A Clinical Trial Evaluating the Efficacy and Safety of Dasatinib in Refractory Metastatic GIST

Recruitment & Eligibility

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
Subject will comply with the study procedures and therapy

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
Women who are pregnant or lactating; No contraception for subject during childbearing period
Subject with other serious acute and chronic physical or mental problems, or laboratory abnormality, will increase the risks associated with trail or drug. It will also interference the judgment of the results. In the judgment of the investigator, subject is inadequate to participant the study

Study & Design

Arm && Interventions

Group	Intervention	Description
Dasatinib	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.

Primary Outcome Measures

Name	Time	Method
Progression-free survive, calculated from registration until progression or death	2 years

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (7)

Chinese PLA General Hospital

🇨🇳

Beijing, Beijing, China

Beijing Cancer Hospital

🇨🇳

Beijing, Beijing, China

The First Affiliated Hospital,Sun Yat-sen University

🇨🇳

Guangzhou, Guangdong, China

No.81 Hospital of Chinese People's Liberation Army

🇨🇳

Nanjing, Jiangsu, China

Fudan University Shanghai Cancer Center

🇨🇳

Shanghai, Shanghai, China

Shanxi Cancer Hospital

🇨🇳

Taiyuan, Shanxi, China

West China Hospital , Sichuan University

🇨🇳

Chengdu, Sichuan, China

Recruitment & Eligibility