Solid Tumors
Conditions
Keywords
Cancer, EPO906, Patupilone
Brief summary
The purpose of this extension study is to evaluate the potential inhibitory effects of patupilone on metabolism using midazolam and omeprazole as the respective probe drugs.
Interventions
DRUGPatupilone
DRUGPatupilone + Omeprazole
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
* Male or female patients 18 years or older * Histologically documented advanced solid tumor, who have failed standard systemic therapy, or for whom standard systemic therapy does not exist * Completed the Core study * Completed all sampling in the core and not dose reduced Patients with adequate hematologic parameters
Exclusion criteria
* Female patients who are pregnant or breast-feeding. * Patients with a severe and/or uncontrolled medical disease * Patients with a known diagnosis of human immunodeficiency virus (HIV) infection * Patients having received an investigational agent within 30 days prior to study entry Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the safety, tolerability and potential activity of patupilone once every 21 days in patients that completed the core study | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of objective response and tumor evaluation will be based on the response evaluation criteria in solid tumors (RECIST) | — |
Outcome results
None listed