Study on DCC-3116 Combined with Other Cancer Treatments for Advanced Cancers

Sponsor: Deciphera Pharmaceuticals, LLC

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05957367

Provider View

This clinical trial is exploring the safety and effectiveness of a new drug, DCC-3116, when used with other cancer treatments in adults with advanced cancers. The study is divided into different parts based on the specific combination of treatments being tested.

Patient Parameters

Program Overview

This study is testing a new drug called DCC-3116 in combination with other cancer treatments to see if it is safe and effective for people with advanced cancers. The study is open-label, meaning both the researchers and participants know which treatments are being given. Different parts of the study focus on different combinations of DCC-3116 with other cancer drugs.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • For Module B, Part 1: Must have a confirmed diagnosis of gastrointestinal stromal tumor (GIST) with a specific mutation and have tried at least one approved treatment that didn't work or couldn't be tolerated. Must not have taken ripretinib before.
  • For Module B, Part 2: Must have GIST with a specific mutation and have tried imatinib without success or couldn't tolerate it, and not have tried other treatments for GIST.
  • Must have measurable cancer.
  • Must have a life expectancy of more than 3 months and be in good general health (ECOG status 0-1).
  • Must have good organ function and bone marrow health based on lab tests.
  • Must provide a fresh tumor biopsy and, if available, a previous tumor tissue sample.
  • Must agree to provide a biopsy during treatment.

Exclusion Criteria

  • Must not have taken certain medications, including some cancer treatments and herbal supplements like St. John's wort, within a specified time before starting the study.
  • Must not have taken grapefruit or grapefruit juice within 14 days before starting the study.
  • Must have recovered from any significant side effects of previous treatments.
  • Must not have severe heart disease or recent heart problems.
  • Must not have cancer that has spread to the brain or spinal cord.
  • Must not have malabsorption syndrome.
  • Must not have bone disease needing treatment within 6 months before the study.
  • Must not have had major surgery within 4 weeks before starting the study.
  • Must not have active infections like HIV, Hepatitis B, or Hepatitis C.

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