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

Primary Purpose

Gastrointestinal Stromal Tumor

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
dasatinib
Sponsored by
Peking University Cancer Hospital & Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastrointestinal Stromal Tumor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Beijing Cancer HospitalRecruiting
  • Chinese PLA General Hospital
  • The First Affiliated Hospital,Sun Yat-sen University
  • No.81 Hospital of Chinese People's Liberation Army
  • Fudan University Shanghai Cancer Center
  • Shanxi Cancer Hospital
  • West China Hospital , Sichuan University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Dasatinib

Arm Description

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.

Outcomes

Primary Outcome Measures

Progression-free survive, calculated from registration until progression or death

Secondary Outcome Measures

Overall survival, overall survival will be calculated from registration until death
Adverse drug reactions according to NCI CTCAE v4.0
Objective response, according to Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria
Tumor control probability, defined as CR＋PR＋SD, determined according to RECIST 1.1 criteria

Full Information

First Posted
May 17, 2016
Last Updated
May 17, 2016
Sponsor
Peking University Cancer Hospital & Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02776878
Brief Title
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

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Unknown status
Study Start Date
May 2016 (undefined)
Primary Completion Date
October 2017 (Anticipated)
Study Completion Date
May 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University Cancer Hospital & Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Stromal Tumor

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
57 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dasatinib
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
dasatinib
Primary Outcome Measure Information:
Title
Progression-free survive, calculated from registration until progression or death
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Overall survival, overall survival will be calculated from registration until death
Time Frame
2 years
Title
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.
Title
Objective response, according to Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria
Time Frame
2 years
Title
Tumor control probability, defined as CR＋PR＋SD, determined according to RECIST 1.1 criteria
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Li Jian
Phone
008613601310849
Email
oncogene@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shen Lin
Organizational Affiliation
Peking University Cancer Hospital & Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Cancer Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100142
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Li Jian
Phone
008613601310849
Email
oncogene@163.com
First Name & Middle Initial & Last Name & Degree
Shen Lin
Facility Name
Chinese PLA General Hospital
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wu Xin
Phone
008613683285233
First Name & Middle Initial & Last Name & Degree
Wu Xin
Facility Name
The First Affiliated Hospital,Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhang Xinhua
Phone
008613828463644
First Name & Middle Initial & Last Name & Degree
Zhang Xinhua
Facility Name
No.81 Hospital of Chinese People's Liberation Army
City
Nanjing
State/Province
Jiangsu
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liu Xiufeng
Phone
008613357837170
First Name & Middle Initial & Last Name & Degree
Liu Xiufeng
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhou Ye
Phone
008613661736873
First Name & Middle Initial & Last Name & Degree
Zhou Ye
Facility Name
Shanxi Cancer Hospital
City
Taiyuan
State/Province
Shanxi
ZIP/Postal Code
030013
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liang Xiaobo
First Name & Middle Initial & Last Name & Degree
Liang Xiaobo
Facility Name
West China Hospital , Sichuan University
City
Chengdu
State/Province
Sichuan
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhang Bo
Phone
008613881952600
First Name & Middle Initial & Last Name & Degree
Zhang Bo

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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