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A Study of the Interaction of Rifampin and Vinflunine in Subjects With Advanced Cancer

Effect of Rifampin on the Pharmacokinetics of Intravenous (IV) Vinflunine in Subjects With Advanced Cancer

Status
Withdrawn
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00534807
Enrollment
0
Registered
2007-09-26
Start date
2007-09-30
Completion date
2008-11-30
Last updated
2015-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

Brief summary

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

Interventions

DRUGVinflunine
DRUGRifampin

Sponsors

Bristol-Myers Squibb
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Cancer unresponsive to previous treatment * Consent for genetic samples

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frame
The Primary Outcome Measure of the effect of rifampin on the pharmacokinetics (PK) of intravenous (IV) vinflunine will be determined from the PK measurementstaken during Cycle 2 of study treatment, at approximately 4 weeks after the start of study treatment

Secondary

MeasureTime frame
The Secondary Outcome Measures of the safety and tolerability of vinflunine when administered alone and with rifampindetermined after 2 complete 21-day Cycles of study treatment, at approximately 6 weeks after the start of study treatment

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026