Ignite Creation Date:
2024-05-06 @ 2:02 PM
Last Modification Date:
2024-10-26 @ 1:24 PM
Study NCT ID:
NCT04197713
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-11-08
First Post:
2019-12-12
Brief Title:
Testing the Sequential Combination of the Anti-cancer Drugs Olaparib Followed by Adavosertib AZD1775 in Patients With Advanced Solid Tumors With Selected Mutations and PARP Resistance STAR Study
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase I Sequential Trial of Agents Against DNA Repair STAR
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase I trial studies the side effects and best dose of adavosertib when given together with olaparib in treating patients with solid tumors that have spread to other places in the body advanced with selected mutations Adavosertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth PARPs are proteins that help repair DNA mutations PARP inhibitors such as olaparib can keep PARP from working so tumor cells cant repair themselves and they may stop growing Giving olaparib and adavosertib one after the other may shrink or stabilize advanced solid tumors as successfully as using them together with fewer side effects
Detailed Description:
PRIMARY OBJECTIVES
I To determine the safety and tolerability of olaparib in sequential treatment with adavosertib AZD1775
II To establish the maximum tolerated doserecommended phase 2 dose MTDRP2D of this sequential schedule in patients with advanced solid tumors in a post-poly adenosine diphosphate ADP ribose polymerase inhibitor PARPi population
III To assess the safety and toxicity profile of the sequential treatment of olaparib and AZD1775 in a post-PARPi population
SECONDARY OBJECTIVES
I To assess putative predictive biomarkers of response and resistance to the sequential treatment of olaparib and AZD1775 in a post-PARPi population
II To evaluate a novel experimental trial design involving sequential dosing of olaparib and AZD1775 in a post-PARPi population
III To observe and record anti-tumor activity
OUTLINE This is a dose-escalation study of adavosertib
Patients receive olaparib orally PO twice daily BID on days 1-5 and 15-19 of each cycle and adavosertib PO once daily QD on days 8-12 and 22-26 of each cycle Cycles repeat every 28 days for 2 years in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up at 30 days and then every 3-6 months for up to 2 years
I To determine the safety and tolerability of olaparib in sequential treatment with adavosertib AZD1775
II To establish the maximum tolerated doserecommended phase 2 dose MTDRP2D of this sequential schedule in patients with advanced solid tumors in a post-poly adenosine diphosphate ADP ribose polymerase inhibitor PARPi population
III To assess the safety and toxicity profile of the sequential treatment of olaparib and AZD1775 in a post-PARPi population
SECONDARY OBJECTIVES
I To assess putative predictive biomarkers of response and resistance to the sequential treatment of olaparib and AZD1775 in a post-PARPi population
II To evaluate a novel experimental trial design involving sequential dosing of olaparib and AZD1775 in a post-PARPi population
III To observe and record anti-tumor activity
OUTLINE This is a dose-escalation study of adavosertib
Patients receive olaparib orally PO twice daily BID on days 1-5 and 15-19 of each cycle and adavosertib PO once daily QD on days 8-12 and 22-26 of each cycle Cycles repeat every 28 days for 2 years in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up at 30 days and then every 3-6 months for up to 2 years
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-2019-08262 | REGISTRY | None | None |
| 10329 | OTHER | None | None |
| 10329 | OTHER | None | None |
| UM1CA186688 | NIH | CTEP | httpsreporternihgovquickSearchUM1CA186688 |