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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN C000000073
Receipt No. 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

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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
Email

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
Email mandoh@ncc.go.jp

Sponsor
Institute Office of Imatinib phase2 study
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000120

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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