TRIAL DETAIL

Efficacy and Safety of Anlotinib in Patients With Advanced Gastrointestinal Stromal Tumor After Failure of Imatinib: a Prospective, Single Arm and Multicenter Trial

Drug:
Trial Name:
Efficacy and Safety of Anlotinib in Patients With Advanced Gastrointestinal Stromal Tumor After Failure of Imatinib: a Prospective, Single Arm and Multicenter Trial
NCT#:
Conditions:
Gastrointestinal Stromal Tumor
Status:
Recruiting
Phase:
2
Start Date 10/23/2018
Age of Trial (yrs) 1.6
Treatment Phase:
Gleevec-resistant
Drug Category:
KIT + VEGFR
Strategy:
Block KIT + Block related tumor signal paths
Trial Type:
Specifically GIST and only GIST
Other Protocol IDs:
2018YJZ42
Sponsor:
CTTQ Chia Tai Tian Qing Pharma
Patient Contact:
Jian LI, PhD 008613601310849 oncogene@163.com Lin Shen
Contact email:
Contact Phone:
Randomized:
IV or Oral:
Oral
Trial Notes:
Inclusion Criteria:

- 1. Male or female, 18 years of age or older. 2. Histologically-proven diagnosis of recurrent or metastatic GIST (Gastrointestinal Stromal Tumors).

3. Patients must have measurable disease meeting the requirement of RECIST 1.1. 4. Failure of prior treatment with imatinib or intolerant to imatinib. 5. No condition for receiving sunitinib and regorafenib. 6. ECOG (Eastern Cooperative Oncology Group) performance status 0 or 1. Resolution of all acute toxic effects Adequate organ function. 7. The estimated survival period is more than 3 months. 8. Ability to understand and the willingness to sign a written informed consent document 9. Subject will comply with the study procedures and therapy

Exclusion Criteria:

1. Local or metastatic GIST is resectable. 2. Be treated with sunitinib or regorafenib. 3. AST and/or ALT > 2.5 times ULN, or Bilirubin >1.5 times upper limit of normal (ULN) 4. Neutrophil count < 1.5 x 10^9/L, or Platelet count <75 x 10^9/L, or Hemoglobin<90g/L 5. Cr >1.5×ULN 6. Other malignancy within the past 5 years except for adequately treated carcinoma in situ of the cervix or cutaneous basal cell carcinoma.

Trial Links

Trial Results

Drug Information

Trial Sites

Name
Address
City
State
Zip
Country
Beijing
China