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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00742105
Recruitment Status : Completed
First Posted : August 27, 2008
Last Update Posted : June 21, 2016
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

August 25, 2008
August 27, 2008
June 21, 2016
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 ]
Maximum tolerate dose (safety and tolerability)
Complete list of historical versions of study NCT00742105 on Archive Site
  • Safety measured by type, frequency and severity of adverse drug reactions [ Time Frame: Every 4 weeks ]
    Safety measures by Common Terminology Criteria for Adverse Events (CTCAE)
  • Preliminary Efficacy od BGT226 [ Time Frame: Every 8 weeks ]
    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 ]
  • Biomarkers: Percentage of change, pre- versus post-treatment [ Time Frame: Every month ]
  • 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
Phase 1
Intervention Model: Single Group Assignment
Masking: None (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 Identifier (NCT Number) in Medline.
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.

Sexes Eligible for Study: All
20 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
June 2016

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