Phase II Clinical Study of Imatinib Mesylate in Patients... | NCT00237172

Studies
Phase II Clinical Study of Imatinib Mesylate in Patients With Malignant Gastrointestinal Stromal Tumors (Extension Study)

NCT00237172

Sponsor

Novartis Pharmaceuticals

Status

Completed

Last Update Posted

May 1, 2012Estimated

Enrollment

72Actual

Phase

Phase 2

Conditions

Gastrointestinal Stromal Tumors

Interventions

Imatinib Mesylate

Countries

Not provided

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

Apr 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2002

Primary Completion Date

Jul 2005Actual

Completion Date

Not provided

First Submitted Date

Oct 9, 2005

First Submission Date that Met QC Criteria

Oct 9, 2005

First Posted Date

Oct 12, 2005Estimated

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

Apr 29, 2012

Last Update Posted Date

May 1, 2012Estimated

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

72Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Imatinib Mesylate	Experimental	400 mg once daily	Drug: Imatinib Mesylate

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Imatinib Mesylate	Drug	once daily	Imatinib Mesylate	STI571

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To study the antineoplastic effect of the investigational drug.

Secondary Outcomes

Measure	Description	Time Frame
To study the safety and pharmacokinetics of the investigational drug.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

- Patients who completed the CSTI571B1201 study

Exclusion Criteria:

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

74 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Novartis Pharmaceuticals	Novartis Pharmaceuticals	Study Director

Condition Browse Module

MeSH Terms

ID	Term
D046152	Gastrointestinal Stromal Tumors

Ancestor Terms

ID	Term
D009372	Neoplasms, Connective Tissue
D018204	Neoplasms, Connective and Soft Tissue
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000068877	Imatinib Mesylate

Ancestor Terms

ID	Term
D001549	Benzamides
D000577	Amides
D009930	Organic Chemicals
D001565	Benzoates
D000146

Browse Leaves

Not provided

Browse Branches

Not provided