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

Phase 1

Withdrawn

• Conditions: Solid Tumors
• Interventions: Drug: Patupilone + Omeprazole; Drug: Patupilone

• Registration Number: NCT00442741
• Lead Sponsor: Novartis Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-03-01
• Study First Submitted QC: 2007-03-01
• Study First Posted: 2007-03-02
• Study Start: 2007-07
• Primary Completion: 2007-07
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-23
• Last Update Posted: 2012-04-25

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patupilone + Omeprazole	Patupilone + Omeprazole	-
Patupilone + Midazolam	Patupilone	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Assessment of objective response and tumor evaluation will be based on the response evaluation criteria in solid tumors (RECIST)