Status:
COMPLETED
Dose-escalation Study of Gimatecan Administered in Two Different Schedules in Adult Patients With Advanced Solid Tumors
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This study will evaluate the Maximum Tolerated Dose and dose limiting toxicity of gimatecan administered orally in patients with advanced solid tumors
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00420485
Start Date
March 1 2006
End Date
November 1 2010
Last Update
April 19 2013
Active Locations (12)
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1
Novartis Investigative Site
Vancouver, British Columbia, Canada
2
MD Anderson Cancer Center - Orlando
Toronto, Ontario, Canada, M5G 2M9
3
Novartis Investigative Site
Copenhagen, Denmark, DK-2100
4
Novartis Investigative Site
Dijon, France, 21034