NCT00442741

Brief 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.

Trial Health

10
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 1, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 2, 2007

Completed
4 months until next milestone

Study Start

First participant enrolled

July 1, 2007

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
Last Updated

April 25, 2012

Status Verified

April 1, 2012

Enrollment Period

Same day

First QC Date

March 1, 2007

Last Update Submit

April 23, 2012

Conditions

Solid Tumors

Keywords

CancerEPO906Patupilone

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

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

Study Arms (2)

Patupilone + Midazolam

EXPERIMENTAL
Drug: Patupilone

Patupilone + Omeprazole

EXPERIMENTAL
Drug: Patupilone + Omeprazole

Interventions

PatupiloneDRUG
Patupilone + Midazolam
Patupilone + OmeprazoleDRUG
Patupilone + Omeprazole

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (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
  • Completed the Core study
  • Completed all sampling in the core and not dose reduced Patients with adequate hematologic parameters

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Neoplasms

Interventions

epothilone BOmeprazole

Intervention Hierarchy (Ancestors)

2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 1, 2007

First Posted

March 2, 2007

Study Start

July 1, 2007

Primary Completion

July 1, 2007

Last Updated

April 25, 2012

Record last verified: 2012-04