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

Novartis

Status and phase: Completed; Phase 1

Conditions: Solid Tumors

Treatments: Drug: Patupilone + Midalzolam; Drug: Patupilone and Omeprazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT00420615

CEPO906A2123

Details and patient eligibility

About

The purpose of this study is to evaluate the potential inhibitory effects of patupilone on metabolism using midazolam and omeprazole as the respective probe drugs.

Enrollment: 34 patients

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
• Life expectancy of 3 months or more
• Patients with adequate hematologic parameters

Exclusion criteria

• Hypersensitivity to midazolam or omeprazole or related compounds
• 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: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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34 participants in 2 patient groups

Patupilone and Omeprazole

Experimental group

Description:

patupiloe + omeprazole

Treatment:

Drug: Patupilone and Omeprazole

patupilone + midalzolam

Experimental group

Description:

patupilone + midalzolam

Treatment:

Drug: Patupilone + Midalzolam