NCT03929965

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 25, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 29, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
Last Updated

April 29, 2019

Status Verified

April 1, 2019

Enrollment Period

1 year

First QC Date

April 25, 2019

Last Update Submit

April 25, 2019

Conditions

Advanced Solid Tumor

Keywords

AnlotinibFGFRsolid tumors

Outcome Measures

Primary Outcomes (1)

  • Objective Response Rate(ORR)

    Evaluation of tumor burden based on RECIST criteria.

    up to 36 months

Study Arms (1)

advanced solid tumors with FGFR alteration

EXPERIMENTAL
Drug: Anlotinib

Interventions

AnlotinibDRUG

Anlotinib

advanced solid tumors with FGFR alteration

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Shanghai Changzheng Hospital

Shanghai, Shanghai Municipality, 200433, China

RECRUITING

Shanghai Changzheng Hospital

Shanghai, Shanghai Municipality, 200433, China

RECRUITING

Shanghai Changzheng Hospital

Shanghai, Shanghai Municipality, 200433, China

RECRUITING

MeSH Terms

Interventions

anlotinib

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
Anlotinib in advanced solid tumors with FGFR alteration

Study Record Dates

First Submitted

April 25, 2019

First Posted

April 29, 2019

Study Start

July 1, 2019

Primary Completion

July 1, 2020

Study Completion

July 1, 2023

Last Updated

April 29, 2019

Record last verified: 2019-04

Locations

CN(3)