Study on Palbociclib and Binimetinib for Treating RAS-Mutant Cancers

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05554367

Provider View

This clinical trial is testing a combination of two drugs, palbociclib and binimetinib, to see if they can help control cancers with specific RAS mutations. The study aims to find out if this combination can delay cancer growth and improve outcomes for patients with certain types of cancer, including low-grade serous ovarian cancer.

Patient Parameters

Program Overview

This study is exploring the effectiveness of combining two drugs, palbociclib and binimetinib, to treat cancers with specific RAS mutations. These drugs work by blocking proteins that cause cancer cells to grow. The trial aims to see if this combination can delay cancer progression in patients with low-grade serous ovarian cancer and other tumors with certain DNA changes. Researchers are also interested in whether this combination can improve outcomes for patients who have previously received a MEK inhibitor.

Description

The main goal of this study is to determine if the combination of palbociclib and binimetinib can improve the time before cancer progresses in patients with low-grade serous ovarian cancer who have not been treated with a MEK inhibitor before. The study also aims to see if this combination can improve response rates in patients whose cancer has progressed after MEK inhibitor treatment, as well as in patients with pancreatic cancer and other tumors with specific RAS mutations.

Participants will be divided into different groups based on their cancer type and previous treatments. They will receive palbociclib and binimetinib in cycles, with regular monitoring through scans and blood tests. The study will also explore how these drugs affect certain biological markers and the genetic makeup of the tumors.

After completing the treatment, participants will be followed up every three months for up to three years to monitor their health and any changes in their cancer.

Eligibility Criteria

Inclusion Criteria

  • Must be enrolled in the EAY191 study and assigned to this trial based on specific genetic mutations.
  • Have a confirmed diagnosis of cancer that cannot be cured with standard treatments.
  • Have specific genetic mutations in the KRAS, NRAS, HRAS, or RAF genes, except for BRAF V600E.
  • Have a tumor that can be safely biopsied or have a recent tissue sample available.
  • Be 18 years or older.
  • Have a good performance status, meaning they are fully active or have some restrictions but can still perform light work.
  • Have adequate blood cell counts and organ function as determined by specific tests.
  • Be able to swallow oral medications.
  • Not be pregnant or nursing, and agree to use effective contraception if of childbearing potential.
  • No history of certain lung diseases, bowel perforation, or serious skin disorders.
  • No history of severe allergic reactions to the study drugs.
  • No prior organ transplants.
  • Any brain metastases must be treated and stable.
  • No significant side effects from previous cancer treatments.
  • HIV-positive patients must have an undetectable viral load.
  • Hepatitis B and C infections must be under control or treated.
  • No use of certain medications that interact with the study drugs within 14 days before starting the trial.
  • Patients who progress on binimetinib alone may switch to the combination treatment if they meet the criteria and start within 21 days.

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