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A Multi-Center, Open-Label Study of Fruquintinib in Solid Tumors, Colorectal, and Breast Cancer

Rectal Cancer Clinical Trial

Official title:
A Multi-Center, Open-Label, Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Anticancer Activity of Fruquintinib in Patients With Advanced Solid Tumors

Clinical Trial Summary

An open-label, dose escalation and expansion clinical trial to evaluate the safety, tolerability, and PK of fruquintinib in patients with advanced solid tumors, metastatic colorectal cancer and metastatic breast cancer.

Clinical Trial 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 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03251378
Study type Interventional
Source Hutchmed
Contact
Status Active, not recruiting
Phase Phase 1
Start date November 10, 2017
Completion date March 31, 2023
View Details
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