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

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ClinicalTrials.gov Identifier: NCT00442741
Recruitment Status : Withdrawn (pts. will be captured in core)
First Posted : March 2, 2007
Last Update Posted : April 25, 2012
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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 or disease Intervention/treatment Phase
Solid Tumors Drug: Patupilone Drug: Patupilone + Omeprazole Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Single Group 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 (Extension)
Study Start Date : July 2007
Actual Primary Completion Date : July 2007

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U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: Patupilone + Midazolam Drug: Patupilone
Experimental: Patupilone + Omeprazole Drug: Patupilone + Omeprazole


Outcome Measures
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Primary Outcome Measures :
  1. To evaluate the safety, tolerability and potential activity of patupilone once every 21 days in patients that completed the core study

Secondary Outcome Measures :
  1. Assessment of objective response and tumor evaluation will be based on the response evaluation criteria in solid tumors (RECIST)

Eligibility Criteria
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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
  • 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT00442741


Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00442741     History of Changes
Other Study ID Numbers: CEPO906A2123E1
First Posted: March 2, 2007    Key Record Dates
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