Phase I Study to Determine the Maximum Tolerate Dose (MTD) of BGT226 in Advanced Solid Tumors in Japan
NCT ID: NCT00742105
Last Updated: 2018-09-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
18 participants
INTERVENTIONAL
2008-11-17
2009-12-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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BGT226
BGT226
Interventions
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BGT226
Eligibility Criteria
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Inclusion Criteria
* Histologically-confirmed, advanced solid tumors
* Progressive, recurrent unresectable disease
* Age ≥ 20
Exclusion Criteria
* No diabetes mellitus or history of gestational diabetes mellitus
* No acute or chronic renal disease
* No acute or chronic liver disease
* No acute or chronic pancreatitis
* No impaired cardiac function or clinically significant cardiac diseases such as ventricular arrhythmia, congestive heart failure, uncontrolled hypertension
* No acute myocardial infarction or unstable angina pectoris within the past 3 months
* Not pregnant or nursing and fertile patients must use barrier contraceptives
20 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
Nagoya, Aichi-ken, Japan
Novartis Investigative Site
Kobe, Hyōgo, Japan
Countries
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Other Identifiers
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CBGT226A1101
Identifier Type: -
Identifier Source: org_study_id
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