Advanced Malignancies
Conditions
Keywords
Cancer, EPO906, Patupilone
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
Participation in study EPO906A2120E1 * 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 * Completed all PK sampling in the core study
Exclusion criteria
* Known diagnosis of human immunodeficiency virus (HIV) infection, hepatitis * Female patients who are pregnant or breast feeding * Patients with a severe and/or uncontrolled medical disease Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety | — |
| Tolerability | — |
| Potential activity of patupilone once every 21 days in patients that completed the core study | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response and tumor evaluation assessed by response evaluation criteria in solid tumors (RECIST) | — |
Countries
United States
Outcome results
None listed