Trial Information
Extension to A Phase I Open-label, Multi-center Dose-escalation Study to Determine the Maximum Tolerated Dose (MTD) and Dose Limiting Toxicity of Gimatecan Administered in Two Different Schedules in Adult Patients With Advanced Solid Tumors
Inclusion Criteria
Inclusion criteria :• Advanced or metastatic cancer
• 18 years and above
Exclusion criteria:
- Previous treatment with 4 or more cycles of carboplatin;
- Previous treatment with 2 or more courses of nitrosourea or mitomycin;
- Previous radiation therapy greater than or equal to 25% of the hematopoietic reserve;
- Severe and/or uncontrolled medical conditions
Other protocol-defined inclusion/exclusion criteria may apply
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Presence of dose limiting toxicities in a 56-day treatment period
Principal Investigator
Novartis
Investigator Role:
Study Chair
Investigator Affiliation:
Novartis
Authority:
United States: Food and Drug Administration
Study ID:
CLBQ707A2101E1
NCT ID:
NCT00462163
Start Date:
February 2006
Completion Date:
Related Keywords:
- Solid Tumors
- Maximum Tolerated Dose
- Solid Tumors
- Dose Limiting Toxicity
- Topoisomerase-1 Inhibitor
- Neoplasms