Overview
An Extension Trial to a Phase I Dose Escalation Study of Gimatecan Administered Orally 5 Consecutive Days to Japanese Patients With Advanced Solid Tumor
Status:
Completed
Completed
Trial end date:
1969-12-31
1969-12-31
Target enrollment:
0
0
Participant gender:
All
All
Summary
CLBQ707A1101 assesses the tolerability, safety, efficacy and pharmacokinetics of gimatecan in Japanese patients.Phase:
Phase 1Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Novartis PharmaceuticalsTreatments:
Camptothecin
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