Trial record 28 of 197 for:
Oral Cancer | ( Map: Mexico )
Efficacy and Safety of Olaparib (MK-7339) in Participants With Previously Treated, Homologous Recombination Repair Mutation (HRRm) or Homologous Recombination Deficiency (HRD) Positive Advanced Cancer (MK-7339-002 / LYNK-002)
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ClinicalTrials.gov Identifier: NCT03742895 |
Recruitment Status :
Recruiting
First Posted : November 15, 2018
Last Update Posted : December 5, 2019
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Sponsor:
Merck Sharp & Dohme Corp.
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
Tracking Information | |||||||
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First Submitted Date ICMJE | November 14, 2018 | ||||||
First Posted Date ICMJE | November 15, 2018 | ||||||
Last Update Posted Date | December 5, 2019 | ||||||
Actual Study Start Date ICMJE | December 12, 2018 | ||||||
Estimated Primary Completion Date | April 30, 2023 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
Objective Response Rate (ORR) [ Time Frame: Up to 53 months ] ORR is defined as the percentage of participants who achieve a confirmed complete response ([CR]; disappearance of all target lesions) or partial response ([PR]: ≥30% decrease in the sum of diameters of target lesions) as assessed by blinded independent central review (BICR) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1). For participants with prostate cancer, ORR will be based on Prostate Cancer Working Group (PCWG)-modified RECIST 1.1 as assessed by BICR.
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Original Primary Outcome Measures ICMJE | Same as current | ||||||
Change History | Complete list of historical versions of study NCT03742895 on ClinicalTrials.gov Archive Site | ||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | Efficacy and Safety of Olaparib (MK-7339) in Participants With Previously Treated, Homologous Recombination Repair Mutation (HRRm) or Homologous Recombination Deficiency (HRD) Positive Advanced Cancer (MK-7339-002 / LYNK-002) | ||||||
Official Title ICMJE | A Phase 2 Study of Olaparib Monotherapy in Participants With Previously Treated, Homologous Recombination Repair Mutation (HRRm) or Homologous Recombination Deficiency (HRD) Positive Advanced Cancer | ||||||
Brief Summary | This study will evaluate the efficacy and safety of olaparib (MK-7339) monotherapy in participants with multiple types of advanced cancer (unresectable and/or metastatic) that: 1) have progressed or been intolerant to standard of care therapy; and 2) are positive for homologous recombination repair mutation (HRRm) or homologous recombination deficiency (HRD). | ||||||
Detailed Description | Not Provided | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 2 | ||||||
Study Design ICMJE | Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Advanced Solid Neoplasms | ||||||
Intervention ICMJE | Drug: Olaparib
Olaparib 300 mg administered BID as two, 150 mg oral tablets.
Other Names:
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Study Arms ICMJE | Experimental: Olaparib
Participants with HRRm or HRD-positive advanced cancer will receive oral olaparib, 300 mg twice daily (BID).
Intervention: Drug: Olaparib
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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 | Recruiting | ||||||
Estimated Enrollment ICMJE |
370 | ||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||
Estimated Study Completion Date ICMJE | April 30, 2023 | ||||||
Estimated Primary Completion Date | April 30, 2023 (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 |
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Listed Location Countries ICMJE | Mexico, Argentina, Australia, Canada, Colombia, Denmark, France, Guatemala, Ireland, Israel, Italy, Japan, Korea, Republic of, Peru, Romania, Russian Federation, Spain, Switzerland, Turkey, United Kingdom, United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT03742895 | ||||||
Other Study ID Numbers ICMJE | 7339-002 MK-7339-002 ( Other Identifier: Merck Protocol Number ) 2018-003007-19 ( EudraCT Number ) LYNK-002 ( Other Identifier: Merck ) 194694 ( Registry Identifier: JAPIC-CTI ) |
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Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Merck Sharp & Dohme Corp. | ||||||
Study Sponsor ICMJE | Merck Sharp & Dohme Corp. | ||||||
Collaborators ICMJE | AstraZeneca | ||||||
Investigators ICMJE |
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PRS Account | Merck Sharp & Dohme Corp. | ||||||
Verification Date | December 2019 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |