APPROVED_FOR_MARKETINGNot Applicable

Expanded Access Program of Ripretinib (DCC-2618) for the Treatment of Patients With Advanced GIST

Plain-language summary

This is an open-label, single-arm, multicenter expanded access study to provide patients who have locally advanced unresectable or metastatic gastrointestinal stromal tumor (GIST) and have received treatment with at least 2 prior Food and Drug Administration (FDA)-approved therapies early access to ripretinib until such time that ripretinib becomes commercially available or the Sponsor chooses to discontinue the program.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Male or female patients, ≥ 18 years of age at the time of informed consent
✓. Histologic diagnosis of GIST
✓. Patients must have received prior treatment with at least 2 of the FDA-approved drugs for GIST: imatinib, sunitinib, and regorafenib.
✓. Female patients of childbearing potential must have a negative pregnancy test at Screening.
✓. Patients of reproductive potential must agree to follow the contraception requirements.
✓. Patient is capable of understanding and complying with the protocol and has signed the ICF. A signed ICF must be obtained before any study specific procedures are performed.
✓. Adequate organ function and bone marrow reserve as determined by the Investigator at Screening.
✓. Resolution to Grade 1 or baseline of all serious toxicities from prior therapy prior to initiating treatment with ripretinib

Exclusion criteria

✕. Eligible to participate in another ongoing clinical study in which the patient may have access to ripretinib
✕. Received treatment with anticancer therapy, including investigational therapy, or investigational procedures within 7 days or 5 × the half-life (whichever is longer) prior to the first dose of ripretinib. For prior biological therapies (eg, monoclonal antibodies with a half-life longer than 3 days), the interval must be at least 28 days prior to the first dose of ripretinib.
✕. Received prior treatment with ripretinib
✕. Known active central nervous system metastases
✕. With a concurrent malignancy for which treatment is being received that may interfere with the potential benefits of ripretinib to the patient
✕. Undergone major surgeries (eg, abdominal laparotomy) within 4 weeks of the first dose of ripretinib. Following major surgeries, \> 4 weeks prior to the first dose of ripretinib, all surgical wounds must be healed and free of infection or dehiscence.
✕. Any other clinically significant comorbidities which in the judgment of the Investigator, could predispose the patient to safety risks
✕. Known human immunodeficiency virus or hepatitis C infection only if the patient is taking medications that must be avoided or taken with caution per protocol, active hepatitis B, or active hepatitis C infection

Trial details

NCT IDNCT04148092

SponsorDeciphera Pharmaceuticals, LLC

Sponsor typeINDUSTRY

Study typeEXPANDED_ACCESS

View on ClinicalTrials.gov More GIST - Gastrointestinal Stromal Tumor trials