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

Primary Purpose

Advanced Gastric Cancer

Status
Active
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
fruquintinib +paclitaxel
fruquintinib placebo + paclitaxel
Sponsored by
Hutchison Medipharma Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Gastric Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Hutchison Medi Pharma Invesigational sites
  • Hutchison Medi Pharma Investigational Site
  • Hutchison Medi Pharma Investigational site
  • Huchison Medi Pharma Investigational site
  • Hutchison Medi Pharma Investigational sites
  • Hutchison Medi Pharma Investigational sites
  • Hutchison Medi Pharma Investigational site

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

fruquintinib+paclitaxel

placebo+paclitaxel

Arm Description

treatment arm (fruquintinib+paclitaxel) : Fruquintinib once daily, 3 weeks on/1week off combined with Paclitaxel 80mg/㎡ day1, 8, 15 of 4 weeks cycle.

control arm (placebo+paclitaxel): Fruquintinib placebo once daily, 3 weeks on/1week off combined with Paclitaxel 80mg/㎡ day1, 8, 15 of 4 weeks cycle.

Outcomes

Primary Outcome Measures

Overall survival (OS)
every two months follow up after EOT observation period at 30 days after the last medication
Progression free survival (PFS)
PFS defined as the time from the date of randomization to the first evidence of disease progression as defined by response evaluation criteria in solid tumors (RECIST) v1.1 or death from any cause.

Secondary Outcome Measures

Objective response rate (ORR)
Tumor assessment will be performed using radiography method every 8 weeks until the occurrence of progressive disease (PD), using RECIST v 1.1
Disease control rate (DCR)
Tumor assessment will be performed using radiography method every 8 weeks until the occurrence of progressive disease (PD), using RECIST v 1.1
Safety and tolerance evaluated by incidence, severity and outcomes of AEs
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
Duration of response, DOR
DOR was the time from the date of first evidence of complete response or partial response to the date of objective progression or the date of death due to any cause, whichever is earlier. CR and PR were defined using the RECIST v1.1.
The European Organization for Reasearch and Treatment of Cancer（EORTC ） Quality of Life Questionnaire-Core 30 V3.0 (QLQ-C30 v3.0)
EORTC QLQ-C30 v3.0 was a self-administered questionnaire with multidimensional scales that measures global health status. There are 30 items in total, which can be divided into 15 fields. Five functional scales: physical function, role function, cognitive function, emotional function, social function; Three symptom scales: fatigue, pain, nausea and vomiting; Six individual measures: dyspnea, insomnia, loss of appetite, constipation, diarrhea, financial difficulties, and a global quality of life scale. The five functional scales and the global quality of life scale were scored independently. After linear transformation, the scores of all items ranged from 1 to 100, and the higher score, the higher functional level. The symptom scale was also scored independently and linearly transformed into a score from 1 to 100, with higher scores indicating more serious problems or symptoms.

Full Information

First Posted
July 18, 2017
Last Updated
August 31, 2022
Sponsor
Hutchison Medipharma Limited
Collaborators
Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT03223376
Brief Title
A Phase III Study of Fruquintinib in Combination With Paclitaxel in Second Line Gastric Cancer(FRUTIGA)
Acronym
FRUTIGA
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 18, 2017 (Actual)
Primary Completion Date
September 2022 (Anticipated)
Study Completion Date
November 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hutchison Medipharma Limited
Collaborators
Sun Yat-sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Gastric Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
703 (Actual)

8. Arms, Groups, and Interventions

Arm Title
fruquintinib+paclitaxel
Arm Type
Active Comparator
Arm Description
treatment arm (fruquintinib+paclitaxel) : Fruquintinib once daily, 3 weeks on/1week off combined with Paclitaxel 80mg/㎡ day1, 8, 15 of 4 weeks cycle.
Arm Title
placebo+paclitaxel
Arm Type
Placebo Comparator
Arm Description
control arm (placebo+paclitaxel): Fruquintinib placebo once daily, 3 weeks on/1week off combined with Paclitaxel 80mg/㎡ day1, 8, 15 of 4 weeks cycle.
Intervention Type
Combination Product
Intervention Name(s)
fruquintinib +paclitaxel
Other Intervention Name(s)
HMPL-013+paclitaxel
Intervention Description
treatment arm(fruquintinib +paclitaxel)- subjects will receive Fruquintinib orally, once daily for 3 wks on/ 1 wk off combined with paclitaxel 80mg/㎡ at day 1,8,15 of 4-week cycle. Patients will receive a cycles of 4 weeks of study treatment or until the occurrence of progressive disease (PD), death, unacceptable toxicity, withdrawal of consent or other conditions that meet the end of treatment cretieria
Intervention Type
Combination Product
Intervention Name(s)
fruquintinib placebo + paclitaxel
Other Intervention Name(s)
HMPL-013 placebo+paclitaxel
Intervention Description
control arm(fruquintinib placebo + paclitaxel)- subjects will receive Fruquintinib placebo orally, once daily for 3 wks on/ 1 wk off combined with paclitaxel 80mg/㎡ at day 1,8,15 of 4-week cycle. Patients will receive a cycles of 4 weeks of study treatment or until the occurrence of progressive disease (PD), death, unacceptable toxicity, withdrawal of consent or other conditions that meet the end of treatment cretieria
Primary Outcome Measure Information:
Title
Overall survival (OS)
Description
every two months follow up after EOT observation period at 30 days after the last medication
Time Frame
from randomization until death due to any cause, assessed up to 3 year
Title
Progression free survival (PFS)
Description
PFS defined as the time from the date of randomization to the first evidence of disease progression as defined by response evaluation criteria in solid tumors (RECIST) v1.1 or death from any cause.
Time Frame
from the date of randomization to the date of the first documented progressive disease or date of death due to any cause, assessed up to 1 year]
Secondary Outcome Measure Information:
Title
Objective response rate (ORR)
Description
Tumor assessment will be performed using radiography method every 8 weeks until the occurrence of progressive disease (PD), using RECIST v 1.1
Time Frame
from randomization up to progressive disease or EOT due to any cause, assessed up to 1 year
Title
Disease control rate (DCR)
Description
Tumor assessment will be performed using radiography method every 8 weeks until the occurrence of progressive disease (PD), using RECIST v 1.1
Time Frame
from randomization up to progressive disease or EOT due to any cause, assessed up to 1 year
Title
Safety and tolerance evaluated by incidence, severity and outcomes of AEs
Description
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
Time Frame
from first dose to 30 days post the last dose
Title
Duration of response, DOR
Description
DOR was the time from the date of first evidence of complete response or partial response to the date of objective progression or the date of death due to any cause, whichever is earlier. CR and PR were defined using the RECIST v1.1.
Time Frame
: From the first documented PR or CR until the first documented PD or death，assessed up to 2 years
Title
The European Organization for Reasearch and Treatment of Cancer（EORTC ） Quality of Life Questionnaire-Core 30 V3.0 (QLQ-C30 v3.0)
Description
EORTC QLQ-C30 v3.0 was a self-administered questionnaire with multidimensional scales that measures global health status. There are 30 items in total, which can be divided into 15 fields. Five functional scales: physical function, role function, cognitive function, emotional function, social function; Three symptom scales: fatigue, pain, nausea and vomiting; Six individual measures: dyspnea, insomnia, loss of appetite, constipation, diarrhea, financial difficulties, and a global quality of life scale. The five functional scales and the global quality of life scale were scored independently. After linear transformation, the scores of all items ranged from 1 to 100, and the higher score, the higher functional level. The symptom scale was also scored independently and linearly transformed into a score from 1 to 100, with higher scores indicating more serious problems or symptoms.
Time Frame
Evaluation before the beginning of each treatment cycle, at the end of treatment, and at the 30 days post the last dose，up to 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ruihua Xu, MD
Organizational Affiliation
Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hutchison Medi Pharma Invesigational sites
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230000
Country
China
Facility Name
Hutchison Medi Pharma Investigational Site
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510030
Country
China
Facility Name
Hutchison Medi Pharma Investigational site
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150081
Country
China
Facility Name
Huchison Medi Pharma Investigational site
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210000
Country
China
Facility Name
Hutchison Medi Pharma Investigational sites
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China
Facility Name
Hutchison Medi Pharma Investigational sites
City
Beijing
ZIP/Postal Code
100142
Country
China
Facility Name
Hutchison Medi Pharma Investigational site
City
Shanghai
ZIP/Postal Code
200125
Country
China

12. IPD Sharing Statement

Learn more about this trial

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

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