OLAParib COmbinations (OLAPCO)
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ClinicalTrials.gov Identifier: NCT02576444 |
Recruitment Status :
Terminated
(The study was paused during COVID and without the ability to initiate the 4th arm in the study, the decision was to terminate the study in 2022.)
First Posted : October 15, 2015
Results First Posted : December 28, 2022
Last Update Posted : December 28, 2022
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Tracking Information | ||||
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First Submitted Date ICMJE | October 12, 2015 | |||
First Posted Date ICMJE | October 15, 2015 | |||
Results First Submitted Date ICMJE | August 25, 2022 | |||
Results First Posted Date ICMJE | December 28, 2022 | |||
Last Update Posted Date | December 28, 2022 | |||
Actual Study Start Date ICMJE | November 2015 | |||
Actual Primary Completion Date | November 18, 2019 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Overall Response Rate [ Time Frame: Change from baseline to 16 weeks ] Tumor overall response rate (ORR) in molecularly selected patients with measurable disease as assessed by the Response Evaluation Criteria in Solid Tumors (RECIST), before versus after 16 weeks of treatment across tumor types in each arm of the study (Note: there will be no formal comparison between arms). Complete Response (CR): disappearance of all target lesions, Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive Disease (PD). Clinical Benefit is defined as the sum of CR, PR, or SD at 16 weeks from the start of treatment.
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Original Primary Outcome Measures ICMJE |
Overal Response Rate [ Time Frame: Change from baseline to 16 weeks ] tumor overall response rate (ORR) in molecularly selected patients with measurable disease as assessed by the Response Evaluation Criteria in Solid Tumors (RECIST), before versus after 16 weeks of treatment across tumor types in each arm of the study (Note: there will be no formal comparison between arms)
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Change History | ||||
Current Secondary Outcome Measures ICMJE | Not Provided | |||
Original Secondary Outcome Measures ICMJE | Not Provided | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | OLAParib COmbinations | |||
Official Title ICMJE | A Phase II Study of the PARP Inhibitor Olaparib (AZD2281) Alone and in Combination With AZD1775, AZD5363, or AZD6738 in Advanced Solid Tumors | |||
Brief Summary | The primary objective of this phase II trial is to determine tumor overall response rate (ORR) in molecularly selected patients with measurable disease as assessed by the Response Evaluation Criteria in Solid Tumors (RECIST), before versus after 16 weeks of treatment across tumor types in each arm of the study. | |||
Detailed Description | This is a phase II signal-searching study in a range of tumor types with the potential to identify novel tumor indications for combination therapy with olaparib that can subsequently be explored in dedicated studies. Patients will be enrolled in this study based on molecular markers from genetic profiling performed on their tumors prior to study entry (outside of protocol). The trial will also identify genetic determinants of response and resistance. Patients with tumors harboring damaging mutations in Homologous - DNA repair (HDR) genes or mutations such as ATM, CHK2, MRN (MRE11/NBS1/RAD50), CDKN2A/B and APOBEC will be treated with olaparib or olaparib and AZD6738. Enrollment to the olaparib monotherapy arm will be completed prior to commencement of enrollment to the olaparib and AZD6738 arm. Patients with tumors harboring IDH1/IDH2 mutations will be treated with olaparib. Patients with tumors harboring either TP53 or KRAS mutations or mutations in KRAS and TP53 will be treated with AZD1775 plus olaparib. Patients with tumors harboring PTEN, PIK3CA, AKT, or ARID1A mutations or other molecular aberrations leading to dysregulation of the PI3K/AKT pathway will be treated with AZD5363 plus olaparib. |
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Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Cancer | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Terminated | |||
Actual Enrollment ICMJE |
67 | |||
Original Estimated Enrollment ICMJE |
64 | |||
Actual Study Completion Date ICMJE | November 18, 2019 | |||
Actual Primary Completion Date | November 18, 2019 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT02576444 | |||
Other Study ID Numbers ICMJE | 1508016363 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Current Responsible Party | Joseph Paul Eder, Yale University | |||
Original Responsible Party | Yale University | |||
Current Study Sponsor ICMJE | Joseph Paul Eder | |||
Original Study Sponsor ICMJE | Yale University | |||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Yale University | |||
Verification Date | November 2022 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |