Clinical Trials

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 (e.g., 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 (e.g., 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.
• If female, the patient is pregnant or lactating. 
• 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. 
• Gastrointestinal abnormalities including but not limited to: 
  • inability to take oral medication;
  • malabsorption syndromes;
  • requirement for intravenous alimentation.
• Any active bleeding excluding hemorrhoidal or gum bleeding.