NCT00388557

Brief Summary

The purpose of the study is to test how ketoconazole affects with handling of vinflunine by the body which might affect how much vinflunine is in the blood stream and for how long

Trial Health

87
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for phase_1 cancer

Timeline
Completed

Started Oct 2005

Shorter than P25 for phase_1 cancer

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

October 1, 2005

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

October 16, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 17, 2006

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
Last Updated

September 19, 2016

Status Verified

September 1, 2016

First QC Date

October 16, 2006

Last Update Submit

September 16, 2016

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

  • To assess the effect of ketoconazole on the pharmacokinetics of vinflunine in patient with advanced cancer. A total of 28 blood samples will be collected

    Days 1 through 5 and Day 8 of Cycles 1 and 2

Secondary Outcomes (1)

  • Evaluate the safety of vinflunine co-administered with ketoconazole and assess the safety of vinflunine in patients with advanced cancer. Safety laboratory assessments and evaluations will be collected

    weekly

Study Arms (1)

1

EXPERIMENTAL
Drug: vinflunine + ketaconazole

Interventions

vinflunine + ketaconazoleDRUG

vinflunine solution for injection, ketaconazole tablets, vinflunine IV, ketaconazole oral, vinflunine 80 to 320mg/m2 + ketaconazole 400 mg, vinflunine every 3 wks, ketaconazole C1 only, variable duration

1

Eligibility Criteria

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

You may qualify if:

  • Advanced cancer excluding cancer within the blood, adequate kidney and liver function.

You may not qualify if:

  • Prior use of vinflunine, other active medical disorders, severe nerve damage

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tennessee Oncology, Pllc

Nashville, Tennessee, 37203, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

vinflunine

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

October 16, 2006

First Posted

October 17, 2006

Study Start

October 1, 2005

Study Completion

September 1, 2007

Last Updated

September 19, 2016

Record last verified: 2016-09

Locations

US(1)