Clinical trial NCT02776878: A Clinical Trial Evaluating the Efficacy and Safety of Dasatinib in Refractory Metastatic GIST
Official title: A Prospective, Single-arm, Multi-center Clinical Trial Evaluating the Efficacy and Safety of Dasatinib in RefrActory MetAstatic Gastrointestinal Stromal Tumor
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gastrointestinal Stromal Tumor
Lead sponsor: Peking University Cancer Hospital & Institute
Sponsor class: OTHER
First posted: 2016-05-18
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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
* 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

Primary outcomes:
measure: Progression-free survive, calculated from registration until progression or death
timeFrame: 2 years
Secondary outcomes:
measure: Overall survival, overall survival will be calculated from registration until death
timeFrame: 2 years
measure: Adverse drug reactions according to NCI CTCAE v4.0
timeFrame: 2 years, Tolerability will be assessed based on the frequency and severity of Adverse Drug Reactions (ADR) coded according to NCI CTCAE v4.0.
measure: Objective response, according to Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria
timeFrame: 2 years
measure: Tumor control probability, defined as CR＋PR＋SD, determined according to RECIST 1.1 criteria
timeFrame: 2 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
city: Guangzhou
country: China
facility: The First Affiliated Hospital,Sun Yat-sen University
state: Guangdong
city: Nanjing
country: China
facility: No.81 Hospital of Chinese People's Liberation Army
state: Jiangsu
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
city: Taiyuan
country: China
facility: Shanxi Cancer Hospital
state: Shanxi
city: Chengdu
country: China
facility: West China Hospital , Sichuan University
state: Sichuan
Study officials:
affiliation: Peking University Cancer Hospital & Institute
name: Shen Lin
role: PRINCIPAL_INVESTIGATOR
References: