A Phase II Study of Dasatinib in Children and Adolescents With Newly Diagnosed Chronic Phase CML or With Ph+ Leukemias Resistant or Intolerant to Imatinib

Bio2RDF identifier

NCT00777036

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Bio2RDF namespace

clinicaltrials

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Bio2RDF uri

http://bio2rdf.org/clinicaltrials:NCT00777036

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identifiers.org URI

NCT00777036

anticipated enrollment [clinicaltrials_vocabulary:anticipated-enrollment]

139

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arm group [clinicaltrials_vocabulary:arm-group]

NCT00777036 arm group 75fbe5afbfbc19f8456ade67fc99a41a [clinicaltrials_resource:NCT00777036/arm-group/75fbe5afbfbc19f8456ade67fc99a41a]

NCT00777036 arm group e903cd12fe52ed8971f70d7a95810699 [clinicaltrials_resource:NCT00777036/arm-group/e903cd12fe52ed8971f70d7a95810699]

NCT00777036 arm group e9786fbd42adf6bd9008e05f00e58f60 [clinicaltrials_resource:NCT00777036/arm-group/e9786fbd42adf6bd9008e05f00e58f60]

authority [clinicaltrials_vocabulary:authority]

clinicaltrials_resource:d942c8692d257084abf3ac87279faff6

brief summary [clinicaltrials_vocabulary:brief-summary]

The purpose of this stu ...... adolescents will be evaluated

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brief title [clinicaltrials_vocabulary:brief-title]

A Phase II Study of Dasatinib ...... tant or Intolerant to Imatinib

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clinicaltrials_vocabulary:primary outcome [clinicaltrials_vocabulary:clinicaltrials_vocabulary:primary-outcome]

Major Cytogenetic Response (MCyR) rate defined as the proportion of all treated subjects who achieve a complete or partial cytogenetic response on study Up to 5 years [clinicaltrials_resource:6bd8593e6a91200913b4ea93a1c0853a]

Major Cytogenetic Response (MCyR) rate defined as the proportion of all treated subjects who achieve a complete or partial cytogenetic response on study Up to 5 years [clinicaltrials_resource:9227bc387d6c9842f882536d681bc578]

Major Cytogenetic Response (MCyR) rate defined as the proportion of all treated subjects who achieve a complete or partial cytogenetic response on study Up to 5 years [clinicaltrials_resource:e2849a24976c3214407281e344ca79d6]

clinicaltrials_vocabulary:secondary outcome [clinicaltrials_vocabulary:clinicaltrials_vocabulary:secondary-outcome]

Major Cytogenetic Response (MCyR) rate defined as the proportion of all treated subjects who achieve a complete or partial cytogenetic response on study Up to 5 years [clinicaltrials_resource:3468a6bd51969caa44a2d268e539972f]

Major Cytogenetic Response (MCyR) rate defined as the proportion of all treated subjects who achieve a complete or partial cytogenetic response on study Up to 5 years [clinicaltrials_resource:575fd1431102470798f74d9d446893d5]

Major Cytogenetic Response (MCyR) rate defined as the proportion of all treated subjects who achieve a complete or partial cytogenetic response on study Up to 5 years [clinicaltrials_resource:7f47acf2b4e99a14f08f961baecaff71]

Major Cytogenetic Response (MCyR) rate defined as the proportion of all treated subjects who achieve a complete or partial cytogenetic response on study Up to 5 years [clinicaltrials_resource:88e03877fbbb62a6f3b2dd6b9ba6f464]

Major Cytogenetic Response (MCyR) rate defined as the proportion of all treated subjects who achieve a complete or partial cytogenetic response on study Up to 5 years [clinicaltrials_resource:ad0d246f813f6aa610122a9b2ebe2c0c]

Major Cytogenetic Response (MCyR) rate defined as the proportion of all treated subjects who achieve a complete or partial cytogenetic response on study Up to 5 years [clinicaltrials_resource:b80b933b9eb4191a37922a1fdf8a52e4]

Major Cytogenetic Response (MCyR) rate defined as the proportion of all treated subjects who achieve a complete or partial cytogenetic response on study Up to 5 years [clinicaltrials_resource:c84870e597d71d13c1395b103e6b12e1]

Major Cytogenetic Response (MCyR) rate defined as the proportion of all treated subjects who achieve a complete or partial cytogenetic response on study Up to 5 years [clinicaltrials_resource:c8e4e70c216541fbb4fd3d67befa2d3b]

Major Cytogenetic Response (MCyR) rate defined as the proportion of all treated subjects who achieve a complete or partial cytogenetic response on study Up to 5 years [clinicaltrials_resource:ca44225df7b74de46c0e7c076e1ec9b4]

Major Cytogenetic Response (MCyR) rate defined as the proportion of all treated subjects who achieve a complete or partial cytogenetic response on study Up to 5 years [clinicaltrials_resource:d7c3657d57ddeef8926d22cc0b92cbfc]

completion date [clinicaltrials_vocabulary:completion-date]

2018-09-01T00:00:00Z

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detailed description [clinicaltrials_vocabulary:detailed-description]

Cohort 2 is closed to enrollment

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download date [clinicaltrials_vocabulary:download-date]

ClinicalTrials.gov processed this data on August 10, 2015

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eligibility [clinicaltrials_vocabulary:eligibility]

eligibility for clinicaltrials:NCT00777036 [clinicaltrials_resource:aeb76f140997ee482ea038a2208b9ddf]

firstreceived date [clinicaltrials_vocabulary:firstreceived-date]

2008-10-21T00:00:00Z

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has expanded access [clinicaltrials_vocabulary:has-expanded-access]

No

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intervention [clinicaltrials_vocabulary:intervention]

Dasatinib [clinicaltrials_resource:d2c73e922436c75a2c1ed5918c4b6fea]

intervention browse [clinicaltrials_vocabulary:intervention-browse]

Dasatinib [clinicaltrials_resource:c569f074f5725b91526e18a5eccb469a]

is fda regulated [clinicaltrials_vocabulary:is-fda-regulated]

Yes

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is section 801 [clinicaltrials_vocabulary:is-section-801]

Yes

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keyword [clinicaltrials_vocabulary:keyword]

Leukemia, Pediatric

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lastchanged date [clinicaltrials_vocabulary:lastchanged-date]

2015-08-06T00:00:00Z

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lead sponsor [clinicaltrials_vocabulary:lead-sponsor]

Bristol-Myers Squibb [clinicaltrials_resource:d4c40cb9f02fd866ab671f3ce45dfa72]

link [clinicaltrials_vocabulary:link]

Investigator Inquiry form [clinicaltrials_resource:2314ff8da7caf18a90888ab03266185c]

FDA Safety Alerts and Recalls [clinicaltrials_resource:3834a9087e4006fa123d334170af525a]

BMS Clinical Trial Information [clinicaltrials_resource:cea6adb53f1855d759c532f4a5cc7e37]

BMS clinical trial educational resource [clinicaltrials_resource:ecfe78d31cdc78071484d9e34e103653]

location [clinicaltrials_vocabulary:location]

Phoenix Children'S Hospital [clinicaltrials_resource:667f70288f8c6d42d8c48fee92c72f37]

nct id [clinicaltrials_vocabulary:nct-id]

NCT00777036

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number of arms [clinicaltrials_vocabulary:number-of-arms]

3

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official title [clinicaltrials_vocabulary:official-title]

A Phase II Study of Dasatinib ...... tant or Intolerant to Imatinib

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org study id [clinicaltrials_vocabulary:org-study-id]

CA180-226

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overall official [clinicaltrials_vocabulary:overall-official]

Bristol-Myers Squibb [clinicaltrials_resource:d3a813b7ce44062a0bf05c46ffe9add7]

overall status [clinicaltrials_vocabulary:overall-status]

Active, not recruiting [clinicaltrials_resource:a6bc1606956390bcd6a391faced78809]

oversight [clinicaltrials_vocabulary:oversight]

United States: Food and Drug Administration [clinicaltrials_resource:c4a209a9a35af202d14c38f2e4e680ed]

phase [clinicaltrials_vocabulary:phase]

Phase 2 [clinicaltrials_resource:56e0338b27a2d68f77402c88327b3f8d]

primary completion date [clinicaltrials_vocabulary:primary-completion-date]

2016-08-01T00:00:00Z

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responsible party [clinicaltrials_vocabulary:responsible-party]

[clinicaltrials_resource:dbd41868ee618d3e64daa1adf8c3a8a0]

secondary id [clinicaltrials_vocabulary:secondary-id]

2008-002260-33

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source [clinicaltrials_vocabulary:source]

Bristol-Myers Squibb [clinicaltrials_resource:d4c40cb9f02fd866ab671f3ce45dfa72]

start date [clinicaltrials_vocabulary:start-date]

2009-02-01T00:00:00Z

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study design [clinicaltrials_vocabulary:study-design]

clinicaltrials:NCT00777036 study design [clinicaltrials_resource:83fea24caa7d709ee77a5ee795152db2]

study type [clinicaltrials_vocabulary:study-type]

Interventional [clinicaltrials_resource:843ac00ae5d0b7c7defb84fb42c2ce31]

url [clinicaltrials_vocabulary:url]

NCT00777036

verification date [clinicaltrials_vocabulary:verification-date]

2014-10-01T00:00:00Z

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identifier

clinicaltrials:NCT00777036

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title

A Phase II Study of Dasatinib ...... tant or Intolerant to Imatinib

@en

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clinicaltrials_resource:bio2rdf.dataset.clinicaltrials.R3