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

NCT04106024 | Unknown Phase 2

• 1 other identifier: 2018YJZ42
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Gastrointestinal stromal tumors (GIST) compose approximately 20% of soft tissue sarcomas with an annual incidence of approximately 7 per million population. GISTs occur throughout the GI tract, most commonly in the stomach or small intestine. The main treatment for localised GIST is surgical resection. At least 40% of these patients will develop recurrence or metastasis following complete resection. Local recurrence, liver metastases and/or dissemination within the abdominal cavity are the most common clinical manifestations. Although imatinib and sunitinib has greatly improved the quality of life and survival of patients with advanced GIST. Analysis of clinical trials revealed that patients with tumours with KIT exon 17 or 18 mutations, with a second mutation in KIT exon 17 or 18, had worse responses to imatinib and sunitinib. Some patients with PDGFRA D842V mutation do not respond to the present standard therapies. Anlotinib (1-\[\[\[4-(4-fluoro-2-methyl-1H-indol-5-yloxy)-6-methoxyquinolin-7-Yl\] oxy\] methyl\]cyclopropanamine dihydrochloride) , a multi-targeted tyrosine kinase inhibitor (TKI), characterized as a highly selective and potent c-KIT, VEGFR, PDGFR, FGFR inhibitor. In vitro and in vivo, Anlotinib has a broad spectrum of inhibitory action on tumor angiogenesis and growth, which showed broad activity against soft tissue sarcoma and GIST with D842V, D816H, V560G and V654A mutations. In 2015, the US FDA granted orphan drug treatment for ovarian cancer.

Conditions

Gastrointestinal Stromal Tumors

Outcome Measures

Primary Outcomes (1)

• PFS

  Progress Free Survival

  18 month

Interventions

Anlotinib DRUG

Anlotinib 12mg.qd ,taken for 2 weeks and discontinued for 1 week, namely 3 weeks (21 days).

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• \. 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.
• \. Known brain metastasis, spinal cord compression, carcinomatous meningitis, or cerebral or soft meningeal disease through CT or MRI during screening stage.
• \. Within the past 1 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. 10. Joining in other trail. 11. 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

• Cttq: lead

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 010, China

RECRUITING

MeSH Terms

Conditions

Gastrointestinal Stromal Tumors

Interventions

anlotinib

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

Study Officials

• Xin Wu

  Chinese PLA General Hospital

  PRINCIPAL INVESTIGATOR

• Xinhua Zhang

  First Affiliated Hospital, Sun Yat-Sen University

  PRINCIPAL INVESTIGATOR

• Ye Zhou

  Fudan University

  PRINCIPAL INVESTIGATOR

• Bo Zhang

  West China Hospital

  PRINCIPAL INVESTIGATOR

• XiaoFeng Sun

  Jiangsu Cancer Institute & Hospital

  PRINCIPAL INVESTIGATOR

• HongYan Qu

  Harbin Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jian LI, PhD

CONTACT

008613601310849; oncogene@163.com

Lin Shen

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2019
• First Posted: September 26, 2019
• Study Start: October 23, 2018
• Primary Completion: October 30, 2019
• Study Completion: April 30, 2020
• Last Updated: September 26, 2019

Record last verified: 2019-09

Locations

CN (1)