Advanced Malignancies
Conditions
Keywords
Cancer, EPO, Patupilone, Solid tumors, Advanced malignancies
Brief summary
To evaluate the effects of patupilone on the pharmacokinetics of warfarin in patients with advanced malignancies.
Interventions
DRUGPatupilone
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years of age * Life expectancy ≥3 months * Histologically documented advanced solid tumors which have progressed after standard systemic therapy or for which standard systemic therapy does not exist * Agents containing warfarin or heparin must be discontinued 7 days prior to enrollment in the study
Exclusion criteria
* History of/or active bleeding disorders * Known hypersensitivity to warfarin or related compounds * The use of vitamin K * Central lines that require anticoagulant maintenance * The use of agents containing warfarin and heparin * Known diagnosis of human immunodeficiency virus (HIV) infection, hepatitis Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the effects of patupilone on the pharmacokinetics of warfarin in patients with advanced malignancies. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the effects of patupilone on the pharmacodynamics of warfarin in patients with advanced malignancies. | — |
| Safety and tolerability of patupilone when administered concomitantly with warfarin in patients with advanced malignancies will be assessed by AE's, SAE's and safety labs. | — |
Countries
United States
Outcome results
None listed