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

May 17, 2016 updated by: Shen Lin, Peking University Cancer Hospital & Institute

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

57

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100142
        • Recruiting
        • Beijing Cancer Hospital
        • Contact:
        • 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival, overall survival will be calculated from registration until death
Time Frame: 2 years
2 years
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.
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
Time Frame: 2 years
2 years
Tumor control probability, defined as CR＋PR＋SD, determined according to RECIST 1.1 criteria
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University Cancer Hospital & Institute

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Other Study ID Numbers

  • DRAMA GIST

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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