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

NCT00420615 | Completed Phase 1

• 1 other identifier: CEPO906A2123
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Solid Tumors

Keywords

Cancer; EPO906; Patupilone

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• 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)

Study Arms (2)

Patupilone and Omeprazole

EXPERIMENTAL

patupiloe + omeprazole

Drug: Patupilone and Omeprazole

patupilone + midalzolam

EXPERIMENTAL

patupilone + midalzolam

Drug: Patupilone + Midalzolam

Interventions

Patupilone and Omeprazole DRUG

Patupilone and Omeprazole

Patupilone + Midalzolam DRUG

patupilone + midalzolam

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• Results can be found for CEPO906A2123 on the Novartis Clinical Trials Results Website

MeSH Terms

Conditions

Neoplasms

Interventions

epothilone B; Omeprazole

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmeceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2007
• First Posted: January 11, 2007
• Study Start: December 1, 2006
• Primary Completion: August 1, 2008
• Last Updated: December 8, 2020

Record last verified: 2012-04

Locations

US (1)