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Phase I Study to Determine the Maximum Tolerate Dose (MTD) of BGT226 in Advanced Solid Tumors in Japan

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00742105
First received: August 25, 2008
Last updated: October 16, 2011
Last verified: October 2011
History of Changes

August 25, 2008
October 16, 2011
November 2008
March 2010   (final data collection date for primary outcome measure)
Incidence of dose limiting toxicity (DLT) at each dose level [ Time Frame: 22-28 days ] [ Designated as safety issue: No ]
Maximum tolerate dose (safety and tolerability)
Complete list of historical versions of study NCT00742105 on ClinicalTrials.gov Archive Site
  • Safety measured by type, frequency and severity of adverse drug reactions [ Time Frame: Every 4 weeks ] [ Designated as safety issue: Yes ]
    Safety measures by Common Terminology Criteria for Adverse Events (CTCAE)
  • Preliminary Efficacy od BGT226 [ Time Frame: Every 8 weeks ] [ Designated as safety issue: No ]
    Measured by Response Evaluation criteria in Solid Tumors (RECIST)
  • Percent of patients in which an altered molecular status is detected for markers related to Pl3K signaling [ Time Frame: Baseline, every 3 weeks ] [ Designated as safety issue: Yes ]
  • Biomarkers: Percentage of change, pre- versus post-treatment [ Time Frame: Every month ] [ Designated as safety issue: No ]
  • Safety assessed by type, frequency and severity of adverse events
  • Efficacy assessed by RECIST
  • Pharmacokinetic assessed by Cmax, Tmax, AUC
  • Pharmacodynamic assessed by blood, tumor and normal skin biomarkers at baseline and post administration of BGT226
Not Provided
Not Provided
 
Phase I Study to Determine the Maximum Tolerate Dose (MTD) of BGT226 in Advanced Solid Tumors in Japan
A Phase I Study of BGT226, Administered Orally in Adult Patients With Advanced Solid Tumor in Japan

This study will confirm safety and tolerability and determine the MTD of BGT226 in Japanese patients with advanced solid tumor.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Cancer
  • Solid Tumor
  • Advanced Solid Tumor
Drug: BGT226
Experimental: BGT226
Intervention: Drug: BGT226
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
57
Not Provided
March 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • World Health Organization (WHO) Performance Status of ≤ 2
  • Histologically-confirmed, advanced solid tumors
  • Progressive, recurrent unresectable disease
  • Age ≥ 20

Exclusion Criteria:

  • Hematopoietic:
  • 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

Other protocol-defined inclusion/exclusion criteria may apply.
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00742105
CBGT226A1101
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP