Study on Avapritinib for Treating CKIT or PDGFRA Mutation-Positive Advanced or Metastatic Solid Tumors

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04771520

Provider View

This clinical trial is testing the drug avapritinib to see if it can help control the growth of solid tumors that have specific genetic mutations and have spread to nearby tissues or other parts of the body.

Patient Parameters

Program Overview

This phase II study is exploring the effects of avapritinib on solid tumors with specific genetic mutations in CKIT or PDGFRA that are either locally advanced or have spread to other parts of the body. Avapritinib works by blocking certain enzymes that tumor cells need to grow, potentially helping to control the tumor's growth.

Description

The main goal of this study is to find out how well avapritinib works in shrinking tumors with CKIT or PDGFRA mutations. Researchers will also look at how long the response lasts, how well the disease is controlled, and the safety of the drug. They will also explore overall survival rates, the drug's effect on brain metastases, and how long patients can stay on the treatment.

Participants will take avapritinib by mouth once a day in 28-day cycles, continuing as long as the treatment is effective and side effects are manageable. After finishing the treatment, patients will have follow-up visits at 30 days and then every 8 weeks.

Eligibility Criteria

Inclusion Criteria

  • Must provide written consent to participate.
  • Must be 18 years or older.
  • Have a solid tumor that is locally advanced or has spread, and has not responded to standard treatments or has no standard treatments available.
  • Have a specific CKIT or PDGFRA mutation confirmed by tests.
  • Have measurable disease according to specific criteria.
  • Have adequate blood cell counts and organ function.
  • Have a life expectancy of at least 3 months.
  • Be willing to comply with study requirements, including treatment and visits.
  • Women must not be pregnant and must use effective contraception if of childbearing potential.
  • Men must use effective contraception if they have partners of childbearing potential.

Exclusion Criteria

  • Have gastrointestinal stromal tumors (GIST).
  • Have certain resistant CKIT mutations.
  • Have untreated or unstable brain metastases.
  • Have serious heart conditions or abnormal heart rhythms.
  • Have participated in another study or used an investigational device recently.
  • Have had recent cancer treatments or surgery without adequate recovery.
  • Have recent blood clots or bleeding events.
  • Have a history of certain brain conditions or bleeding.
  • Have active infections or other serious medical conditions.
  • Are pregnant or breastfeeding.
  • Cannot swallow pills or have digestive issues affecting absorption of the drug.
  • Have another progressing cancer requiring treatment.

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