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

NCT ID: NCT00420615

Last Updated: 2020-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Brief Summary

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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

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Conditions

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Solid Tumors

Keywords

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Cancer EPO906 Patupilone

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Patupilone and Omeprazole

patupiloe + omeprazole

Group Type EXPERIMENTAL

Patupilone and Omeprazole

Intervention Type DRUG

patupilone + midalzolam

patupilone + midalzolam

Group Type EXPERIMENTAL

Patupilone + Midalzolam

Intervention Type DRUG

Interventions

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Patupilone and Omeprazole

Intervention Type DRUG

Patupilone + Midalzolam

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmeceuticals

Locations

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The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Site Status

Countries

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United States

Related Links

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https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=6803

Results can be found for CEPO906A2123 on the Novartis Clinical Trials Results Website

Other Identifiers

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CEPO906A2123

Identifier Type: -

Identifier Source: org_study_id