Anlotinib in Advanced Solid Tumors With FGFR Alteration

• Sponsor: Shanghai Changzheng Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03929965
• Collaborator: (none)
• Enrollment: 30
• Locations: 3
• Arm: 1
• Anticipated Duration (Months): 48
• Patients Per Site: 10
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

This clinical trial aims to evaluate the efficacy, safety of Anlotinib in advanced solid tumors with FGFR alteration.

Condition or Disease	Intervention/Treatment	Phase
Advanced Solid Tumor	Drug: Anlotinib	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Anlotinib in Advanced Solid Tumors With FGFR Alteration
• Anticipated Study Start Date: Jul 1, 2019
• Anticipated Primary Completion Date: Jul 1, 2020
• Anticipated Study Completion Date: Jul 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: advanced solid tumors with FGFR alteration	Drug: Anlotinib; Anlotinib

Outcome Measures

Primary Outcome Measures

1. Objective Response Rate(ORR) [up to 36 months]

   Evaluation of tumor burden based on RECIST criteria.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

Patients should be histologically diagnosed with advanced solid tumors; Patients with FGFR mutation(including mutation, fusion, rearrangements ); Patients have measurable lesions; Patients are not available for targeted therapy or patients refuse to receive targeted therapy afer second-line treatment; Over 3 weeks after radiotherapy and the radiotherapy focus was not be measured; Age should be 18-25 years; Performance status should be 0-2; Life expectancy should be more than 12 weeks;

Exclusion Criteria:

Patients underwented major surgery or severe trauma within 4 weeks; Patients allergiced to experimental drugs; Patient ready to give birth or who is pregnant; Patients with brain metastases; Patients with chemotherapy contraindication; Patients could not tolerate chemotherapy; Patients have secondary primary tumor.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shanghai Changzheng Hospital	Shanghai	Shanghai	China	200433
2	Shanghai Changzheng Hospital	Shanghai	Shanghai	China	200433
3	Shanghai Changzheng Hospital	Shanghai	Shanghai	China	200433

Sponsors and Collaborators

• Shanghai Changzheng Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Zhan Wang, Anlotinib in advanced solid tumors with FGFR alteration, Shanghai Changzheng Hospital
• ClinicalTrials.gov Identifier: NCT03929965
• Other Study ID Numbers: ASTFA
• First Posted: Apr 29, 2019
• Last Update Posted: Apr 29, 2019
• Last Verified: Apr 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Zhan Wang, Anlotinib in advanced solid tumors with FGFR alteration, Shanghai Changzheng Hospital: Anlotinib; FGFR; solid tumors
• Additional relevant MeSH terms: Neoplasms

Study Results

No Results Posted as of Apr 29, 2019