Phase I Study to Determine the Maximum Tolerate Dose (MTD... | NCT00742105

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

NCT00742105

Sponsor

Novartis Pharmaceuticals

Status

Terminated

Last Update Posted

Sep 25, 2018Actual

Enrollment

18Actual

Phase

Phase 1

Conditions

Cancer
Solid Tumor
Advanced Solid Tumor

Interventions

BGT226

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2018

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 17, 2008Actual

Primary Completion Date

Dec 22, 2009Actual

Completion Date

Dec 22, 2009Actual

First Submitted Date

Aug 25, 2008

First Submission Date that Met QC Criteria

Aug 26, 2008

First Posted Date

Aug 27, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 21, 2018

Last Update Posted Date

Sep 25, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

18Actual

Label	Type	Description	Intervention Names
BGT226	Experimental		Drug: BGT226

Name	Type	Description	Arm Group Labels	Other Names
BGT226	Drug		BGT226

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of dose limiting toxicity (DLT) at each dose level		22-28 days

Secondary Outcomes

Measure	Description	Time Frame
Safety measured by type, frequency and severity of adverse drug reactions	Safety measures by Common Terminology Criteria for Adverse Events (CTCAE)	Every 4 weeks
Preliminary Efficacy od BGT226

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Novartis Pharmaceuticals	Novartis Pharmaceuticals	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Novartis Investigative Site		Nagoya	Aichi-ken	464-8681	Japan
Novartis Investigative Site

Condition Browse Module

MeSH Terms

ID	Term
D009369	Neoplasms

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C570852	8-(6-methoxypyridin-3-yl)-3-methyl-1-(4-piperazin-1-yl-3-trifluoromethylphenyl)-1,3-dihydroimidazo(4,5-c)quinolin-2-one

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided