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NCT05554380 · ClinicalTrials.gov record · last posted 2026-08-24

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

StatusActive, Not Recruiting
PhasePhase 2
Started2023-09-22
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from the ClinicalTrials.gov record
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.

Protocol amendment history 3 changes detected by DataLookout

2026-08-25
notable
Primary completion pushed: 2026-08-31 → 2027-02-01
2026-08-25
minor
Completion pushed: 2026-08-31 → 2027-02-01
2026-08-20
notable
Trial status changed: Suspended → Active, Not Recruiting
Trial Details
NCT Number NCT05554380
Lead Sponsor National Cancer Institute (NCI)
Conditions Locally Advanced Malignant Solid Neoplasm, Metastatic Malignant Solid Neoplasm, Unresectable Malignant Solid Neoplasm
Enrollment 33 participants
Start Date 2023-09-22
Primary Completion 2027-02-01 (estimated)
Study Completion 2027-02-01 (estimated)
Updated on ClinicalTrials.gov 2026-08-24