NCT00426140

Brief Summary

The main purpose of this study is to characterize the distribution, metabolism, and elimination (ADME) of Patupilone after a single intravenous administration in patients with advanced solid tumor malignancies

Trial Health

80
On Track

Trial Health Score

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

Enrollment
5

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

August 1, 2006

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 23, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 24, 2007

Completed
Last Updated

December 8, 2020

Status Verified

April 1, 2010

Enrollment Period

3 months

First QC Date

January 23, 2007

Last Update Submit

December 6, 2020

Conditions

Advanced MalignanciesSolid Tumors

Keywords

EPOPatupiloneSolid Tumors

Outcome Measures

Primary Outcomes (1)

  • To characterize the pharmacokinetic profile of patupilone including any potential metabolite(s) in blood/plasma as well as the total radioactivity in blood and plasma.

    one week

Secondary Outcomes (2)

  • Safety and tolerability will be assessed by AEs, SAEs and out of range lab values.

    every 6 weeks

  • Radiological scans will also be completed at approximately 6 weeks to asses anti-tumor activity.

    every 6 weeks

Study Arms (1)

EPO906

EXPERIMENTAL
Drug: Patupilone

Interventions

PatupiloneDRUG
EPO906

Eligibility Criteria

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

You may qualify if:

  • years or older
  • World Health Organization (WHO) Performance Status Score of: 0- you are fully active and more or less as you were before your illness, 1 - you cannot carry out heavy physical work, but can do anything else.
  • Adequate hematological laboratory parameters
  • No major impairment of renal or hepatic function
  • Female patients must have a negative serum pregnancy test at screening.

You may not qualify if:

  • Severe and/or uncontrolled medical disease;
  • Severe cardiac insufficiency with uncontrolled and/or unstable cardiac or coronary artery disease;
  • Known diagnosis of human immunodeficiency virus (HIV) infection;
  • Presence of any other active or suspected acute or chronic uncontrolled infection;
  • Symptomatic brain metastases or leptomeningeal disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cancer Therapy and Research Center, Institution for Drug Development

San Antonio, Texas, 78229, United States

Location

Related Links

MeSH Terms

Interventions

epothilone B

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

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

January 23, 2007

First Posted

January 24, 2007

Study Start

August 1, 2006

Primary Completion

November 1, 2006

Last Updated

December 8, 2020

Record last verified: 2010-04

Locations

US(1)