A Phase III Study of Fruquintinib in Combination With Paclitaxel in Second Line Gastric Cancer(FRUTIGA)

HUTCHMED

Status and phase

Completed

Phase 3

Conditions

Advanced Gastric Cancer

Treatments

Combination Product: fruquintinib placebo + paclitaxel

Combination Product: fruquintinib +paclitaxel

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03223376

2017-013-00CH1

Details and patient eligibility

About

Fruquintinib once daily in 4 weeks treatment cycle (three weeks on and one week off) in combination with Paclitaxel 80mg/㎡（day1, 8, 15 of 4 weeks cycle) was well tolerated and demonstrated encouraging preliminary clinical antitumor activity in patients with advanced GC in ph1b/2 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.

Full 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 1:1. Primary Efficacy Endpoint: Overall Survival (OS), Progression free survival (PFS) (According to RECIST Version 1.1). 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 4.03.

Enrollment

703 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Signed informed consent
Histologically or cytologically confirmed gastric or gastroesophageal junction adenocarcinoma
Metastatic disease or locally advanced, unresectable disease
Disease progression during or within 4 months after the last dose of the first-line therapy (with platinum/fluoropyrimidine )
Adequate hepatic, renal, heart, and hematologic functions
At least one measurable lesion (larger than 10 mm in diameter by spiral CT scan)
Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure
Good performance status Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 to 1

Exclusion criteria

Pregnant or lactating women
Any factors that influence the usage of oral administration
Evidence of CNS metastasis
Intercurrence with one of the following: non-controlled hypertension, coronary artery disease, arrhythmia and heart failure
Abuse of alcohol or drugs
Less than 4 weeks from the last clinical trial
Previous treatment with VEGFR inhibition
Disability of serious uncontrolled intercurrence infection
Proteinuria ≥ 2+ (1.0g/24hr)
Have evidence or a history of bleeding tendency within two months of the enrollment randomization, regardless of seriousness
Within 12 months before the first treatment occurs artery/venous thromboembolic events, such as cerebral vascular accident (including transient ischemic attack) etc.
Within 6 months before the first treatment occurs acute myocardial infarction, acute coronary syndrome or CABG
Bone fracture or wounds that was not cured for a long time
Coagulation dysfunction, hemorrhagic tendency or receiving anticoagulant Therapy
The tumor invades a large vessel structure, such as the pulmonary artery, superior vena cava, or inferior vena cava