Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06580314
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-28
Brief Title:
Testing Olaparib for One or Two Years With or Without Bevacizumab to Treat Ovarian Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase III Trial of One vs Two Years of Maintenance Olaparib With or Without Bevacizumab in Patients With BRCA12 Mutated or Homologous Recombination Deficient HRD Ovarian Cancer Following Response to First Line Platinum Based Chemotherapy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase III trial compares the effect of olaparib for one year versus two years with or without bevacizumab for the treatment of BRCA 12 mutated or homologous recombination deficient stage III or IV ovarian cancer Olaparib is a polyadenosine 539-diphosphoribose polymerase PARP enzyme inhibitor and may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth Bevacizumab is in a class of medications called antiangiogenic agents It works by stopping the formation of blood vessels that bring oxygen and nutrients to tumor This may slow the growth and spread of tumor Giving olaparib for one year with or without bevacizumab may be effective in treating patients with BRCA 12 mutated or homologous recombination deficient stage III or IV ovarian cancer when compared to two years of olaparib
Detailed Description:
PRIMARY OBJECTIVE
I To determine investigator assessed progression-free survival PFS using Response Evaluation Criteria in Solid Tumors RECIST version v11 non-inferiority for one versus vs two years of maintenance olaparib in the modified intent to treat ITT population
SECONDARY OBJECTIVES
I To evaluate PFS2 and overall survival OS in the modified ITT population II To evaluate PFS PFS2 and OS in the as-treated population III To evaluate toxicity including rates of myelodysplastic syndrome MDS acute myeloid leukemia AML and other secondary malignancies in the safety population
EXPLORATORY OBJECTIVE
I To evaluate the moderating effect of physician-choice bevacizumab as stratified on randomized treatment effect estimates
TRANSLATIONAL OBJECTIVES
I To assess BRCA reversion mutations in circulating tumor deoxyribonucleic acid ctDNA as a predictor of poor response in the BRCA mutated BRCAm population
II To correlate a combined assay assessing quantitative BRCA1 and RAD51C promoter methylation and pathogenic variants in core homologous recombination repair HRR genes with clinical homologous recombination deficiency HRD testing and outcomes in the BRCA wildtype BRCAwt population
OUTLINE Patients are randomized to 1 of 2 arms
ARM I REFERENCE Patients receive olaparib orally PO twice daily BID on days 1-21 of each cycle Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity Patients may also receive bevacizumab IV on day 1 of each cycle Cycles of bevacizumab repeat every 21 days for up to 1 year in the absence of disease progression or unacceptable toxicity Patients also undergo blood sample collection and computed tomography CT andor magnetic resonance imaging MRI throughout the study
ARM II EXPERIMENTAL Patients receive olaparib PO BID on days 1-21 of each cycle Cycles repeat every 21 days for up to 1 year in the absence of disease progression or unacceptable toxicity Patients may also receive bevacizumab IV on day 1 of each cycle Cycles of bevacizumab repeat every 21 days for up to 1 year in the absence of disease progression or unacceptable toxicity Patients also undergo blood sample collection and CT andor MRI throughout the study
After completion of study treatment patients are followed up every 3 months for 2 years then every 6 months for 3 years
I To determine investigator assessed progression-free survival PFS using Response Evaluation Criteria in Solid Tumors RECIST version v11 non-inferiority for one versus vs two years of maintenance olaparib in the modified intent to treat ITT population
SECONDARY OBJECTIVES
I To evaluate PFS2 and overall survival OS in the modified ITT population II To evaluate PFS PFS2 and OS in the as-treated population III To evaluate toxicity including rates of myelodysplastic syndrome MDS acute myeloid leukemia AML and other secondary malignancies in the safety population
EXPLORATORY OBJECTIVE
I To evaluate the moderating effect of physician-choice bevacizumab as stratified on randomized treatment effect estimates
TRANSLATIONAL OBJECTIVES
I To assess BRCA reversion mutations in circulating tumor deoxyribonucleic acid ctDNA as a predictor of poor response in the BRCA mutated BRCAm population
II To correlate a combined assay assessing quantitative BRCA1 and RAD51C promoter methylation and pathogenic variants in core homologous recombination repair HRR genes with clinical homologous recombination deficiency HRD testing and outcomes in the BRCA wildtype BRCAwt population
OUTLINE Patients are randomized to 1 of 2 arms
ARM I REFERENCE Patients receive olaparib orally PO twice daily BID on days 1-21 of each cycle Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity Patients may also receive bevacizumab IV on day 1 of each cycle Cycles of bevacizumab repeat every 21 days for up to 1 year in the absence of disease progression or unacceptable toxicity Patients also undergo blood sample collection and computed tomography CT andor magnetic resonance imaging MRI throughout the study
ARM II EXPERIMENTAL Patients receive olaparib PO BID on days 1-21 of each cycle Cycles repeat every 21 days for up to 1 year in the absence of disease progression or unacceptable toxicity Patients may also receive bevacizumab IV on day 1 of each cycle Cycles of bevacizumab repeat every 21 days for up to 1 year in the absence of disease progression or unacceptable toxicity Patients also undergo blood sample collection and CT andor MRI throughout the study
After completion of study treatment patients are followed up every 3 months for 2 years then every 6 months for 3 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None