NCT02511223

Efficacy and Safety of PARPi to Treat Pancreatic Cancer

PHASE II Study - EFFICACY AND SAFETY OF (PARPi )Polyadenosine Diphosphoribose [Poly Polymerisation inhibitorTO TREAT PANCREATIC CANCER

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Sheba Medical Center · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

An open label, single arm, phase II trial of Olaparib for PDAC patients with BRCAness (BRCA-Breast Cancer susceptibility gene). Patients with previously identified Loss of ATM (ATM serine/threonine kinase)by (IHC) Immunohistochemistry OR (overall survival) - Family history of BRCA (Brest Cancer gene)-associated cancers: breast, ovarian, pancreatic, gastric or prostate must be present in 2 or more first-degree relatives OR- Patients with previously identified genetic aberrations that are associated with (HRD) Homologous recombination deficiency will be eligible \[e.g. somatic BRCA mutation, Fanconi Anemia gene or RAD51(eukaryote gene) mutations\]. All patients will be retrospectively investigated for (HRD)Homologous recombination repair deficiencies signature using transcriptome profiling and ATM expression and the results correlated with (PARPi) (Polyadenosine 5'diphosphoribose \[poly (ADP ribose)\] polymerization INHIBITOR) response rates. Eligible patients will receive treatment with Olaparib tablets p.o 300 (mg) milligram twice daily until progression. Each treatment cycle is described as 28 days long. Patients will have tumor assessments according to RECIST 1.1(Response Evaluation Criteria In Solid Tumors) at baseline. Patients will then be followed for the final analysis of (OS) overall survival. Eligible patients will be those patients with stage IV pancreas cancer previously treated for metastatic disease. Patients must have received one prior therapy for the treatment of metastatic disease or refused chemotherapy. Following study entry, patients will attend clinic visits every two weeks for the first 4 weeks of treatment (Days 1 and 15,). Patients will then attend clinic visits every 4 weeks whilst on study treatment. Patients should continue to receive study treatment until objective radiological disease progression as per RECIST as assessed by the investigator and as long as in the investigator's opinion they are benefiting from treatment and they do not meet any other discontinuation criteria. Following discontinuation of study treatment, patients should be seen at 30 days post discontinuation for the evaluations outlined in the study schedule. Patients will be contacted in the 7 days following a specified date (data cut-off date) to capture survival status at that point for each survival analysis. Patients will have tumor assessments according to RECIST at baseline and every 8 weeks (±1week) up to 40 weeks and then every 12 weeks (±1 week) relative to date of enrolment until objective radiological disease progression according to modified RECIST criteria. Ongoing collection of site review tumor assessment is required and must be recorded in the electronic case report form (eCRF). Any patient who discontinues study treatment for reasons other than objective radiological progression should continue to undergo scheduled objective tumor assessments according to the study schedule, in order to assess objective radiological progression of disease. Failure to do so may result in bias to the study results.

Conditions

• Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	OLAPARIB	Olaparib 300 (mg) twice a day per os given every day until disease progression or toxicity

Timeline

• Start date: 2016-07-01
• Primary completion: 2021-04-18
• Completion: 2021-04-18
• First posted: 2015-07-29
• Last updated: 2023-04-19

Locations

1 site across 1 country: Israel