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

Primary Purpose

Gastrointestinal Stromal Tumors

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Anlotinib

About this trial

This is an interventional treatment trial for Gastrointestinal Stromal Tumors

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.
7. Known brain metastasis, spinal cord compression, carcinomatous meningitis, or cerebral or soft meningeal disease through CT or MRI during screening stage.
8. 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.
9. Known human immunodeficiency virus positivity. 10. Joining in other trail. 11. Women who are pregnant or lactating; No contraception for subject during childbearing period.
12. 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.

Sites / Locations

Beijing Cancer HospitalRecruiting

Outcomes

Primary Outcome Measures

PFS

Progress Free Survival

Secondary Outcome Measures

Full Information

NCT ID

NCT04106024

First Posted

September 25, 2019

Last Updated

September 25, 2019

Sponsor

Cttq

1. Study Identification

Unique Protocol Identification Number

NCT04106024

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2019

Overall Recruitment Status

Unknown status

Study Start Date

October 23, 2018 (Actual)

Primary Completion Date

October 30, 2019 (Anticipated)

Study Completion Date

April 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Cttq

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gastrointestinal Stromal Tumors

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Anlotinib

Intervention Description

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

Primary Outcome Measure Information:

Title

PFS

Description

Progress Free Survival

Time Frame

18 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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. 7. Known brain metastasis, spinal cord compression, carcinomatous meningitis, or cerebral or soft meningeal disease through CT or MRI during screening stage. 8. 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. 9. Known human immunodeficiency virus positivity. 10. Joining in other trail. 11. Women who are pregnant or lactating; No contraception for subject during childbearing period. 12. 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jian LI, PhD

Phone

008613601310849

oncogene@163.com

First Name & Middle Initial & Last Name or Official Title & Degree

Lin Shen

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Xin Wu

Organizational Affiliation

Chinese PLA General Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Xinhua Zhang

Organizational Affiliation

First Affiliated Hospital, Sun Yat-Sen University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Ye Zhou

Organizational Affiliation

Fudan University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Bo Zhang

Organizational Affiliation

West China Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

XiaoFeng Sun

Organizational Affiliation

Jiangsu Cancer Institute & Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

HongYan Qu

Organizational Affiliation

Harbin Medical University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Beijing Cancer Hospital

City

Beijing

State/Province

Beijing

ZIP/Postal Code

010

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

shen lin

12. IPD Sharing Statement

Learn more about this trial

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

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