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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2018-05-31

Brief Summary

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

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Detailed Description

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Conditions

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Gastrointestinal Stromal Tumor

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

dasatinib

Intervention Type DRUG

Interventions

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dasatinib

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Shen Lin

MD，PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shen Lin

Role: PRINCIPAL_INVESTIGATOR

Peking University Cancer Hospital & Institute

Locations

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Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING