- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04148092
Expanded Access Program of Ripretinib (DCC-2618) for the Treatment of Patients With Advanced GIST
May 27, 2020 updated by: Deciphera Pharmaceuticals LLC
Expanded Access Program for Ripretinib in Patients With Locally Advanced Unresectable or Metastatic GIST Who Have Received Treatment With Prior Therapies
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.
Study Overview
Status
Approved for marketing
Conditions
Intervention / Treatment
Detailed Description
The EAP is no longer enrolling patients in the United States.
Study Type
Expanded Access
Expanded Access Type
- Individual Patients
- Treatment IND/Protocol
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Description
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
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
October 30, 2019
First Submitted That Met QC Criteria
October 30, 2019
First Posted (Actual)
November 1, 2019
Study Record Updates
Last Update Posted (Actual)
May 29, 2020
Last Update Submitted That Met QC Criteria
May 27, 2020
Last Verified
May 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DCC-2618-99-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on GIST - Gastrointestinal Stromal Tumor
-
Centre Leon BerardRecruitingMetastatic Gastrointestinal Stromal Tumor | Unresectable Gastrointestinal Stromal Tumor (GIST) | Locally Advanced Gastrointestinal Stromal Tumor (GIST)France
-
Centre Leon BerardRecruitingC-KIT Mutation | Metastatic Gastrointestinal Stromal Tumor (GIST) | Advanced Gastrointestinal Stromal Tumor (GIST)France
-
Hospital Universitario Virgen de la ArrixacaNot yet recruitingLiver Diseases | Liver Transplantation | Liver Neoplasms | Gastrointestinal Stromal Tumors | Metastasis | Liver Metastases | Liver Transplant; Complications | Liver Cancer | Liver Transplant Disorder | Liver Carcinoma | GIST, Malignant | GIST | Metastases | Metastatic Liver Cancer | Gastrointestinal Stromal Tumor of... and other conditionsSpain
-
Ascentage Pharma Group Inc.HealthQuest Pharma Inc.RecruitingSolid Tumor, Adult | Gastrointestinal Stromal Tumor (GIST)China
-
National Health Research Institutes, TaiwanNational Taiwan University Hospital; Mackay Memorial Hospital; China Medical... and other collaboratorsRecruitingGastrointestinal Stromal Tumor (GIST)Taiwan
-
Kristen GanjooGlaxoSmithKlineTerminatedGastrointestinal Stromal Tumor (GIST)United States
-
Instituto Ecuatoriano de Enfermedades DigestivasRecruitingGastrointestinal Stromal Tumor (GIST)Ecuador
-
Sichuan Provincial People's HospitalRecruitingGastrointestinal Stromal Tumor(GIST)China
-
Memorial Sloan Kettering Cancer CenterActive, not recruitingGastrointestinal Stromal Tumor (GIST)United States
-
Memorial Sloan Kettering Cancer CenterPlexxikon; Array BioPharmaCompletedGastrointestinal Stromal Tumor (GIST)United States
Clinical Trials on ripretinib
-
Peking UniversityThe First Affiliated Hospital with Nanjing Medical University; Xiangya Hospital... and other collaboratorsActive, not recruitingGastrointestinal Stromal TumorsChina
-
Zai Lab (Shanghai) Co., Ltd.CompletedGastrointestinal Stromal TumorsChina
-
Deciphera Pharmaceuticals LLCCompletedGastrointestinal Stromal Tumors | Advanced Cancers | Advanced Systemic MastocytosisUnited States, Canada, Germany, Italy, Netherlands, United Kingdom
-
Deciphera Pharmaceuticals LLCCompletedGastrointestinal Stromal TumorsUnited States, France, Finland, United Kingdom, Germany, Netherlands, Italy, Belgium, Spain, Canada, Australia, Poland, Singapore
-
RenJi HospitalRecruitingGastrointestinal Stromal TumorsChina
-
Deciphera Pharmaceuticals LLCWithdrawnGastrointestinal Stromal Tumors
-
Deciphera Pharmaceuticals LLCActive, not recruitingGIST - Gastrointestinal Stromal TumorUnited States
-
Deciphera Pharmaceuticals LLCPfizerRecruitingColorectal Cancer | GISTUnited States
-
Zai Lab (Shanghai) Co., Ltd.CompletedGastrointestinal Stromal Tumor(GIST)China
-
Deciphera Pharmaceuticals LLCRecruitingGISTUnited States, Korea, Republic of, Spain, Taiwan, Australia, Canada, United Kingdom, Italy, Netherlands, Brazil, Chile, Poland