UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000019303
Receipt No. R000022321
Scientific Title Phase II clinical trial of pazopanib with unresectable or metastatic malignant peripheral nerve sheath tumor (1st cohort) and in patients with chemoresistant tumors; alveolar soft part sarcoma, epithelioid sarcoma, and clear cell sarcoma (2nd cohort)
Date of disclosure of the study information 2015/10/09
Last modified on 2019/08/09

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Phase II clinical trial of pazopanib with unresectable or metastatic malignant peripheral nerve sheath tumor (1st cohort) and in patients with chemoresistant tumors; alveolar soft part sarcoma, epithelioid sarcoma, and clear cell sarcoma (2nd cohort)
Acronym Phase II clinical trial of pazopanib in patients with malignant peripheral nerve sheath tumor or chemoresistant tumor
Scientific Title Phase II clinical trial of pazopanib with unresectable or metastatic malignant peripheral nerve sheath tumor (1st cohort) and in patients with chemoresistant tumors; alveolar soft part sarcoma, epithelioid sarcoma, and clear cell sarcoma (2nd cohort)
Scientific Title:Acronym Phase II clinical trial of pazopanib in patients with malignant peripheral nerve sheath tumor or chemoresistant tumor
Region
Japan

Condition
Condition 1st cohort: patients with unresectable or metastatic malignant peripheral nerve sheath tumor, 2nd cohort: patients with chemoresistant tumors; alveolar soft part sarcoma, epithelioid sarcoma, and clear cell sarcoma
Classification by specialty
Hematology and clinical oncology Orthopedics
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To investigate the clinical benefit rate of pazopanib in patients with unresectable or metastatic malignant peripheral nerve sheath tumor and chemoresistant tumors; alveolar soft part sarcoma, epithelioid sarcoma, and clear cell sarcoma
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes clinical benefit rate at 12 weeks (RECIST)
Key secondary outcomes clinical benefit rate at 12 weeks (Choi), response rate and progression free survival (RECIST/Choi), overall 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 pazopanib 800mg/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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1st cohort: patients with unresectable or metastatic malignant peripheral nerve sheath tumor, 2nd cohort: patients with unresectable or metastatic chemoresistant tumors; alveolar soft part sarcoma, epithelioid sarcoma, and clear cell sarcoma
Key exclusion criteria cerebrovascular disease, gastrointestinal disorder, bleeding tendency, hypersensitivity, pregnancy
Target sample size 46

Research contact person
Name of lead principal investigator
1st name Yoshihiro
Middle name
Last name Nishida
Organization Nagoya University Graduate School and School of Medicine
Division name Department of Orthopaedic Surgery
Zip code 466-8550
Address 65 Tsurumai, Showa-ku, Nagoya
TEL 052-744-1908
Email ynishida@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name Hiroshi
Middle name
Last name Urakawa
Organization Nagoya University Graduate School and School of Medicine
Division name Department of Orthopaedic Surgery
Zip code 466-8550
Address 65 Tsurumai, Showa-ku, Nagoya
TEL 052-744-1908
Homepage URL
Email urakawa@med.nagoya-u.ac.jp

Sponsor
Institute Japanese Musculoskeletal Oncology Group
Institute
Department

Funding Source
Organization Novartis Pharma K.K
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

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

IRB Contact (For public release)
Organization Nagoya University Ethics Committee
Address 65 Tsurumai, Showa-ku, Nagoya
Tel 052-744-1901
Email iga-souk@adm.nagoya-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

Other administrative information
Date of disclosure of the study information
2015 Year 10 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 20
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
2015 Year 09 Month 18 Day
Date of IRB
2016 Year 01 Month 15 Day
Anticipated trial start date
2016 Year 01 Month 15 Day
Last follow-up date
2019 Year 08 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 10 Month 09 Day
Last modified on
2019 Year 08 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022321

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.