Olaparib in Treating Patients With Stage IV Pancreatic Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02677038|
Recruitment Status : Active, not recruiting
First Posted : February 9, 2016
Last Update Posted : May 10, 2021
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Pancreatic Adenocarcinoma Pancreatic Ductal Adenocarcinoma Stage IV Pancreatic Cancer AJCC v6 and v7||Drug: Olaparib||Phase 2|
I. To determine the efficacy of olaparib monotherapy in stage IV pancreatic ductal adenocarcinoma (PDAC) with breast cancer, early onset (BRCA)ness.
I. To further determine the efficacy of olaparib in the study population.
I. To assess the safety and tolerability of olaparib.
I. To identify tissue based biomarkers of defective homologous recombination repair (HRD).
Patients receive olaparib orally (PO) twice daily (BID) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 days and then every 8 weeks thereafter.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||34 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Olaparib for BRCAness Phenotype in Pancreatic Cancer: Phase II Study|
|Actual Study Start Date :||November 11, 2016|
|Estimated Primary Completion Date :||November 30, 2021|
|Estimated Study Completion Date :||November 30, 2022|
Experimental: Treatment (olaparib)
Patients receive olaparib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- Objective response rate (defined as complete response or partial response) assessed using Response Evaluation Criteria in Solid Tumors 1.1 [ Time Frame: At 24 weeks ]Simon's optimal two-stage design will be implemented for the study. The objective response rate and its corresponding exact 95% confidence interval will be estimated.
- Overall survival (OS) [ Time Frame: Time from date of study entry to the date of death from any cause or to the date of last follow-up if patients are alive, assessed up to 3 years ]The Kaplan-Meier method will be used to estimate the probability of OS. The Log rank test and Cox proportional hazards models will be used to determine the association of OS with patient characteristics.
- Progression free survival (PFS) [ Time Frame: Time from the date of study entry to the date of progression or to the date of death from any cause, whichever occurred first, or to the last follow-up date if patients are alive without disease progression, assessed up to 3 years ]The Kaplan-Meier method will be used to estimate the probability of PFS. The Log rank test and Cox proportional hazards models will be used to determine the association of PFS with patient characteristics.
- Change in cancer antigen 19-9 (CA19-9) clinical response [ Time Frame: Baseline to up to 8 weeks ]Defined as the percentage reduction before and after 8 weeks of treatment. The mean, standard deviation, median and range will be summarized for the percentage reduction of CA 19-9.
- Incidence of unacceptable toxicity [ Time Frame: Up to 30 days after the completion of study treatment ]Defined as treatment related grade 3 or higher toxicities graded by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Unacceptable toxicities will be monitored closely using the method of Thall et al.
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): NCT02677038
|United States, Texas|
|M D Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Milind Javle||M.D. Anderson Cancer Center|