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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000016425
Receipt No. R000019076
Scientific Title The assessment of factor affecting toxicity of multikinase inhibitor pazopanib in soft tissue sarcoma
Date of disclosure of the study information 2015/02/02
Last modified on 2021/02/09

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Basic information
Public title The assessment of factor affecting toxicity of multikinase inhibitor pazopanib in soft tissue sarcoma
Acronym The assessment of factor affecting toxicity of pazopanib in soft tissue sarcoma
Scientific Title The assessment of factor affecting toxicity of multikinase inhibitor pazopanib in soft tissue sarcoma
Scientific Title:Acronym The assessment of factor affecting toxicity of pazopanib in soft tissue sarcoma
Region
Japan

Condition
Condition Soft tissue sarcoma
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To evaluate the relationship between pharmacokinetics of pazopanib and genetic polymorphisms of metabolic enzymes and transporters
Basic objectives2 Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To identify the pharmacokinetic factors that is associated with toxicity induced by pazopanib
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
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Pazopanib
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) Histologically confirmed soft tissue sarcoma
2) Unresectable advanced or recurrent disease
3) Age is over 20 years.
4) Eastern Cooperative Oncology Group (ECOG) performance status (PS) is 0 to 2.
5) Adequate organ function, evidenced by following laboratory results within 14 days prior to starting chemotherapy.
Absolute neutrophil count>1,500/mm3
Platelet count<100,000/mm3
Hemoglobin<9.0g/dl
Total bilirubin<2.0mg/dl
AST and ALT<2.5 times the upper limit of normal(ULN)
Creatinine<1.5mg/dl
6) Left ventricular ejection fraction (LVEF) in cardiac ultrasonography is over 50%.
7) QT interval time in electrocardiogram is under 480msec.
8) Blood pressure is under 150/90mmHg. If the patient receives the therapy for hypertension, blood pressure is controlled under 150/90mmHg by hypotensive drug.
9) Signed, written informed concent is obtained.
Key exclusion criteria 1) Interstitial pneumonia, pulmonary fibrosis
2) Severe active infection
3) Serological positive for HBs-antigen or HCV-antibody
4) Previous therapy with pazopanib
5) Unstable angina or myocardial infarction within 3 months
6) Thrombosis (e.g., cerebral infarction, pulmonary infarction, deep venous thrombosis)within 6 months
7) Peptic ulcer within 6 months
8) Surgery within 28 days
9) Severe complication (e.g., uncontrollable diabetis mellitus, liver disease)
10) Active synchronous cancer
11) Severe psychiatric disorder
12) Pregnant or lactating women, or men and women without wanting pregnancy
13) Severe hypersensitivity to medicine
14) Taking medicine (e.g., phenytoin, carbamazepine, rifampicin, phenobarbital, ketokonazole, macrolide) affecting CYP3A4 within one week
15) Taking proton pump inhibitor or H2 blocker within one week
16) Patients who were judged inappropriate for the study
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Hiroo
Middle name
Last name Ishida
Organization Showa University School of Medicine
Division name Division of Medical Oncology, Department of Medicine
Zip code 142-8666
Address 1-5-8 Hatanodai, Shinagawa-ku, Tokyo
TEL 03-3784-8000
Email hishida@med.showa-u.ac.jp

Public contact
Name of contact person
1st name Hiroo
Middle name
Last name Ishida
Organization Showa University School of Medicine
Division name Division of Medical Oncology, Department of Medicine
Zip code 142-8666
Address 1-5-8 Hatanodai, Shinagawa-ku, Tokyo
TEL 03-3784-8000
Homepage URL
Email hishida@med.showa-u.ac.jp

Sponsor
Institute Showa University
Institute
Department

Funding Source
Organization Showa University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Showa University Research Administration Center
Address 1-5-8 Hatanodai, Shinagawa-ku, Tokyo
Tel 03-3784-8129
Email m-rinri@ofc.showa-u.ac.jp

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 昭和大学病院(東京都)、杏林大学付属病院(東京都)、昭和大学江東豊洲病院(東京都)、昭和大学横浜市北部病院(神奈川県)

Other administrative information
Date of disclosure of the study information
2015 Year 02 Month 02 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 22
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 No longer recruiting
Date of protocol fixation
2014 Year 09 Month 19 Day
Date of IRB
2014 Year 09 Month 19 Day
Anticipated trial start date
2014 Year 11 Month 01 Day
Last follow-up date
2021 Year 12 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
2015 Year 02 Month 02 Day
Last modified on
2021 Year 02 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019076

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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