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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02776878
Other study ID # DRAMA GIST
Secondary ID
Status Recruiting
Phase N/A
First received May 17, 2016
Last updated May 17, 2016
Start date May 2016
Est. completion date May 2018

Study information

Verified date May 2016
Source Beijing Cancer Hospital
Contact Li Jian
Phone 008613601310849
Email oncogene@163.com
Is FDA regulated No
Health authority China: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Recruiting
Enrollment 57
Est. completion date May 2018
Est. primary completion date October 2017
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
dasatinib


Locations

Country Name City State
China Beijing Cancer Hospital Beijing Beijing
China Chinese PLA General Hospital Beijing Beijing
China West China Hospital , Sichuan University Chengdu Sichuan
China The First Affiliated Hospital,Sun Yat-sen University Guangzhou Guangdong
China No.81 Hospital of Chinese People's Liberation Army Nanjing Jiangsu
China Fudan University Shanghai Cancer Center Shanghai Shanghai
China Shanxi Cancer Hospital Taiyuan Shanxi

Sponsors (1)

Lead Sponsor Collaborator
Beijing Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Progression-free survive, calculated from registration until progression or death 2 years No
Secondary Overall survival, overall survival will be calculated from registration until death 2 years No
Secondary 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. Yes
Secondary Objective response, according to Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria 2 years No
Secondary Tumor control probability, defined as CR+PR+SD, determined according to RECIST 1.1 criteria 2 years No
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