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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
390
Olaparib 300 mg administered BID as two, 150 mg oral tablets.
The University of Arizona Cancer Center - North Campus ( Site 0011)
Tucson, Arizona, United States
St Joseph Heritage Healthcare-Oncology ( Site 0056)
Fullerton, California, United States
Cedars Sinai Medical Center ( Site 0002)
Los Angeles, California, United States
UCSF Helen Diller Family Comprehensive Cancer Center ( Site 0007)
San Francisco, California, United States
Rocky Mountain Regional Veterans Affairs Medical Center ( Site 0092)
Aurora, Colorado, United States
Objective Response Rate (ORR)
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, modified to follow a maximum of 10 target lesions in total and a maximum of 5 target lesions per organ (modified 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.
Time frame: Up to 53 months
Duration of Response (DOR)
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 modified RECIST 1.1 or PCWG-modified RECIST 1.1 for participants with prostate cancer.
Time frame: Up to 53 months
Overall Survival (OS)
OS is defined as the time from the date of the first dose to the date of death due to any cause.
Time frame: Up to 53 months
Progression Free Survival (PFS)
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 modified RECIST 1.1 or PCWG-modified RECIST 1.1 for participants with prostate cancer; or 2) death due to any cause, whichever occurs first.
Time frame: Up to 53 months
Number of Participants Experiencing an Adverse Event (AE)
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.
Time frame: Up to 53 months
Number of Participants Discontinuing Study Treatment due to an Adverse Event (AE)
The number of participants discontinuing study treatment due to an AE will be assessed.
Time frame: Up to 52 months
Objective Response Rate (ORR) in Participants with HRRm or HRD Positive Cancer
For participants with homologous recombination repair mutation (HRRm) or homologous recombination deficiency (HRD) positive cancer, the ORR will be assessed. 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, modified to follow a maximum of 10 target lesions in total and a maximum of 5 target lesions per organ (modified 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.
Time frame: Up to 53 months
Time to Earliest Progression by Cancer Antigen-125 (CA-125)
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.
Time frame: Up to 53 months
Prostate-specific Antigen (PSA) Response Rate in Participants with Prostate Cancer
For participants with prostate cancer, the PSA response rate will be presented. PSA response rate is defined as the percentage of participants in the analysis population with PSA reduction of ≥50% from baseline measured twice at least 3 weeks apart.
Time frame: Up to 53 months
Progression-Free Survival After Next-Line Treatment in Participants with sBRCAm Breast Cancer
For participants with somatic BRCA mutated (sBRCAm) breast cancer, the PFS after next-line treatment will be presented. PFS is defined as the time from the date of the first dose to either: 1) the first documented disease progression on the next-line of treatment, as assessed by BICR according to modified RECIST 1.1; or 2) death due to any cause, whichever occurs first.
Time frame: Up to 53 months
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Winship Cancer Institute of Emory University ( Site 0025)
Atlanta, Georgia, United States
Augusta University ( Site 0028)
Augusta, Georgia, United States
Markey Cancer Center ( Site 0018)
Lexington, Kentucky, United States
University of Maryland ( Site 0050)
Baltimore, Maryland, United States
Weinberg Cancer Institute at Franklin Square ( Site 0054)
Baltimore, Maryland, United States
...and 120 more locations