Ignite Creation Date:
2024-05-06 @ 10:18 AM
Last Modification Date:
2024-10-26 @ 12:28 PM
Study NCT ID:
NCT03223376
Status:
UNKNOWN
Last Update Posted:
2022-09-02
First Post:
2017-07-18
Brief Title:
A Phase III Study of Fruquintinib in Combination With Paclitaxel in Second Line Gastric CancerFRUTIGA
Sponsor:
Hutchison Medipharma Limited
Organization:
Hutchmed
Study Overview
Official Title:
A Phase III Study to Evaluate the Efficacy and Safety of Fruquintinib in Combination With Paclitaxel Versus Paclitaxel Alone in Second Line Gastric Cancer
Status:
UNKNOWN
Status Verified Date:
2022-08
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FRUTIGA
Brief Summary:
Fruquintinib once daily in 4 weeks treatment cycle three weeks on and one week off in combination with Paclitaxel 80mgday1 8 15 of 4 weeks cycle was well tolerated and demonstrated encouraging preliminary clinical antitumor activity in patients with advanced GC in ph1b2 study This study is aimed to evaluate the efficacy and safety of Fruquintinib in combination with Paclitaxel in the treatment of patients with aGC who have progressed after first line standard chemotherapy
Detailed Description:
This is a randomized double-blind placebo-controlled multicenter Phase III clinical trial to compare the efficacy and safety of Fruquintinib combined with Paclitaxel versus Paclitaxel alone in patients with advanced gastric cancer who have progressed after first-line standard chemotherapy After checking eligibility criteria subjects will be randomized into Fruquintinib combined with Paclitaxel group treatment group or placebo combined with Paclitaxel group control group in a ratio of 11 Primary Efficacy Endpoint Overall Survival OS Progression free survival PFS According to RECIST Version 11 Secondary Efficacy Endpoints Objective Response Rate ORR Disease Control Rate DCR Duration of Response DOR EORTC QLQ-C30 V3 Safety and tolerance will be evaluated by incidence severity and outcomes of AEs and categorized by severity in accordance with the NCI CTC AE Version 403
Study Oversight
Has Oversight DMC:
None
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?:
None