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

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT00420615

Collaborator

(none)

Enrollment

Location

Arms

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Solid Tumors	Drug: Patupilone and Omeprazole Drug: Patupilone + Midalzolam	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

34 participants

Allocation:

Randomized

Intervention Model:

Parallel 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

Study Start Date :

Dec 1, 2006

Actual Primary Completion Date :

Aug 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Patupilone and Omeprazole patupiloe + omeprazole	Drug: Patupilone and Omeprazole
Experimental: patupilone + midalzolam patupilone + midalzolam	Drug: Patupilone + Midalzolam

Arm

Intervention/Treatment

Experimental: Patupilone and Omeprazole

patupiloe + omeprazole

Drug: Patupilone and Omeprazole

Experimental: patupilone + midalzolam

patupilone + midalzolam

Drug: Patupilone + Midalzolam

Outcome Measures

Primary Outcome Measures

To evaluate the effects of patupilone on the pharmacokinetics of midazolam in patients with advanced malignancies. [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)]
To evaluate the effects of patupilone on the pharmacokinetics of omeprazole in patients with advanced malignancies [Day 1 (0.33h (20m), 0.67h (40m), 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h)]

Secondary Outcome Measures

To evaluate the safety and tolerability of Patupilone when administered concomitantly with midazolam in patients with advanced malignancies. [at each visit (week 1, week 2, week 5, and end of study)]
To evaluate the safety and tolerability of Patupilone when administered concomitantly with omeprazole in patients with advanced malignancies. [at each visit (week 1, week 2, week 5, and end of study)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.