Locally Recurrent or Metastatic Cancer of the Head and NeckPhase 2NCT00116909
A Study of OSI-7904L as Treatment in Patients With Head and Neck Cancer Who Have Failed First-Line Therapy
A Phase 2 study testing OSI 7904L in people with Locally Recurrent or Metastatic Cancer of the Head and Neck and Must Have Failed First-Line Therapy, run by OSI Pharmaceuticals at 4 sites in United States.
Trial summary
Multi-center, Phase II study to evaluate the efficacy and safety of OSI-7904Lin head and neck cancer in patients who have failed first-line therapy Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Recurrent or Metastatic Cancer of the Head and Neck, Must Have Failed First-Line Therapy
- What is being tested?
- OSI 7904L
- How many people
- 85 participants
- Where
- 4 sitesUnited States
- Study dates
- Aug 2004to Aug 2005
- Phase
- Phase 2
- 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
- Histologically or cytologically confirmed metastatic or locally recurrent SCCHN that is incurable with surgery or radiation therapy ECOG performance status 0-2 No more tha 1 prior chemotharapy regimen for metastatic or locally recurrent disease Adequate bone marrow, Hepatic and renal function. At least one target lesion greater than or equal to 20 mm.
Who cannot join
- Symptomatic brain metasteses which are not stable, are not adequately controlled, are potenially life threatening or required radiation in the last 28 days Pregnant or lactating women. Concurrent anticancer therapy or other investigational drugs Patients with active or uncontrolled infections or other serious illnesses or medical conditions.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
Sarah Cannon Cancer Center
Nashville, Tennessee, 37203
The Vanderbilt Cancer Center
Nashville, Tennessee, 37232
Stony Brook University Hospital
Stony Brook, New York, 11794
About this study
Official title: A Phase II Study of Single-Agent OSI-7904L in Patients With Locally Advanced or Metastatic Squamous Cell Carcinoma of the Head and Neck Who Have Failed First-Line Therapy
Multi-center, Phase II study to evaluate the efficacy and safety of OSI-7904Lin head and neck cancer in patients who have failed first-line therapy
- Conditions
- Locally Recurrent or Metastatic Cancer of the Head and Neck, Must Have Failed First-Line Therapy
- Being tested
- OSI 7904L
- 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.
OSI 7904LDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2005 (estimated)
- Study startAug 2004
- Study completionAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Recurrent or Metastatic Cancer of the Head and NeckStudies of the same condition, open and under way.
- 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
- Enrolment
- 85 participants
Sponsor and investigators
- Lead sponsor
- OSI Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00116909
- Sponsor's protocol ID
- OSI-904-203
- Status last verified
- Mar 2007
- First submitted
- 30 Jun 2005
- Last updated
- 14 Mar 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Single-Agent OSI-7904L in Patients With Locally Advanced or Metastatic Squamous Cell Carcinoma of the Head and Neck Who Have Failed First-Line Therapy
- ClinicalTrials.gov ID
- NCT00116909
- Acronym / sponsor ID
- OSI-904-203
- Conditions
- Locally Recurrent or Metastatic Cancer of the Head and Neck, Must Have Failed First-Line Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants
- Lead sponsor
- OSI PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Aug 2004
- Study completion
- Aug 2005
- First posted
- 1 Jul 2005 (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.
Multi-center, Phase II study to evaluate the efficacy and safety of OSI-7904Lin head and neck cancer in patients who have failed first-line therapy
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Histologically or cytologically confirmed metastatic or locally recurrent SCCHN that is incurable with surgery or radiation therapy ECOG performance status 0-2 No more tha 1 prior chemotharapy regimen for metastatic or locally recurrent disease Adequate bone marrow, Hepatic and renal function. At least one target lesion greater than or equal to 20 mm.
Key exclusion criteria (1 listed)
- Symptomatic brain metasteses which are not stable, are not adequately controlled, are potenially life threatening or required radiation in the last 28 days Pregnant or lactating women. Concurrent anticancer therapy or other investigational drugs Patients with active or uncontrolled infections or other serious illnesses or medical conditions.
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 |
|---|---|---|
| OSI 7904L | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2007.
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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.
4 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 OSI 7904L in people with Locally Recurrent or Metastatic Cancer of the Head and Neck and Must Have Failed First-Line Therapy, run by OSI Pharmaceuticals at 4 sites 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 1 inclusion and 1 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 14 Mar 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 14 Mar 2007.