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

Phase 1

Terminated

• Conditions: Cancer; Solid Tumor; Advanced Solid Tumor
• Interventions: Drug: BGT226

• Registration Number: NCT00742105
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-08-25
• Study First Submitted QC: 2008-08-26
• Study First Posted: 2008-08-27
• Study Start: 2008-11-17
• Primary Completion: 2009-12-22
• Study Completion: 2009-12-22
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-21
• Last Update Posted: 2018-09-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 18

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BGT226	BGT226	-

Primary Outcome Measures

Name	Time	Method
Incidence of dose limiting toxicity (DLT) at each dose level	22-28 days

Secondary Outcome Measures

Name	Time	Method
Safety measured by type, frequency and severity of adverse drug reactions	Every 4 weeks	Safety measures by Common Terminology Criteria for Adverse Events (CTCAE)
Percent of patients in which an altered molecular status is detected for markers related to Pl3K signaling	Baseline, every 3 weeks
Preliminary Efficacy od BGT226	Every 8 weeks	Measured by Response Evaluation criteria in Solid Tumors (RECIST)
Biomarkers: Percentage of change, pre- versus post-treatment	Every month

Trial Locations

Locations (1)

Novartis Investigative Site; 🇯🇵 Kobe-shi, Hyogo, Japan