A Prospective, Single-arm, Multi-center Clinical Trial Evaluating the Efficacy and Safety of Dasatinib in RefrActory MetAstatic Gastrointestinal Stromal Tumor

Peking University Cancer Hospital & Institute7 sites in 1 country57 target enrollmentMay 2016

ConditionsGastrointestinal Stromal Tumor

Interventionsdasatinib

Drugsdasatinib

Overview

Phase: Not Applicable
Intervention: dasatinib
Conditions: Gastrointestinal Stromal Tumor
Sponsor: Peking University Cancer Hospital & Institute
Enrollment: 57
Locations: 7
Primary Endpoint: Progression-free survive, calculated from registration until progression or death
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to determine whether dasatinib is effective and safe in the treatment of refractory metastatic gastrointestinal stromal tumor

Registry

clinicaltrials.gov

Start Date

May 2016

End Date

May 2018

Last Updated

9 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Peking University Cancer Hospital & Institute

Responsible Party

Principal Investigator

Shen Lin

MD，PhD

Peking University Cancer Hospital & Institute

Eligibility Criteria

Inclusion Criteria

•Histologically confirmed recurrent/metastatic gastrointestinal stromal tumor (GIST). Immunohistochemically, the detection KIT and/or DOG-1 are/is positive
•Patients must have measurable disease meeting the requirement of RECIST 1.1
•Received the gene mutation detection of c - kit/PDGFRA
•Subjects with mutation in exon 11, in exon 9 and wild type c-kit/PDGFRA have failed to imatinib and sunitinib
•Subjects with primary mutation in exon 17 or 18 have failed to imatinib
•Subjects with primary mutation in exon 11 and secondary mutation in exon 17 or 18 have failed to imatinib
•Subjects with mutation in exon 18 of PDGFRA,have received TKI or not
•Eastern Cooperative Oncology Group (ECOG) performance status = 0-2
•Expected OS ≥3 months
•Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria

•Local or metastatic GIST is resectable
•Unable to receive the gene mutation detection of c-kit (c-kitproto-oncogeneprotein)/PDGFRA
•AST and/or ALT \> 2.5 times ULN, or Bilirubin \>1.5 times upper limit of normal (ULN)
•Neutrophil count \< 1.5 x 10\^9/L, or Platelet count \<75 x 10\^9/L, or Hemoglobin\<90g/L
•Cr \>1.5×ULN
•Other malignancy within the past 5 years except for adequately treated carcinoma in situ of the cervix or cutaneous basal cell carcinoma
•Known brain metastasis, spinal cord compression, carcinomatous meningitis, or cerebral or soft meningeal disease through CT or MRI during screening stage
•Within the past 5 years, subjects have one of the following disease: myocardial infarction, serious/instable angina pectoris, symptomatic congestive heart failure or cerebrovascular accident from coronary/peripheral artery bypass grafting
•Known human immunodeficiency virus positivity
•Joining in other trail

Arms & Interventions

Dasatinib

Dasatinib is given orally 50 mg 2 times a day for the first week, if subject is tolerate, then increased to 70 mg 2 times a day. Dasatinib will be continued until unacceptable toxicity and progression.

Intervention: dasatinib

Outcomes

Primary Outcomes

Progression-free survive, calculated from registration until progression or death

Time Frame: 2 years

Secondary Outcomes

Overall survival, overall survival will be calculated from registration until death(2 years)
Adverse drug reactions according to NCI CTCAE v4.0(2 years, Tolerability will be assessed based on the frequency and severity of Adverse Drug Reactions (ADR) coded according to NCI CTCAE v4.0.)
Tumor control probability, defined as CR＋PR＋SD, determined according to RECIST 1.1 criteria(2 years)
Objective response, according to Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria(2 years)