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

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ClinicalTrials.gov Identifier: NCT03223376
Recruitment Status : Recruiting
First Posted : July 21, 2017
Last Update Posted : November 8, 2017
Sponsor:
Collaborator:
Sun Yat-sen University
Information provided by (Responsible Party):
Hutchison Medipharma Limited

Brief Summary:
Fruquintinib 4mg once daily in 4 weeks treatment cycle (three weeks on and one week off) in combination with Paclitaxel 80mg/m2 (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.

Condition or disease Intervention/treatment Phase
Advanced Gastric Cancer Combination Product: fruquintinib +paclitaxel Combination Product: fruquintinib placebo + paclitaxel Phase 3

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 eligbility criteria, subjects will be randomized into Fruquintinib combined with Paclitaxel group (treatment group) or placebo combined with Paclitaxel group (control group) in a ration of 1:1. Primary Efficacy Endpoint: Overall Survival (OS). Secondary Efficacy Endpoints: Progression free survival (PFS) (According to RECIST Version 1.1), Objective Response Rate (ORR), Disease Control Rate (DCR), . 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  (Clinical Trial)
Estimated Enrollment : 544 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase III Study to Evaluate the Efficacy and Safety of Fruquitinib in Combination With Paclitaxel Versus Paclitaxel Alone in Second Line Gastric Cancer
Actual Study Start Date : October 18, 2017
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer
Drug Information available for: Paclitaxel

Arm Intervention/treatment
Active Comparator: fruquintinib+paclitaxel
treatment arm (fruquintinib+paclitaxel) : Fruquintinib 4mg once daily, 3 weeks on/1week off combined with Paclitaxel 80mg/m2 day1, 8, 15 of 4 weeks cycle.
Combination Product: fruquintinib +paclitaxel
treatment arm(fruquintinib +paclitaxel)- subjects will receive Fruquintinib 4mg orally, once daily for 3 wks on/ 1 wk off combined with paclitaxel 80mg/m2 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 Name: HMPL-013+paclitaxel

Placebo Comparator: placebo+paclitaxel
control arm (placebo+paclitaxel): Fruquintinib placebo 4mg once daily, 3 weeks on/1week off combined with Paclitaxel 80mg/m2 day1, 8, 15 of 4 weeks cycle.
Combination Product: fruquintinib placebo + paclitaxel
control arm(fruquintinib placebo + paclitaxel)- subjects will receive Fruquintinib placebo 4mg orally, once daily for 3 wks on/ 1 wk off combined with paclitaxel 80mg/m2 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 Name: HMPL-013 placebo+paclitaxel




Primary Outcome Measures :
  1. Overall survival (OS) [ Time Frame: from randomization until death due to any cause, assessed up to 3 year ]
    every two months follow up after EOT observation period at 30 days after the last medication


Secondary Outcome Measures :
  1. Progression free survival (PFS) [ Time Frame: from randomization up to progressive disease or EOT due to any cause, assessed up to 1 year ]
    Tumor assessment will be performed using radiography method every 8 weeks, until the occurrence of progressive disease (PD), using RECIST v 1.1

  2. Objective response rate (ORR) [ Time Frame: from randomization up to progressive disease or EOT due to any cause, assessed up to 1 year ]
    Tumor assessment will be performed using radiography method every 8 weeks until the occurrence of progressive disease (PD), using RECIST v 1.1

  3. Disease control rate (DCR) [ Time Frame: from randomization up to progressive disease or EOT due to any cause, assessed up to 1 year ]
    Tumor assessment will be performed using radiography method every 8 weeks until the occurrence of progressive disease (PD), using RECIST v 1.1

  4. Safety and tolerance evaluated by incidence, severity and outcomes of AEs [ Time Frame: from first dose to 30 days post the last dose ]
    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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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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, 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03223376


Contacts
Contact: Songhua Fan, MD 862120673058 songhuaf@hmplglobal.com
Contact: Ye Hua, MD 862120673007 yeh@hmplglobal.com

Locations
China, Anhui
Hutchison Medi Pharma Invesigational sites Not yet recruiting
Hefei, Anhui, China, 230000
Contact: Songhua Fan, MD    862120673058    songhuaf@hmplglobal.com   
China, Guangdong
Hutchison Medi Pharma Investigational Site Recruiting
Guangzhou, Guangdong, China, 510030
Contact: Songhua Fan, MD    862120673058    songhuaf@hmplglobal.com   
Principal Investigator: Ruihua Xu, PhD,MD         
China, Heilongjiang
Hutchison Medi Pharma Investigational site Not yet recruiting
Harbin, Heilongjiang, China, 150081
Contact: Songhua Fan, MD    862120673058    songhuaf@hmplglobal.com   
China, Jiangsu
Huchison Medi Pharma Investigational site Not yet recruiting
Nanjing, Jiangsu, China, 210000
Contact: Songhua Fan, MD    862120673058    songhuaf@hmplglobal.com   
China, Zhejiang
Hutchison Medi Pharma Investigational sites Not yet recruiting
Hangzhou, Zhejiang, China, 310000
Contact: Songhua Fan, MD    862120673058    songhuaf@hmplglobal.com   
China
Hutchison Medi Pharma Investigational sites Not yet recruiting
Beijing, China, 100142
Contact: Songhua Fan, MD    862120673058    songhuaf@hmplglobal.com   
Hutchison Medi Pharma Investigational site Not yet recruiting
Shanghai, China, 200125
Contact: Songhua Fan, MD    862120673058    songhuaf@hmplglobal.com   
Sponsors and Collaborators
Hutchison Medipharma Limited
Sun Yat-sen University
Investigators
Principal Investigator: Ruihua Xu, PhD,MD Sun Yat-sen University

Responsible Party: Hutchison Medipharma Limited
ClinicalTrials.gov Identifier: NCT03223376     History of Changes
Other Study ID Numbers: 2017-013-00CH1
First Posted: July 21, 2017    Key Record Dates
Last Update Posted: November 8, 2017
Last Verified: November 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action