A Phase 1 Study of OCV-C02 in Patients With Advanced or Relapsed Colorectal Cancer Who Are Refractory or Intolerant to Standard Chemotherapy
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), and then up to dose level 3 (at 3 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.
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Dose Limiting Toxicity
Common Terminology Criteria for Adverse Events (CTCAE), ver. 4.0
1 Month (29Day)
Kyoji Imaoka, Mr
Otsuka Pharmaceutical Co., Ltd.
Japan: Ministry of Health, Labor and Welfare