Status:
WITHDRAWN
Evaluate the Effects of Patupilone on the Pharmacokinetics of Midazolam and Omeprazole in Patients With Advanced Malignancies (Extension)
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- 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/exclusion criteria may apply
Exclusion
Key Trial Info
Start Date :
July 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00442741
Start Date
July 1 2007
Last Update
April 25 2012
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