A Phase II Study of TRK-750 in oxaliplatin-induced CIPN
Research type
Research Study
Full 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
IRAS ID
274764
Contact name
Lesley Colvin
Contact email
Sponsor organisation
Toray Industries, Inc.
Eudract number
2019-003561-17
Duration of Study in the UK
1 years, 5 months, 3 days
Research summary
This is a Phase II, randomised, double-blind, placebo controlled, crossover study conducted at multiple study sites to assess the safety, tolerability, pharmacokinetic (PK), and efficacy of multiple oral (BID) doses of TRK-750 in colorectal cancer patients with Chemotherapy induced Peripheral Neuropathy (CIPN). Patients will be randomly assigned in a 1:1 ration into 1 of 2 treatments sequences, TRK750/Placebo or Placebo/TRK750. Patients will be administered 580 mg TRK 750 or placebo orally twice daily for approximately 12 weeks before crossing over into treatment period 2 to receive the alternative treatment. Upto 120 patients will be ramdomised in order that 100 patients complete the study.
Planned Screening duration: approximately 2 weeks, planned Run in period: approximately 2 weeks and planned study duration (Screening to Follow up): approximately 32 weeks.REC name
London - City & East Research Ethics Committee
REC reference
20/LO/0022
Date of REC Opinion
20 Jan 2020
REC opinion
Favourable Opinion