Head and Neck CancerPhase 2NCT00971867
Rollover Study of Weekly Paclitaxel (BMS-181339) in Patients With Head and Neck Cancer
A Phase 2 study testing Paclitaxel in people with Head and Neck Cancer, run by Bristol-Myers Squibb at 9 sites in Japan.
Trial summary
The purpose of this study is to provide access to paclitaxel therapy to subjects with advanced head and neck cancer who have completed the previous late phase 2 study (CA139-388) and should have continued therapy with paclitaxel as the discretion of the investigator, and to evaluate the frequency and the severity of… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- Paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 9 sitesJapan
- Study dates
- 4 Aug 2006to 26 Nov 2008
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subjects with advanced head and neck cancer who have completed the previous late phase 2 study (CA139-388) and should have continued therapy with paclitaxel as the discretion of the investigator
Who cannot join
None listed.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Japan9 sites
Local Institution
Kagoshima, Kagoshima-ken, 8900075
Local Institution
Kanagawa
Local Institution
Kashiwa-shi, Chiba, 2778577
Local Institution
Matsuyama, Ehime
Local Institution
Meguro-ku, Tokyo, 1520021
Local Institution
Osaka, Osaka, 5458586
Local Institution
Sunto-gun, Shizuoka, 4118777
Local Institution
Tochigi, 329-0498
Local Institution
Yokohama, Kanagawa, 241-0815
About this study
The purpose of this study is to provide access to paclitaxel therapy to subjects with advanced head and neck cancer who have completed the previous late phase 2 study (CA139-388) and should have continued therapy with paclitaxel as the discretion of the investigator, and to evaluate the frequency and the severity of observed adverse reactions in treated subjects
- Conditions
- Head and Neck Cancer
- Being tested
- Paclitaxel
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PaclitaxelDrug
Also called Taxol, BMS-181339
Solution, I.V., 100 mg/m2 Weekly for 6 of 7 weeks, Until disease progression or unacceptable toxicity became apparent
| Study group | Role | What they receive |
|---|---|---|
| Paclitaxel | Experimental | Not described Receives: Drug: Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With SAEs
Number of Participants with SAEs
Measured: From the first infusion to the completion of study. Approximately up to 28 months
Number of Participants With Adverse Events Leading to Discontinuation
Number of Participants with Adverse Events Leading to Discontinuation
Measured: From the first infusion to the completion of study. Approximately up to 28 months
Number of Participants With Adverse Events
Number of Participants with Adverse Events
Measured: From the first infusion to the completion of study. Approximately up to 28 months
Number of Participants With Laboratory Abnormalities
Number of Participants with Laboratory Abnormalities
Measured: From the first infusion to the completion of study. Approximately up to 28 months
Number of Participants With Drug Related Laboratory Abnormalities
Number of Participants with Drug Related Laboratory Abnormalities
Measured: From the first infusion to the completion of study. Approximately up to 28 months
Secondary outcomes (4)
Number of Participants With Best Overall Response Per RECIST Criteria
Best overall response is represented by the number participants who have had complete response, partial response and have stable disease.
Measured: From the enrollment in CA139-388 (NCT00855764) study up to 904 days after the first infusion in CA139-388 study. Approximately up to 42 Months
Number of Participants With Best Overall Response Per the General Rules for Clinical and Pathological Studies of Head and Neck Cancer
Best overall response is represented by the number participants who have had complete response, partial response and not completed.
Measured: From the enrollment in CA139-388 (NCT00855764) study up to 904 days after the first infusion in CA139-388 study. Approximately up to 42 Months
Duration of Overall Response as Per RECIST Criteria
DOR is defined as the median time from the first date of Partial Response to the first date of Progressive Disease. Participants were evaluated for DOR in a separate study (NCT00971867).
Measured: From the enrollment in CA139-388 (NCT00855764) study up to 904 days after the first infusion in CA139-388 study. Approximately up to 42 Months
Duration of Overall Response as Per the General Rules for Clinical and Pathological Studies of Head and Neck Cancer
Best overall response is represented by the number participants who have had complete response, partial response and not completed.
Measured: From the enrollment in CA139-388 (NCT00855764) study up to 904 days after the first infusion in CA139-388 study. Approximately up to 42 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2009 (estimated)
- Study start4 Aug 2006
- Primary completion26 Nov 2008
- Study completion26 Nov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Head and Neck 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00971867
- Sponsor's protocol ID
- CA139-539
- Status last verified
- Feb 2022
- First submitted
- 3 Sep 2009
- Last updated
- 8 Apr 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rollover Study of Weekly Paclitaxel (BMS-181339) in Patients With Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT00971867
- Acronym / sponsor ID
- CA139-539
- Conditions
- Head and Neck Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 4 Aug 2006 (actual)
- Primary completion
- 26 Nov 2008 (actual)
- Study completion
- 26 Nov 2008 (actual)
- First posted
- 4 Sep 2009 (estimated)
- Results
- Posted 8 Apr 2022
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 provide access to paclitaxel therapy to subjects with advanced head and neck cancer who have completed the previous late phase 2 study (CA139-388) and should have continued therapy with paclitaxel as the discretion of the investigator, and to evaluate the frequency and the severity of observed adverse reactions in treated subjects
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Paclitaxel | Experimental | Drug: Paclitaxel |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects with advanced head and neck cancer who have completed the previous late phase 2 study (CA139-388) and should have continued therapy with paclitaxel as the discretion of the investigator
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| PaclitaxelAlso: Taxol, BMS-181339Solution, I.V., 100 mg/m2 Weekly for 6 of 7 weeks, Until disease progression or unacceptable toxicity became apparent | Drug | Paclitaxel |
Primary outcome
Number of Participants With SAEs
Time frame: From the first infusion to the completion of study. Approximately up to 28 months
Number of Participants with SAEs
Number of Participants With Adverse Events Leading to Discontinuation
Time frame: From the first infusion to the completion of study. Approximately up to 28 months
Number of Participants with Adverse Events Leading to Discontinuation
Number of Participants With Adverse Events
Time frame: From the first infusion to the completion of study. Approximately up to 28 months
Number of Participants with Adverse Events
Number of Participants With Laboratory Abnormalities
Time frame: From the first infusion to the completion of study. Approximately up to 28 months
Number of Participants with Laboratory Abnormalities
Number of Participants With Drug Related Laboratory Abnormalities
Time frame: From the first infusion to the completion of study. Approximately up to 28 months
Number of Participants with Drug Related Laboratory Abnormalities
4 secondary outcomes
Number of Participants With Best Overall Response Per RECIST Criteria
Time frame: From the enrollment in CA139-388 (NCT00855764) study up to 904 days after the first infusion in CA139-388 study. Approximately up to 42 Months
Number of Participants With Best Overall Response Per the General Rules for Clinical and Pathological Studies of Head and Neck Cancer
Time frame: From the enrollment in CA139-388 (NCT00855764) study up to 904 days after the first infusion in CA139-388 study. Approximately up to 42 Months
Duration of Overall Response as Per RECIST Criteria
Time frame: From the enrollment in CA139-388 (NCT00855764) study up to 904 days after the first infusion in CA139-388 study. Approximately up to 42 Months
Duration of Overall Response as Per the General Rules for Clinical and Pathological Studies of Head and Neck Cancer
Time frame: From the enrollment in CA139-388 (NCT00855764) study up to 904 days after the first infusion in CA139-388 study. Approximately up to 42 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Paclitaxel in people with Head and Neck Cancer, run by Bristol-Myers Squibb at 9 sites in Japan.
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 1 inclusion and 0 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: finished, as of the sponsor's last update on 8 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Japan. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Apr 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With SAEs (time frame: From the first infusion to the completion of study. Approximately up to 28 months). The study lists 5 primary outcomes in all. 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 8 Apr 2022.