Phase II Clinical Study of Imatinib Mesylate in Patients With Malignant Gastrointestinal Stromal Tumors (Extension Study)
1 other identifier
interventional
72
0 countries
N/A
Brief Summary
This is a extension study of CSTI571B1201 study
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2005
CompletedFirst Submitted
Initial submission to the registry
October 9, 2005
CompletedFirst Posted
Study publicly available on registry
October 12, 2005
CompletedMay 1, 2012
April 1, 2012
2.8 years
October 9, 2005
April 29, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To study the antineoplastic effect of the investigational drug.
Secondary Outcomes (1)
To study the safety and pharmacokinetics of the investigational drug.
Study Arms (1)
Imatinib Mesylate
EXPERIMENTAL400 mg once daily
Interventions
Eligibility Criteria
You may qualify if:
- \- Patients who completed the CSTI571B1201 study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 9, 2005
First Posted
October 12, 2005
Study Start
September 1, 2002
Primary Completion
July 1, 2005
Last Updated
May 1, 2012
Record last verified: 2012-04