UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016425 |
|---|---|
| Receipt number | 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 | 2023/03/18 18:09:07 |
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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
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
hishida@med.showa-u.ac.jp
Sponsor or person
Institute
Showa University
Institute
Department
Personal name
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
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
| Delay expected |
Results Delay Reason
We are now analizying the data of this study.
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
| 2023 | Year | 03 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019076
