Study of Chemotherapy Plus Ipatasertib for People with Solid Tumors with PTEN/AKT Mutations

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05554380

Provider View

This clinical trial is testing a combination of chemotherapy and a targeted therapy drug, ipatasertib, in patients with solid tumors that have specific genetic changes (PTEN/AKT mutations) and cannot be removed by surgery. The study aims to see if this combination can shrink tumors or stop them from growing.

Patient Parameters

Program Overview

This study is exploring whether adding the drug ipatasertib to the chemotherapy drug paclitaxel can help control solid tumors that have specific genetic changes (PTEN/AKT mutations). These tumors cannot be removed by surgery and may have spread to other parts of the body. Paclitaxel works by stopping cancer cells from growing and dividing, while ipatasertib targets specific enzymes needed for cancer cell growth. Researchers hope this combination will increase the number of tumors that shrink and extend the time they remain stable.

Description

The main goal of this study is to see how well the combination of paclitaxel and ipatasertib works in shrinking tumors in patients with advanced solid tumors that have PTEN/AKT mutations and have not responded to previous treatments. Researchers will also look at how long patients live without the cancer getting worse, how long the response to treatment lasts, and overall survival rates. They will monitor any side effects from the treatment.

Participants will receive paclitaxel through an IV on specific days and take ipatasertib by mouth over a 28-day cycle, repeating for up to 35 cycles unless the cancer progresses or side effects become too severe. Throughout the trial, patients will have scans and blood tests, and a tumor biopsy will be done before starting treatment and during follow-up.

After finishing the study treatment, patients will be monitored until death or for up to three years, whichever comes first.

Eligibility Criteria

Inclusion Criteria

  • Must be part of the ComboMATCH study and have a specific genetic mutation (PTEN/AKT) identified.
  • Must have a solid tumor that cannot be removed by surgery and has spread locally or to other parts of the body.
  • Must have measurable disease as confirmed by scans.
  • Must be 18 years or older and able to swallow pills.
  • Must have good overall health and organ function as determined by specific medical tests.
  • Must not have received certain treatments recently and must not be planning to receive other cancer treatments during the study.
  • Must agree to use effective birth control if of reproductive potential.

Exclusion Criteria

  • Must not have certain other genetic mutations (KRAS, NRAS, HRAS, BRAF).
  • Must not have untreated or uncontrolled brain metastases or spinal cord compression.
  • Must not have received an AKT inhibitor before.
  • Must not have certain medical conditions like active bowel inflammation or uncontrolled diabetes.
  • Must not be pregnant or breastfeeding.
  • Must not have a history of severe allergic reactions to similar drugs.
  • Must not have any other serious medical conditions that could interfere with the study.

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