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

Phase 1TerminatedNCT00742105

Novartis Pharmaceuticals18 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Cancer Solid Tumor Advanced Solid Tumor

Interventions

BGT226DRUG

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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.

Locations (2)

Novartis Investigative Site

Nagoya, Aichi-ken, Japan

Novartis Investigative Site

Kobe, Hyōgo, Japan

Outcomes

Primary Outcomes

Incidence of dose limiting toxicity (DLT) at each dose level

Time frame: 22-28 days

Secondary Outcomes

Safety measured by type, frequency and severity of adverse drug reactions

Safety measures by Common Terminology Criteria for Adverse Events (CTCAE)

Time frame: Every 4 weeks

Preliminary Efficacy od BGT226

Measured by Response Evaluation criteria in Solid Tumors (RECIST)

Time frame: Every 8 weeks

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

Data from ClinicalTrials.gov

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