Study on Copanlisib for Treating Cancers with PIK3CA Mutations

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0

ClinicalTrials ID:NCT05490771

Provider View

This clinical trial is exploring the use of copanlisib, a drug that may help stop cancer growth by targeting a specific genetic change called PIK3CA mutation. The study aims to see if copanlisib can shrink tumors or stop them from growing in patients with this mutation.

Patient Parameters

Program Overview

This phase II study is testing copanlisib, a drug that might block a protein called PIK3, which is important for cancer cell growth. The trial is for patients whose cancer has a PIK3CA mutation, a genetic change that can affect how cancer grows. Researchers want to find out if copanlisib can help shrink these tumors or stop them from growing.

Description

The main goal of this study is to see how many patients experience a reduction in their cancer size after receiving copanlisib. 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 receive copanlisib through an IV on specific days of a 28-day cycle. This will continue as long as the cancer does not progress and the treatment is tolerated. Patients will have tumor biopsies and scans to monitor the cancer's response to the treatment. After finishing the treatment, patients will have follow-up visits every few months to check on their health.

Eligibility Criteria

Inclusion Criteria

  • Must meet eligibility criteria from the main MATCH study.
  • Must have a PIK3CA mutation.
  • Must have a recent ECG with no major heart issues.
  • Must stop using herbal medications at least 7 days before starting copanlisib.
  • If diabetic, must have controlled blood sugar levels.
  • Must have certain blood counts and organ function levels.
  • Must agree to use contraception during and after the study.

Exclusion Criteria

  • Cannot have allergies to copanlisib or similar drugs.
  • Cannot have had previous treatment with similar drugs.
  • Cannot have certain genetic mutations or types of cancer.
  • Cannot be taking certain medications that affect the liver or heart.
  • Cannot have certain medical conditions like non-healing wounds or lung issues.

Locations

FACILITYZIPCITYSTATE
ECOG-ACRIN Cancer Research Group19103PhiladelphiaPennsylvania

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