A Multi-Center, Open-Label Study of Fruquintinib in Solid Tumors, Colorectal, and Breast Cancer
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 18
Summary
- Conditions
- Advanced Solid Tumors
- HER2 Negative Breast Cancer
- Hormone Receptor Positive Breast Carcinoma
- Metastatic Breast Cancer
- Metastatic Colon Cancer
- Rectal Cancer
- Triple -Negative Breast Cancer
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: Non-RandomizedIntervention Model: Sequential AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
The study is an open-label, dose escalation and expansion clinical trial to evaluate the safety, tolerability, and PK of fruquintinib in patients with advanced solid tumors. The study will consist of two phases: A dose escalation phase - A 3+3 design will be used for this portion of the study. A dos...
The study is an open-label, dose escalation and expansion clinical trial to evaluate the safety, tolerability, and PK of fruquintinib in patients with advanced solid tumors. The study will consist of two phases: A dose escalation phase - A 3+3 design will be used for this portion of the study. A dose expansion phase - Five cohorts will be evaluated in Dose Expansion. Cohort A will evaluate the MTD/RP2D in patients with advanced solid tumors. Cohort B and Cohort C will evaluate the MTD/RP2D in metastatic colorectal cancer patients. Cohort D and Cohort E will evaluate the MTD/RP2D in metastatic breast cancer patients. Study will be conducted in up to 9 sites in the US.
Tracking Information
- NCT #
- NCT03251378
- Collaborators
- Not Provided
- Investigators
- Study Director: William Schelman Hutchison MediPharma International Inc.
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