Expanded Access Program of Ripretinib (DCC-2618) for the Treatment of Patients With Advanced GIST
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
Detailed Description
The EAP is no longer enrolling patients in the United States.
Study Design
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
Criteria
Inclusion Criteria:
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Male or female patients, ≥ 18 years of age at the time of informed consent
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Histologic diagnosis of GIST
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Patients must have received prior treatment with at least 2 of the FDA-approved drugs for GIST: imatinib, sunitinib, and regorafenib.
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Female patients of childbearing potential must have a negative pregnancy test at Screening.
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Patients of reproductive potential must agree to follow the contraception requirements.
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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.
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Adequate organ function and bone marrow reserve as determined by the Investigator at Screening.
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Resolution to Grade 1 or baseline of all serious toxicities from prior therapy prior to initiating treatment with ripretinib
Exclusion Criteria:
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Eligible to participate in another ongoing clinical study in which the patient may have access to ripretinib
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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.
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Received prior treatment with ripretinib
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Known active central nervous system metastases
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With a concurrent malignancy for which treatment is being received that may interfere with the potential benefits of ripretinib to the patient
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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.
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Any other clinically significant comorbidities which in the judgment of the Investigator, could predispose the patient to safety risks
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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
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If female, the patient is pregnant or lactating.
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Known allergy or hypersensitivity to any component of the investigational product. Patients with a history of Stevens-Johnson syndrome on a prior tyrosine kinase inhibitor are excluded.
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Gastrointestinal abnormalities including but not limited to:
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inability to take oral medication
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malabsorption syndromes
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requirement for intravenous alimentation
- Any active bleeding excluding hemorrhoidal or gum bleeding
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Deciphera Pharmaceuticals LLC
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- DCC-2618-99-001