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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Novartis ( Novartis Pharmaceuticals )

ClinicalTrials.gov Identifier:

NCT00420615

First received: January 10, 2007

Last updated: April 23, 2012

Last verified: April 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

January 10, 2007

Last Updated Date

April 23, 2012

Start Date ^ICMJE

December 2006

Primary Completion Date

August 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

To evaluate the effects of patupilone on the pharmacokinetics of midazolam in patients with advanced malignancies. [ Time Frame: Day 1 (0.5h, 1h, 1.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h), Day 29 (0.5h, 1h, 1.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h) ] [ Designated as safety issue: No ]
To evaluate the effects of patupilone on the pharmacokinetics of omeprazole in patients with advanced malignancies [ Time Frame: Day 1 (0.33h (20m), 0.67h (40m), 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h) ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

To evaluate the effects of patupilone on the pharmacokinetics of midazolam in patients with advanced malignancies.
To evaluate the effects of patupilone on the pharmacokinetics of omeprazole in patients with advanced malignancies

Change History

Complete list of historical versions of study NCT00420615 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

To evaluate the safety and tolerability of Patupilone when administered concomitantly with midazolam in patients with advanced malignancies. [ Time Frame: at each visit (week 1, week 2, week 5, and end of study) ] [ Designated as safety issue: Yes ]
To evaluate the safety and tolerability of Patupilone when administered concomitantly with omeprazole in patients with advanced malignancies. [ Time Frame: at each visit (week 1, week 2, week 5, and end of study) ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

To evaluate the safety and tolerability of Patupilone when administered concomitantly with midazolam in patients with advanced malignancies.
To evaluate the safety and tolerability of Patupilone when administered concomitantly with omeprazole in patients with advanced malignancies.

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Solid Tumors

Intervention ^ICMJE

Drug: Patupilone and Omeprazole
Drug: Patupilone + Midalzolam

Study Arm (s)

Experimental: Patupilone and Omeprazole
patupiloe + omeprazole

Intervention: Drug: Patupilone and Omeprazole
Experimental: patupilone + midalzolam
patupilone + midalzolam

Intervention: Drug: Patupilone + Midalzolam

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Not Provided

Primary Completion Date

August 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00420615

Other Study ID Numbers ^ICMJE

CEPO906A2123

Has Data Monitoring Committee

Not Provided

Responsible Party

Novartis ( Novartis Pharmaceuticals )

Study Sponsor ^ICMJE

Novartis Pharmaceuticals

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Novartis Pharmaceuticals

Novartis Pharmeceuticals

Information Provided By

Novartis

Verification Date

April 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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