Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06393751
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-04-30
Brief Title:
Testing the Addition of ASTX660 Tolinapant to the Usual Chemotherapy Treatment Paclitaxel With or Without Bevacizumab in Patients With Recurrent Ovarian Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Randomized Phase 12 Trial Evaluating the Addition of Tolinapant to Weekly Paclitaxel With or Without Bevacizumab in Patients With Recurrent Epithelial Ovarian Cancer
Status:
NOT_YET_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 III trial tests the safety best dose and effectiveness of adding tolinapant ASTX660 to paclitaxel with or without bevacizumab in treating patients with ovarian cancer that has come back after a period of improvement recurrent Tolinapant may stop the growth of tumor cells by blocking proteins such as XIAP and cIAP1 that promote the growth of tumor cells and increase resistance to chemotherapy Paclitaxel is in a class of medications called antimicrotubule agents It stops tumor cells from growing and dividing and may kill them 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 the tumor This may slow the growth and spread of tumor cells Adding ASTX660 to paclitaxel with or without bevacizumab may be safe tolerable andor effective in treating patients with recurrent ovarian cancer
Detailed Description:
PRIMARY OBJECTIVES
I To assess the safety and tolerability of adding ASTX660 tolinapant to a regimen of weekly paclitaxel with bevacizumab Phase I II To determine the recommended phase 2 dose RP2D for the combination of ASTX660 tolinapant and weekly paclitaxel with bevacizumab Phase I III To assess the efficacy of adding ASTX660 tolinapant to weekly paclitaxel with or without bevacizumab investigator choice as measured by progression free survival PFS Phase II
SECONDARY OBJECTIVES
I To assess the objective response rate ORR of the addition of ASTX660 tolinapant to weekly paclitaxel with or without bevacizumab as compared to weekly paclitaxel with or without bevacizumab
II To assess overall survival
EXPLORATORY OBJECTIVE
I To explore whether lack of cIAP1 expression results in no benefit for the addition of ASTX660 tolinapant to weekly paclitaxel - bevacizumab
OUTLINE This is a phase I dose escalation study of ASTX660 and paclitaxel with or without bevacizumab followed by a dose expansion study The phase II study will follow completion of the phase I study
PHASE I
Patients receive paclitaxel intravenously IV on days 1 8 and 15 bevacizumab IV on days 1 and 15 and ASTX660 orally PO on days 1-7 and 15-21 of each cycle Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity Additionally patients undergo blood sample collection computed tomography CT and magnetic resonance imaging MRI throughout the study
PHASE II Patients are randomized to 1 of 2 arms
ARM I CONTROL Patients receive paclitaxel IV on days 1 8 and 15 of each cycle Patients may also receive bevacizumab IV on days 1 and 15 of each cycle per provider Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity Additionally patients undergo blood sample collection CT and MRI throughout the study
ARM II EXPERIMENTAL Patients receive paclitaxel IV on days 1 8 and 15 and ASTX660 PO on days 1-7 and 15-21 of each cycle Patients may also receive bevacizumab IV on days 1 and 15 of each cycle per provider Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity Additionally patients undergo blood sample collection CT and 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 assess the safety and tolerability of adding ASTX660 tolinapant to a regimen of weekly paclitaxel with bevacizumab Phase I II To determine the recommended phase 2 dose RP2D for the combination of ASTX660 tolinapant and weekly paclitaxel with bevacizumab Phase I III To assess the efficacy of adding ASTX660 tolinapant to weekly paclitaxel with or without bevacizumab investigator choice as measured by progression free survival PFS Phase II
SECONDARY OBJECTIVES
I To assess the objective response rate ORR of the addition of ASTX660 tolinapant to weekly paclitaxel with or without bevacizumab as compared to weekly paclitaxel with or without bevacizumab
II To assess overall survival
EXPLORATORY OBJECTIVE
I To explore whether lack of cIAP1 expression results in no benefit for the addition of ASTX660 tolinapant to weekly paclitaxel - bevacizumab
OUTLINE This is a phase I dose escalation study of ASTX660 and paclitaxel with or without bevacizumab followed by a dose expansion study The phase II study will follow completion of the phase I study
PHASE I
Patients receive paclitaxel intravenously IV on days 1 8 and 15 bevacizumab IV on days 1 and 15 and ASTX660 orally PO on days 1-7 and 15-21 of each cycle Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity Additionally patients undergo blood sample collection computed tomography CT and magnetic resonance imaging MRI throughout the study
PHASE II Patients are randomized to 1 of 2 arms
ARM I CONTROL Patients receive paclitaxel IV on days 1 8 and 15 of each cycle Patients may also receive bevacizumab IV on days 1 and 15 of each cycle per provider Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity Additionally patients undergo blood sample collection CT and MRI throughout the study
ARM II EXPERIMENTAL Patients receive paclitaxel IV on days 1 8 and 15 and ASTX660 PO on days 1-7 and 15-21 of each cycle Patients may also receive bevacizumab IV on days 1 and 15 of each cycle per provider Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity Additionally patients undergo blood sample collection CT and 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?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2024-03344 | REGISTRY | None | None |
| NRG-GY034 | OTHER | None | None |
| NRG-GY034 | OTHER | None | None |
| U10CA180868 | NIH | CTEP | httpsreporternihgovquickSearchU10CA180868 |