A Phase 1 Study of OCV-C02 in Patients With Advanced or Relapsed Colorectal Cancer
A Phase 1 Study of OCV-C02 in Patients With Advanced or Relapsed Colorectal Cancer Who Are Refractory or Intolerant to Standard Chemotherapy
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
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Nagoya, Japan
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Sunto-gun, Japan
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Tokyo, Japan
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Dose level 1
|
0.3 mg of each
1 mg of each
3 mg of each
6 mg of each
|
|
Experimental: Dose level 2
|
0.3 mg of each
1 mg of each
3 mg of each
6 mg of each
|
|
Experimental: Dose level 3
|
0.3 mg of each
1 mg of each
3 mg of each
6 mg of each
|
|
Experimental: Dose level 4
|
0.3 mg of each
1 mg of each
3 mg of each
6 mg of each
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Dose Limiting Toxicity (DLT)
Time Frame: Day 29
|
[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:
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Subjects With CTCAE Grade 3 or Higher TEAEs
Time Frame: From the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
|
The severity (grade) of an AE was evaluated using the 5-point scale from Grade 1 to Grade 5 in accordance with CTCAE version 4.0 (Japanese version) , where Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe or medically significant but not immediately life-threatening; Grade 4 = Life-threatening consequences; Grade 5 = Death related to AE.
|
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
Time Frame: Day 29
|
Tumor response was graded in accordance with the new Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1). Complete Response (CR): Disappearance of all target lesions (any malignant lymph nodes selected as target lesions must have a reduction in the minor axis to <10 mm) Partial Response (PR): At least a 30% decrease in the diameter sum of the target lesions as compared with the diameter sum at screening Progressive Disease (PD): At least a 20% increase in the diameter sum of the target lesions as compared with the smallest diameter sum recorded after the start of treatment, and at least 5 mm increase in the absolute increase of at least 5 mm Stable Disease (SD): Neither tumor shrinkage equivalent to PR nor tumor enlargement equivalent to PD Not Evaluable (NE): No examination is feasible or the tumor response cannot be considered as any of CR, PR, PD, and SD |
Day 29
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Junichi Hashimoto, PhD, Otsuka Pharmaceutical Co., Ltd.
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 293-12-001
- JapicCTI-132075 (Other Identifier: Japic)
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