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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006744
Receipt No. R000007969
Scientific Title Phase I/II study of bexarotene capsule (BSC-1) in patients with Cutaneous T-cell Lymphoma (CTCL)
Date of disclosure of the study information 2011/12/01
Last modified on 2016/04/07

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Basic information
Public title Phase I/II study of bexarotene capsule (BSC-1) in patients with Cutaneous T-cell Lymphoma (CTCL)
Acronym Phase I/II study of bexarotene capsule (BSC-1) in patients with Cutaneous T-cell Lymphoma (CTCL)
Scientific Title Phase I/II study of bexarotene capsule (BSC-1) in patients with Cutaneous T-cell Lymphoma (CTCL)
Scientific Title:Acronym 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

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

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
1st name
Middle name
Last name Hideo Inoue
Organization Research and Development Division
Division name Reserch Laboratory
Zip code
Address 2-2-3, Komatsubara, Zama-shi, Kanagawa
TEL 0359090027
Email t_yoshida@minophagen.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tsuyoshi Yoshida
Organization Minophagen Pharmaceutical Co. Ltd
Division name Regulatory Compliance Department
Zip code
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

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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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
2011 Year 10 Month 20 Day
Date of IRB
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

Other
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-open-bin/ctr_e/ctr_view.cgi?recptno=R000007969

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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