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

Solid Tumors Clinical Trial

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)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00442741
• Other study ID #: CEPO906A2123E1
• Status: Withdrawn
• Phase: Phase 1
• First received: March 1, 2007
• Last updated: April 23, 2012
• Start date: July 2007

Study information

• Verified date: April 2012
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Solid Tumors

Intervention

Drug:
• Patupilone

• Patupilone + Omeprazole

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the safety, tolerability and potential activity of patupilone once every 21 days in patients that completed the core study
Secondary	Assessment of objective response and tumor evaluation will be based on the response evaluation criteria in solid tumors (RECIST)