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| Name | Class |
|---|---|
| Celgene Corporation | INDUSTRY |
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The purpose of this study is to study specific FcRIIIa polymorphisms and their correlation with clinical outcome in subjects treated with cetuximab and lenalidomide.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sub Group 1 | Experimental | All Subjects Enrolled in the Trial |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cetuximab and Lenalidomide | Drug | The treatment of Head and Neck Cancer with Cetuximab and Lenalidomide |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Fatigue Related to Cetuximab/Lenalidomide | Toxicity was scored according to NCI/CTC version 4 | 24 months |
| Number of Participants With Maculopapular Rash Related to Cetuximab/Lenalidomide |
Not provided
Inclusion Criteria:
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.
Laboratory test results within these ranges:
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.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Everett Vokes, M.D. | University of Chicago | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Chicago | Chicago | Illinois | 60637 | United States |
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| Label | URL |
|---|---|
| The University of Chicago Cancer Research Center Website | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cetuximab and Lenalidomide | Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
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| ID | Title | Description |
|---|---|---|
| BG000 | Cetuximab and Lenalidomide | Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Median | Full Range | months | 24 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cetuximab and Lenalidomide | Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Everett Vokes | The University of Chicago | 773-702-9306 | evokes@medicine.bsd.uchicago.edu |
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| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000068818 | Cetuximab |
| D000077269 | Lenalidomide |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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Toxicity was scored according to NCI/CTC version 4
| 24 months |
| Number of Participants With Constipation Related to Cetuximab/Lenalidomide | Toxicity was scored according to NCI/CTC version 4 | 24 months |
| Number of Participants With Anemia Related to Cetuximab/Lenalidomide | Toxicity was scored according to NCI/CTC version 4 | 24 months |
| Number of Participants With Anorexia Related to Cetuximab/Lenalidomide | Toxicity was scored according to NCI/CTC version 4 | 24 months |
| Number of Participants With Nausea Related to Cetuximab/Lenalidomide | Toxicity was scored according to NCI/CTC version 4 | 24 months |
| Number of Participants With Hypoalbuminemia Related to Cetuximab/Lenalidomide | Toxicity was scored according to NCI/CTC version 4 | 24 months |
| Number of Participants With Lymphopenia Related to Cetuximab/Lenalidomide | Toxicity was scored according to NCI/CTC version 4 | 24 months |
| Number of Participants With Oral Mucositis Related to Cetuximab/Lenalidomide | Toxicity was scored according to NCI/CTC version 4 | 24 months |
| Number of Participants With Pain Related to Cetuximab/Lenalidomide | Toxicity was scored according to NCI/CTC version 4 | 24 month |
| Number of Participants With Vomiting Related to Cetuximab/Lenalidomide | Toxicity was scored according to NCI/CTC version 4 | 24 months |
| Number of Participants With White Blood Cell Decreased Related to Cetuximab/Lenalidomide | Toxicity was scored according to NCI/CTC version 4 | 24 months |
| Number of Participants With Diarrhea Related to Cetuximab/Lenalidomide | Toxicity was scored according to NCI/CTC version 4 | 24 months |
| Number of Participants With Hyponatremia Related to Cetuximab/Lenalidomide | Toxicity was scored according to NCI/CTC version 4 | 24 months |
| Number of Participants With Neutropenia Related to Cetuximab/Lenalidomide | Toxicity was scored according to NCI/CTC version 4 | 24 months |
| Number of Participants With Headache Related to Cetuximab/Lenalidomide | Toxicity was scored according to NCI/CTC version 4 | 24 month |
| Number of Participants With Hypokalemia Related to Cetuximab/Lenalidomide | Toxicity was scored according to NCI/CTC version 4 | 24 months |
| Number of Participants With Hypophosphatemia Related to Cetuximab/Lenalidomide | Toxicity was scored according to NCI/CTC version 4 | 24 month |
| Number of Participants With Thrombocytopenia Related to Cetuximab/Lenalidomide | Toxicity was scored according to NCI/CTC version 4 | 24 months |
| Number of Participants With Acneiform Rash Related to Cetuximab/Lenalidomide | Toxicity was scored according to NCI/CTC version 4 | 24 month |
| Number of Participants With Hyperglycemia Related to Cetuximab/Lenalidomide | Toxicity was scored according to NCI/CTC version 4 | 24 month |
| Number of Participants With Alkaline Phosphatase Increased Related to Cetuximab/Lenalidomide | Toxicity was scored according to NCI/CTC version 4 | 24 month |
| Number of Participants With Aspartate Aminotransferase Increased Related to Cetuximab/Lenalidomide | Toxicity was scored according to NCI/CTC version 4 | 24 month |
| Number of Participants With Xerostomia Related to Cetuximab/Lenalidomide | Toxicity was scored according to NCI/CTC version 3 | 24 months |
| Number of Participants With Fever Related to Cetuximab/Lenalidomide | Toxicity was scored according to NCI/CTC version 4 | 24 months |
| Number of Participants With Hypocalcaemia Related to Cetuximab/Lenalidomide | Toxicity was scored according to NCI/CTC version 4 | 24 months |
| Number of Participants With Neck Pain Related to Cetuximab/Lenalidomide | Toxicity was scored according to NCI/CTC version 4 | 24 month |
| Number of Participants With Peripheral Sensory Neuropathy Related to Cetuximab/Lenalidomide | Toxicity was scored according to NCI/CTC version 4 | 24 month |
| Number of Participants With Alanine Aminotransferase Increased Related to Cetuximab/Lenalidomide | Toxicity was scored according to NCI/CTC version 4 | 24 month |
| Number of Participants With Back Pain Related to Cetuximab/Lenalidomide | Toxicity was scored according to NCI/CTC version 4 | 24 month |
| Number of Participants With Dyspnea Related to Cetuximab/Lenalidomide | Toxicity was scored according to NCI/CTC version 4 | 24 month |
| Number of Participants With Weight Loss Related to Cetuximab/Lenalidomide | Toxicity was scored according to NCI/CTC version 4 | 24 month |
| Number of Participants With Blood Bilirubin Increased Related to Cetuximab/Lenalidomide | Toxicity was scored according to NCI/CTC version 4 | 24 month |
| Number of Participants With Infusion Related Reaction Related to Cetuximab/Lenalidomide | Toxicity was scored according to NCI/CTC version 4 | 24 month |
| Number of Participants With C. Diff Infection Related to Cetuximab/Lenalidomide | Toxicity was scored according to NCI/CTC version 4 | 24 month |
| Number of Participants With Febrile Neutropenia Related to Cetuximab/Lenalidomide | Toxicity was scored according to NCI/CTC version 4 | 24 month |
| Number of Participants With Lymphocyte Count Increased Related to Cetuximab/Lenalidomide | Toxicity was scored according to NCI/CTC version 4 | 24 month |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Number of Participants With Fatigue Related to Cetuximab/Lenalidomide | Toxicity was scored according to NCI/CTC version 4 | The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3-4 adverse events related to cetuximab/lenalidomide | Posted | Number | participants | 24 months |
|
|
|
| Secondary | Number of Participants With Maculopapular Rash Related to Cetuximab/Lenalidomide | Toxicity was scored according to NCI/CTC version 4 | The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3-4 adverse events related to cetuximab/lenalidomide | Posted | Number | participants | 24 months |
|
|
|
| Secondary | Number of Participants With Constipation Related to Cetuximab/Lenalidomide | Toxicity was scored according to NCI/CTC version 4 | The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3-4 adverse events related to cetuximab/lenalidomide | Posted | Number | participants | 24 months |
|
|
|
| Secondary | Number of Participants With Anemia Related to Cetuximab/Lenalidomide | Toxicity was scored according to NCI/CTC version 4 | The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3-4 adverse events related to cetuximab/lenalidomide | Posted | Number | participants | 24 months |
|
|
|
| Secondary | Number of Participants With Anorexia Related to Cetuximab/Lenalidomide | Toxicity was scored according to NCI/CTC version 4 | The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3-4 adverse events related to cetuximab/lenalidomide | Posted | Number | participants | 24 months |
|
|
|
| Secondary | Number of Participants With Nausea Related to Cetuximab/Lenalidomide | Toxicity was scored according to NCI/CTC version 4 | The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3-4 adverse events related to cetuximab/lenalidomide | Posted | Number | participants | 24 months |
|
|
|
| Secondary | Number of Participants With Hypoalbuminemia Related to Cetuximab/Lenalidomide | Toxicity was scored according to NCI/CTC version 4 | The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3-4 adverse events related to cetuximab/lenalidomide | Posted | Number | participants | 24 months |
|
|
|
| Secondary | Number of Participants With Lymphopenia Related to Cetuximab/Lenalidomide | Toxicity was scored according to NCI/CTC version 4 | The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3-4 adverse events related to cetuximab/lenalidomide | Posted | Number | participants | 24 months |
|
|
|
| Secondary | Number of Participants With Oral Mucositis Related to Cetuximab/Lenalidomide | Toxicity was scored according to NCI/CTC version 4 | The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3-4 adverse events related to cetuximab/lenalidomide | Posted | Number | participants | 24 months |
|
|
|
| Secondary | Number of Participants With Pain Related to Cetuximab/Lenalidomide | Toxicity was scored according to NCI/CTC version 4 | The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3-4 adverse events related to cetuximab/lenalidomide | Posted | Number | participants | 24 month |
|
|
|
| Secondary | Number of Participants With Vomiting Related to Cetuximab/Lenalidomide | Toxicity was scored according to NCI/CTC version 4 | The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3-4 adverse events related to cetuximab/lenalidomide | Posted | Number | participants | 24 months |
|
|
|
| Secondary | Number of Participants With White Blood Cell Decreased Related to Cetuximab/Lenalidomide | Toxicity was scored according to NCI/CTC version 4 | The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3-4 adverse events related to cetuximab/lenalidomide | Posted | Number | participants | 24 months |
|
|
|
| Secondary | Number of Participants With Diarrhea Related to Cetuximab/Lenalidomide | Toxicity was scored according to NCI/CTC version 4 | The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3-4 adverse events related to cetuximab/lenalidomide | Posted | Number | participants | 24 months |
|
|
|
| Secondary | Number of Participants With Hyponatremia Related to Cetuximab/Lenalidomide | Toxicity was scored according to NCI/CTC version 4 | The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3-4 adverse events related to cetuximab/lenalidomide | Posted | Number | participants | 24 months |
|
|
|
| Secondary | Number of Participants With Neutropenia Related to Cetuximab/Lenalidomide | Toxicity was scored according to NCI/CTC version 4 | The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3-4 adverse events related to cetuximab/lenalidomide | Posted | Number | participants | 24 months |
|
|
|
| Secondary | Number of Participants With Headache Related to Cetuximab/Lenalidomide | Toxicity was scored according to NCI/CTC version 4 | The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3-4 adverse events related to cetuximab/lenalidomide | Posted | Number | participants | 24 month |
|
|
|
| Secondary | Number of Participants With Hypokalemia Related to Cetuximab/Lenalidomide | Toxicity was scored according to NCI/CTC version 4 | The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3-4 adverse events related to cetuximab/lenalidomide | Posted | Number | participants | 24 months |
|
|
|
| Secondary | Number of Participants With Hypophosphatemia Related to Cetuximab/Lenalidomide | Toxicity was scored according to NCI/CTC version 4 | The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3-4 adverse events related to cetuximab/lenalidomide | Posted | Number | participants | 24 month |
|
|
|
| Secondary | Number of Participants With Thrombocytopenia Related to Cetuximab/Lenalidomide | Toxicity was scored according to NCI/CTC version 4 | The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3-4 adverse events related to cetuximab/lenalidomide | Posted | Number | participants | 24 months |
|
|
|
| Secondary | Number of Participants With Acneiform Rash Related to Cetuximab/Lenalidomide | Toxicity was scored according to NCI/CTC version 4 | The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3-4 adverse events related to cetuximab/lenalidomide | Posted | Number | participants | 24 month |
|
|
|
| Secondary | Number of Participants With Hyperglycemia Related to Cetuximab/Lenalidomide | Toxicity was scored according to NCI/CTC version 4 | The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3-4 adverse events related to cetuximab/lenalidomide | Posted | Number | participants | 24 month |
|
|
|
| Secondary | Number of Participants With Alkaline Phosphatase Increased Related to Cetuximab/Lenalidomide | Toxicity was scored according to NCI/CTC version 4 | The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3-4 adverse events related to cetuximab/lenalidomide | Posted | Number | participants | 24 month |
|
|
|
| Secondary | Number of Participants With Aspartate Aminotransferase Increased Related to Cetuximab/Lenalidomide | Toxicity was scored according to NCI/CTC version 4 | The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3-4 adverse events related to cetuximab/lenalidomide | Posted | Number | participants | 24 month |
|
|
|
| Secondary | Number of Participants With Xerostomia Related to Cetuximab/Lenalidomide | Toxicity was scored according to NCI/CTC version 3 | The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3-4 adverse events related to cetuximab/lenalidomide | Posted | Number | participants | 24 months |
|
|
|
| Secondary | Number of Participants With Fever Related to Cetuximab/Lenalidomide | Toxicity was scored according to NCI/CTC version 4 | The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3-4 adverse events related to cetuximab/lenalidomide | Posted | Number | participants | 24 months |
|
|
|
| Secondary | Number of Participants With Hypocalcaemia Related to Cetuximab/Lenalidomide | Toxicity was scored according to NCI/CTC version 4 | The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3-4 adverse events related to cetuximab/lenalidomide | Posted | Number | participants | 24 months |
|
|
|
| Secondary | Number of Participants With Neck Pain Related to Cetuximab/Lenalidomide | Toxicity was scored according to NCI/CTC version 4 | The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3-4 adverse events related to cetuximab/lenalidomide | Posted | Number | participants | 24 month |
|
|
|
| Secondary | Number of Participants With Peripheral Sensory Neuropathy Related to Cetuximab/Lenalidomide | Toxicity was scored according to NCI/CTC version 4 | Analysis Population Description: The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3-4 adverse events related to cetuximab/lenalidomide | Posted | Number | participants | 24 month |
|
|
|
| Secondary | Number of Participants With Alanine Aminotransferase Increased Related to Cetuximab/Lenalidomide | Toxicity was scored according to NCI/CTC version 4 | Analysis Population Description: The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3-4 adverse events related to cetuximab/lenalidomide | Posted | Number | participants | 24 month |
|
|
|
| Secondary | Number of Participants With Back Pain Related to Cetuximab/Lenalidomide | Toxicity was scored according to NCI/CTC version 4 | Analysis Population Description: The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3-4 adverse events related to cetuximab/lenalidomide | Posted | Number | participants | 24 month |
|
|
|
| Secondary | Number of Participants With Dyspnea Related to Cetuximab/Lenalidomide | Toxicity was scored according to NCI/CTC version 4 | Analysis Population Description: The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3-4 adverse events related to cetuximab/lenalidomide | Posted | Number | participants | 24 month |
|
|
|
| Secondary | Number of Participants With Weight Loss Related to Cetuximab/Lenalidomide | Toxicity was scored according to NCI/CTC version 4 | Analysis Population Description: The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3-4 adverse events related to cetuximab/lenalidomide | Posted | Number | participants | 24 month |
|
|
|
| Secondary | Number of Participants With Blood Bilirubin Increased Related to Cetuximab/Lenalidomide | Toxicity was scored according to NCI/CTC version 4 | Analysis Population Description: The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3-4 adverse events related to cetuximab/lenalidomide | Posted | Number | participants | 24 month |
|
|
|
| Secondary | Number of Participants With Infusion Related Reaction Related to Cetuximab/Lenalidomide | Toxicity was scored according to NCI/CTC version 4 | Analysis Population Description: The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3-4 adverse events related to cetuximab/lenalidomide | Posted | Number | participants | 24 month |
|
|
|
| Secondary | Number of Participants With C. Diff Infection Related to Cetuximab/Lenalidomide | Toxicity was scored according to NCI/CTC version 4 | Analysis Population Description: The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3-4 adverse events related to cetuximab/lenalidomide | Posted | Number | participants | 24 month |
|
|
|
| Secondary | Number of Participants With Febrile Neutropenia Related to Cetuximab/Lenalidomide | Toxicity was scored according to NCI/CTC version 4 | Analysis Population Description: The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3-4 adverse events related to cetuximab/lenalidomide | Posted | Number | participants | 24 month |
|
|
|
| Secondary | Number of Participants With Lymphocyte Count Increased Related to Cetuximab/Lenalidomide | Toxicity was scored according to NCI/CTC version 4 | Analysis Population Description: The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3-4 adverse events related to cetuximab/lenalidomide | Posted | Number | participants | 24 month |
|
|
|
| 16 |
| 40 |
| 39 |
| 40 |
| Acute coronary syndrome | Cardiac disorders |
|
| Chest pain - cardiac | Cardiac disorders |
|
| Oral hemorrhage | Gastrointestinal disorders |
|
| Small intestinal obstruction | Gastrointestinal disorders |
|
| Death | General disorders |
|
| Fever | General disorders |
|
| Infusion related reaction | General disorders |
|
| Skin infection | Infections and infestations |
|
| INR increased | Investigations |
|
| Neutrophil count decreased | Investigations |
|
| Dehydration | Metabolism and nutrition disorders |
|
| Bone pain | Musculoskeletal and connective tissue disorders |
|
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders |
|
| Trismus | Musculoskeletal and connective tissue disorders |
|
| Aspiration | Respiratory, thoracic and mediastinal disorders |
|
| Pulmonary edema | Respiratory, thoracic and mediastinal disorders |
|
| Thromboembolic event | Vascular disorders |
|
| Abdominal pain | Gastrointestinal disorders |
|
| Constipation | Gastrointestinal disorders |
|
| Diarrhea | Gastrointestinal disorders |
|
| Dry mouth | Gastrointestinal disorders |
|
| Mucositis oral | Gastrointestinal disorders |
|
| Nausea | Gastrointestinal disorders |
|
| Oral pain | Gastrointestinal disorders |
|
| Vomiting | Gastrointestinal disorders |
|
| Facial pain | General disorders |
|
| Fatigue | General disorders |
|
| Fever | General disorders |
|
| Pain | General disorders |
|
| Papulopustular rash | Infections and infestations |
|
| Alanine aminotransferase increased | Investigations |
|
| Alkaline phosphatase increased | Investigations |
|
| Aspartate aminotransferase increased | Investigations |
|
| Blood bilirubin increased | Investigations |
|
| Lymphocyte count decreased | Investigations |
|
| Neutrophil count decreased | Investigations |
|
| Platelet count decreased | Investigations |
|
| Weight loss | Investigations |
|
| White blood cell decreased | Investigations |
|
| Anorexia | Metabolism and nutrition disorders |
|
| Hyperglycemia | Metabolism and nutrition disorders |
|
| Hypoalbuminemia | Metabolism and nutrition disorders |
|
| Hypocalcemia | Metabolism and nutrition disorders |
|
| Hypoglycemia | Metabolism and nutrition disorders |
|
| Hypokalemia | Metabolism and nutrition disorders |
|
| Hypomagnesemia | Metabolism and nutrition disorders |
|
| Hyponatremia | Metabolism and nutrition disorders |
|
| Hypophosphatemia | Metabolism and nutrition disorders |
|
| Back pain | Musculoskeletal and connective tissue disorders |
|
| Neck pain | Musculoskeletal and connective tissue disorders |
|
| Neoplasms benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
| Dizziness | Nervous system disorders |
|
| Headache | Nervous system disorders |
|
| Peripheral sensory neuropathy | Nervous system disorders |
|
| Anxiety | Psychiatric disorders |
|
| Insomnia | Psychiatric disorders |
|
| Aspiration | Respiratory, thoracic and mediastinal disorders |
|
| Cough | Respiratory, thoracic and mediastinal disorders |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders |
|
| Sore throat | Respiratory, thoracic and mediastinal disorders |
|
| Alopecia | Skin and subcutaneous tissue disorders |
|
| Dry skin | Skin and subcutaneous tissue disorders |
|
| Rash acneiform | Skin and subcutaneous tissue disorders |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders |
|
Not provided
Not provided
Not provided
| D018307 |
| Neoplasms, Squamous Cell |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D010881 | Piperidones |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |