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

• Status: Completed
• Trial end date: 2017-03-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hutchison Medipharma Limited
• Treatments: Albumin-Bound Paclitaxel; Paclitaxel

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;