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

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 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


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

Value
https://center6.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