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

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

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).

Trial Description

Primary Outcome:

• Objective Response Rate (ORR)

• Duration of Response (DOR)
• Overall Survival (OS)
• Progression Free Survival (PFS)
• Number of Participants Experiencing an Adverse Event (AE)
• Number of Participants Discontinuing Study Treatment due to an Adverse Event (AE)
• Objective Response Rate (ORR) in Participants with HRRm or HRD Positive Cancer
• Time to Earliest Progression by Cancer Antigen-125 (CA-125)
• Prostate-specific Antigen (PSA) Response Rate in Participants with Prostate Cancer
• Progression-Free Survival After Next-Line Treatment in Participants with sBRCAm Breast Cancer

View this trial on ClinicalTrials.gov