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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:
ClinicalTrials.gov Identifier:
NCT00742105
First Posted: August 27, 2008
Last Update Posted: June 21, 2016
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.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
  Purpose
This study will confirm safety and tolerability and determine the MTD of BGT226 in Japanese patients with advanced solid tumor.

Condition Intervention Phase
Cancer Solid Tumor Advanced Solid Tumor Drug: BGT226 Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Study of BGT226, Administered Orally in Adult Patients With Advanced Solid Tumor in Japan

Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

Primary Outcome Measures:
  • Incidence of dose limiting toxicity (DLT) at each dose level [ Time Frame: 22-28 days ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 21
Study Start Date: November 2008
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BGT226 Drug: BGT226

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00742105


Locations
Japan
Novartis Investigative Site
Nagoya, Aichi, Japan, 464-8681
Novartis Investigative Site
Kobe, Hyogo, Japan, 650-0017
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00742105     History of Changes
Other Study ID Numbers: CBGT226A1101
First Submitted: August 25, 2008
First Posted: August 27, 2008
Last Update Posted: June 21, 2016
Last Verified: June 2016

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
PI3K
mTOR
Advanced solid tumor
Adult

Additional relevant MeSH terms:
Neoplasms