CancerPhase 1NCT00534807
A Study of the Interaction of Rifampin and Vinflunine in Subjects With Advanced Cancer
A Phase 1 study testing Vinflunine and Rifampin in people with Cancer, run by Bristol-Myers Squibb at 1 site in United States.
Trial summary
The purpose of this study is to test how vinflunine interacts with rifampin in the human body Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Vinflunine and Rifampin
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2007to Nov 2008
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cancer unresponsive to previous treatment
- Consent for genetic samples
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Rifampin on the Pharmacokinetics of Intravenous (IV) Vinflunine in Subjects With Advanced Cancer
The purpose of this study is to test how vinflunine interacts with rifampin in the human body
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VinflunineDrug
RifampinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
The Primary Outcome Measure of the effect of rifampin on the pharmacokinetics (PK) of intravenous (IV) vinflunine will be determined from the PK measurements
Measured: 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
Measured: determined after 2 complete 21-day Cycles of study treatment, at approximately 6 weeks after the start of study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2007 (estimated)
- Study startSep 2007
- Primary completionNov 2008 (estimated)
- Study completionNov 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00534807
- Sponsor's protocol ID
- CA183-033
- Status last verified
- Oct 2007
- First submitted
- 25 Sep 2007
- Last updated
- 1 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Rifampin on the Pharmacokinetics of Intravenous (IV) Vinflunine in Subjects With Advanced Cancer
- ClinicalTrials.gov ID
- NCT00534807
- Acronym / sponsor ID
- CA183-033
- Conditions
- Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Sep 2007
- Primary completion
- Nov 2008 (estimated)
- Study completion
- Nov 2008 (estimated)
- First posted
- 26 Sep 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to test how vinflunine interacts with rifampin in the human body
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Cancer unresponsive to previous treatment
- Consent for genetic samples
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vinflunine | Drug | – |
| Rifampin | Drug | – |
Primary outcome
The Primary Outcome Measure of the effect of rifampin on the pharmacokinetics (PK) of intravenous (IV) vinflunine will be determined from the PK measurements
Time frame: taken during Cycle 2 of study treatment, at approximately 4 weeks after the start of study treatment
1 secondary outcome
The Secondary Outcome Measures of the safety and tolerability of vinflunine when administered alone and with rifampin
Time frame: determined after 2 complete 21-day Cycles of study treatment, at approximately 6 weeks after the start of study treatment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Vinflunine and Rifampin in people with Cancer, run by Bristol-Myers Squibb at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 1 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Primary Outcome Measure of the effect of rifampin on the pharmacokinetics (PK) of intravenous (IV) vinflunine will be determined from the PK measurements (time frame: taken during Cycle 2 of study treatment, at approximately 4 weeks after the start of study treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2015.