UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000073 |
|---|---|
| Receipt number | R000000120 |
| Scientific Title | Phase2 Study of Glivec (imatinib mesylate, formerly known as STI571) in Patients with Relapsed or Refractory Sarcomas with c-kit or PDGFR Expression |
| Date of disclosure of the study information | 2005/08/22 |
| Last modified on | 2012/03/26 12:10:41 |
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Basic information
Public title
Phase2 Study of Glivec (imatinib mesylate, formerly known as STI571) in Patients with Relapsed or Refractory Sarcomas with c-kit or PDGFR Expression
Acronym
Phase2 Study of Glivec (imatinib mesylate, formerly known as STI571) in Patients with Relapsed or Refractory Sarcomas with c-kit or PDGFR Expression
Scientific Title
Phase2 Study of Glivec (imatinib mesylate, formerly known as STI571) in Patients with Relapsed or Refractory Sarcomas with c-kit or PDGFR Expression
Scientific Title:Acronym
Phase2 Study of Glivec (imatinib mesylate, formerly known as STI571) in Patients with Relapsed or Refractory Sarcomas with c-kit or PDGFR Expression
Region
| Japan |
Condition
Condition
Sarcoma with c-kit or PDGFR expression by immunohistochemistry
Classification by specialty
| Orthopedics |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To evaluate efficacy and safety of imatinib for relapsed or refractory sarcomas with c-kit or PDGFR
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
Response rate in patients with Imatinib 600mg/day
Key secondary outcomes
1) Response rate in patients with Imatinib 800mg/day
2) Adverse events
3) Time to progression
4) To evaluate relationships between response and profile of gene expression
5) Pharmacokinetics in adolescence patients
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
Imatinib 600mg once 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
| 12 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Histologically confirmed metastatic or unresectable locally advanced sarcomas (excluding gastrointestinal stromal tumor) Eligible subtypes: Ewing's sarcoma / Primitive neuroectodermal tumor(PNET); Synovial sarcoma; Neuroblastoma; Desmoplastic small round cell tumor; Leiomyosarcoma; Rabdomyosarcoma; Liposarcoma; Fibrosarcoma; Angiosarcoma; Malignant fibrous histiocytoma; Malignant peripheral nerve sheath tumor; Osteosarcom; Alveolar soft part sarcoma; Epitheloid sarcom; Clear cell sarcoma
2) c-kit positive tumor(CD117 expression on immunohistochmial staining)
3) Tumor tissue blocks must be available
4) Relapsed or refractory to comventional chemotherapy
5) At least 1 measurable lesion: At least 20mm by conventional techniques or at least 10mm by spiral CT scan
6) Chemotherapy: at least 4 weeks since prior chemotherapy and no concurrent therapy
7) Age: 12<= and <75
8) Written informed consent
Key exclusion criteria
1) controlable or active infection
2) pregnacy or lactation
3) brain metastasis with clinical symptom
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuhiro Fujiwara, MD, PhD |
Organization
National Cancer Center Hospital
Division name
Chief of Breast and Medical Oncology Division, Director of Outpatient Treatment Center, Director of Clinical Trial Coodinating Office
Zip code
Address
Tsukiji 5-1-1, Chuo-ku, Tokyo, 104-0045, JAPAN
TEL
03-3542-2511
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masashi Ando, MD |
Organization
Office of Imatinib phase2 study
Division name
Dept of Medical Oncology, National Cancer Center Hospital
Zip code
Address
Tsukiji 5-1-1, Chuo-ku, Tokyo, 104-0045, JAPAN
TEL
03-3542-2511
Homepage URL
mandoh@ncc.go.jp
Sponsor or person
Institute
Office of Imatinib phase2 study
Institute
Department
Personal name
Funding Source
Organization
Center for Clinical Trials, Japan Medical Association
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
治験届出日2004年11月2日 届出回数6回
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2005 | Year | 08 | Month | 22 | Day |
Related information
URL releasing protocol
http://www.springerlink.com/content/878710nt36492371/
Publication of results
Published
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
Terminated
Date of protocol fixation
| 2004 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2005 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2006 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2007 | Year | 01 | Month | 01 | Day |
Date trial data considered complete
| 2007 | Year | 02 | Month | 01 | Day |
Date analysis concluded
| 2007 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2005 | Year | 08 | Month | 22 | Day |
Last modified on
| 2012 | Year | 03 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000120
