Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2026-02-11 @ 2:17 AM
Study NCT ID:
NCT03684967
Status:
WITHDRAWN
Last Update Posted:
2019-11-19
First Post:
2018-08-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Fruquintinib (HMPL-013) in High Risk Patients With Advanced NSCLC
Sponsor:
Hutchison Medipharma Limited
Organization:
Study Overview
Official Title:
An Open-label Single Arm Multi-center Phase II Study to Assess Fruquintinib in High Risk Patients With Advanced Non-squamous Non-small Cell Lung Cancer
Status:
WITHDRAWN
Status Verified Date:
2018-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
the study stopped because the company's strategy.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Fruquintinib administered at 4 mg once daily in cycle 1 and 5 mg once daily in followed cycles (3 weeks on and 1 week off, 4 weeks as 1 cycle) was well tolerated and demonstrated encouraging preliminary clinical antitumor activity in patients with advanced NSCLC in phase II study.
This study is aimed to evaluate the efficacy and safety of Fruquintinib in the treatment of high risk patients with advanced NSCLC who is \> 75 years, or Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) = 2, or without systemic chemotherapy, or with at least three lines systemic chemotherapies.
This study is aimed to evaluate the efficacy and safety of Fruquintinib in the treatment of high risk patients with advanced NSCLC who is \> 75 years, or Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) = 2, or without systemic chemotherapy, or with at least three lines systemic chemotherapies.
Detailed Description:
This is an open-label single arm multi-center phase II study to assess the efficacy and safety of Fruquintinib in high risk patients with advanced NSCLC who is \> 75 years, or ECOG PS = 2, or without systemic chemotherapy, or with at least three lines systemic chemotherapies.
After checking eligibility criteria, subjects will take Fruquintinib as below: 4 mg once daily in the Cycle 1, administration for 3 weeks followed by 1 week break. 5mg once daily in followed cycles, administration for 3 weeks followed by 1 week break.
Primary Efficacy Endpoint:
Disease Control Rate (DCR) (According to RECIST Version 1.1). Safety and tolerance will be evaluated by incidence, severity and outcomes of adverse events (AEs) and categorized by severity in accordance with the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.
Secondary Efficacy Endpoints:
Objective Response Rate (ORR), Duration of Response (DOR), Progression free survival (PFS), Overall Survival (OS) and Quality of Life (QoL).
After checking eligibility criteria, subjects will take Fruquintinib as below: 4 mg once daily in the Cycle 1, administration for 3 weeks followed by 1 week break. 5mg once daily in followed cycles, administration for 3 weeks followed by 1 week break.
Primary Efficacy Endpoint:
Disease Control Rate (DCR) (According to RECIST Version 1.1). Safety and tolerance will be evaluated by incidence, severity and outcomes of adverse events (AEs) and categorized by severity in accordance with the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.
Secondary Efficacy Endpoints:
Objective Response Rate (ORR), Duration of Response (DOR), Progression free survival (PFS), Overall Survival (OS) and Quality of Life (QoL).
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: