Study on Copanlisib for Treating Cancers with PTEN Gene Changes

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0

ClinicalTrials ID:NCT06400238

Provider View

This clinical trial is testing how well the drug copanlisib works in treating patients with cancers that have specific genetic changes in the PTEN gene. Copanlisib is a type of medication that may help slow or stop the growth of cancer cells by blocking certain proteins.

Patient Parameters

Program Overview

This study is exploring the effectiveness of copanlisib, a drug that targets cancers with changes in the PTEN gene. Copanlisib belongs to a group of drugs called kinase inhibitors, which work by blocking proteins that signal cancer cells to grow. The goal is to see if copanlisib can help slow down or stop the spread of cancer in patients with these genetic changes.

Description

The main goal of this study is to see how many patients experience a reduction in their cancer with copanlisib treatment. Researchers will also look at how many patients are alive and have no cancer progression after six months of treatment. They will study how long it takes for the cancer to progress or for patients to pass away. Additionally, the study will explore other potential markers that might predict how well the treatment works or why it might not work.

Patients will receive copanlisib through an IV infusion over 60 minutes on specific days of each 28-day cycle. The treatment will continue as long as the cancer does not progress and side effects are manageable. Patients will also have CT or MRI scans and provide blood samples and biopsies during the study. After finishing the treatment, patients will have follow-up visits every three months for two years, then every six months for one year.

Eligibility Criteria

Inclusion Criteria

  • Must meet eligibility criteria from the MATCH Master Protocol before joining this study.
  • Must have a PTEN gene mutation with at least 1% expression as confirmed by specific tests.
  • Must not have other genetic changes in certain pathways (MAPK or PI3K/MTOR).
  • Must have a recent ECG with no significant heart issues.
  • Must not be allergic to copanlisib or similar drugs.
  • Must not have had previous treatment with copanlisib or similar drugs.
  • Must not be taking certain medications that affect liver enzymes.
  • Must stop using herbal medications at least 7 days before starting copanlisib.
  • If diabetic, must have controlled blood sugar levels.
  • Must not have uncontrolled high blood pressure.
  • Must not have certain types of breast cancer or non-Hodgkin's lymphoma.
  • Must not be on certain heart medications.
  • Must have adequate blood counts and organ function.
  • Must not have non-healing wounds or certain lung conditions.
  • Must agree to use contraception during and for one month after treatment.

Locations

FACILITYZIPCITYSTATE
ECOG-ACRIN Cancer Research Group19103PhiladelphiaPennsylvania

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