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

Gastrointestinal Stromal Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02776878
• Other study ID #: DRAMA GIST
• 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

Related Conditions & MeSH terms

• Gastrointestinal Stromal Tumor
• Gastrointestinal Stromal Tumors

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