UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011308 |
|---|---|
| Receipt number | R000013251 |
| Scientific Title | A Placebo Controlled Phase III Double Blind Study of ITK-1 in Patients with Prostate Cancer - A Clinical Evaluation of ITK-1 in Castration-Resistant, Docetaxel Refractory Prostate Cancer Patients with HLA-A24 positive <Confirmatory Study> - |
| Date of disclosure of the study information | 2013/08/01 |
| Last modified on | 2018/05/22 18:51:08 |
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Basic information
Public title
A Placebo Controlled Phase III Double Blind Study of ITK-1 in Patients with Prostate Cancer
- A Clinical Evaluation of ITK-1 in Castration-Resistant, Docetaxel Refractory Prostate Cancer Patients with HLA-A24 positive <Confirmatory Study> -
Acronym
A Placebo Controlled Phase III Double Blind Study of ITK-1 in Patients with Prostate Cancer
Scientific Title
A Placebo Controlled Phase III Double Blind Study of ITK-1 in Patients with Prostate Cancer
- A Clinical Evaluation of ITK-1 in Castration-Resistant, Docetaxel Refractory Prostate Cancer Patients with HLA-A24 positive <Confirmatory Study> -
Scientific Title:Acronym
A Placebo Controlled Phase III Double Blind Study of ITK-1 in Patients with Prostate Cancer
Region
| Japan |
Condition
Condition
Prostate cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The objective is to evaluate the efficacy and safety of ITK-1 comparing with placebo in castration-resistant, docetaxel refractory prostate cancer patients with HLA-A24 positive under the best supportive care (BSC).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase III
Assessment
Primary outcomes
Overall survival
Key secondary outcomes
1.Survival rate at 12 months
2.Serum prostate specific antigen (PSA) level
3.Anti-peptide antibody titer
4.Cytotoxic T lymphocyte activity
5.Frequency of adverse reactions and adverse events
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
YES
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
ITK-1 group : Peptide vaccine (3mg/1.5mL) with selected 2 to 4 are injected subcutaneously once weekly in total 6 times. After that, study drugs are subcutaneously injected biweekly 30 times in total. The maximum administration frequency is 36 times.
Interventions/Control_2
Placebo group : Placebo(1.5mL) with selected 2 to 4 are injected subcutaneously once weekly in total 6 times. After that, placebo are subcutaneously injected biweekly 30 times in total. The maximum administration frequency is 36 times.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 85 | years-old | > |
Gender
Male
Key inclusion criteria
1. Written Informed Consent
2. HLA-A24 positive
3. Showing immune response to 2 or more out of 12 ITK-1 peptides
4. Diagnosed prostate cancer histopathologically
5. Met both criteria below for the treatment of prostate cancer.
1) Disease progression confirmed after the hormone therapy or the maximum androgen blockade (MAB) therapy
2) Disease progression confirmed after the treatment with docetaxel
6. Maintains castration status with 50 ng/dL (0.5 ng/mL) or less serum testosterone level
7. Serum PSA level >= 2 ng/mL
8. ECOG performance status of 0 or 1
9. Expected to survive more than 12 weeks
10. Adequate organ function
11. Agreed to perform contraception during the period from giving informed consent to 70 days after completion of administration of study drugs
Key exclusion criteria
1.Received the Taxane antitumor agents except for Docetaxcel
2. Hypersensitivity to mineral oil or mannitol oleate
3. Severe complications
4. Active multiple cancers
5. Received ITK-1 in the past
6. Entry to the other clinical trial within 2 months prior to entry to this study
7. Difficult to participate in this trial because of psychiatric symptoms
8. The patient who is suspected to suffer from any improper disadvantages by not participating in this study
9. Any other cases who are judged as being ineligible for this study by physician
Target sample size
333
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masanori Noguchi |
Organization
Kurume University
Division name
Research center of Innovative Cancer Therapy
Zip code
Address
Asahi-machi 67, Kurume, fukuoka 830-0011
TEL
0942-31-7989
noguchi@med.kurume-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shogo Hirota |
Organization
BrightPath Biotherapeutics Co., Ltd.
Division name
Pharmaceutical Development Dept.
Zip code
Address
2-2-4 Kojimachi, Chiyoda-ku, Tokyo
TEL
03-5840-7697
Homepage URL
hirota_s@brightpathbio.com
Sponsor or person
Institute
BrightPath Biotherapeutics Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
FUJIFILM Corporation
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
YES
Study ID_1
JapicCTI-132199
Org. issuing International ID_1
Japan Pharmaceutical Information Center
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 08 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2013 | Year | 05 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 07 | Month | 29 | Day |
Last modified on
| 2018 | Year | 05 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013251
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