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

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

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

Study Overview

• Status: Unknown
• Conditions: Gastrointestinal Stromal Tumor
• Intervention / Treatment: Drug: dasatinib

• Study Type: Interventional
• Enrollment (Anticipated): 57
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Progression-free survive, calculated from registration until progression or death	2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
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.
Objective response, according to Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria	2 years
Tumor control probability, defined as CR＋PR＋SD, determined according to RECIST 1.1 criteria	2 years

Collaborators and Investigators

• Sponsor: Peking University Cancer Hospital & Institute
• Investigators: Principal Investigator: Shen Lin, Peking University Cancer Hospital & Institute

Study record dates

Study Major Dates

• Study Start: May 1, 2016
• Primary Completion (Anticipated): October 1, 2017
• Study Completion (Anticipated): May 1, 2018

Study Registration Dates

• First Submitted: May 17, 2016
• First Submitted That Met QC Criteria: May 17, 2016
• First Posted (Estimate): May 18, 2016

Study Record Updates

• Last Update Posted (Estimate): May 18, 2016
• Last Update Submitted That Met QC Criteria: May 17, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Neoplasms, Connective Tissue; Gastrointestinal Stromal Tumors; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Dasatinib
• Other Study ID Numbers: DRAMA GIST

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED