Olaparib 300mg tablets for Ovarian Cancer

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Ovarian Cancer+6 MoreOlaparib 300mg tablets - Drug
Eligibility
18 - 130
Female
What conditions do you have?
Select

Study Summary

This trial looked at olaparib as a possible treatment for ovarian cancer in patients who had the BRCA gene mutation.

Eligible Conditions
  • International Federation of Gynecology and Obstetrics (FIGO) Stage III-IV
  • Partial Response
  • Ovarian Cancer
  • Newly Diagnosed
  • BRCA Mutations
  • First Line Platinum Chemotherapy
  • Complete Response

Treatment Effectiveness

Study Objectives

1 Primary · 8 Secondary · Reporting Duration: CA-125 performed at baseline then every 4 weeks. Radiologic scans performed at baseline then every 12 weeks up to 156 weeks, then every 24 weeks until objective radiological disease progression. Analysis of data assessed up to a maximum of 54 months.

Month 54
Efficacy in Patients Following First Line Platinum Based Chemotherapy by Assessment of Time to First Subsequent Therapy or Death (TFST)
Month 54
Efficacy in Patients Following First Line Platinum Based Chemotherapy by Assessment of Time to Second Subsequent Therapy or Death (TSST)
Month 54
Efficacy in Patients Following First Line Platinum Based Chemotherapy by Assessment of Time to Earliest Progression by RECIST or Cancer Antigen (CA-125) or Death
Month 54
Efficacy in Patients Following First Line Platinum Based Chemotherapy by Assessment of Time From Randomization to Second Progression
Month 24
Ovary
Month 54
Efficacy in Patients With a Deleterious or Suspected Deleterious Variant in Either of the BRCA Genes by Assessment of PFS
Month 54
Progression Free Survival (PFS) Using Investigator Assessment According to Modified Response Evaluation Criteria in Solid Tumours (RECIST 1.1)
Month 54
Efficacy in Patients Following First Line Platinum Based Chemotherapy by Assessment of Overall Survival
Month 54
Efficacy in Patients Following First Line Platinum Based Chemotherapy by Assessment of Time From Randomization to Study Treatment Discontinuation or Death (TDT)

Trial Safety

Trial Design

2 Treatment Groups

Olaparib tablets p.o. 300mg twice daily
1 of 2
Placebo tablets p.o. twice daily
1 of 2

Experimental Treatment

Non-Treatment Group

450 Total Participants · 2 Treatment Groups

Primary Treatment: Olaparib 300mg tablets · Has Placebo Group · Phase 3

Olaparib tablets p.o. 300mg twice daily
Drug
Experimental Group · 1 Intervention: Olaparib 300mg tablets · Intervention Types: Drug
Placebo tablets p.o. twice daily
Drug
PlaceboComparator Group · 1 Intervention: Olaparib 300mg tablets · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: ca-125 performed at baseline then every 4 weeks. radiologic scans performed at baseline then every 12 weeks up to 156 weeks, then every 24 weeks until objective radiological disease progression. analysis of data assessed up to a maximum of 54 months.

Who is running the clinical trial?

GOG FoundationNETWORK
29 Previous Clinical Trials
11,574 Total Patients Enrolled
6 Trials studying Ovarian Cancer
2,343 Patients Enrolled for Ovarian Cancer
Myriad Genetic Laboratories, Inc.Industry Sponsor
31 Previous Clinical Trials
14,210 Total Patients Enrolled
1 Trials studying Ovarian Cancer
Merck Sharp & Dohme LLCIndustry Sponsor
3,684 Previous Clinical Trials
4,957,678 Total Patients Enrolled
36 Trials studying Ovarian Cancer
5,858 Patients Enrolled for Ovarian Cancer
AstraZenecaLead Sponsor
3,996 Previous Clinical Trials
247,423,182 Total Patients Enrolled
44 Trials studying Ovarian Cancer
23,775 Patients Enrolled for Ovarian Cancer
Prof Kathleen Moore, MDPrincipal InvestigatorUniversity of Oklahoma Health Sciences Center, Oklahoma City, USA
Prof Paul DiSilvestro, MDPrincipal InvestigatorWomen & Infants Hospital, Providence, Rhode Island, USA

Eligibility Criteria

Age 18 - 130 · Female Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have high risk advanced BRCA mutated high grade serous or high grade endometrioid ovarian cancer, primary peritoneal cancer and / or fallopian tube cancer
Patients must have, in the opinion of the investigator, clinical complete response or partial response and have no clinical evidence of disease progression on the post-treatment scan or rising CA-125 level, following completion of this chemotherapy course.
You have a documented mutation in BRCA1 or BRCA2 that is predicted to be deleterious or suspected deleterious (known or predicted to be detrimental/lead to loss of function).
Patients must be randomized within 8 weeks of their last dose of chemotherapy.

Who else is applying?

What state do they live in?
North Carolina100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria100.0%
References