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A Study to Investigate the Safety and Efficacy of TRK-750 for the Treatment of Patients With CIPN (Chopin Study)

Chemotherapy-induced Peripheral Neuropathy Clinical Trial

Official title:
A Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of TRK-750 in Colorectal Cancer Patients With Chemotherapy-induced Peripheral Neuropathy Following Oxaliplatin-containing Chemotherapy in the Adjuvant Setting

Clinical Trial Summary

The primary objective of the study is: • to assess the safety and tolerability of multiple oral (twice daily [BID]) doses of TRK-750 in oxaliplatin-treated colorectal cancer patients with chemotherapy-induced peripheral neuropathy (CIPN). The secondary objectives of the study are: - to assess the efficacy of multiple oral (BID) doses of TRK-750 in reducing neuropathic symptoms, improving quality of life (QoL), and clinician-reported outcomes in oxaliplatin-treated colorectal cancer patients with CIPN. - to study the relationship between plasma concentrations of TRK-750 and safety and efficacy variables in oxaliplatin-treated colorectal cancer patients with CIPN. The exploratory objective of this study is: • to assess the efficacy of multiple oral (BID) doses of TRK-750 on pharmacodynamic (PD) biomarker(s) in blood, psychophysical, electrophysiological, and histological parameters of neuropathy in oxaliplatin-treated colorectal cancer patients with CIPN.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04282590
Study type Interventional
Source Toray Industries, Inc
Contact
Status Withdrawn
Phase Phase 2
Start date April 2020
Completion date December 2021
View Details
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