Ignite Creation Date:
2024-05-06 @ 3:27 PM
Last Modification Date:
2024-10-26 @ 1:49 PM
Study NCT ID:
NCT04633239
Status:
RECRUITING
Last Update Posted:
2024-07-15
First Post:
2020-11-17
Brief Title:
Testing the Addition of Abemaciclib to Olaparib for Women With Recurrent Ovarian Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase 11b Dose Escalation Study of Abemaciclib and Olaparib for Recurrent Platinum-Resistant Ovarian Cancer
Status:
RECRUITING
Status Verified Date:
2024-06
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 IIb trial identifies the side effects and best dose of abemaciclib when given together with olaparib in treating patients with ovarian cancer that responds at first to treatment with drugs that contain the metal platinum but then comes back within a certain period recurrent platinum-resistant Abemaciclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth Olaparib is an inhibitor of PARP an enzyme that helps repair deoxyribonucleic acid DNA when it becomes damaged Blocking PARP may help keep tumor cells from repairing their damaged DNA causing them to die PARP inhibitors are a type of targeted therapy Adding abemaciclib to olaparib may work better to treat recurrent platinum-resistant ovarian cancer
Detailed Description:
PRIMARY OBJECTIVE
I To assess the safety of abemaciclib plus olaparib in patients with platinum-resistant ovarian cancer by determining the maximum tolerated dose and recommended phase 2 dose
SECONDARY OBJECTIVE
I To observe and record anti-tumor activity using overall response rate ORR and duration of response DoR with abemaciclib and olaparib given in combination in patients with platinum-resistant ovarian cancer
EXPLORATORY OBJECTIVES
I To assess proof of mechanism RB phosphoRB cleaved caspase 3 Ki67 geminin gamma-H2AX RAD51 nuclear foci pNBS multiplex Myc transcriptional targets ODC1 and LDHA homologous recombination genes BRCA1 BRCA2 RAD51 serum thymidine kinase plasma and tumor pharmacokinetics and subgroups of response immunohistochemistry IHC for Myc cyclin E next generation sequencing NGSwhole exome sequencing WES for DCAF hormone receptor HR repair gene alterations Myc and CCNE1 ribonucleic acid sequencing RNAseq for Myc and CCNE1
II To contribute genetic analysis data from de-identified biospecimens to Genomic Data Commons GDC a well annotated cancer molecular and clinical data repository for current and future research specimens will be annotated with key clinical data including presentation diagnosis staging summary treatment and if possible outcome
III To bank formalin-fixed paraffin-embedded FFPE tissue blood for cell-free DNA analysis and nucleic acids obtained from patients at the Experimental Therapeutics Clinical Trials Network EET Biobank at Nationwide Childrens Hospital
OUTLINE This is a dose-escalation study of abemaciclib
Patients receive olaparib orally PO twice daily BID on days 1-28 and abemaciclib PO BID on days 8-28 of cycle 1 and days 1-28 of subsequent cycles Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity Patients also undergo collection of blood and undergo tumor biopsy on study
After completion of study treatment patients are followed up at 30 days
I To assess the safety of abemaciclib plus olaparib in patients with platinum-resistant ovarian cancer by determining the maximum tolerated dose and recommended phase 2 dose
SECONDARY OBJECTIVE
I To observe and record anti-tumor activity using overall response rate ORR and duration of response DoR with abemaciclib and olaparib given in combination in patients with platinum-resistant ovarian cancer
EXPLORATORY OBJECTIVES
I To assess proof of mechanism RB phosphoRB cleaved caspase 3 Ki67 geminin gamma-H2AX RAD51 nuclear foci pNBS multiplex Myc transcriptional targets ODC1 and LDHA homologous recombination genes BRCA1 BRCA2 RAD51 serum thymidine kinase plasma and tumor pharmacokinetics and subgroups of response immunohistochemistry IHC for Myc cyclin E next generation sequencing NGSwhole exome sequencing WES for DCAF hormone receptor HR repair gene alterations Myc and CCNE1 ribonucleic acid sequencing RNAseq for Myc and CCNE1
II To contribute genetic analysis data from de-identified biospecimens to Genomic Data Commons GDC a well annotated cancer molecular and clinical data repository for current and future research specimens will be annotated with key clinical data including presentation diagnosis staging summary treatment and if possible outcome
III To bank formalin-fixed paraffin-embedded FFPE tissue blood for cell-free DNA analysis and nucleic acids obtained from patients at the Experimental Therapeutics Clinical Trials Network EET Biobank at Nationwide Childrens Hospital
OUTLINE This is a dose-escalation study of abemaciclib
Patients receive olaparib orally PO twice daily BID on days 1-28 and abemaciclib PO BID on days 8-28 of cycle 1 and days 1-28 of subsequent cycles Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity Patients also undergo collection of blood and undergo tumor biopsy on study
After completion of study treatment patients are followed up at 30 days
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2020-10084 | REGISTRY | None | None |
| 10422 | OTHER | None | None |
| 10422 | OTHER | None | None |
| UM1CA186689 | NIH | CTEP | httpsreporternihgovquickSearchUM1CA186689 |