Study on Ipatasertib for Treating Cancers with AKT Genetic Changes
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT06400251
This clinical trial is exploring how well the drug ipatasertib works in treating patients with cancers that have specific genetic changes known as AKT mutations. Ipatasertib is designed to stop cancer cells from growing and may help kill them.
Patient Parameters
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Program Overview
This study is testing the effectiveness of ipatasertib, a medication that targets specific genetic changes in cancer cells called AKT mutations. The goal is to see if ipatasertib can help shrink tumors and stop cancer from progressing in patients with advanced cancers that have not responded to other treatments. Patients will take ipatasertib daily in 28-day cycles, and their progress will be monitored through scans and regular check-ups. The study will also collect blood samples and perform biopsies to better understand how the treatment works.
Description
The main goal of this study is to see how many patients experience a reduction in their cancer after taking ipatasertib. Researchers will also look at how long patients live without their cancer getting worse and identify any markers that might predict how well the treatment works. Patients will take ipatasertib by mouth every day for 28 days, with cycles repeating as long as the treatment is effective and side effects are manageable. Regular scans and tests will be conducted to monitor the cancer's response to the treatment. After finishing the treatment, patients will have follow-up visits every three months for two years, then every six months for another year.
Eligibility Criteria
Inclusion Criteria
- Must meet eligibility criteria from the main MATCH Protocol before joining this study.
- Must have a specific genetic change called an AKT mutation.
- Cannot have breast cancer.
- Men with prostate cancer must maintain low testosterone levels and can continue certain medications if they were already taking them.
- Cannot have allergies to ipatasertib or similar drugs.
- Cannot have certain other genetic mutations that might affect treatment response.
- Patients with diabetes can join if their condition is stable and controlled.
- Cannot have a history of certain bowel diseases.
- Cannot have taken certain medications that affect liver enzymes recently.
- Male patients must not donate sperm during the study and for four months after.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| ECOG-ACRIN Cancer Research Group | 19103 | Philadelphia | Pennsylvania |
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