Study on GDC-0032 (Taselisib) for Treating Cancers with PIK3CA Genetic Changes

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0

ClinicalTrials ID:NCT04439175

Provider View

This clinical trial is testing a new drug, GDC-0032 (taselisib), to see if it can help stop or shrink cancers that have a specific genetic change called a PIK3CA mutation. The study aims to find out if taselisib can block a protein needed for cancer cell growth.

Patient Parameters

Program Overview

This study is exploring the effects of a drug called GDC-0032 (taselisib) on cancers that have a genetic change known as a PIK3CA mutation. Taselisib works by blocking a protein that may help cancer cells grow. Researchers want to see if this drug can shrink tumors or stop them from growing in patients with this mutation.

Description

The main goal of this study is to see how many patients experience a reduction in their cancer size after taking taselisib. Researchers will also look at how long patients live without their cancer getting worse and how long they live overall. They will study other factors that might predict how well the treatment works, using various tests and imaging techniques.

Participants will take taselisib by mouth once a day in 28-day cycles, as long as the cancer does not progress or cause severe side effects. After finishing the treatment, patients will have follow-up visits every three months for up to two years, and then every six months in the third year.

Eligibility Criteria

Inclusion Criteria

  • Must meet eligibility criteria from the main MATCH study.
  • Must have a PIK3CA mutation confirmed by the MATCH study.
  • Must have a recent ECG with no significant heart issues.
  • If known heart problems exist, must have a recent heart function test showing normal results.
  • Must have a fasting blood sugar level of 125 mg/dL or lower.
  • Previous treatment with mTOR inhibitors is allowed.

Exclusion Criteria

  • Cannot have allergies to taselisib or similar drugs.
  • Cannot have breast cancer.
  • Cannot have certain lung cancers if eligible for another specific study.
  • Cannot have KRAS or PTEN mutations in the tumor.
  • Cannot have had previous treatment with PI3K or Akt inhibitors.
  • Cannot have diabetes requiring medication.
  • Cannot have breathing difficulties at rest or need daily oxygen.
  • Cannot have inflammatory bowel diseases or active bowel inflammation.

Locations

FACILITYZIPCITYSTATE
ECOG-ACRIN Cancer Research Group19103PhiladelphiaPennsylvania

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