Status:
COMPLETED
Bioequivalence of 2 Formulations of TKI258 in Patients With Advanced Solid Tumors
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Advanced Solid Tumors
Excluding Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This is a multi-center, open-label, two way crossover study designed to test the bioequivalence of 2 different oral forms of TKI258, FMI capsule and FMI tablet in patients with advanced solid tumors, ...
Eligibility Criteria
Inclusion
- Patients with a histopathologically or cytopathologically confirmed diagnosis of an advanced solid tumor, excluding breast cancer, who have progressed despite standard therapy, or for which no standard therapy exists
- ECOG performance status (PS) 0, 1 or 2
- Patients must meet protocol-specified laboratory values
Exclusion
- Patients with brain metastases
- Patients who have concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study
- Patients who have not recovered from previous anti-cancer therapies
- Patients who are expected to receive any prohibited medications during the bioequivalence phase of the study
- Female patients who are pregnant, breast feeding
- Fertile male or women of child-bearing potential not willing to use two highly effective methods of contraception
- Other protocol-defined inclusion/exclusion criteria may apply
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2014
Estimated Enrollment :
166 Patients enrolled
Trial Details
Trial ID
NCT01421004
Start Date
December 1 2011
End Date
July 1 2014
Last Update
December 21 2020
Active Locations (14)
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1
City of Hope National Medical Center SC-2
Duarte, California, United States, 91010-3000
2
University of California at Los Angeles UCLA LeConte Location
Los Angeles, California, United States, 90095
3
University of California San Francisco UCSF (SC)
San Francisco, California, United States, 94101
4
Florida Cancer Specialists Sarasota Office
Fort Myers, Florida, United States, 33901