NCT00448396

Brief Summary

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

Trial Health

80
On Track

Trial Health Score

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

Enrollment
17

participants targeted

Target at below P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

March 1, 2007

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

March 15, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 16, 2007

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
Last Updated

November 19, 2009

Status Verified

November 1, 2009

Enrollment Period

11 months

First QC Date

March 15, 2007

Last Update Submit

November 18, 2009

Conditions

Advanced Malignancies

Keywords

CancerEPOPatupiloneSolid tumorsAdvanced malignancies

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (2)

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

  • Safety and tolerability of patupilone when administered concomitantly with warfarin in patients with advanced malignancies will be assessed by AE's, SAE's and safety labs.

Study Arms (1)

Patupilone

EXPERIMENTAL
Drug: Patupilone

Interventions

PatupiloneDRUG
Patupilone

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
  • Agents containing warfarin or heparin must be discontinued 7 days prior to enrollment in the study

You may not qualify if:

  • History of/or active bleeding disorders
  • Known hypersensitivity to warfarin or related compounds
  • The use of vitamin K
  • Central lines that require anticoagulant maintenance
  • The use of agents containing warfarin and heparin

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

March 15, 2007

First Posted

March 16, 2007

Study Start

March 1, 2007

Primary Completion

February 1, 2008

Last Updated

November 19, 2009

Record last verified: 2009-11

Locations

US(1)