Fruquintinib in Combination With Sintilimab in Patients With Advanced Solid Tumor
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 87
Summary
- Conditions
- Advanced Solid Tumor
- Type
- Interventional
- Phase
- Phase 1Phase 2
- Design
- Allocation: N/AIntervention Model: Sequential AssignmentIntervention Model Description: Open-Label Phase 1b/II Study of Fruquintinib in Combination with Sintilimab to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy in Patients with Advanced Solid Tumor.Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 75 years
- Gender
- Both males and females
Description
This study is composed of dose escalation stage and dose expansion stage. In dose escalation stage, 9-12 patients with advance solid tumor will be sequentially enrolled in Cohort A (Fruquintinib 3 mg QD (once a day), oral dosing, 3 weeks on/1 weeks off+Sintilimab 200mg Q4W(4 times a week), intraveno...
This study is composed of dose escalation stage and dose expansion stage. In dose escalation stage, 9-12 patients with advance solid tumor will be sequentially enrolled in Cohort A (Fruquintinib 3 mg QD (once a day), oral dosing, 3 weeks on/1 weeks off+Sintilimab 200mg Q4W(4 times a week), intravenous dosing) and Cohort B (Fruquintinib 4 mg QD, oral dosing, 3 weeks on/1 week off+Sintilimab 200mg Q4W, intravenous dosing). The MTD or RP2D will be determined in this stage. In dose expansion stage, 75 patients with advanced solid tumor will be enrolled and treated with RP2D. Efficacy, safety and tolerability will be assessed and PK (Pharmacokinetics) analysis will be performed in this study.
Tracking Information
- NCT #
- NCT03903705
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Jin Li Shanghai East Hospital
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