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

NCT ID: NCT01801930

Last Updated: 2021-02-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2015-01-31

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 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dose level 1

Group Type: EXPERIMENTAL

OCV-103 and OCV-104

Intervention Type: DRUG

0.3 mg of each

Dose level 2

Group Type: EXPERIMENTAL

OCV-103 and OCV-104

Intervention Type: DRUG

1 mg of each

Dose level 3

Group Type: EXPERIMENTAL

OCV-103 and OCV-104

Intervention Type: DRUG

3 mg of each

Dose level 4

Group Type: EXPERIMENTAL

OCV-103 and OCV-104

Intervention Type: DRUG

6 mg of each

Interventions

OCV-103 and OCV-104

0.3 mg of each

Intervention Type: DRUG

OCV-103 and OCV-104

1 mg of each

Intervention Type: DRUG

OCV-103 and OCV-104

3 mg of each

Intervention Type: DRUG

OCV-103 and OCV-104

6 mg of each

Intervention Type: DRUG

Eligibility Criteria

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)

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Otsuka Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Junichi Hashimoto, PhD

Role: STUDY_DIRECTOR

Otsuka Pharmaceutical Co., Ltd.

Locations

Nagoya, , Japan

Sunto-gun, , Japan

Tokyo, , Japan

Countries

Japan

References

Taniguchi H, Iwasa S, Yamazaki K, Yoshino T, Kiryu C, Naka Y, Liew EL, Sakata Y. Phase 1 study of OCV-C02, a peptide vaccine consisting of two peptide epitopes for refractory metastatic colorectal cancer. Cancer Sci. 2017 May;108(5):1013-1021. doi: 10.1111/cas.13227. Epub 2017 May 11.

Reference Type: DERIVED

PMID: 28266765 (View on PubMed)

Other Identifiers

JapicCTI-132075

Identifier Type: OTHER

Identifier Source: secondary_id

293-12-001

Identifier Type: -

Identifier Source: org_study_id