NCT01801930

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1 colorectal-cancer

Timeline
Completed

Started Mar 2013

Shorter than P25 for phase_1 colorectal-cancer

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 27, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 1, 2013

Completed
Same day until next milestone

Study Start

First participant enrolled

March 1, 2013

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
6.2 years until next milestone

Results Posted

Study results publicly available

February 26, 2021

Completed
Last Updated

February 26, 2021

Status Verified

February 1, 2021

Enrollment Period

1.8 years

First QC Date

February 27, 2013

Results QC Date

February 9, 2021

Last Update Submit

February 9, 2021

Conditions

Colorectal Cancer

Keywords

OCV-C02Colorectal CancerAntigen specific cancer immunotherapeutic

Outcome Measures

Primary Outcomes (1)

  • Dose Limiting Toxicity (DLT)

    \[Definition of DLT\] Any of the following adverse events (AEs) that occurred by Day 29 of Cycle 1 and for which a causal relationship to OCV-C02 could not be ruled out: * Grade 3 or higher non-hematological toxicities (except for injection site reaction and laboratory abnormalities lasting \< 7 days without clinical symptoms) * The following hematological toxicities: Grade 4 or higher anemia, Grade 4 or higher neutropenia or lymphocytopenia lasting 7 days, Grade 3 or higher febrile neutropenia, Grade 4 or higher platelet count decreased. The severity of AEs was graded in accordance with Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (Japanese version). In addition, a DLT-equivalent treatment-emergent adverse event (TEAE) was defined as a DLT occurred during the extend treatment period (at Cycle 2 and thereafter).

    Day 29

Secondary Outcomes (2)

  • Number of Subjects With CTCAE Grade 3 or Higher TEAEs

    From the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)

  • Tumor Response Rate in Cycle 1

    Day 29

Study Arms (4)

Dose level 1

EXPERIMENTAL
Drug: OCV-103 and OCV-104

Dose level 2

EXPERIMENTAL
Drug: OCV-103 and OCV-104

Dose level 3

EXPERIMENTAL
Drug: OCV-103 and OCV-104

Dose level 4

EXPERIMENTAL
Drug: OCV-103 and OCV-104

Interventions

OCV-103 and OCV-104DRUG

0.3 mg of each

Dose level 1

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Unknown Facility

Nagoya, Japan

Location

Unknown Facility

Sunto-gun, Japan

Location

Unknown Facility

Tokyo, Japan

Location

Related Publications (1)

  • 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.

    PMID: 28266765DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Results Point of Contact

Title
Director of Clinical Trials
Organization
Otsuka Pharmaceutical Co., LTD.
CL_OPCJ_RDA_Team@otsuka.jp
+81-3-6361-7366

Study Officials

  • Junichi Hashimoto, PhD

    Otsuka Pharmaceutical Co., Ltd.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 27, 2013

First Posted

March 1, 2013

Study Start

March 1, 2013

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

February 26, 2021

Results First Posted

February 26, 2021

Record last verified: 2021-02

Locations

JP(3)