Trial Information
A Phase IA, Open-label, Dose Escalation Study of Patupilone Administered Intravenously Every 3 Weeks in Adult Patients With Advanced Solid Tumors
Inclusion Criteria
Inclusion criteria:
- Patients with a histologically/cytologically confirmed diagnosis of advanced solid
tumors refractory to or unsuitable for standard therapy, or for whom no standard
therapy exists
- Patients with WHO Performance Status of 0-1 ( Karnofsky Performance Status of
80-100)
- At least one measurable lesion
Exclusion criteria:
- Patients with any peripheral neuropathy
- Patients with unresolved diarrhea
- Patients with severe and/or uncontrolled medical conditions or infections that
require systemic therapy
Other protocol-defined inclusion/exclusion criteria may apply
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Dose-limiting Toxicity
Outcome Time Frame:
18 months
Safety Issue:
Yes
Principal Investigator
Novartis Pharmaceuticals
Investigator Role:
Study Director
Investigator Affiliation:
Novartis Pharmaceuticals
Authority:
Japan: Ministry of Health, Labor and Welfare
Study ID:
CEPO906A1103
NCT ID:
NCT00412789
Start Date:
August 2006
Completion Date:
Related Keywords:
- Tumors
- Advanced solid tumor
- Patupilone