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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This study has been withdrawn prior to enrollment.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:
ClinicalTrials.gov Identifier:
NCT00442741
First Posted: March 2, 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 )
March 1, 2007
March 2, 2007
April 25, 2012
July 2007
July 2007   (Final data collection date for primary outcome measure)
To evaluate the safety, tolerability and potential activity of patupilone once every 21 days in patients that completed the core study
Same as current
Complete list of historical versions of study NCT00442741 on ClinicalTrials.gov Archive Site
Assessment of objective response and tumor evaluation will be based on the response evaluation criteria in solid tumors (RECIST)
Same as current
Not Provided
Not Provided
 
Evaluate the Effects of Patupilone on the Pharmacokinetics of Midazolam and Omeprazole in Patients With Advanced Malignancies (Extension)
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)
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.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Solid Tumors
  • Drug: Patupilone
  • Drug: Patupilone + Omeprazole
  • Experimental: Patupilone + Midazolam
    Intervention: Drug: Patupilone
  • Experimental: Patupilone + Omeprazole
    Intervention: Drug: Patupilone + Omeprazole
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
Not Provided
July 2007   (Final data collection date for primary outcome measure)

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

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
United States
 
NCT00442741
CEPO906A2123E1
Not Provided
Not Provided
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP