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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
  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: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Study of BGT226, Administered Orally in Adult Patients With Advanced Solid Tumor in Japan

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Incidence of dose limiting toxicity (DLT) at each dose level [ Time Frame: 22-28 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 57
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

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00742105

Locations
Japan
Novartis Investigative Site
Aichi, Japan
Novartis Investigative Site
Hyogo, Japan
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00742105     History of Changes
Other Study ID Numbers: CBGT226A1101
Study First Received: August 25, 2008
Last Updated: October 16, 2011
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Novartis:
PI3K
mTOR
Advanced solid tumor
Adult

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on May 23, 2013