- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03223376
A Phase III Study of Fruquintinib in Combination With Paclitaxel in Second Line Gastric Cancer(FRUTIGA) (FRUTIGA)
August 31, 2022 updated by: Hutchison Medipharma Limited
A Phase III Study to Evaluate the Efficacy and Safety of Fruquintinib in Combination With Paclitaxel Versus Paclitaxel Alone in Second Line Gastric Cancer
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
703
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Beijing, China, 100142
- Hutchison Medi Pharma Investigational sites
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Shanghai, China, 200125
- Hutchison Medi Pharma Investigational Site
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Anhui
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Hefei, Anhui, China, 230000
- Hutchison Medi Pharma Invesigational sites
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Guangdong
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Guangzhou, Guangdong, China, 510030
- Hutchison Medi Pharma Investigational Site
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Heilongjiang
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Harbin, Heilongjiang, China, 150081
- Hutchison Medi Pharma Investigational Site
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Jiangsu
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Nanjing, Jiangsu, China, 210000
- Huchison Medi Pharma Investigational site
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Zhejiang
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Hangzhou, Zhejiang, China, 310000
- Hutchison Medi Pharma Investigational sites
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: fruquintinib+paclitaxel
treatment arm (fruquintinib+paclitaxel) : Fruquintinib once daily, 3 weeks on/1week off combined with Paclitaxel 80mg/㎡ day1, 8, 15 of 4 weeks cycle.
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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
Other Names:
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Placebo Comparator: placebo+paclitaxel
control arm (placebo+paclitaxel): Fruquintinib placebo once daily, 3 weeks on/1week off combined with Paclitaxel 80mg/㎡ day1, 8, 15 of 4 weeks cycle.
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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
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall survival (OS)
Time Frame: from randomization until death due to any cause, assessed up to 3 year
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every two months follow up after EOT observation period at 30 days after the last medication
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from randomization until death due to any cause, assessed up to 3 year
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Progression free survival (PFS)
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]
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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.
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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]
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective response rate (ORR)
Time Frame: from randomization up to progressive disease or EOT due to any cause, assessed up to 1 year
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Tumor assessment will be performed using radiography method every 8 weeks until the occurrence of progressive disease (PD), using RECIST v 1.1
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from randomization up to progressive disease or EOT due to any cause, assessed up to 1 year
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Disease control rate (DCR)
Time Frame: from randomization up to progressive disease or EOT due to any cause, assessed up to 1 year
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Tumor assessment will be performed using radiography method every 8 weeks until the occurrence of progressive disease (PD), using RECIST v 1.1
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from randomization up to progressive disease or EOT due to any cause, assessed up to 1 year
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Safety and tolerance evaluated by incidence, severity and outcomes of AEs
Time Frame: from first dose to 30 days post the last dose
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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
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from first dose to 30 days post the last dose
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Duration of response, DOR
Time Frame: : From the first documented PR or CR until the first documented PD or death,assessed up to 2 years
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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.
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: From the first documented PR or CR until the first documented PD or death,assessed up to 2 years
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The European Organization for Reasearch and Treatment of Cancer(EORTC ) Quality of Life Questionnaire-Core 30 V3.0 (QLQ-C30 v3.0)
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
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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.
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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
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 18, 2017
Primary Completion (Anticipated)
September 1, 2022
Study Completion (Anticipated)
November 1, 2022
Study Registration Dates
First Submitted
July 18, 2017
First Submitted That Met QC Criteria
July 18, 2017
First Posted (Actual)
July 21, 2017
Study Record Updates
Last Update Posted (Actual)
September 2, 2022
Last Update Submitted That Met QC Criteria
August 31, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Stomach Diseases
- Stomach Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Paclitaxel
- Albumin-Bound Paclitaxel
Other Study ID Numbers
- 2017-013-00CH1
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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