UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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> -
Title of the study (Brief title)	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	Masanori Noguchi
Organization	Kurume University
Division name	Research center of Innovative Cancer Therapy
Address	Asahi-machi 67, Kurume, fukuoka 830-0011
TEL	0942-31-7989
Email	noguchi@med.kurume-u.ac.jp

Public contact
Name of contact person	Shogo Hirota
Organization	BrightPath Biotherapeutics Co., Ltd.
Division name	Pharmaceutical Development Dept.
Address	2-2-4 Kojimachi, Chiyoda-ku, Tokyo
TEL	03-5840-7697
Homepage URL
Email	hirota_s@brightpathbio.com

Sponsor
Institute	BrightPath Biotherapeutics Co., Ltd.
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 05 Month 31 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013251