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

An Open Label Phase I Study to Evaluate the Effects of Patupilone on the Pharmacokinetics of Midazolam and Omeprazole in Patients With Advanced Malignancies

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00420615

Enrollment

Registered

2007-01-11

Start date

2006-12-31

Completion date

Unknown

Last updated

2020-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Solid Tumors

Keywords

Cancer, EPO906, Patupilone

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.

Interventions

DRUGPatupilone and Omeprazole

DRUGPatupilone + Midalzolam

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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/

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026