UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase I/II study of bexarotene capsule (BSC-1) in patients with Cutaneous T-cell Lymphoma (CTCL)
Title of the study (Brief title)	Phase I/II study of bexarotene capsule (BSC-1) in patients with Cutaneous T-cell Lymphoma (CTCL)
Region	Japan

Condition
Condition	Cutaneous T-Cell Lymphoma
Classification by specialty	Dermatology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Phase I: To evaluate the tolerability and pharmacokinetics of 150 mg/m2/day or 300 mg/m2/day of bexarotene capsules in Japanese patients with cutaneous T-cell lymphoma (CTCL). Phase II: To evaluate the efficacy, safety and tolerability of 300 mg/m2/day bexarotene capsules in Japanese patients with CTCL.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase I,II

Assessment
Primary outcomes	Primary efficacy endopoint: -Modified Severity-weighted Assessment Tool (mSWAT) -Physician's Global Assessment (PGA) -Composite Assessment of Index Lesion Disease Severity (CA) -abnormal lymph nodes, cutaneous tumors, visceral disease
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Patients enrolled in phase 1 were treated in sequential cohorts of patients and orally administered bexarotene at a dose level of 150 mg/m2 or 300 mg/m2 once daily within 30 minutes of a meals for 4 weeks.In the phase 2 study, patients were orally administered a 300 mg/m2 dose of bexarotene once daily within 30 minutes of a meal for 24 weeks.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. A clinical diagnosis of cutaneous T-cell lymphoma, CTCL, confirmed by biopsy to be histologically consistent with CTCL diagnosis by a dermatopathologist. stage IIB-IV, stage IB-IIA with refractory to at least one systemic therapy for CTCL. 2. Age>=20 years. 3. Eastern Cooperative Oncology Group, ECOG, performance status Performance Status 0-2 4. Adequate abdominal function as below. A. Adequate renal function as evidenced by serum creatinine =<2.0 mg/dL, or calculated creatinine clearance >=40 mL/min as per the Cockroft and Gault formula. B. Adequate hepatic function that is characterized by aspartate aminotransferase (AST), alanine aminotransferase (ALT), or serum bilirubin more than 2.5 times the upper limit of normal. C. Adequate bone marrow function as evidenced by hemoglobin more than 8 g/dL, absolute neutrophil count more than 1,000/mm3, and platelets more than 50,000/mm3. 5. Fasting serum triglyceride within normal limits, <150 mg/dL, or in treatment with anti-dyslipidaemia. prior to study entry. 6. Females of childbearing potential must have a negative serum beta human chorionic gonadotropin within seven days prior to the initiation of treatment, and must have used highly effective methods of contraception for at least 4 weeks prior to the negative pregnancy test through entry to the study. 7. Male patients with female partners of childbearing potential must agree to practice the effective contraception during the entire period of bexarotene capsule treatment and for at least 1 month after treatment is discontinued. 8. Must be willing and able to give informed consent, complete and understand, either oral or written, study procedures and assessments.
Key exclusion criteria	1. Cutaneous T-cell lymphoma involving the central nervous system 2. Subjects with known adult T-cell leukemia/lymphoma 3. Systemic antibiotic therapy within 2 weeks of entry in the study 4. Topical CTCL therapy, regional chemotherapy, topical steroid and other, within 2 weeks of entry the study 5. PUVA or UVB therapy within 3 weeks 6. Radiation therapy within 4 weeks of entry to the study 7. Systemic anticancer therapy of any kind within 4 weeks of entry to the study 8. Systemic therapy with Vitamin A in doses of greater than 15,000 IU, 5,000 mcg, per day within 4 weeks of entry to the study 9. Received systemic steroids within 4 weeks of entry in the study 10. Participation in any other investigational drug study within 12 week of entry in this study 11.Received Etretinate therapy within one year of entry in the study 12. Patients with pregnancy, intent to become pregnant, breast-feeding or unwillingness to effective contraception. 13. Subjects have critical intercurrent illness or serious infection diseases 14. History of pancreatitis or significant risk factors for developing pancreatitis (e.g., prior pancreatitis, uncontrolled hyperlipidemia, excessive alcohol consumption, uncontrolled diabetes mellitus, biliary tract disease, and medications known to increase triglyceride levels or to be associated with pancreatic toxicity 15. Known or suspected hypersensitivity to bexarotene or any other retinoid preparations 16. Known serious allergic reaction or critical hypersensitivity to drugs 17. Unwillingness or inability to minimize exposure to sunlight and artificial ultraviolet light 18. Principal investigator judged inadequate
Target sample size	16

Research contact person
Name of lead principal investigator	Hideo Inoue
Organization	Research and Development Division
Division name	Reserch Laboratory
Address	2-2-3, Komatsubara, Zama-shi, Kanagawa
TEL	0359090027
Email	t_yoshida@minophagen.co.jp

Public contact
Name of contact person	Tsuyoshi Yoshida
Organization	Minophagen Pharmaceutical Co. Ltd
Division name	Regulatory Compliance Department
Address	3-2-11, Nishi-Shinjuku, Shinjuku-ku, Tokyo
TEL	03-5909-0029
Homepage URL
Email	t_yoshida@minophagen.co.jp

Sponsor
Institute	Minophagen Pharmaceutical Co. Ltd.
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Minophagen Pharmaceutical Co. Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	福島県立医科大学附属病院（福島県）、東京大学医学部附属病院（東京都）、東京医科大学病院（東京都）、東京医科大学八王子医療センター（東京都）、浜松医科大学（静岡県）、大阪大学病院（大阪府）、岡山大学病院（岡山県）、宮崎大学医学部附属病院（宮崎県）、鹿児島大学医学部・歯学部附属病院（鹿児島県）、今村病院分院（鹿児島県）

Other administrative information
Date of disclosure of the study information	2011 Year 12 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 10 Month 20 Day
Anticipated trial start date	2012 Year 01 Month 01 Day
Last follow-up date	2013 Year 12 Month 27 Day
Date of closure to data entry	2014 Year 04 Month 23 Day
Date trial data considered complete	2014 Year 07 Month 11 Day
Date analysis concluded	2014 Year 11 Month 06 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2011 Year 11 Month 18 Day
Last modified on	2016 Year 04 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-bin/ctr_e/ctr_view.cgi?recptno=R000007969