Ignite Creation Date:
2024-05-06 @ 5:20 PM
Last Modification Date:
2024-10-26 @ 2:27 PM
Study NCT ID:
NCT05276973
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2022-03-11
Brief Title:
Testing the Addition of Ipatasertib to the Usual Chemotherapy Treatment Paclitaxel and Carboplatin for Stage III or IV Epithelial Ovarian Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase IIB Safety and Pharmacodynamic Study of Neoadjuvant NACT Paclitaxel and Carboplatin With Ipatasertib as Initial Therapy of Ovarian Cancer PTMA 100805
Status:
RECRUITING
Status Verified Date:
2024-07
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 tests the safety side effects and best dose of ipatasertib in combination with paclitaxel and carboplatin in treating patients with stage III or IV epithelial ovarian cancer Ipatasertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth Paclitaxel is in a class of medications called taxanes It stops tumor cells from growing and dividing and may kill them Carboplatin is in a class of medications known as platinum-containing compounds It works in a way similar to the anticancer drug cisplatin but may be better tolerated than cisplatin Carboplatin works by killing stopping or slowing the growth of tumor cells Giving ipatasertib in combination with paclitaxel and carboplatin may lower the chance of the tumor growing or spreading for longer than the paclitaxel and carboplatin alone
Detailed Description:
PRIMARY OBJECTIVES
I To estimate the maximum tolerated dose MTD and the dose limiting toxicities DLTs of ipatasertib in combination with paclitaxel and carboplatin as neoadjuvant chemotherapy for ovarian cancer
II To determine the feasibility of the treatment regimen once the MTD is estimated
III To assess the toxicities of ipatasertib in combination with paclitaxel and carboplatin by the National Cancer Institute NCI Common Terminology Criteria for Adverse Events CTCAE version 50
SECONDARY OBJECTIVE
I Objective response rate by Response Evaluation Criteria in Solid Tumors RECIST 11 prior to interval debulking surgery IDS
TRANSLATIONAL RESEARCH OBJECTIVES
I To evaluate the change of phosphorylated pPRAS40 expression in the pre-treatment tumor versus vs on-treatment tumor
II To identify the pharmacokinetics of ipatasertib in the tissue and blood III To correlate antitumor response with genomic alterations in PI3K pathway genes PTEN PIK3CA PIK3R1 AKT1 p53 loss KRAS NF1 TSC1TSC1
IV To correlate antitumor response with transcriptomic alterations in PI3K pathway genes PTEN PIK3CA PIK3R1 AKT1 p53 loss KRAS NF1 TSC1TSC1
V To correlate response with PTEN loss
OUTLINE This is a dose-escalation study of ipatasertib followed by a dose-expansion study
Patients receive paclitaxel intravenously IV over 3 hours and carboplatin IV over 30-60 minutes on day 1 Treatment repeats every 21 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity Patients also receive ipatasertib orally PO once daily QD until 24 hours before surgery in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up at 30 and 90 days
I To estimate the maximum tolerated dose MTD and the dose limiting toxicities DLTs of ipatasertib in combination with paclitaxel and carboplatin as neoadjuvant chemotherapy for ovarian cancer
II To determine the feasibility of the treatment regimen once the MTD is estimated
III To assess the toxicities of ipatasertib in combination with paclitaxel and carboplatin by the National Cancer Institute NCI Common Terminology Criteria for Adverse Events CTCAE version 50
SECONDARY OBJECTIVE
I Objective response rate by Response Evaluation Criteria in Solid Tumors RECIST 11 prior to interval debulking surgery IDS
TRANSLATIONAL RESEARCH OBJECTIVES
I To evaluate the change of phosphorylated pPRAS40 expression in the pre-treatment tumor versus vs on-treatment tumor
II To identify the pharmacokinetics of ipatasertib in the tissue and blood III To correlate antitumor response with genomic alterations in PI3K pathway genes PTEN PIK3CA PIK3R1 AKT1 p53 loss KRAS NF1 TSC1TSC1
IV To correlate antitumor response with transcriptomic alterations in PI3K pathway genes PTEN PIK3CA PIK3R1 AKT1 p53 loss KRAS NF1 TSC1TSC1
V To correlate response with PTEN loss
OUTLINE This is a dose-escalation study of ipatasertib followed by a dose-expansion study
Patients receive paclitaxel intravenously IV over 3 hours and carboplatin IV over 30-60 minutes on day 1 Treatment repeats every 21 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity Patients also receive ipatasertib orally PO once daily QD until 24 hours before surgery in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up at 30 and 90 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-2022-01930 | REGISTRY | None | None |
| NRG-GY027 | OTHER | None | None |
| NRG-GY027 | OTHER | None | None |
| U10CA180868 | NIH | CTEP | httpsreporternihgovquickSearchU10CA180868 |