Status:
COMPLETED
An Extension Trial to a Phase I Dose Escalation Study of Gimatecan Administered Orally 5 Consecutive Days to Japanese Patients With Advanced Solid Tumor
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Advanced Solid Tumors
Eligibility:
All Genders
20+ years
Phase:
PHASE1
Brief Summary
CLBQ707A1101 assesses the tolerability, safety, efficacy and pharmacokinetics of gimatecan in Japanese patients.
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT00441610
Start Date
January 1 2007
Last Update
December 19 2020
Active Locations (1)
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1
Novartis Investigative Site
Chiba, Japan