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

This study has been withdrawn prior to enrollment.

(pts. will be captured in core)

Sponsor:

Information provided by (Responsible Party):

Novartis ( Novartis Pharmaceuticals )

ClinicalTrials.gov Identifier:

NCT00442741

First received: March 1, 2007

Last updated: April 23, 2012

Last verified: April 2012

History of Changes

Purpose

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	Intervention	Phase
Solid Tumors	Drug: Patupilone Drug: Patupilone + Omeprazole	Phase 1


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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)

Resource links provided by NLM:

Drug Information available for: Midazolam maleate Midazolam hydrochloride Omeprazole Omeprazole magnesium

U.S. FDA Resources

Further study details as provided by Novartis:

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)


Enrollment:	0
Study Start Date:	July 2007
Primary Completion Date:	July 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Patupilone + Midazolam	Drug: Patupilone
Experimental: Patupilone + Omeprazole	Drug: Patupilone + Omeprazole

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00442741

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators


Study Director:	Novartis Pharmaceuticals	Novartis Pharmaceuticals

More Information


Responsible Party:	Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00442741 History of Changes
Other Study ID Numbers:	CEPO906A2123E1
Study First Received:	March 1, 2007
Last Updated:	April 23, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:


Cancer EPO906 Patupilone

Additional relevant MeSH terms:


Omeprazole Midazolam Epothilone B Epothilones Anti-Ulcer Agents Gastrointestinal Agents Proton Pump Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Adjuvants, Anesthesia Hypnotics and Sedatives Central Nervous System Depressants Physiological Effects of Drugs	Anti-Anxiety Agents Tranquilizing Agents Psychotropic Drugs Anesthetics, Intravenous Anesthetics, General Anesthetics GABA Modulators GABA Agents Neurotransmitter Agents Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators

ClinicalTrials.gov processed this record on September 30, 2016

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