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UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000002466
Receipt No. R000003019
Scientific Title Multi-Center Phase II Clinical Trial on Efficacy and Safety of Interferon Alfa-n1 + Sorafenib Combination Therapy in Renal Cell Carcinoma
Date of disclosure of the study information 2009/09/09
Last modified on 2014/04/08

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Basic information
Public title Multi-Center Phase II Clinical Trial on Efficacy and Safety of
Interferon Alfa-n1 + Sorafenib Combination Therapy in Renal Cell Carcinoma
Acronym Phase II of Interferon Alfa-n1 + Sorafenib in Renal Cell Carcinoma
Scientific Title Multi-Center Phase II Clinical Trial on Efficacy and Safety of
Interferon Alfa-n1 + Sorafenib Combination Therapy in Renal Cell Carcinoma
Scientific Title:Acronym Phase II of Interferon Alfa-n1 + Sorafenib in Renal Cell Carcinoma
Region
Japan

Condition
Condition Renal cell carcinoma
Classification by specialty
Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The purpose of the trial is to study the efficacy and safety of Interferon Alfa-n1 and sorafenib combination therapy in patients with renal cell carcinoma who have no history of cytokine therapy.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Response Rate (CR+PR)
Key secondary outcomes Disease Control Rate(CR+PR+SD),Progression Free Survival,Safety

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Interferon Alfa-n1 monotherapy will be performed for 2 weeks. Patients will be checked for adverse event caused by Interferon Alfa-n1. Interferon Alfa-n1+ sorafenib combination therapy will be performed after it has been confirmed that there are no problems. Interferon Alfa-n1 will be given by subcutaneous or intramuscular injection 300MU once a day, 3 times a week. Sorafenib will be given by daily oral administration of 400 mg twice a day.
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) Age: 20 <=
2) Patients with confirmed clear cell renal cell carcinoma
3) Patients who have already tried nephrectomy
4) patients with no previous history of chamotherapy,cytokine therapy,or molecularly targeted drug therapy(however,patients using IFN alfa as post-nephrectomy adjuvant therapy for primary tumors will be eligible if not used for 6 or more months)
5) Patients with ECOG PS 0 or 1
6) patients with at least 1 measurable lesion on CT, as defined by RECIST
7) Patients who are expected to survive at least 12 weeks
8) Patients who meet(1)through(9) of the following test within 7 days before the start of Interferon Alfa-n1 monotherapy
(1) hemoglobin >= 9.0 g/dL
(2) neutrophil count >= 1,500/microL
(3)
(4) PT or PT-INR and APTT <= 1.5 times the maximum of the normal range at the study site
(5) total bilirubin <= 1.5 times the maximum of the normal range at the study site
(6) ALT and AST <= 2.5 times the maximum of the normal range at the study site ( <= 5 times the maximum of the normal range at the study site in patients with hepatic metastasis)
(7) alkali phosphatase <= 4 times the maximum of the normal range at the study site
(8) serum creatinine <= 2.0 times the maximum of the normal range at the study site
(9) amylases and lipases <=2.0 times the maximum of the normal range at the study site
9) Patients who give written informed consent prior to the study
Key exclusion criteria 1) Congestive cardiac failure
2) Severe arrhythmias
3) Active or symptomatic angina pectoris or coronary artery disease
4) Poorly controlled hypertension
5) History of HIV infection, or active chronic hepatitis caused by type B or type C hepatitis virus
6) Active infection
7) Intracranial metastasis
8) Convulsive disorders requiring treatment with anticonvulsants
9) History of organ transplant
10) Poorly controlled depression
11) Autoimmune hepatitis
12) History of malignant tumors
13) Radiation therapy, except for palliative therapy, within 3 weeks prior to the start of treatment
14) Significantly invasive surgery within 4 weeks prior to the start of treatment
15) Use of G-CSF within 3 weeks prior to the start of treatment
16) Pts with a history of treatment using drugs targeting VEGF or VEGF receptor
17) Pts with a history of treatment using Raf kinase, MEK, farnesyl transferase inhibitors
18) Pts being treated with adrenocortical steroids
19) Pts being treated with Minor Bupleurum Formula
20) Pts who have or have had interstitial pulmonary disease
21) Pregnant or nursing patients
22) Pts who are unable to practice appropriate contraception throughout the study period
23) Pts who abuse drugs or who have health conditions, psychological states, or social circumstances which would interfere with participation in the study or assessment of results
24) Pts with diseases or disability potentially affecting drug assessment
25) Patients who have had, or are suspected of having, allergies to sorafenib, Interferon Alfa-n1, or other interferon formulations
26) Pts with a history of hypersensitivity to biological preparations such as vaccines
27) Patients for whom oral medication may be difficult to take
28) Patients who previously encountered difficulties in treatment with IFN alfa due to adverse events caused by IFN alfa, or patients in whom IFN alfa-induced adverse events persist to this day



Target sample size 45

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masatoshi Eto
Organization Graduate School of Medical Science, Kumamoto University
Division name Department of Urology
Zip code
Address 1-1-1, Honjo Kumamoto, 860-8556 Japan
TEL 096-373-5240
Email

Public contact
Name of contact person
1st name
Middle name
Last name Masatoshi Eto
Organization Graduate School of Medical Science, Kumamoto University
Division name Department of Urology
Zip code
Address 1-1-1, Honjo Kumamoto, 860-8556 Japan
TEL 096-373-5240
Homepage URL
Email

Sponsor
Institute Japan RCC Trialist Collaborative Group (JRTCG)
Institute
Department

Funding Source
Organization Clinical Research Foundation
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

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 東京女子医科大学 (東京都)
神戸大学大学院医学研究科 (兵庫県)
九州大学大学院医学研究院 (福岡県)
自治医科大学 (栃木県)
大阪大学大学院医学研究科器官制御外科学 (大阪府)
鹿児島大学大学院医歯学総合研究科 (鹿児島県)
四国がんセンター (愛媛県)
広島大学大学院医歯薬学総合研究科 (広島県)
防衛医科大学校医学研究科 (埼玉医大)
横浜市立大学大学院医学研究科 (神奈川県)
名古屋大学大学院医学研究科 (愛知県)
日本医科大学 (東京都)
京都大学大学院医学研究科 (京都府)
奈良県立医科大学 (奈良県)
倉敷中央病院 (岡山県)
山形大学医学部 (山形県)
北海道大学大学院医学研究科 (北海道)
広島市立安佐市民病院 (広島県)
弘前大学大学院医学研究科 (青森県)
原三信病院 (福岡県)
慶應義塾大学 (東京都)
熊本大学大学院医学薬学研究部 (熊本県)
仙台社会保険病院 (宮城県)
浜松医科大学医学部 (静岡県)
徳島大学大学院 (徳島県)
札幌医科大学 (北海道)
獨協医科大学 (栃木県)
筑波大学大学院 (茨城県)
北海道がんセンター (北海道)
砂川市立病院 (北海道)
旭川医科大学 (北海道)
伊勢崎市民病院 (群馬県)
東京女子医科大学東医療センター(東京都)
東北大学大学院医学系研究科(宮城県)
宮崎大学(宮崎県)

Other administrative information
Date of disclosure of the study information
2009 Year 09 Month 09 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 Main results already published
Date of protocol fixation
2009 Year 07 Month 24 Day
Date of IRB
Anticipated trial start date
2009 Year 09 Month 01 Day
Last follow-up date
2013 Year 07 Month 31 Day
Date of closure to data entry
2013 Year 08 Month 31 Day
Date trial data considered complete
2013 Year 09 Month 30 Day
Date analysis concluded
2013 Year 10 Month 15 Day

Other
Other related information

Management information
Registered date
2009 Year 09 Month 07 Day
Last modified on
2014 Year 04 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003019

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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