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

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Withdrawn

CT.gov ID

NCT00442741

Collaborator

(none)

Enrollment

Arms

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Solid Tumors	Drug: Patupilone Drug: Patupilone + Omeprazole	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

An Open Label Phase I Study to Evaluate the Effects of Patupilone on the Pharmacokinetics of Midazolam and Omeprazole in Patients With Advanced Malignancies (Extension)

Study Start Date :

Jul 1, 2007

Actual Primary Completion Date :

Jul 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Patupilone + Midazolam	Drug: Patupilone
Experimental: Patupilone + Omeprazole	Drug: Patupilone + Omeprazole

Arm

Intervention/Treatment

Experimental: Patupilone + Midazolam

Drug: Patupilone

Experimental: Patupilone + Omeprazole

Drug: Patupilone + Omeprazole

Outcome Measures

Primary Outcome Measures

To evaluate the safety, tolerability and potential activity of patupilone once every 21 days in patients that completed the core study []

Secondary Outcome Measures

Assessment of objective response and tumor evaluation will be based on the response evaluation criteria in solid tumors (RECIST) []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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