Study on Copanlisib for Treating Cancers with PTEN Loss

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0

ClinicalTrials ID:NCT06360588

Provider View

This clinical trial is testing how well the drug copanlisib works in treating patients with cancers that have lost a protein called PTEN. Copanlisib may help stop cancer cells from growing by blocking certain enzymes they need.

Patient Parameters

Program Overview

The purpose of this study is to see if copanlisib can effectively treat cancers that have lost the PTEN protein. This drug might help stop the growth of cancer cells by blocking enzymes they need to grow. Patients will receive copanlisib through an IV on specific days of each treatment cycle, which repeats every 28 days as long as the cancer does not progress or cause severe side effects. Throughout the study, patients will have tumor biopsies, imaging tests, and blood samples taken to monitor their response to the treatment. After finishing the treatment, patients will have follow-up visits every few months for up to three years.

Description

The main goal of this study is to see how many patients respond to copanlisib treatment. 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 each 28-day cycle. They will have regular check-ups, including tumor biopsies and imaging tests, to see how the treatment is working. After completing the treatment, patients will have follow-up visits every few months for up to three years to monitor their health and any changes in their cancer.

Eligibility Criteria

Inclusion Criteria

  • Must meet eligibility criteria from the main MATCH Protocol before joining this study.
  • Must have a complete loss of PTEN protein in cancer cells, as confirmed by specific tests.
  • Must not have other specific genetic changes in certain pathways related to cancer growth.
  • Must have a recent ECG with no major heart issues.
  • Must not be allergic to copanlisib or similar drugs.
  • Must not have taken copanlisib or similar drugs before.
  • Must not be taking certain medications that affect liver enzymes.
  • Must stop using herbal supplements at least 7 days before starting treatment.
  • If diabetic, must have controlled blood sugar levels.
  • Must not have uncontrolled high blood pressure.
  • Must not have certain types of breast cancer or lymphoma.
  • Must not be on certain heart medications.
  • Must have adequate blood cell counts and organ function.
  • Must not have any non-healing wounds or bone fractures.
  • Must not have a history of lung inflammation.
  • Must agree to use contraception during and for one month after treatment.

Locations

FACILITYZIPCITYSTATE
ECOG-ACRIN Cancer Research Group19103PhiladelphiaPennsylvania

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