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| ID | Type | Description | Link |
|---|---|---|---|
| JapicCTI-132075 | Other Identifier | Japic |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose level 1 | Experimental |
| |
| Dose level 2 | Experimental |
| |
| Dose level 3 | Experimental |
| |
| Dose level 4 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OCV-103 and OCV-104 | Drug | 0.3 mg of each |
| |
| OCV-103 and OCV-104 |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With CTCAE Grade 3 or Higher TEAEs | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Junichi Hashimoto, PhD | Otsuka Pharmaceutical Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nagoya | Japan | |||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28266765 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Dose Level 1 | OCV-103 and OCV-104 (0.3 mg of each) One cycle was defined as 28 days of treatment. Each subject received subcutaneous injections on Days 1, 8, 15, and 22 of each cycle. |
| FG001 | Dose Level 2 | OCV-103 and OCV-104 (1 mg of each) One cycle was defined as 28 days of treatment. Each subject received subcutaneous injections on Days 1, 8, 15, and 22 of each cycle. |
| FG002 | Dose Level 3 | OCV-103 and OCV-104 (3 mg of each) One cycle was defined as 28 days of treatment. Each subject received subcutaneous injections on Days 1, 8, 15, and 22 of each cycle. |
| FG003 | Dose Level 4 | OCV-103 and OCV-104 (6 mg of each) One cycle was defined as 28 days of treatment. Each subject received subcutaneous injections on Days 1, 8, 15, and 22 of each cycle. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Dose Level 1 | OCV-103 and OCV-104 (0.3 mg of each) One cycle was defined as 28 days of treatment. Each subject received subcutaneous injections on Days 1, 8, 15, and 22 of each cycle. |
| BG001 | Dose Level 2 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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:
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). | Posted | Number | participants | Day 29 |
|
TEAEs were collected from the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dose Level 1 | OCV-103 and OCV-104 (0.3 mg of each) One cycle was defined as 28 days of treatment. Each subject received subcutaneous injections on Days 1, 8, 15, and 22 of each cycle. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lung infection | Infections and infestations | MedDRA Ver. 18.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchopneumonia | Infections and infestations | MedDRA Ver. 18.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Trials | Otsuka Pharmaceutical Co., LTD. | +81-3-6361-7366 | CL_OPCJ_RDA_Team@otsuka.jp |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| Drug |
1 mg of each |
|
| OCV-103 and OCV-104 | Drug | 3 mg of each |
|
| OCV-103 and OCV-104 | Drug | 6 mg of each |
|
| Tumor Response Rate in Cycle 1 | 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 |
| Sunto-gun |
| Japan |
| Tokyo | Japan |
| DLT occurs |
|
OCV-103 and OCV-104 (1 mg of each)
One cycle was defined as 28 days of treatment. Each subject received subcutaneous injections on Days 1, 8, 15, and 22 of each cycle.
| BG002 | Dose Level 3 | OCV-103 and OCV-104 (3 mg of each) One cycle was defined as 28 days of treatment. Each subject received subcutaneous injections on Days 1, 8, 15, and 22 of each cycle. |
| BG003 | Dose Level 4 | OCV-103 and OCV-104 (6 mg of each) One cycle was defined as 28 days of treatment. Each subject received subcutaneous injections on Days 1, 8, 15, and 22 of each cycle. |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
OCV-103 and OCV-104 (0.3 mg of each)
One cycle was defined as 28 days of treatment. Each subject received subcutaneous injections on Days 1, 8, 15, and 22 of each cycle.
| OG001 | Dose Level 2 | OCV-103 and OCV-104 (1 mg of each) One cycle was defined as 28 days of treatment. Each subject received subcutaneous injections on Days 1, 8, 15, and 22 of each cycle. |
| OG002 | Dose Level 3 | OCV-103 and OCV-104 (3 mg of each) One cycle was defined as 28 days of treatment. Each subject received subcutaneous injections on Days 1, 8, 15, and 22 of each cycle. |
| OG003 | Dose Level 4 | OCV-103 and OCV-104 (6 mg of each) One cycle was defined as 28 days of treatment. Each subject received subcutaneous injections on Days 1, 8, 15, and 22 of each cycle. |
|
|
| Secondary | Number of Subjects With CTCAE Grade 3 or Higher TEAEs | 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. | Posted | Number | participants | From the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration) |
|
|
|
| Secondary | Tumor Response Rate in Cycle 1 | 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 | Posted | Number | percentage of participants | Day 29 |
|
|
|
| 0 |
| 6 |
| 2 |
| 6 |
| 6 |
| 6 |
| EG001 | Dose Level 2 | OCV-103 and OCV-104 (1 mg of each) One cycle was defined as 28 days of treatment. Each subject received subcutaneous injections on Days 1, 8, 15, and 22 of each cycle. | 0 | 6 | 2 | 6 | 6 | 6 |
| EG002 | Dose Level 3 | OCV-103 and OCV-104 (3 mg of each) One cycle was defined as 28 days of treatment. Each subject received subcutaneous injections on Days 1, 8, 15, and 22 of each cycle. | 0 | 6 | 1 | 6 | 6 | 6 |
| EG003 | Dose Level 4 | OCV-103 and OCV-104 (6 mg of each) One cycle was defined as 28 days of treatment. Each subject received subcutaneous injections on Days 1, 8, 15, and 22 of each cycle. | 0 | 6 | 3 | 6 | 6 | 6 |
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Ver. 18.0 | Non-systematic Assessment |
|
| Colorectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Ver. 18.0 | Non-systematic Assessment |
|
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA Ver. 18.0 | Non-systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA Ver. 18.0 | Non-systematic Assessment |
|
| Suicidal ideation | Psychiatric disorders | MedDRA Ver. 18.0 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA Ver. 18.0 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA Ver. 18.0 | Non-systematic Assessment |
|
| Hepatic failure | Hepatobiliary disorders | MedDRA Ver. 18.0 | Non-systematic Assessment |
|
| Bile duct stenosi | Hepatobiliary disorders | MedDRA Ver. 18.0 | Non-systematic Assessment |
|
| Gait disturbance | General disorders | MedDRA Ver. 18.0 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA Ver. 18.0 | Non-systematic Assessment |
|
| Infection | Infections and infestations | MedDRA Ver. 18.0 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA Ver. 18.0 | Non-systematic Assessment |
|
| Tracheitis | Infections and infestations | MedDRA Ver. 18.0 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA Ver. 18.0 | Non-systematic Assessment |
|
| Tinea infection | Infections and infestations | MedDRA Ver. 18.0 | Non-systematic Assessment |
|
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Ver. 18.0 | Non-systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA Ver. 18.0 | Non-systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA Ver. 18.0 | Non-systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA Ver. 18.0 | Non-systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA Ver. 18.0 | Non-systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA Ver. 18.0 | Non-systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA Ver. 18.0 | Non-systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA Ver. 18.0 | Non-systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA Ver. 18.0 | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA Ver. 18.0 | Non-systematic Assessment |
|
| Restlessness | Psychiatric disorders | MedDRA Ver. 18.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA Ver. 18.0 | Non-systematic Assessment |
|
| Hypersomnia | Nervous system disorders | MedDRA Ver. 18.0 | Non-systematic Assessment |
|
| Memory impairment | Nervous system disorders | MedDRA Ver. 18.0 | Non-systematic Assessment |
|
| Brain oedema | Nervous system disorders | MedDRA Ver. 18.0 | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA Ver. 18.0 | Non-systematic Assessment |
|
| Orthostatic hypotension | Vascular disorders | MedDRA Ver. 18.0 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Ver. 18.0 | Non-systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA Ver. 18.0 | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Ver. 18.0 | Non-systematic Assessment |
|
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA Ver. 18.0 | Non-systematic Assessment |
|
| Pulmonary haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA Ver. 18.0 | Non-systematic Assessment |
|
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA Ver. 18.0 | Non-systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA Ver. 18.0 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA Ver. 18.0 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA Ver. 18.0 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA Ver. 18.0 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA Ver. 18.0 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA Ver. 18.0 | Non-systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA Ver. 18.0 | Non-systematic Assessment |
|
| Hepatosplenomegaly | Hepatobiliary disorders | MedDRA Ver. 18.0 | Non-systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA Ver. 18.0 | Non-systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA Ver. 18.0 | Non-systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA Ver. 18.0 | Non-systematic Assessment |
|
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA Ver. 18.0 | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA Ver. 18.0 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA Ver. 18.0 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA Ver. 18.0 | Non-systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA Ver. 18.0 | Non-systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | MedDRA Ver. 18.0 | Non-systematic Assessment |
|
| Chills | General disorders | MedDRA Ver. 18.0 | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA Ver. 18.0 | Non-systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA Ver. 18.0 | Non-systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA Ver. 18.0 | Non-systematic Assessment |
|
| Injection site induration | General disorders | MedDRA Ver. 18.0 | Non-systematic Assessment |
|
| Injection site reaction | General disorders | MedDRA Ver. 18.0 | Non-systematic Assessment |
|
| Malaise | General disorders | MedDRA Ver. 18.0 | Non-systematic Assessment |
|
| Oedema | General disorders | MedDRA Ver. 18.0 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA Ver. 18.0 | Non-systematic Assessment |
|
| Induration | General disorders | MedDRA Ver. 18.0 | Non-systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA Ver. 18.0 | Non-systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA Ver. 18.0 | Non-systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA Ver. 18.0 | Non-systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA Ver. 18.0 | Non-systematic Assessment |
|
| Blood lactate dehydrogenase increased | Investigations | MedDRA Ver. 18.0 | Non-systematic Assessment |
|
| Blood urea increased | Investigations | MedDRA Ver. 18.0 | Non-systematic Assessment |
|
| Eosinophil count increased | Investigations | MedDRA Ver. 18.0 | Non-systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA Ver. 18.0 | Non-systematic Assessment |
|
| Blood urine present | Investigations | MedDRA Ver. 18.0 | Non-systematic Assessment |
|
| Lymphocyte count decreased | Investigations | MedDRA Ver. 18.0 | Non-systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA Ver. 18.0 | Non-systematic Assessment |
|
| Excoriation | Injury, poisoning and procedural complications | MedDRA Ver. 18.0 | Non-systematic Assessment |
|
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA Ver. 18.0 | Non-systematic Assessment |
|
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| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| PR |
|
| SD |
|
| PD |
|
| NE |
|