Evaluate the Effects of Patupilone on the Pharmacokinetics of Midazolam and Omeprazole in Patients With Advanced Malignancies - Full Text View

Sponsored by:	Novartis Pharmaceuticals
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00420615

Purpose

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.

Condition	Intervention	Phase
Solid Tumors	Drug: Patupilone and Omeprazole Drug: Patupilone + Midalzolam	Phase I

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Pharmacokinetics Study
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Midazolam Omeprazole Omeprazole magnesium Epothilone B Esomeprazole Sodium Esomeprazole magnesium

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Enrollment:	34
Study Start Date:	December 2006
Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Patupilone and Omeprazole: Experimental patupiloe + omeprazole	Drug: Patupilone and Omeprazole
patupilone + midalzolam: Experimental patupilone + midalzolam	Drug: Patupilone + Midalzolam

Eligibility

Ages Eligible for Study:	18 Years and older
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
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00420615

Locations

United States, Texas
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

Study Director:

Novartis Pharmaceuticals

Novartis Pharmeceuticals

More Information

No publications provided

Responsible Party:	Novartis Pharmaceuticals ( External Affairs )
Study ID Numbers:	CEPO906A2123
Study First Received:	January 10, 2007
Last Updated:	May 20, 2009
ClinicalTrials.gov Identifier:	NCT00420615 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

Cancer
EPO906
Patupilone

Study placed in the following topic categories:

Epothilone B
Epothilones
Tubulin Modulators

Omeprazole
Antimitotic Agents
Midazolam

Additional relevant MeSH terms:

Epothilone B
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Mitosis Modulators
Tubulin Modulators

Anti-Ulcer Agents
Gastrointestinal Agents
Omeprazole
Enzyme Inhibitors
Antimitotic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 09, 2009