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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00420615
First received: January 10, 2007
Last updated: April 23, 2012
Last verified: April 2012
  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
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel 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

Resource links provided by NLM:


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
Experimental: Patupilone and Omeprazole
patupiloe + omeprazole
Drug: Patupilone and Omeprazole
Experimental: patupilone + midalzolam
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
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: 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 ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00420615     History of Changes
Other Study ID Numbers: CEPO906A2123
Study First Received: January 10, 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
Epothilone B
Epothilones
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators

ClinicalTrials.gov processed this record on October 19, 2014