A Phase Ib/2 Clinical Study of Fruquintinib Combined With Paclitaxel in the Treatment of Advanced Gastric Cancer
Condition: Gastric Cancer
MeSH terms: Stomach Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

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.
    

Intervention name(s): fruquintinib+paclitaxel
Intervention type(s): Drug
Intervention description(s): 28-day cycle of fruquintinib qd for 3 weeks followed by 1-week break combined with paclitaxel 80 mg/m2
Other intervention name(s): HMPL-013+paclitaxel
Intervention MeSH terms: Paclitaxel; Albumin-Bound Paclitaxel
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment