An Extension Trial to a Phase I Dose Escalation Study of LBQ707 (Gimatecan) Administered Orally 5 Consecutive Days to Japanese Patients With Advanced Solid Tumor
Phase 1
20 Years
N/A
20 Years
N/A
Not Enrolling
Both
Advanced Solid Tumors
Both
Advanced Solid Tumors
Trial Information
An Extension Trial to a Phase I Dose Escalation Study of LBQ707 (Gimatecan) Administered Orally 5 Consecutive Days to Japanese Patients With Advanced Solid Tumor
Inclusion Criteria
Inclusion criteria:
- Patients completing the core protocol (CLBQ707A1101, NCT00410358) exhibiting stable
disease, or a partial or complete response as defined by the core protocol. If
patients only have non-measurable lesions, he/she must not be exhibiting progressive
disease
Exclusion criteria:
- Documented progressive disease as defined by the core protocol
- Patients with performance status of 3 or 4 on the ECOG scale
Other protocol-defined inclusion/exclusion criteria may apply
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Safety and tolerability assessed by Adverse Events
Outcome Time Frame:
2.8 years
Safety Issue:
Yes
Principal Investigator
Novartis Pharmaceuticals
Investigator Role:
Study Director
Investigator Affiliation:
Novartis Pharmaceuticals
Authority:
Japan: Pharmaceuticals and Medical Devices Agency
Study ID:
CLBQ707A1101E1
NCT ID:
NCT00441610
Start Date:
January 2007
Completion Date:
Related Keywords:
- Advanced Solid Tumors
- Gimatecan
- topoisomerase I inhibitor
- advanced solid tumors
- Neoplasms
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