UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019303 |
|---|---|
| Receipt number | 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 | 2022/04/14 10:37:00 |
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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
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
urakawa@med.nagoya-u.ac.jp
Sponsor or person
Institute
Japanese Musculoskeletal Oncology Group
Institute
Department
Personal name
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
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
https://pubmed.ncbi.nlm.nih.gov/32638374/
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/32638374/
Number of participants that the trial has enrolled
20
Results
Cohort1
CBR at 12 weeks was both 50.0% (RECIST and Choi).
Cohort2
The CBRs were 87.5% (7 of 8) and 75.0% (6 of 8) according to RECIST and Choi criteria at 12 weeks after pazopanib treatment, respectively.
Results date posted
| 2022 | Year | 04 | Month | 14 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Cohort1
Seven had Grade 2 and five Grade 3 according to the FNCLCC evaluation.
Cohort2
The histological subtypes were 5 ASPS, 2 ES, and 1 CCS.
Participant flow
Cohort1 and Cohort2
All patients initially received pazopanib 800 mg once daily.
Adverse events
Cohort1
Grade 4 adverse events of neutropenia and lipase elevation were noted in one patient each.
Cohort2
There are no Grade 4 adverse events.
Outcome measures
Cohort1
Partial response was observed in 1 according to RECIST and 3 according to Choi criteria at 12 weeks after pazopanib treatment.
Cohort2
Partial response was observed in 1 ASPS according to RECIST and 3 ASPS and 1 ES according to Choi criteria at 12 weeks after pazopanib treatment.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
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
| 2023 | Year | 01 | Month | 14 | 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
| 2022 | Year | 04 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022321
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