Squamous Cell CarcinomaPhase 2NCT01133665
Cetuximab and Lenalidomide in Head and Neck
A Phase 2 study testing Cetuximab and Lenalidomide in people with Squamous Cell Carcinoma, run by University of Chicago at 1 site in United States.
Trial summary
The purpose of this study is to study specific FcRIIIa polymorphisms and their correlation with clinical outcome in subjects treated with cetuximab and lenalidomide. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Squamous Cell Carcinoma
- What is being tested?
- Cetuximab and Lenalidomide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2010to Aug 2012
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Understand and voluntarily sign an informed consent form.
- Age ≥18 years at the time of signing the informed consent form.
- Able to adhere to the study visit schedule and other protocol requirements.
- Recurrent or metastatic squamous cell or undifferentiated carcinoma of the head and neck that is not amenable to curative therapy. Patients who are candidates for local or locoregional therapy should not be deprived of proven beneficial palliative therapies.
- All previous cancer therapy, including radiation, hormonal therapy, EGFR inhibitors, and surgery, must have been discontinued at least 4 weeks prior to treatment in this study.
- ECOG performance status of 0-1 at study entry.
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- Laboratory test results within these ranges:
- Absolute neutrophil count to ≥ 1000/mm³
- Platelet count ≥ 100,000/mm³
- Calculated creatinine clearance ≥ 50ml/min by Cockcroft-Gault estimation
- Total bilirubin < 1.5 x ULN
- AST (SGOT) and ALT (SGPT) < 3 x ULN or < 5 x ULN if hepatic metastases are present.
- Disease free of prior malignancies for < 3 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "in-situ" of the cervix or breast. Patients with malignancies diagnosed less than 3 years prior to study entry are eligible if the first cancer was no greater than stage I and did not recur. Patients with malignancies diagnosed less than 3 years prior to study entry must have the diagnosis of recurrent or metastatic squamous cell carcinoma of the head and neck confirmed pathologically.
- All study participants must be registered into the mandatory RevAssist® program, and be willing and able to comply with the requirements of RevAssist®.
- Females of childbearing potential (FCBP)† must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10 - 14 days prior to and again within 24 hours of prescribing lenalidomide (prescriptions must be filled within 7 days) and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking lenalidomide. FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy. See Appendix: Risks of Fetal Exposure, Pregnancy Testing Guidelines and Acceptable Birth Control Methods.
- Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant to ASA may use warfarin or low molecular weight heparin).
- Measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded), with minimum lesion size ≥ 2 cm on conventional measurement techniques or ≥ 1 cm on spiral computed tomography (CT) scan. Lesions that can be measured clinically must be at least 1 cm in greatest dimension by caliper measurement.
Who cannot join
- Primary head and neck carcinomas of the salivary gland, skin, or thyroid regardless of pathology
- Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
- Pregnant or breast feeding females. (Lactating females must agree not to breast feed while taking lenalidomide).
- Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
- Use of any other experimental drug or therapy within 28 days of baseline.
- Prior therapy with lenalidomide for squamous cell carcinoma of the head and neck
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- Known hypersensitivity to thalidomide.
- The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
- Concurrent use of other anti-cancer agents or treatments.
- Known positive for HIV or infectious hepatitis, type B or C.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Study of Cetuximab and Lenalidomide in Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck
The purpose of this study is to study specific FcRIIIa polymorphisms and their correlation with clinical outcome in subjects treated with cetuximab and lenalidomide.
Read the detailed description
To study specific FcRIIIa polymorphisms and their correlation with clinical outcome in subjects treated with cetuximab and lenalidomide. There is evidence with cetuximab in CRC, trastuzumab in breast cancer and rituximab with follicular lymphoma, that FcRIIIa polymorphisms correlate with clinical response to antibody therapy and clinical outcome. It is our hypothesis that patients with SCCHN will have clinical outcomes to cetuximab and lenalidomide that correlate with patient FcRIIIa genotype.
Secondary:
To evaluate the safety and toxicity profile of the combination of cetuximab and lenalidomide given to treat subjects with SCCHN.
To study FcRIIIa polymorphisms and the correlation with the ability of NK cells to mediate ADCC against SCCHN. It is our hypothesis that NK cells from patients with advanced SCCHN can mediate ADCC against SCCHN cell lines in the presence of cetuximab and lenalidomide and that the efficiency of ADCC correlates with FcRIIIa polymorphisms.
To evaluate the ability of NK cells to induce ADCC expression of specific activation markers on the NK cell surface. It is our hypothesis that NK cells that induce ADCC will express specific activation markers that are predictive of efficiency of ADCC.
- Conditions
- Squamous Cell Carcinoma
- Being tested
- Cetuximab and Lenalidomide
- Keywords
- Head and Neck, Squamous Cell, Recurrent or metastatic squamous cell or undifferentiated carcinoma of the head and neck that is not amenable to curative therapy
- Medical subject headings
- Carcinoma, Squamous Cell, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cetuximab and LenalidomideDrug
The treatment of Head and Neck Cancer with Cetuximab and Lenalidomide
| Study group | Role | What they receive |
|---|---|---|
| Sub Group 1 | Experimental | All Subjects Enrolled in the Trial Receives: Drug: Cetuximab and Lenalidomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlate the Presence of Specific Fc RIIIa Polymorphisms With Progression-free Survival in Subjects Receiving Cetuximab and Lenalidomide for SCCHN.
Progression-free survival (PFS) was defined as time from date of the first treatment dose administered to the earlier of disease progression or death from any cause. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Measured: 24 months
Secondary outcomes (37)
Number of Participants With Fatigue Related to Cetuximab/Lenalidomide
Toxicity was scored according to NCI/CTC version 4
Measured: 24 months
Number of Participants With Maculopapular Rash Related to Cetuximab/Lenalidomide
Toxicity was scored according to NCI/CTC version 4
Measured: 24 months
Number of Participants With Constipation Related to Cetuximab/Lenalidomide
Toxicity was scored according to NCI/CTC version 4
Measured: 24 months
Number of Participants With Anemia Related to Cetuximab/Lenalidomide
Toxicity was scored according to NCI/CTC version 4
Measured: 24 months
Number of Participants With Anorexia Related to Cetuximab/Lenalidomide
Toxicity was scored according to NCI/CTC version 4
Measured: 24 months
Number of Participants With Nausea Related to Cetuximab/Lenalidomide
Toxicity was scored according to NCI/CTC version 4
Measured: 24 months
Number of Participants With Hypoalbuminemia Related to Cetuximab/Lenalidomide
Toxicity was scored according to NCI/CTC version 4
Measured: 24 months
Number of Participants With Lymphopenia Related to Cetuximab/Lenalidomide
Toxicity was scored according to NCI/CTC version 4
Measured: 24 months
Number of Participants With Oral Mucositis Related to Cetuximab/Lenalidomide
Toxicity was scored according to NCI/CTC version 4
Measured: 24 months
Number of Participants With Pain Related to Cetuximab/Lenalidomide
Toxicity was scored according to NCI/CTC version 4
Measured: 24 month
Number of Participants With Vomiting Related to Cetuximab/Lenalidomide
Toxicity was scored according to NCI/CTC version 4
Measured: 24 months
Number of Participants With White Blood Cell Decreased Related to Cetuximab/Lenalidomide
Toxicity was scored according to NCI/CTC version 4
Measured: 24 months
Number of Participants With Diarrhea Related to Cetuximab/Lenalidomide
Toxicity was scored according to NCI/CTC version 4
Measured: 24 months
Number of Participants With Hyponatremia Related to Cetuximab/Lenalidomide
Toxicity was scored according to NCI/CTC version 4
Measured: 24 months
Number of Participants With Neutropenia Related to Cetuximab/Lenalidomide
Toxicity was scored according to NCI/CTC version 4
Measured: 24 months
Number of Participants With Headache Related to Cetuximab/Lenalidomide
Toxicity was scored according to NCI/CTC version 4
Measured: 24 month
Number of Participants With Hypokalemia Related to Cetuximab/Lenalidomide
Toxicity was scored according to NCI/CTC version 4
Measured: 24 months
Number of Participants With Hypophosphatemia Related to Cetuximab/Lenalidomide
Toxicity was scored according to NCI/CTC version 4
Measured: 24 month
Number of Participants With Thrombocytopenia Related to Cetuximab/Lenalidomide
Toxicity was scored according to NCI/CTC version 4
Measured: 24 months
Number of Participants With Acneiform Rash Related to Cetuximab/Lenalidomide
Toxicity was scored according to NCI/CTC version 4
Measured: 24 month
Number of Participants With Hyperglycemia Related to Cetuximab/Lenalidomide
Toxicity was scored according to NCI/CTC version 4
Measured: 24 month
Number of Participants With Alkaline Phosphatase Increased Related to Cetuximab/Lenalidomide
Toxicity was scored according to NCI/CTC version 4
Measured: 24 month
Number of Participants With Aspartate Aminotransferase Increased Related to Cetuximab/Lenalidomide
Toxicity was scored according to NCI/CTC version 4
Measured: 24 month
Number of Participants With Xerostomia Related to Cetuximab/Lenalidomide
Toxicity was scored according to NCI/CTC version 3
Measured: 24 months
Number of Participants With Fever Related to Cetuximab/Lenalidomide
Toxicity was scored according to NCI/CTC version 4
Measured: 24 months
Number of Participants With Hypocalcaemia Related to Cetuximab/Lenalidomide
Toxicity was scored according to NCI/CTC version 4
Measured: 24 months
Number of Participants With Neck Pain Related to Cetuximab/Lenalidomide
Toxicity was scored according to NCI/CTC version 4
Measured: 24 month
Number of Participants With Peripheral Sensory Neuropathy Related to Cetuximab/Lenalidomide
Toxicity was scored according to NCI/CTC version 4
Measured: 24 month
Number of Participants With Alanine Aminotransferase Increased Related to Cetuximab/Lenalidomide
Toxicity was scored according to NCI/CTC version 4
Measured: 24 month
Number of Participants With Back Pain Related to Cetuximab/Lenalidomide
Toxicity was scored according to NCI/CTC version 4
Measured: 24 month
Number of Participants With Dyspnea Related to Cetuximab/Lenalidomide
Toxicity was scored according to NCI/CTC version 4
Measured: 24 month
Number of Participants With Weight Loss Related to Cetuximab/Lenalidomide
Toxicity was scored according to NCI/CTC version 4
Measured: 24 month
Number of Participants With Blood Bilirubin Increased Related to Cetuximab/Lenalidomide
Toxicity was scored according to NCI/CTC version 4
Measured: 24 month
Number of Participants With Infusion Related Reaction Related to Cetuximab/Lenalidomide
Toxicity was scored according to NCI/CTC version 4
Measured: 24 month
Number of Participants With C. Diff Infection Related to Cetuximab/Lenalidomide
Toxicity was scored according to NCI/CTC version 4
Measured: 24 month
Number of Participants With Febrile Neutropenia Related to Cetuximab/Lenalidomide
Toxicity was scored according to NCI/CTC version 4
Measured: 24 month
Number of Participants With Lymphocyte Count Increased Related to Cetuximab/Lenalidomide
Toxicity was scored according to NCI/CTC version 4
Measured: 24 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2010 (estimated)
- Study startFeb 2010
- Primary completionAug 2011
- Study completionAug 2012
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 Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe 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
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Celgene Corporation
- Responsible party
- Sponsor
- Investigators
- Everett Vokes, M.D., Study chair, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01133665
- Sponsor's protocol ID
- 09-206-B
- Status last verified
- Nov 2014
- First submitted
- 27 May 2010
- Last updated
- 24 Nov 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Cetuximab and Lenalidomide in Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck
- ClinicalTrials.gov ID
- NCT01133665
- Acronym / sponsor ID
- 09-206-B
- Conditions
- Squamous Cell Carcinoma
- Keywords
- Head and Neck, Squamous Cell, Recurrent or metastatic squamous cell or undifferentiated carcinoma of the head and neck that is not amenable to curative therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- Celgene Corporation
- Study start
- Feb 2010
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 31 May 2010 (estimated)
- Results
- Posted 24 Nov 2014
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 study specific FcRIIIa polymorphisms and their correlation with clinical outcome in subjects treated with cetuximab and lenalidomide.
Detailed description
To study specific FcRIIIa polymorphisms and their correlation with clinical outcome in subjects treated with cetuximab and lenalidomide. There is evidence with cetuximab in CRC, trastuzumab in breast cancer and rituximab with follicular lymphoma, that FcRIIIa polymorphisms correlate with clinical response to antibody therapy and clinical outcome. It is our hypothesis that patients with SCCHN will have clinical outcomes to cetuximab and lenalidomide that correlate with patient FcRIIIa genotype.
Secondary:
To evaluate the safety and toxicity profile of the combination of cetuximab and lenalidomide given to treat subjects with SCCHN.
To study FcRIIIa polymorphisms and the correlation with the ability of NK cells to mediate ADCC against SCCHN. It is our hypothesis that NK cells from patients with advanced SCCHN can mediate ADCC against SCCHN cell lines in the presence of cetuximab and lenalidomide and that the efficiency of ADCC correlates with FcRIIIa polymorphisms.
To evaluate the ability of NK cells to induce ADCC expression of specific activation markers on the NK cell surface. It is our hypothesis that NK cells that induce ADCC will express specific activation markers that are predictive of efficiency of ADCC.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sub Group 1 | Experimental | Drug: Cetuximab and LenalidomideAll Subjects Enrolled in the Trial |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Understand and voluntarily sign an informed consent form.
- Age ≥18 years at the time of signing the informed consent form.
- Able to adhere to the study visit schedule and other protocol requirements.
- Recurrent or metastatic squamous cell or undifferentiated carcinoma of the head and neck that is not amenable to curative therapy. Patients who are candidates for local or locoregional therapy should not be deprived of proven beneficial palliative therapies.
- All previous cancer therapy, including radiation, hormonal therapy, EGFR inhibitors, and surgery, must have been discontinued at least 4 weeks prior to treatment in this study.
Key exclusion criteria (10 listed)
- Primary head and neck carcinomas of the salivary gland, skin, or thyroid regardless of pathology
- Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
- Pregnant or breast feeding females. (Lactating females must agree not to breast feed while taking lenalidomide).
- Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
- Use of any other experimental drug or therapy within 28 days of baseline.
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 |
|---|---|---|
| Cetuximab and LenalidomideThe treatment of Head and Neck Cancer with Cetuximab and Lenalidomide | Drug | Sub Group 1 |
Primary outcome
Correlate the Presence of Specific Fc RIIIa Polymorphisms With Progression-free Survival in Subjects Receiving Cetuximab and Lenalidomide for SCCHN.
Time frame: 24 months
Progression-free survival (PFS) was defined as time from date of the first treatment dose administered to the earlier of disease progression or death from any cause. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
37 secondary outcomes
Number of Participants With Fatigue Related to Cetuximab/Lenalidomide
Time frame: 24 months
Number of Participants With Maculopapular Rash Related to Cetuximab/Lenalidomide
Time frame: 24 months
Number of Participants With Constipation Related to Cetuximab/Lenalidomide
Time frame: 24 months
Number of Participants With Anemia Related to Cetuximab/Lenalidomide
Time frame: 24 months
Number of Participants With Anorexia Related to Cetuximab/Lenalidomide
Time frame: 24 months
Number of Participants With Nausea Related to Cetuximab/Lenalidomide
Time frame: 24 months
Number of Participants With Hypoalbuminemia Related to Cetuximab/Lenalidomide
Time frame: 24 months
Number of Participants With Lymphopenia Related to Cetuximab/Lenalidomide
Time frame: 24 months
Number of Participants With Oral Mucositis Related to Cetuximab/Lenalidomide
Time frame: 24 months
Number of Participants With Pain Related to Cetuximab/Lenalidomide
Time frame: 24 month
Number of Participants With Vomiting Related to Cetuximab/Lenalidomide
Time frame: 24 months
Number of Participants With White Blood Cell Decreased Related to Cetuximab/Lenalidomide
Time frame: 24 months
Number of Participants With Diarrhea Related to Cetuximab/Lenalidomide
Time frame: 24 months
Number of Participants With Hyponatremia Related to Cetuximab/Lenalidomide
Time frame: 24 months
Number of Participants With Neutropenia Related to Cetuximab/Lenalidomide
Time frame: 24 months
Number of Participants With Headache Related to Cetuximab/Lenalidomide
Time frame: 24 month
Number of Participants With Hypokalemia Related to Cetuximab/Lenalidomide
Time frame: 24 months
Number of Participants With Hypophosphatemia Related to Cetuximab/Lenalidomide
Time frame: 24 month
Number of Participants With Thrombocytopenia Related to Cetuximab/Lenalidomide
Time frame: 24 months
Number of Participants With Acneiform Rash Related to Cetuximab/Lenalidomide
Time frame: 24 month
Number of Participants With Hyperglycemia Related to Cetuximab/Lenalidomide
Time frame: 24 month
Number of Participants With Alkaline Phosphatase Increased Related to Cetuximab/Lenalidomide
Time frame: 24 month
Number of Participants With Aspartate Aminotransferase Increased Related to Cetuximab/Lenalidomide
Time frame: 24 month
Number of Participants With Xerostomia Related to Cetuximab/Lenalidomide
Time frame: 24 months
Number of Participants With Fever Related to Cetuximab/Lenalidomide
Time frame: 24 months
Number of Participants With Hypocalcaemia Related to Cetuximab/Lenalidomide
Time frame: 24 months
Number of Participants With Neck Pain Related to Cetuximab/Lenalidomide
Time frame: 24 month
Number of Participants With Peripheral Sensory Neuropathy Related to Cetuximab/Lenalidomide
Time frame: 24 month
Number of Participants With Alanine Aminotransferase Increased Related to Cetuximab/Lenalidomide
Time frame: 24 month
Number of Participants With Back Pain Related to Cetuximab/Lenalidomide
Time frame: 24 month
Number of Participants With Dyspnea Related to Cetuximab/Lenalidomide
Time frame: 24 month
Number of Participants With Weight Loss Related to Cetuximab/Lenalidomide
Time frame: 24 month
Number of Participants With Blood Bilirubin Increased Related to Cetuximab/Lenalidomide
Time frame: 24 month
Number of Participants With Infusion Related Reaction Related to Cetuximab/Lenalidomide
Time frame: 24 month
Number of Participants With C. Diff Infection Related to Cetuximab/Lenalidomide
Time frame: 24 month
Number of Participants With Febrile Neutropenia Related to Cetuximab/Lenalidomide
Time frame: 24 month
Number of Participants With Lymphocyte Count Increased Related to Cetuximab/Lenalidomide
Time frame: 24 month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- The University of Chicago Cancer Research Center WebsiteLink provided by the sponsor.
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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.
Everett Vokes, M.D. study chair
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cetuximab and Lenalidomide in people with Squamous Cell Carcinoma, run by University of Chicago 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 17 inclusion and 10 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 24 Nov 2014. 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 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 24 Nov 2014). 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?
Correlate the Presence of Specific Fc RIIIa Polymorphisms With Progression-free Survival in Subjects Receiving Cetuximab and Lenalidomide for SCCHN. (time frame: 24 months). 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 24 Nov 2014.