pancreatic Cancer

Eligibility Criteria

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

Interventions

  • Olaparib 150 MG — DRUG
    Olaparib should be dosed 2 x 150 mg tablets (300 BID)

Study Details

This is a Phase II, non-randomized, multicenter, unblinded open-label study of Olaparib in monotherapy in participants with advanced (locally advanced/metastatic) PALB2-related pancreatic cancer that have progressed after at least one treatment for advanced disease.

Key Dates

Start date
Aug 1, 2023
Status verified
May 2024
Primary completion
Aug 1, 2025
Completion
Aug 1, 2026

Study Design

Enrollment
16 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Olaparb

Primary Outcome Measure

To evaluate the ORR according to RECIST 1.1 following Olaparib administration [ Time Frame: 2-3 years ]

Central Contacts

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