NCT05554380|SuspendedPhase 2FDA Drug

Study Stopped

Other - study has reached accrual goal for analysis

Study of Chemotherapy Plus Ipatasertib for People With Solid Tumors With PTEN/AKT Mutations, A ComboMATCH Treatment Trial

Phase 2 Study of Paclitaxel (NSC #673089) + Ipatasertib (NSC #781451) in Taxane-Refractory Participants With PTEN/AKT-Altered Advanced Non-Breast Solid Tumors: A ComboMATCH Treatment Trial

National Cancer Institute (NCI)ClinicalTrials.gov

Compare

3 other identifiers

NCI-2022-07304EAY191-S3U10CA180888

Study Type

interventional

Target

Locations

2 countries

Sites

209

Timeline

RegisteredSep 2022

StartedSep 2023

CompletionAug 2026

Brief Summary

This phase II ComboMATCH treatment trial tests the usual treatment of chemotherapy (paclitaxel) plus ipatasertib in patients with solid tumor cancers that that cannot be removed by surgery (unresectable), has spread to nearby tissue or lymph nodes (locally advanced) or from where it first started (primary site) to other places in the body (metastatic), and has PTEN and AKT genetic changes. Chemotherapy drugs, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Targeted therapy, such as Ipatasertib, may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. The addition of ipatasertib to paclitaxel in solid tumors with PTEN and AKT genetic changes could increase the percentage of tumors that shrink as well as lengthen the time that the tumors remain stable (without progression). Researchers hope to learn if paclitaxel plus ipatasertib will shrink this type of cancer or stop its growth.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial recruitment is currently suspended

Enrollment

participants targeted

Target at P25-P50 for phase_2

Timeline

4mo left

Started Sep 2023

Typical duration for phase_2

Geographic Reach

2 countries

209 active sites

Status

suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.9 years study duration

Study Progress89%

Sep 2023Aug 2026

First Submitted

Initial submission to the registry

September 22, 2022

Completed

4 days until next milestone

First Posted

Study publicly available on registry

September 26, 2022

Completed

12 months until next milestone

Study Start

First participant enrolled

September 22, 2023

Completed

2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2026

Expected

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2026

Last Updated

May 4, 2026

Status Verified

December 1, 2025

Enrollment Period

2.9 years

First QC Date

September 22, 2022

Last Update Submit

May 1, 2026

Conditions

Locally Advanced Malignant Solid Neoplasm Metastatic Malignant Solid Neoplasm Unresectable Malignant Solid Neoplasm

Outcome Measures

Primary Outcomes (1)

Objective response rate (ORR)
The proportion of participants who have a partial or complete response (confirmed or unconfirmed) as best response.
Up to 3 years

Secondary Outcomes (3)

Progression free survival
From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause, assessed up to 3 years
Overall survival
From date of registration to date of death due to any cause, assessed up to 3 years
Duration of response
From date of first documentation of response (complete response, partial response, confirmed or unconfirmed) to date of first documentation of progression or symptomatic deterioration, or death due to any cause, assessed up to 3 years

Study Arms (1)

Treatment (paclitaxel, ipatasertib)

EXPERIMENTAL

Patients receive paclitaxel IV on days 1, 8, and 15 and ipatasertib PO on days 1-21 of each cycle. Treatment repeats every 28 days for up to 35 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo a CT or MRI and blood collection throughout the trial. Patients also undergo a tumor biopsy during screening and optionally during follow-up.

Procedure: Biopsy ProcedureProcedure: Biospecimen CollectionProcedure: Computed TomographyDrug: IpatasertibProcedure: Magnetic Resonance ImagingDrug: Paclitaxel