NCT04282590

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

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

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Toray Industries, Inc · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chemotherapy-induced Peripheral Neuropathy

Interventions

Type	Name	Description
DRUG	TRK-750/Placebo	Powder for oral solution
DRUG	Placebo/TRK-750	Powder for oral solution

Timeline

• Start date: 2020-04-01
• Primary completion: 2021-12-01
• Completion: 2021-12-01
• First posted: 2020-02-25
• Last updated: 2022-03-15