Know Cancer

or
forgot password

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


Phase 1
20 Years
N/A
Open (Enrolling)
Both
Colorectal Cancer

Thank you

Trial Information

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.


Inclusion Criteria:



- 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 Criteria:

- 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)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Dose Limiting Toxicity

Outcome Description:

Common Terminology Criteria for Adverse Events (CTCAE), ver. 4.0

Outcome Time Frame:

1 Month (29Day)

Safety Issue:

Yes

Principal Investigator

Kyoji Imaoka, Mr

Investigator Role:

Study Director

Investigator Affiliation:

Otsuka Pharmaceutical Co., Ltd.

Authority:

Japan: Ministry of Health, Labor and Welfare

Study ID:

293-12-001

NCT ID:

NCT01801930

Start Date:

March 2013

Completion Date:

September 2014

Related Keywords:

  • Colorectal Cancer
  • OCV-C02
  • Colorectal Cancer
  • Antigen specific cancer immunotherapeutic
  • Colorectal Neoplasms

Name

Location