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

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ClinicalTrials.gov Identifier: NCT00742105
Recruitment Status : Terminated
First Posted : August 27, 2008
Last Update Posted : September 25, 2018
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
This study will confirm safety and tolerability and determine the MTD of BGT226 in Japanese patients with advanced solid tumor.

Condition or disease Intervention/treatment Phase
Cancer Solid Tumor Advanced Solid Tumor Drug: BGT226 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Non-Randomized
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
Actual Study Start Date : November 17, 2008
Actual Primary Completion Date : December 22, 2009
Actual Study Completion Date : December 22, 2009

Arm Intervention/treatment
Experimental: BGT226 Drug: BGT226

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

Secondary Outcome Measures :
  1. 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)

  2. Preliminary Efficacy od BGT226 [ Time Frame: Every 8 weeks ]
    Measured by Response Evaluation criteria in Solid Tumors (RECIST)

  3. Percent of patients in which an altered molecular status is detected for markers related to Pl3K signaling [ Time Frame: Baseline, every 3 weeks ]
  4. Biomarkers: Percentage of change, pre- versus post-treatment [ Time Frame: Every month ]

Information from the National Library of Medicine

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

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.

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

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Novartis Investigative Site
Nagoya, Aichi, Japan, 464-8681
Novartis Investigative Site
Kobe-shi, Hyogo, Japan, 650-0017
Sponsors and Collaborators
Novartis Pharmaceuticals
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00742105    
Other Study ID Numbers: CBGT226A1101
First Posted: August 27, 2008    Key Record Dates
Last Update Posted: September 25, 2018
Last Verified: September 2018
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Advanced solid tumor
Additional relevant MeSH terms:
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