Status:
COMPLETED
Efficacy and Safety of Patupilone in Patients With Advanced Solid Tumors in Japan
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Tumors
Eligibility:
All Genders
20+ years
Phase:
PHASE1
Brief Summary
The study will evaluate the safety and efficacy of Patupilone in adult patients with advanced solid tumors.
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00412789
Start Date
August 1 2006
Last Update
May 31 2010
Active Locations (1)
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1
Novartis Investigative Site
Tokyo, Japan