Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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This study has been withdrawn prior to enrollment.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)
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals ) Identifier:
First received: March 1, 2007
Last updated: April 23, 2012
Last verified: April 2012

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 Intervention Phase
Solid Tumors
Drug: Patupilone
Drug: Patupilone + Omeprazole
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group 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 (Extension)

Resource links provided by NLM:

Further study details as provided by Novartis:

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

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

Enrollment: 0
Study Start Date: July 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Patupilone + Midazolam Drug: Patupilone
Experimental: Patupilone + Omeprazole Drug: Patupilone + Omeprazole


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
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 identifier: NCT00442741

Sponsors and Collaborators
Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals ) Identifier: NCT00442741     History of Changes
Other Study ID Numbers: CEPO906A2123E1
Study First Received: March 1, 2007
Last Updated: April 23, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:

Additional relevant MeSH terms:
Epothilone B
Anti-Ulcer Agents
Antimitotic Agents
Antineoplastic Agents
Enzyme Inhibitors
Gastrointestinal Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Proton Pump Inhibitors
Therapeutic Uses
Tubulin Modulators processed this record on March 01, 2015