Study on DCC-3116 Combined with Other Cancer Treatments for Advanced Cancers
Sponsor: Deciphera Pharmaceuticals, LLC
ClinicalTrials ID:NCT05957367
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
| Parameter | Options |
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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.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Southern California - Norris Comprehensive Cancer Center | 90033 | Los Angeles | California |
| UCLA Department of Medicine-Hematology/Oncology | 90095 | Los Angeles | California |
| Sylvester Comprehensive Cancer Center | 33136 | Miami | Florida |
| START Midwest | 49546 | Grand Rapids | Michigan |
| Washington University School of Medicine - Siteman Cancer Center | 63110 | Saint Louis | Missouri |
| Laura & Isaac Perlmutter Cancer Center at NYU Langone Health | 10016 | New York | New York |
| Memorial Sloan Kettering Cancer Center - Main Campus | 10065 | New York | New York |
| Cleveland Clinic Taussig Cancer Center | 44195 | Cleveland | Ohio |
| Oregon Health & Science University | 97239 | Portland | Oregon |
| Fox Chase Cancer Center | 19111 | Philadelphia | Pennsylvania |
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