Status:
COMPLETED
A Phase 1 Study of OCV-C02 in Patients With Advanced or Relapsed Colorectal Cancer
Lead Sponsor:
Otsuka Pharmaceutical Co., Ltd.
Conditions:
Colorectal Cancer
Eligibility:
All Genders
20+ years
Phase:
PHASE1
Brief 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 ...
Eligibility Criteria
Inclusion
- Patients who have human leukocyte antigen (HLA)-A\*24:02
- Patients who have histologically-confirmed colorectal cancer (adenocarcinoma)
- Patients with advanced or relapsed colorectal cancer who are refractory or intolerant to standard chemotherapy
- Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 1 at the time of enrollment in the trial.
Exclusion
- Patients who are HIV antibody test positive
- Patients with an active infection
- Patients who have or are suspected to have CNS metastasis of colon cancer (such as metastatis of the brain)
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2015
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01801930
Start Date
March 1 2013
End Date
January 1 2015
Last Update
February 26 2021
Active Locations (3)
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1
Nagoya, Japan
2
Sunto-gun, Japan
3
Tokyo, Japan