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)
|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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03742895|
Recruitment Status : Recruiting
First Posted : November 15, 2018
Last Update Posted : May 21, 2020
|Condition or disease||Intervention/treatment||Phase|
|Advanced Solid Neoplasms||Drug: Olaparib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||370 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||December 12, 2018|
|Estimated Primary Completion Date :||February 13, 2023|
|Estimated Study Completion Date :||February 13, 2023|
Participants with HRRm or HRD-positive advanced cancer will receive oral olaparib, 300 mg twice daily (BID).
Olaparib 300 mg administered BID as two, 150 mg oral tablets.
- 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.
- Duration of Response (DOR) [ Time Frame: Up to 53 months ]DOR is defined as the time from first documented evidence of CR or PR until the first documented sign of disease progression or death due to any cause, whichever occurs first. DOR will be assessed by BICR according to either RECIST 1.1 or PCWG-modified RECIST 1.1 for participants with prostate cancer.
- Overall Survival (OS) [ Time Frame: Up to 53 months ]OS is defined as the time from the date of the first dose to the date of death due to any cause.
- Progression Free Survival (PFS) [ Time Frame: Up to 53 months ]PFS is defined as the time from the date of the first dose to either: 1) the first documented disease progression as assessed either by BICR according to RECIST 1.1 or PCWG-modified RECIST 1.1 for participants with prostate cancer; or 2) death due to any cause, whichever occurs first.
- Number of Participants Experiencing an Adverse Event (AE) [ Time Frame: Up to 53 months ]An AE is any unfavorable and unintended sign, symptom, or disease (new or exacerbated) in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants experiencing an AE will be assessed.
- Number of Participants Discontinuing Study Treatment due to an Adverse Event (AE) [ Time Frame: Up to 52 months ]The number of participants discontinuing study treatment due to an AE will be assessed.
- Time to Earliest Progression by Cancer Antigen-125 (CA-125) [ Time Frame: Up to 53 months ]For participants with BRCA1/2 non-mutated ovarian cancer only, the time to earliest progression by CA-125 will be assessed. Progression by CA-125 is defined as an increase in CA-125 level ≥2x upper limit normal (ULN) on 2 occasions, 1 week apart. For participants with elevated CA-125 (≥ULN) at baseline, progression by CA-125 is defined as an increase in CA-125 level ≥2x the nadir value on 2 occasions, 1 week apart.
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): NCT03742895
|Contact: Toll Free Number||1-888-577-8839||Trialsites@merck.com|
|Study Director:||Medical Director||Merck Sharp & Dohme Corp.|