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| Name | Class |
|---|---|
| NATL COMP CA NETWORK | UNKNOWN |
| Pfizer | INDUSTRY |
The purpose of this study is to find out the good and bad effects that occur when temsirolimus is added to standard chemotherapy with carboplatin and paclitaxel.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Temsirolimus + Weekly Paclitaxel + Carboplatin | Experimental | In Part 1 (Phase I) of the study, the primary endpoint is to establish the phase II recommended dose for the combination of temsirolimus + weekly paclitaxel + carboplatinPart 1 (Phase I) features a standard 3 + 3 phase I dose escalation design. Up to 3 dose levels are planned in the Phase I portion of the study. In Part 2 (Phase II) of the study, the primary endpoint is to determine the objective response rate (CR or PR) after two cycles (approximately 6 weeks) of treatment with the combination of temsirolimus + weekly paclitaxel + carboplatin as palliative therapy for recurrent or metastatic HNSCC. A two-stage design will be employed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Temsirolimus + Weekly Paclitaxel + Carboplatin | Drug | Temsirolimus Per dose escalation scheme Level 1 (15 mg) 2 (20 mg) Level 3 (25 mg) IVPB 30 minutes weekly (3 weeks on, 1 week off) days 1 and 8. Paclitaxel 80 mg/m2 IVPB 1 hour weekly (2 weeks on, 1 week off) days 1 and 8. Carboplatin AUC 1.5 IVPB 30 minutes days 1 and 8. On Day 15 of each cycle, patients begin the rest week. |
| Measure | Description | Time Frame |
|---|---|---|
| Phase II Recommended Dose for the Combination of Temsirolimus + Weekly Paclitaxel + Carboplatin. | 2 years | |
| To Determine the Objective Response Rate (CR or PR) After Two Cycles of Treatment With the Combination of Temsirolimus + Weekly Paclitaxel + Carboplatin as Palliative Therapy for Recurrent or Metastatic HNSCC | Evaluation of target lesions: Complete Response - disappearance of all target lesions Partial Response - at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter Progressive Disease - at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started, or the appearance of one of more new lesions Stable Disease - neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum longest diameter since the treatment started | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experienced Adverse Events | Safety will be assessed in terms of AEs according to CTCAE version 3.0 | 2 years |
| Median Overall Survival | 2 years |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Pfister, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan Kettering Cancer Center at Basking Ridge | Basking Ridge | New Jersey | 07939 | United States | ||
Not provided
| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Phase 1, Dose Level 1 | Temsirolimus 15mg, Paclitaxel 80mg/m2, Carboplatin AUC 5 |
| FG001 | Phase 1, Dose Level 2 | Temsirolimus 20mg, Paclitaxel 80mg/m2, Carboplatin AUC |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 22, 2015 |
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|
| Number of Participants With Potential Molecular Markers of Resistance to mTOR Inhibition | 2 years |
| Memorial Sloan Kettering Cancer Center @ Suffolk |
| Commack |
| New York |
| 11725 |
| United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| Memorial Sloan Kettering at Mercy Medical Center | Rockville Centre | New York | United States |
| Memorial Sloan Kettering Cancer Center at Phelps Memorial Hospital Center | Sleepy Hollow | New York | 10591 | United States |
| FG002 | Phase 1, Dose Level 3 | Temsirolimus 25mg, Paclitaxel 80mg/m2, Carboplatin AUC 1.5 |
| FG003 | Phase 2, Dose Level 3 | Temsirolimus 25mg, Paclitaxel 80mg/m2, Carboplatin AUC 1.5 |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Phase 1, Dose Level 1 | Temsirolimus 15mg, Paclitaxel 80mg/m2, Carboplatin AUC 5 |
| BG001 | Phase 1, Dose Level 2 | Temsirolimus 20mg, Paclitaxel 80mg/m2, Carboplatin AUC |
| BG002 | Phase 1, Dose Level 3 | Temsirolimus 25mg, Paclitaxel 80mg/m2, Carboplatin AUC 1.5 |
| BG003 | Phase 2, Dose Level 3 | Temsirolimus 25mg, Paclitaxel 80mg/m2, Carboplatin AUC 1.5 |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
|
| 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 | Phase II Recommended Dose for the Combination of Temsirolimus + Weekly Paclitaxel + Carboplatin. | The phase II recommended dose of Temsirolimus was established at dose level three (Carboplatin AUC 1.5, Taxol 80 mg/m2, Temsirolimus 25 mg). 6 participants treated on Phase I, dose level 3 and 30 participants treated on the Phase II portion were combined for analysis. | Posted | Number | mg | 2 years |
|
|
| |||||||||||||||||||||||||||
| Primary | To Determine the Objective Response Rate (CR or PR) After Two Cycles of Treatment With the Combination of Temsirolimus + Weekly Paclitaxel + Carboplatin as Palliative Therapy for Recurrent or Metastatic HNSCC | Evaluation of target lesions: Complete Response - disappearance of all target lesions Partial Response - at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter Progressive Disease - at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started, or the appearance of one of more new lesions Stable Disease - neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum longest diameter since the treatment started | The phase II recommended dose of Temsirolimus was established at dose level three (Carboplatin AUC 1.5, Taxol 80 mg/m2, Temsirolimus 25 mg). 6 participants treated on Phase I, dose level 3 and 30 participants treated on the Phase II portion were combined for analysis. | Posted | Count of Participants | Participants | 6 weeks |
| ||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Experienced Adverse Events | Safety will be assessed in terms of AEs according to CTCAE version 3.0 | Posted | Count of Participants | Participants | 2 years |
|
| ||||||||||||||||||||||||||||
| Secondary | Median Overall Survival | The phase II recommended dose of Temsirolimus was established at dose level three (Carboplatin AUC 1.5, Taxol 80 mg/m2, Temsirolimus 25 mg). 7 participants treated on Phase I, dose level 3 and 30 participants treated on the Phase II portion were combined for analysis. | Posted | Median | 95% Confidence Interval | months | 2 years |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Participants With Potential Molecular Markers of Resistance to mTOR Inhibition | Posted | Count of Participants | Participants | 2 years |
|
|
2 years
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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 | Phase 1, Dose Level 1 | Temsirolimus 15mg, Paclitaxel 80mg/m2, Carboplatin AUC 5 | 4 | 4 | 2 | 4 | 4 | 4 |
| EG001 | Phase 1, Dose Level 2 | Temsirolimus 20mg, Paclitaxel 80mg/m2, Carboplatin AUC | 6 | 7 | 4 | 7 | 7 | 7 |
| EG002 | Phase 1, Dose Level 3 | Temsirolimus 25mg, Paclitaxel 80mg/m2, Carboplatin AUC 1.5 | 7 | 7 | 5 | 7 | 7 | 7 |
| EG003 | Phase 2, Dose Level 3 | Temsirolimus 25mg, Paclitaxel 80mg/m2, Carboplatin AUC 1.5 | 28 | 30 | 21 | 30 | 30 | 30 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Albumin, low (hypoalbuminemia) | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Allerg rhinitis (w sneez, nas stuff, postnas drip) | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| ALT, SGPT | Investigations | Systematic Assessment |
| ||
| Aspiration | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| AST, SGOT | Investigations | Systematic Assessment |
| ||
| Atrial fibrillation | Cardiac disorders | Systematic Assessment |
| ||
| Bronchospasm, wheezing | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Calcium, high (hypercalcemia) | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Calcium, low (hypocalcemia) | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Conduct abnorm AV Block- 2nd deg Mobitz type II | Cardiac disorders | Systematic Assessment |
| ||
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Creatinine | Investigations | Systematic Assessment |
| ||
| Death not assoc w CTCAE term- Sudden death | General disorders | Systematic Assessment |
| ||
| Dehydration | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dizziness | Nervous system disorders | Systematic Assessment |
| ||
| Dysphagia (Difficulty swallowing) | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dyspnea (shortness of breath) | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Edema: head and neck | General disorders | Systematic Assessment |
| ||
| Esophagitis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Fatigue (asthenia, lethargy, malaise) | General disorders | Systematic Assessment |
| ||
| Febrile neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Fever (in the absence of neutropenia) | General disorders | Systematic Assessment |
| ||
| Fistula, pulm/upp respir - Trachea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Hemoglobin | Investigations | Systematic Assessment |
| ||
| Hemorrhage, Bronchopulmonary NOS | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Hemorrhage, Nose | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Hemorrhage, Rectum | Gastrointestinal disorders | Systematic Assessment |
| ||
| Hemorrhage, Upper GI NOS | Gastrointestinal disorders | Systematic Assessment |
| ||
| Hypertension | Vascular disorders | Systematic Assessment |
| ||
| Hypotension | Vascular disorders | Systematic Assessment |
| ||
| Inf norm ANC/gr1/2 neut-Pneumonia(lung) | Infections and infestations | Systematic Assessment |
| ||
| Inf unknown ANC-Peripheral nerve | Infections and infestations | Systematic Assessment |
| ||
| Inf unknown ANC-Pneumonia(lung) | Infections and infestations | Systematic Assessment |
| ||
| Infection w/ Gr 3/4 neut, Bone (osteomyelitis) | Infections and infestations | Systematic Assessment |
| ||
| Infection w/ Gr 3/4 neut, Lung (pneumonia) | Infections and infestations | Systematic Assessment |
| ||
| Infection, other | Infections and infestations | Systematic Assessment |
| ||
| INR | Investigations | Systematic Assessment |
| ||
| Leukocytes (total WBC) | Investigations | Systematic Assessment |
| ||
| Lymphopenia | Investigations | Systematic Assessment |
| ||
| Mental status | Psychiatric disorders | Systematic Assessment |
| ||
| Muscle weakness - Whole body/general | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Ophthalmoplegia/diplopia (double vision) | Eye disorders | Systematic Assessment |
| ||
| Pain - Abdomen NOS | Gastrointestinal disorders | Systematic Assessment |
| ||
| Pain - Face | General disorders | Systematic Assessment |
| ||
| Pain - Neck | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Pain - Oral cavity | Gastrointestinal disorders | Systematic Assessment |
| ||
| Pain - Throat/pharynx/larynx | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pain - Tumor pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Phosphate, low (hypophosphatemia) | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Platelets | Investigations | Systematic Assessment |
| ||
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pulm/upp respiratory - Other (spec) | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Stricture/stenosis, Esophagus | Gastrointestinal disorders | Systematic Assessment |
| ||
| Supraventricular tachycardia | Cardiac disorders | Systematic Assessment |
| ||
| Syncope (fainting) | Nervous system disorders | Systematic Assessment |
| ||
| Thrombosis/thrombus/embolism | Vascular disorders | Systematic Assessment |
| ||
| Thyroid function, high | Endocrine disorders | Systematic Assessment |
| ||
| Vitreous hemorrhage | Eye disorders | Systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Albumin, low (hypoalbuminemia) | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Constipation | Gastrointestinal disorders | Systematic Assessment |
| ||
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Fatigue (asthenia, lethargy, malaise) | General disorders | Systematic Assessment |
| ||
| Glucose, high (hyperglycemia) | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hemoglobin | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Leukocytes (total WBC) | Investigations | Systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Pain - Pain NOS | General disorders | Systematic Assessment |
| ||
| Platelets | Investigations | Systematic Assessment |
| ||
| Cholesterol,high(hypercholestremia) | Investigations | Systematic Assessment |
| ||
| Edema: head and neck | General disorders | Systematic Assessment |
| ||
| Lymphopenia | Investigations | Systematic Assessment |
| ||
| Neuropathy: sensory | Nervous system disorders | Systematic Assessment |
| ||
| Neutrophils/granulocytes (ANC/AGC) | Investigations | Systematic Assessment |
| ||
| Pain - face | General disorders | Systematic Assessment |
| ||
| Trglycrde, high (hypertriglyceridemia) | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| ALT, SGPT | Investigations | Systematic Assessment |
| ||
| Alkaline phosphatase | Investigations | Systematic Assessment |
| ||
| Dysphagia (Difficulty swallowing) | Gastrointestinal disorders | Systematic Assessment |
| ||
| AST, SGOT | Investigations | Systematic Assessment |
| ||
| Anorexia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Calcium, low (hypocalcemia) | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Dizziness | Nervous system disorders | Systematic Assessment |
| ||
| Dyspnea (shortness of breath) | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Fever (in the absence of neutropenia) | General disorders | Systematic Assessment |
| ||
| Hypertension | Vascular disorders | Systematic Assessment |
| ||
| INR | Investigations | Systematic Assessment |
| ||
| Pneumonia/Lung Infection | Infections and infestations | Systematic Assessment |
| ||
| Magnesium, low (hypomagnesemia) | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Mucositis - oral cavity | Gastrointestinal disorders | Systematic Assessment |
| ||
| Pain - Extremity-limb | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Pain - Head/headache | Nervous system disorders | Systematic Assessment |
| ||
| Potassium, high (hyperkalemia) | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Sodium, low (hyponatremia) | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Vision-blurred vision | Eye disorders | Systematic Assessment |
| ||
| Pain - Throat/pharynx/larynx | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Weight Loss | Investigations | Systematic Assessment |
| ||
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Dry Skin | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Hair loss/alopecia (scalp or body) | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Hemorrhage, Bronchopulmonary NOS | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pain - Chest/thorax NOS | General disorders | Systematic Assessment |
| ||
| Hypernatremia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Phosphate, low (hypophosphatemia) | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Potassium, low (hypokalemia) | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Pain - Dental/Teeth/Peridontal | Gastrointestinal disorders | Systematic Assessment |
| ||
| Joint Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Pain - oral cavity | Gastrointestinal disorders | Systematic Assessment |
| ||
| Trismus (dffclty,pain whn opn mouth) | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
| ||
| Pain - Muscle | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Creatinine | Investigations | Systematic Assessment |
| ||
| Glucose, low (hypoglycemia) | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Pain - back | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Aspiration | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Edema: limb | General disorders | Systematic Assessment |
| ||
| Infection, other | Infections and infestations | Systematic Assessment |
| ||
| Rash/desquamation | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Rash: erythema multiforme | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Voice changes/dysarthria | Nervous system disorders | Systematic Assessment |
| ||
| Dry eye syndrome | Eye disorders | Systematic Assessment |
| ||
| Mood alteration - Anxiety | Psychiatric disorders | Systematic Assessment |
| ||
| Pain - External ear | Ear and labyrinth disorders | Systematic Assessment |
| ||
| Pain - Neck | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Palpitations | Cardiac disorders | Systematic Assessment |
| ||
| Pruritus/itching | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Vent arrhythmia- Ventricular tachycardia | Cardiac disorders | Systematic Assessment |
| ||
| Pain - Chest wall | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Ocular/Visual - Other (specify) | Eye disorders | Systematic Assessment |
| ||
| Fistula, GI- Oral cavity | Gastrointestinal disorders | Systematic Assessment |
| ||
| Allerg rhinitis (w sneez, nas stuff, postnas drip) | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Hemorrhage, Nose | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Rash: acne/acneiform | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Urinary frequency/urgency | Renal and urinary disorders | Systematic Assessment |
| ||
| Watery eye (epiphora, tearing) | Eye disorders | Systematic Assessment |
| ||
| Taste alteration (dysgeusia) | Nervous system disorders | Systematic Assessment |
| ||
| Dry mouth/salivary gland (xerostomia) | Gastrointestinal disorders | Systematic Assessment |
| ||
| Hemorrhage/Bleeding, other | General disorders | Systematic Assessment |
| ||
| Tinnitus | Ear and labyrinth disorders | Systematic Assessment |
| ||
| Flu-like syndrome | General disorders | Systematic Assessment |
| ||
| Pain - Abdomen NOS | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dermatology/Skin, other | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Muscle weakness - Extremity-lower | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Gastritis (incl bile reflux gastritis) | Gastrointestinal disorders | Systematic Assessment |
| ||
| Insomnia | Psychiatric disorders | Systematic Assessment |
| ||
| Auditory/Ear, other | Ear and labyrinth disorders | Systematic Assessment |
| ||
| Thyroid function, low | Endocrine disorders | Systematic Assessment |
| ||
| PTT | Investigations | Systematic Assessment |
| ||
| Sweating (diaphoresis) | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Mood alteration - Depression | Psychiatric disorders | Systematic Assessment |
| ||
| Neuropathy: motor | Nervous system disorders | Systematic Assessment |
| ||
| Sinus tachycardia | Cardiac disorders | Systematic Assessment |
| ||
| Flushing | Vascular disorders | Systematic Assessment |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. David Pfister, MD | Memorial Sloan Kettering Cancer Center | 646-888-4237 | pfisterd@mskcc.org |
| Oct 2, 2018 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D018307 | Neoplasms, Squamous Cell |
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009371 | Neoplasms by Site |
Not provided
Not provided
| ID | Term |
|---|---|
| C401859 | temsirolimus |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| PIK3CA Mutation |
| |||||
| AKT3 S472F Mutation |
| |||||
| PTEN R130Q Mutation |
| |||||
| TSC2 Mutation |
| |||||
| TSC1 Mutation |
|