NCT01801930

A Phase 1 Study of OCV-C02 in Patients With Advanced or Relapsed Colorectal Cancer

A Phase 1 Study of OCV-C02 in Patients With Advanced or Relapsed Colorectal Cancer Who Are Refractory or Intolerant to Standard Chemotherapy

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Otsuka Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

To assess the safety and tolerability of OCV-C02 in Patients With Advanced or Relapsed Colorectal Cancer Who Are Refractory or Intolerant to Standard Chemotherapy

Detailed description

The incidence of dose limiting toxicity (DLT) will be evaluated in cohorts of six patients by starting OCV-C02 administration at dose level 1 (OCV-103 and OCV-104 at 0.3 mg each), increasing the dose to dose level 2 (at 1 mg each), level 3 (at 3 mg each), and then up to dose level 4 (at 6 mg each). Once-weekly administration will be repeated four times in each treatment cycle, and the incidence of DLT from Day 1 to Day 29 will be evaluated. At the end of Cycle 1, patients who wish to continue OCV-C02 treatment and have provided their written consent will be permitted to continue participation in the trial using the same dosing schedule for each subsequent cycle as that for Cycle 1.

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
DRUG	OCV-103 and OCV-104	0.3 mg of each
DRUG	OCV-103 and OCV-104	1 mg of each
DRUG	OCV-103 and OCV-104	3 mg of each
DRUG	OCV-103 and OCV-104	6 mg of each

Timeline

• Start date: 2013-03-01
• Primary completion: 2015-01-01
• Completion: 2015-01-01
• First posted: 2013-03-01
• Last updated: 2021-02-26
• Results posted: 2021-02-26

Locations

3 sites across 1 country: Japan