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A Phase Ib/2 Clinical Study of Fruquintinib Combined With Paclitaxel in the Treatment of Advanced Gastric Cancer

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Descriptive Information
Brief Title † A Phase Ib/2 Clinical Study of Fruquintinib Combined With Paclitaxel in the Treatment of Advanced Gastric Cancer
Official Title † A Phase Ib/2 Clinical Study to Evaluate the Safety, Pharmacokinetic Characteristics and Preliminary Efficacy of Fruquintinib Combined With Paclitaxel in Patients With Advanced Gastric Cancer
Brief Summary An open-label, dose escalation and maximum tolerated dose (MTD) and/or recommended phase II dose (RPTD) study of fruquintinib combined with paclitaxel in patients with advanced gastric cancer who did not respond to first-line standard chemotherapy.
Detailed Description In dose escalation period, 12-24 patients with advanced gastric cancer will be enrolled. Patients meeting enrollment eligibility will receive 28-day cycles of fruquintinib 2-5 mg qd combined with paclitaxel 80 mg/m2. Safety information and pharmacokinetic data will be collected till disease progression or intolerable toxicity to determine MTD and/or RPTD of fruquintinib combined with paclitaxel in patients with advanced gastric cancer. This period will include the following 4 dose groups from low to high: A: Fruquintinib 2 mg qd for 3 weeks followed by 1-week break + paclitaxel 80 mg/m2 once a week during the first three weeks of each cycle B: Fruquintinib 3 mg qd for 3 weeks followed by 1-week break + paclitaxel 80 mg/m2 once a week during the first three weeks of each cycle C: Fruquintinib 4 mg qd for 3 weeks followed by 1-week break + paclitaxel 80 mg/m2 once a week during the first three weeks of each cycle D: Fruquintinib 5 mg qd for 3 weeks followed by 1-week break + paclitaxel 80mg/m2 once a week during the first three weeks of each cycle This study will use traditional 3+3 trial design (3 subjects will be enrolled in each dose group first. If 1 case of DLT is observed, additional 3 subjects will be enrolled in the same dose group to further evaluate toxicity) to observe DLT and evaluate MTD. If there are 2 or more cases of DLT in one dose group, the group lower than this dose group by one level is MTD dose group. At least 6 subjects are required in MTD dose group for confirmation. If MTD is not achieved at the end of dose escalation and there are 6 subjects in the highest dose group, RPTD can be determined based on obtained safety, tolerability, PK and efficacy information. Dose escalation and study in the next dose group can be initiated only after the first treatment cycle (DLT window observation period) is completed and subject safety and tolerability are confirmed in this dose group (0/3 or ≤1/6 subjects experience DLT). Subjects in the original dose group will continue to receive the next cycle of treatment at the original dose till disease progression or treatment withdrawal due to any of the following reasons: 1) death, 2) intolerable toxicity, 3) pregnancy, 4) the investigator considers the study should be terminated for the subject's best interests, 5) the subject or legal representative requests withdrawal, 6) loss to follow-up, 7) the subject has poor compliance and cannot comply with the study protocol.
Study Phase Phase 1/Phase 2
Study Type † Interventional
Study Design †
Primary Outcome Measure † incidence of DLT
Secondary Outcome Measure † Objective response rate (ORR)
Condition † Gastric Cancer
Intervention † Drugfruquintinib+paclitaxel
Study Arms / Comparison Groups fruquintinib+paclitaxel fruquintinib combined with paclitaxel. Fruquintinib treatment: administration for 3 weeks followed by 1-week break, and administration every day for the first 21 days.Paclitaxel is administered once weekly in the first three weeks of each cycle.
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Drug
Estimated Enrollment † 34
Start Date † September 2014
Completion Date March 31, 2017
Primary Completion Date March 31, 2017
Eligibility Criteria † Inclusion Criteria: 1. Fully understand the study and sign the informed consent form voluntarily; 2. Patients with local advanced and/or metastatic gastric cancer confirmed by histology and/or cytology; 3. Fail in previous first-line standard chemotherapy 4. Aged 18-70years (inclusive); 5. Body weight ≥40 kg; 6. At least one measurable lesion (according to RECIST1.1); 7. Physical status score (ECOG score) 0-1; 8. Expected survival >12 weeks. Exclusion Criteria: 1. Who are participating in another drug clinical trial in the past 4 weeks; or receive systemic anti-tumor chemotherapy, radiotherapy or biotherapy within 4 weeks prior to administration of the study drug; 2. Who previously received VEGF/VEGFR inhibitors; 3. Who have not recovered from toxicity caused by previous anti-cancer treatment (CTCAE>grade 1), or not completely recovered from previous surgery; 4. Active brain metastasis(with clinical symptom); 5. Other malignancies except squamous-cell or basal cell carcinoma, and cervical carcinoma in situ in the past 5 years; 6. Uncontrolled clinical active infection, e.g. acute pneumonia, hepatitis B or active hepatitis C; 7. Dysphagia, intractable vomiting or known drug malabsorption;
Gender All
Ages 18 Years - 70 Years
Accepts Healthy Volunteers No
Contacts ††
Location Countries † China
Administrative Information
NCT ID † NCT02415023
Organization ID 2014-013-00CH3
Secondary IDs ††
Responsible Party Sponsor
Study Sponsor † Hutchison Medipharma Limited
Collaborators ††
Investigators † Study Director: Songhua Fan, M.D., HMP
Information Provided By
Verification Date February 2017
First Received Date † April 1, 2015
Last Updated Date February 23, 2017
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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