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

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ClinicalTrials.gov Identifier: NCT02776878
Recruitment Status : Unknown
Verified May 2016 by Shen Lin, Beijing Cancer Hospital.
Recruitment status was:  Recruiting
First Posted : May 18, 2016
Last Update Posted : May 18, 2016
Sponsor:
Information provided by (Responsible Party):
Shen Lin, Beijing Cancer Hospital

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

Condition or disease Intervention/treatment Phase
Gastrointestinal Stromal Tumor Drug: dasatinib Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 57 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Single-arm, Multi-center Clinical Trial Evaluating the Efficacy and Safety of Dasatinib in RefrActory MetAstatic Gastrointestinal Stromal Tumor
Study Start Date : May 2016
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : May 2018


Arm Intervention/treatment
Experimental: 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.
Drug: dasatinib



Primary Outcome Measures :
  1. Progression-free survive, calculated from registration until progression or death [ Time Frame: 2 years ]

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


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02776878


Contacts
Contact: Li Jian 008613601310849 oncogene@163.com

Locations
China, Beijing
Beijing Cancer Hospital Recruiting
Beijing, Beijing, China, 100142
Contact: Li Jian    008613601310849    oncogene@163.com   
Principal Investigator: Shen Lin         
Chinese PLA General Hospital Not yet recruiting
Beijing, Beijing, China
Contact: Wu Xin    008613683285233      
Principal Investigator: Wu Xin         
China, Guangdong
The First Affiliated Hospital,Sun Yat-sen University Not yet recruiting
Guangzhou, Guangdong, China
Contact: Zhang Xinhua    008613828463644      
Principal Investigator: Zhang Xinhua         
China, Jiangsu
No.81 Hospital of Chinese People's Liberation Army Not yet recruiting
Nanjing, Jiangsu, China
Contact: Liu Xiufeng    008613357837170      
Principal Investigator: Liu Xiufeng         
China, Shanghai
Fudan University Shanghai Cancer Center Not yet recruiting
Shanghai, Shanghai, China
Contact: Zhou Ye    008613661736873      
Principal Investigator: Zhou Ye         
China, Shanxi
Shanxi Cancer Hospital Not yet recruiting
Taiyuan, Shanxi, China, 030013
Contact: Liang Xiaobo         
Principal Investigator: Liang Xiaobo         
China, Sichuan
West China Hospital , Sichuan University Not yet recruiting
Chengdu, Sichuan, China
Contact: Zhang Bo    008613881952600      
Principal Investigator: Zhang Bo         
Sponsors and Collaborators
Beijing Cancer Hospital
Investigators
Principal Investigator: Shen Lin Beijing Cancer Hospital

Responsible Party: Shen Lin, MD,PhD, Beijing Cancer Hospital
ClinicalTrials.gov Identifier: NCT02776878     History of Changes
Other Study ID Numbers: DRAMA GIST
First Posted: May 18, 2016    Key Record Dates
Last Update Posted: May 18, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Gastrointestinal Stromal Tumors
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Dasatinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action