Study on Palbociclib as a Targeted Treatment for Cancers with CCND1, 2, or 3 Amplification

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0

ClinicalTrials ID:NCT04439201

Provider View

This clinical trial is testing the drug Palbociclib to see if it can help shrink or stop the growth of cancers that have specific genetic changes called CCND1, 2, or 3 amplification. Palbociclib works by blocking certain proteins that help cancer cells grow.

Patient Parameters

Program Overview

The purpose of this study is to find out if Palbociclib can effectively treat cancers with genetic changes known as CCND1, 2, or 3 amplification. These changes can make cancer cells grow, and Palbociclib aims to block proteins called CDK4 and CDK6 to stop this growth. Researchers want to see if the drug can shrink the cancer or stop it from getting worse.

Description

The main goal of this study is to see how many patients experience a reduction in their cancer size after taking Palbociclib. Researchers also want to know how many patients are still alive and have not seen their cancer worsen after six months of treatment. They will also look at how long it takes for the cancer to progress or for the patient to pass away. Additionally, the study will explore other factors that might predict how well the treatment works, using various tests and imaging techniques.

Participants in the study will take Palbociclib by mouth once a day for 21 days, followed by a 7-day break, making a 28-day cycle. This cycle will continue as long as the cancer does not progress and the patient can tolerate the treatment. After finishing the treatment, patients will have follow-up visits every three months for the first two years, and then every six months in the third year.

Eligibility Criteria

Inclusion Criteria

  • Must meet the eligibility criteria from the main MATCH study before joining this specific treatment study.
  • Must have genetic changes called CCND1, 2, or 3 amplification, or similar changes, as identified in the main MATCH study.
  • Must have a recent electrocardiogram (ECG) showing no major heart rhythm or structural issues.

Exclusion Criteria

  • Cannot have an allergy to Palbociclib or similar drugs.
  • Cannot have breast cancer, mantle cell lymphoma, or myeloma.
  • Cannot have heart problems related to the left side of the heart.
  • Cannot have been treated with Palbociclib or similar drugs before.
  • Cannot be taking certain medications or foods that affect how Palbociclib works.

Locations

FACILITYZIPCITYSTATE
ECOG-ACRIN Cancer Research Group19103PhiladelphiaPennsylvania

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