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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00420615
First Posted: January 11, 2007
Last Update Posted: April 25, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
  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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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

Resource links provided by NLM:


Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

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) ]
  • 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) ]

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) ]
  • 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) ]

Enrollment: 34
Study Start Date: December 2006
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Patupilone and Omeprazole
patupiloe + omeprazole
Drug: Patupilone and Omeprazole
Experimental: patupilone + midalzolam
patupilone + midalzolam
Drug: Patupilone + Midalzolam

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00420615     History of Changes
Other Study ID Numbers: CEPO906A2123
First Submitted: January 10, 2007
First Posted: January 11, 2007
Last Update Posted: April 25, 2012
Last Verified: April 2012

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Cancer
EPO906
Patupilone

Additional relevant MeSH terms:
Midazolam
Omeprazole
Epothilone B
Epothilones
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
Molecular Mechanisms of Pharmacological Action
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators