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

Cancer Clinical Trial

Official title:

A Phase I Study of BGT226, Administered Orally in Adult Patients With Advanced Solid Tumor in Japan

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00742105
• Other study ID #: CBGT226A1101
• Status: Terminated
• Phase: Phase 1
• Start date: November 17, 2008
• Est. completion date: December 22, 2009

Study information

• Verified date: September 2018
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 18
• Est. completion date: December 22, 2009
• Est. primary completion date: December 22, 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Solid Tumor
• Cancer
• Neoplasms
• Solid Tumor

Intervention

Drug:
• BGT226

Locations

Country	Name	City	State
Japan	Novartis Investigative Site	Kobe-shi	Hyogo
Japan	Novartis Investigative Site	Nagoya	Aichi

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of dose limiting toxicity (DLT) at each dose level		22-28 days
Secondary	Safety measured by type, frequency and severity of adverse drug reactions	Safety measures by Common Terminology Criteria for Adverse Events (CTCAE)	Every 4 weeks
Secondary	Preliminary Efficacy od BGT226	Measured by Response Evaluation criteria in Solid Tumors (RECIST)	Every 8 weeks
Secondary	Percent of patients in which an altered molecular status is detected for markers related to Pl3K signaling		Baseline, every 3 weeks
Secondary	Biomarkers: Percentage of change, pre- versus post-treatment		Every month