A Study to Evaluate the Efficacy and Safety of Novel Treatment Combinations in Participants With Ovarian Cancer

Official Title

A Phase 1B/2 Multicohort Umbrella Study to Evaluate the Safety and Efficacy of Novel Treatments And/Or Combinations of Treatments in Participants With Ovarian Cancer (OPAL)

Summary:

This study will evaluate the efficacy and safety of niraparib and novel treatment combinations of niraparib as described within each cohort-specific supplement in participants with ovarian, fallopian tube, or primary peritoneal cancer. Cohort A (single arm) includes participants with recurrent ovarian cancer. Cohort B will not be initiated. Cohort C (randomized-2 arms) includes participants with newly diagnosed ovarian cancer.

Trial Description

Primary Outcome Measures :

  • Cohort A: Objective response rate
    • Objective Response Rate is defined as percentage of participants who have achieved confirmed complete response (CR) or partial response (PR), evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 based on investigator assessment.
  • Cohort C: Pre-IDS ORR
    • ORR is defined as the percentage of participants with unconfirmed complete or partial response on study treatment pre-IDS as assessed per RECIST v1.1 by the investigator.
Secondary Outcome Measures :
  • Cohort A: Progression free survival (PFS)
    • PFS is defined as the time from the date of the first dose of study treatment to the earliest date of assessment of progression or death by any cause in the absence of progression by RECIST version 1.1.
  • Cohort A: Overall survival (OS)
    • OS is defined as the time from the date of the first dose of study treatment to the date of death by any cause.
  • Cohort A: Duration of Response (DOR)
    • DOR is defined as the time from first documentation of response (CR or PR) until the time of first documentation of disease progression by RECIST version 1.1 based on Investigator's assessment or death by any cause.
  • Cohort A: Disease Control Rate (DCR)
    • DCR is defined as the percentage of participants who have achieved best overall response of CR, PR, or stable disease (SD) per RECIST version 1.1 based on Investigator's assessment.
  • Cohort A: Number of participants with adverse events (AEs) and serious adverse events (SAEs)
    • An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgment.
  • Cohort C: Number of participants with cancer antigen (CA)-125 progression
    • Serum samples will be collected to determine CA-125 progression by Gynecological Cancer InterGroup (GCIG) CA-125 response criteria.
  • Cohort C: PFS
    • PFS is defined as the time from the date of treatment randomization to the date of first documentation of progression of disease (PD) per RECIST v1.1 or death by any cause, whichever occurs first, as determined by the investigator.
  • Cohort C: PFS12
    • PFS12 is defined as the percentage of participants without documented PD per RECIST v1.1 or death within 12 months after the date of treatment randomization.
  • Cohort C: PFS18
    • PFS18 is defined as the percentage of participants without documented PD per RECIST v1.1 or death within 18 months after the date of treatment randomization.
  • Cohort C: PFS24
    • PFS24 is defined as the percentage of participants without documented PD per RECIST v1.1 or death within 24 months after the date of treatment randomization.
  • Cohort C: OS
    • OS will be defined as the time from the date of treatment randomization to the date of death by any cause.
  • Cohort C: Time to first subsequent treatment (TFST)
    • TFST will be defined as the time from the date of treatment randomization to the date of first subsequent anticancer therapy or death.

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society