Efficacy and Safety of PARPi to Treat Pancreatic Cancer
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|ClinicalTrials.gov Identifier: NCT02511223|
Recruitment Status : Unknown
Verified March 2017 by Sheba Medical Center.
Recruitment status was: Recruiting
First Posted : July 29, 2015
Last Update Posted : September 29, 2017
This is an open label, single arm, phase II trial of Olaparib for PDAC patients with BRCAness. 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.
To determine the efficacy of Olaparib monotherapy in stage IV pancreatic ductal adenocarcinoma (PDAC)with BRCAness (BRCA-Breast Cancer susceptibility gene).
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer||Drug: OLAPARIB||Phase 2|
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 OR- Family history of BRCA-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 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)] polymerisation INHIBITOR) response rates.
Eligible patients will receive treatment with Olaparib tablets p.o 300 mg 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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||PHASE II Study - EFFICACY AND SAFETY OF PARPi TO TREAT PANCREATIC CANCER|
|Actual Study Start Date :||July 2016|
|Estimated Primary Completion Date :||September 2017|
|Estimated Study Completion Date :||October 2017|
Experimental: Single Arm
Only one Arm,All patients will receive Olaparib 300 mg (MILIGRAM)bid p.o till disease progression
Olaparib 300 MG twice a day per os given every day until disease progression or toxicity
Other Name: PARPi
- Objective Response Rate (ORR) by using RECIST 1.1 [ Time Frame: approximately- 24 months ]
- Overall Survival (OS) [ Time Frame: approximately- 24 months ]
- Progression Free Survival (PFS) [ Time Frame: approximately- 24 months ]
- Carbohydrate antigen (CA )19-9 response rate [ Time Frame: approximately- 24 months ]
- Number of adverse events (AEs) and serious adverse events (SAEs); [ Time Frame: approximately- 24 months ]
- Composite measure of dose interruptions, reductions and dose intensity [ Time Frame: approximately- 24 months ]
- Retrospective analysis of HRD signature by composite measure: ATM expression (IHC) DNA exploratory analysis [ Time Frame: approximately- 24 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02511223
|Contact: Talia Golan, MD||+972 3 5307099||Talia.Golan@sheba.health.gov.il|
|Contact: Aliza Ackerstein, Msc||00972-3-5308402||Aliza.Ackerstein@sheba.health.gov.il|
|Principal Investigator:||Talia Golan, MD||Sheba medical centre Israel|