Evaluate the Effects of Patupilone on the Pharmacokinetics of Midazolam and Omeprazole in Patients With Advanced Malignancies (Extension)

Novartis

Status and phase: Withdrawn; Phase 1

Conditions: Solid Tumors

Treatments: Drug: Patupilone; Drug: Patupilone + Omeprazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT00442741

CEPO906A2123E1

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Patupilone + Midazolam

Experimental group

Treatment:

Drug: Patupilone

Patupilone + Omeprazole

Experimental group

Treatment:

Drug: Patupilone + Omeprazole