NCT00534807

Brief Summary

The purpose of this study is to test how vinflunine interacts with rifampin in the human body

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2007

Shorter than P25 for phase_1 cancer

Geographic Reach
1 country

1 active site

Status
withdrawn

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

September 1, 2007

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

September 25, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 26, 2007

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
Last Updated

September 1, 2015

Status Verified

October 1, 2007

Enrollment Period

1.2 years

First QC Date

September 25, 2007

Last Update Submit

August 31, 2015

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

  • The Primary Outcome Measure of the effect of rifampin on the pharmacokinetics (PK) of intravenous (IV) vinflunine will be determined from the PK measurements

    taken during Cycle 2 of study treatment, at approximately 4 weeks after the start of study treatment

Secondary Outcomes (1)

  • The Secondary Outcome Measures of the safety and tolerability of vinflunine when administered alone and with rifampin

    determined after 2 complete 21-day Cycles of study treatment, at approximately 6 weeks after the start of study treatment

Interventions

VinflunineDRUG
RifampinDRUG

Eligibility Criteria

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

You may qualify if:

  • Cancer unresponsive to previous treatment
  • Consent for genetic samples

You may not qualify if:

  • Cancer of the blood
  • Spread of cancer to the brain
  • Moderate or severe nerve damage
  • Low white blood cell counts and platelet counts
  • Inadequate liver or kidney function
  • Prior treatment with vinflunine
  • Use of certain medications that might interfere with the metabolism of vinflunine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Local Institution

Detroit, Michigan, 48201, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

vinflunineRifampin

Intervention Hierarchy (Ancestors)

RifamycinsHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsLactams, MacrocyclicMacrocyclic CompoundsPolycyclic Compounds
0

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

September 25, 2007

First Posted

September 26, 2007

Study Start

September 1, 2007

Primary Completion

November 1, 2008

Study Completion

November 1, 2008

Last Updated

September 1, 2015

Record last verified: 2007-10

Locations

US(1)