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
Effectiveness Progress
This is further along than 85% of similar trials
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
Safety Progress
This is further along than 85% of similar trials
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: DrugPlacebo tablets p.o. twice daily
Drug
PlaceboComparator Group · 1 Intervention: Olaparib 300mg tablets · Intervention Types: DrugTrial 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 Carolina | 100.0% |
What portion of applicants met pre-screening criteria?
| Did not meet criteria | 100.0% |
References
- Moore, Kathleen, Nicoletta Colombo, Giovanni Scambia, Byoung-Gie Kim, Ana Oaknin, Michael Friedlander, Alla Lisyanskaya, et al.. 2018. “Maintenance Olaparib in Patients with Newly Diagnosed Advanced Ovarian Cancer”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa1810858.
- Friedlander, Michael, Kathleen N Moore, Nicoletta Colombo, Giovanni Scambia, Byoung-Gie Kim, Ana Oaknin, Alla Lisyanskaya, et al.. 2021. “Patient-centred Outcomes and Effect of Disease Progression on Health Status in Patients with Newly Diagnosed Advanced Ovarian Cancer and a BRCA Mutation Receiving Maintenance Olaparib or Placebo (SOLO1): A Randomised, Phase 3 Trial”. The Lancet Oncology. Elsevier BV. doi:10.1016/s1470-2045(21)00098-x.
- Banerjee, Susana, Kathleen N Moore, Nicoletta Colombo, Giovanni Scambia, Byoung-Gie Kim, Ana Oaknin, Michael Friedlander, et al.. 2021. “Maintenance Olaparib for Patients with Newly Diagnosed Advanced Ovarian Cancer and a BRCA Mutation (SOLO1/GOG 3004): 5-year Follow-up of a Randomised, Double-blind, Placebo-controlled, Phase 3 Trial”. The Lancet Oncology. Elsevier BV. doi:10.1016/s1470-2045(21)00531-3.
- Banerjee, Susana, Kathleen N Moore, Nicoletta Colombo, Giovanni Scambia, Byoung-Gie Kim, Ana Oaknin, Michael Friedlander, et al.. 2021. “Maintenance Olaparib for Patients with Newly Diagnosed Advanced Ovarian Cancer and a BRCA Mutation (SOLO1/GOG 3004): 5-year Follow-up of a Randomised, Double-blind, Placebo-controlled, Phase 3 Trial”. The Lancet Oncology. Elsevier BV. doi:10.1016/s1470-2045(21)00531-3.
- Tattersall A, Ryan N, Wiggans AJ, Rogozińska E, Morrison J. Poly(ADP-ribose) polymerase (PARP) inhibitors for the treatment of ovarian cancer. Cochrane Database Syst Rev. 2022 Feb 16;2:CD007929. doi: 10.1002/14651858.CD007929.pub4. Review.
- DiSilvestro, Paul, Susana Banerjee, Nicoletta Colombo, Giovanni Scambia, Byoung-Gie Kim, Ana Oaknin, Michael Friedlander, et al.. 2022. “Overall Survival with Maintenance Olaparib at a 7-year Follow-up in Patients with Newly Diagnosed Advanced Ovarian Cancer and a BRCA Mutation: The SOLO1/GOG 3004 Trial”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.22.01549.
- DiSilvestro P, Banerjee S, Colombo N, Scambia G, Kim BG, Oaknin A, Friedlander M, Lisyanskaya A, Floquet A, Leary A, Sonke GS, Gourley C, Oza A, Gonzalez-Martin A, Aghajanian C, Bradley W, Mathews C, Liu J, McNamara J, Lowe ES, Ah-See ML, Moore KN; SOLO1 Investigators. Overall Survival With Maintenance Olaparib at a 7-Year Follow-Up in Patients With Newly Diagnosed Advanced Ovarian Cancer and a BRCA Mutation: The SOLO1/GOG 3004 Trial. J Clin Oncol. 2022 Sep 9:JCO2201549. doi: 10.1200/JCO.22.01549. Online ahead of print.
- Moore K, Colombo N, Scambia G, Kim BG, Oaknin A, Friedlander M, Lisyanskaya A, Floquet A, Leary A, Sonke GS, Gourley C, Banerjee S, Oza A, Gonzalez-Martin A, Aghajanian C, Bradley W, Mathews C, Liu J, Lowe ES, Bloomfield R, DiSilvestro P. Maintenance Olaparib in Patients with Newly Diagnosed Advanced Ovarian Cancer. N Engl J Med. 2018 Dec 27;379(26):2495-2505. doi: 10.1056/NEJMoa1810858. Epub 2018 Oct 21.
- Banerjee S, Moore KN, Colombo N, Scambia G, Kim BG, Oaknin A, Friedlander M, Lisyanskaya A, Floquet A, Leary A, Sonke GS, Gourley C, Oza A, Gonzalez-Martin A, Aghajanian C, Bradley WH, Holmes E, Lowe ES, DiSilvestro P. Maintenance olaparib for patients with newly diagnosed advanced ovarian cancer and a BRCA mutation (SOLO1/GOG 3004): 5-year follow-up of a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2021 Dec;22(12):1721-1731. doi: 10.1016/S1470-2045(21)00531-3. Epub 2021 Oct 26. Erratum In: Lancet Oncol. 2021 Dec;22(12):e539.
- Friedlander M, Moore KN, Colombo N, Scambia G, Kim BG, Oaknin A, Lisyanskaya A, Sonke GS, Gourley C, Banerjee S, Oza A, Gonzalez-Martin A, Aghajanian C, Bradley WH, Liu J, Mathews C, Selle F, Lortholary A, Lowe ES, Hettle R, Flood E, Parkhomenko E, DiSilvestro P. Patient-centred outcomes and effect of disease progression on health status in patients with newly diagnosed advanced ovarian cancer and a BRCA mutation receiving maintenance olaparib or placebo (SOLO1): a randomised, phase 3 trial. Lancet Oncol. 2021 May;22(5):632-642. doi: 10.1016/S1470-2045(21)00098-X. Epub 2021 Apr 13.
- Tattersall A, Ryan N, Wiggans AJ, Rogozinska E, Morrison J. Poly(ADP-ribose) polymerase (PARP) inhibitors for the treatment of ovarian cancer. Cochrane Database Syst Rev. 2022 Feb 16;2(2):CD007929. doi: 10.1002/14651858.CD007929.pub4.
- 2013. "Olaparib Maintenance Monotherapy in Patients With BRCA Mutated Ovarian Cancer Following First Line Platinum Based Chemotherapy.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01844986.
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