NCT00468260

Brief Summary

To evaluate the effects of patupilone on the pharmacokinetics of warfarin in patients with advanced malignancies.

Trial Health

35
At Risk

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 1, 2007

Completed
Same day until next milestone

Study Start

First participant enrolled

May 1, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 2, 2007

Completed
Last Updated

November 19, 2009

Status Verified

November 1, 2009

First QC Date

May 1, 2007

Last Update Submit

November 18, 2009

Conditions

Advanced Malignancies

Keywords

CancerEPO906Patupilone

Outcome Measures

Primary Outcomes (3)

  • Safety

  • Tolerability

  • Potential activity of patupilone once every 21 days in patients that completed the core study

Secondary Outcomes (1)

  • Objective response and tumor evaluation assessed by response evaluation criteria in solid tumors (RECIST)

Interventions

PatupiloneDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 years of age
  • Life expectancy ≥ 3 months
  • Histologically documented advanced solid tumors which have progressed after standard systemic therapy or for which standard systemic therapy does not exist
  • Completed all PK sampling in the core study

You may not qualify if:

  • Known diagnosis of human immunodeficiency virus (HIV) infection, hepatitis
  • Female patients who are pregnant or breast feeding
  • Patients with a severe and/or uncontrolled medical disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

San Antonio, Texas, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

epothilone B

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

May 1, 2007

First Posted

May 2, 2007

Study Start

May 1, 2007

Last Updated

November 19, 2009

Record last verified: 2009-11

Locations

US(1)