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

NCT02776878 | Unknown

• 1 other identifier: DRAMA GIST
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 7

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

Conditions

Gastrointestinal Stromal Tumor

Outcome Measures

Primary Outcomes (1)

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

  2 years

Secondary Outcomes (4)

• 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

Study Arms (1)

Dasatinib

EXPERIMENTAL

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

Interventions

dasatinib DRUG

Dasatinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking University Cancer Hospital & Institute: lead

Study Sites (7)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

Chinese PLA General Hospital

Beijing, Beijing Municipality, China

NOT YET RECRUITING

The First Affiliated Hospital,Sun Yat-sen University

Guangzhou, Guangdong, China

NOT YET RECRUITING

No.81 Hospital of Chinese People's Liberation Army

Nanjing, Jiangsu, China

NOT YET RECRUITING

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

NOT YET RECRUITING

Shanxi Cancer Hospital

Taiyuan, Shanxi, 030013, China

NOT YET RECRUITING

West China Hospital , Sichuan University

Chengdu, Sichuan, China

NOT YET RECRUITING

MeSH Terms

Conditions

Gastrointestinal Stromal Tumors

Interventions

Dasatinib

Condition Hierarchy (Ancestors)

Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Study Officials

• Shen Lin

  Peking University Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Li Jian

CONTACT

008613601310849; oncogene@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD，PhD

Study Record Dates

• First Submitted: May 17, 2016
• First Posted: May 18, 2016
• Study Start: May 1, 2016
• Primary Completion: October 1, 2017
• Study Completion: May 1, 2018
• Last Updated: May 18, 2016

Record last verified: 2016-05

Locations

CN (7)