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MK2206 and Erlotinib Hydrochloride in Treating Patients With Advanced Non-Small Cell Lung Cancer Who Have Progressed After Previous Response to Erlotinib Hydrochloride Therapy

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ClinicalTrials.gov Identifier: NCT01294306
Recruitment Status : Completed
First Posted : February 11, 2011
Results First Posted : October 17, 2016
Last Update Posted : November 29, 2016
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Adenosquamous Lung Carcinoma
Bronchioloalveolar Carcinoma
Large Cell Lung Carcinoma
Lung Adenocarcinoma
Recurrent Non-Small Cell Lung Carcinoma
Squamous Cell Lung Carcinoma
Interventions Drug: Akt Inhibitor MK2206
Drug: Erlotinib Hydrochloride
Other: Laboratory Biomarker Analysis
Other: Pharmacological Study
Enrollment 80
Recruitment Details  
Pre-assignment Details  
Arm/Group Title EGFR-Mutated Tumors EGFR Wild-Type Tumors
Hide Arm/Group Description Patients with EGFR-mutated tumors. Patients with EGFR wild-type tumors.
Period Title: Overall Study
Started 45 35
Completed 45 35
Not Completed 0 0
Arm/Group Title EGFR-Mutated Tumors EGFR Wild-Type Tumors Total
Hide Arm/Group Description Patients with EGFR-mutated tumors. Patients with EGFR wild-type tumors. Total of all reporting groups
Overall Number of Baseline Participants 45 35 80
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 45 participants 35 participants 80 participants
64
(44 to 86)
63
(40 to 83)
64
(40 to 86)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants 35 participants 80 participants
Female
31
  68.9%
20
  57.1%
51
  63.7%
Male
14
  31.1%
15
  42.9%
29
  36.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants 35 participants 80 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
21
  46.7%
6
  17.1%
27
  33.8%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
   2.2%
1
   2.9%
2
   2.5%
White
20
  44.4%
27
  77.1%
47
  58.8%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
3
   6.7%
1
   2.9%
4
   5.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 45 participants 35 participants 80 participants
45 35 80
1.Primary Outcome
Title Disease-control Rate
Hide Description Disease-control rate defined as response rate + stable disease at 12 weeks. Stable disease must have been achieved for 12 weeks or longer. Response evaluated per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Progression, 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; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression.
Time Frame At 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title EGFR-Mutated Tumors EGFR Wild-Type Tumors
Hide Arm/Group Description:
Patients with EGFR-mutated tumors.
Patients with EGFR wild-type tumors.
Overall Number of Participants Analyzed 45 35
Measure Type: Number
Unit of Measure: percentage of subjects
40 43
2.Primary Outcome
Title Objective Response
Hide Description Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Objective Response = CR + PR
Time Frame Up to 2 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title EGFR-Mutated Tumors EGFR Wild-Type Tumors
Hide Arm/Group Description:
Patients with EGFR-mutated tumors.
Patients with EGFR wild-type tumors.
Overall Number of Participants Analyzed 45 35
Measure Type: Number
Unit of Measure: percentage of subjects
9 3
3.Secondary Outcome
Title Median Progression-free Survival
Hide Description Estimated using the product-limit method of Kaplan and Meier. 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.
Time Frame Up to 2 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title EGFR-Mutated Tumors EGFR Wild-Type Tumors
Hide Arm/Group Description:
Patients with EGFR-mutated tumors.
Patients with EGFR wild-type tumors.
Overall Number of Participants Analyzed 45 35
Median (95% Confidence Interval)
Unit of Measure: Months
4.4
(2.7 to 6.6)
4.6
(2.9 to 8.5)
4.Secondary Outcome
Title Toxicity of Akt Inhibitor MK2206 Plus Erlotinib Hydrochloride
Hide Description Toxicities of Grade 3 or higher Attributed to Akt inhibitor MK2206 plus erlotinib hydrochloride, graded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
Time Frame Time Frame: Up to 2 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title EGFR-Mutated Tumors EGFR Wild-Type Tumors
Hide Arm/Group Description:
Patients with EGFR-mutated tumors.
Patients with EGFR wild-type tumors.
Overall Number of Participants Analyzed 45 35
Measure Type: Number
Unit of Measure: participants
Anemia 0 1
Diarrhea 5 5
Mucositis 4 1
Nausea 1 2
Vomiting 0 1
Fatigue 5 3
Skin infection 0 1
Lung infection 2 0
Urinary tract infection 1 1
Creatinine increased 0 1
Lymphocyte count decreased 6 3
Anorexia 0 1
Dehydration 3 0
Hyperglycemia 3 0
Hypokalemia 2 0
Hyponatremia 0 2
Hypophophatemia 1 0
Myalgia 1 0
Neoplasm 0 1
Dyspnea 1 1
Dry skin 0 3
Erythema multiforme 1 0
Skin peeling (feet) 0 1
Pruritus 0 1
Rash 9 3
Hypertension 1 0
5.Secondary Outcome
Title Median Overall Survival
Hide Description Estimated using the product-limit method of Kaplan and Meier. Event defined as death due to any cause.
Time Frame Up to 2 Years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title EGFR-Mutated Tumors EGFR Wild-Type Tumors
Hide Arm/Group Description:
Patients with EGFR-mutated tumors.
Patients with EGFR wild-type tumors.
Overall Number of Participants Analyzed 45 35
Median (95% Confidence Interval)
Unit of Measure: Months
10.6
(8.6 to 23.2)
11.1
(7.3 to 22.1)
Time Frame Adverse events collected over a period of 4 years and 8 months.
Adverse Event Reporting Description Includes all adverse events regardless of attribution and grade.
 
Arm/Group Title EGFR-Mutated Tumors EGFR Wild-Type Tumors
Hide Arm/Group Description Patients with EGFR-mutated tumors. Patients with EGFR wild-type tumors.
All-Cause Mortality
EGFR-Mutated Tumors EGFR Wild-Type Tumors
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
EGFR-Mutated Tumors EGFR Wild-Type Tumors
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   17/45 (37.78%)      21/35 (60.00%)    
Blood and lymphatic system disorders     
Anemia * 1  1/45 (2.22%)  1 1/35 (2.86%)  1
Cardiac disorders     
Atrial fibrillation * 1  1/45 (2.22%)  1 0/35 (0.00%)  0
Gastrointestinal disorders     
Abdominal pain * 1  0/45 (0.00%)  0 1/35 (2.86%)  1
Constipation * 1  0/45 (0.00%)  0 1/35 (2.86%)  1
Diarrhea * 1  2/45 (4.44%)  2 1/35 (2.86%)  1
Mucositis oral * 1  7/45 (15.56%)  9 3/35 (8.57%)  3
General disorders     
Death NOS * 1  1/45 (2.22%)  1 1/35 (2.86%)  1
Fatigue * 1  1/45 (2.22%)  1 0/35 (0.00%)  0
Fever * 1  0/45 (0.00%)  0 1/35 (2.86%)  1
Infusion site extravasation * 1  0/45 (0.00%)  0 1/35 (2.86%)  1
Infections and infestations     
Lung infection * 1  3/45 (6.67%)  3 3/35 (8.57%)  3
Paronychia * 1  1/45 (2.22%)  1 1/35 (2.86%)  2
Sepsis * 1  2/45 (4.44%)  2 0/35 (0.00%)  0
Skin infection * 1  0/45 (0.00%)  0 1/35 (2.86%)  1
Upper respiratory infection * 1  0/45 (0.00%)  0 1/35 (2.86%)  1
Urinary tract infection * 1  1/45 (2.22%)  1 2/35 (5.71%)  2
Investigations     
Creatinine increased * 1  0/45 (0.00%)  0 2/35 (5.71%)  2
Lymphocyte count decreased * 1  5/45 (11.11%)  8 6/35 (17.14%)  8
Neutrophil count decreased * 1  1/45 (2.22%)  1 0/35 (0.00%)  0
Metabolism and nutrition disorders     
Dehydration * 1  3/45 (6.67%)  3 0/35 (0.00%)  0
Hyperglycemia * 1  1/45 (2.22%)  1 0/35 (0.00%)  0
Hypoalbuminemia * 1  2/45 (4.44%)  3 1/35 (2.86%)  1
Hypokalemia * 1  2/45 (4.44%)  3 0/35 (0.00%)  0
Hyponatremia * 1  0/45 (0.00%)  0 1/35 (2.86%)  1
Hypophosphatemia * 1  1/45 (2.22%)  1 0/35 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Bursitis * 1  0/45 (0.00%)  0 1/35 (2.86%)  1
Muscle weakness upper limb * 1  1/45 (2.22%)  1 0/35 (0.00%)  0
Myalgia * 1  0/45 (0.00%)  0 1/35 (2.86%)  2
Pain in extremity * 1  0/45 (0.00%)  0 1/35 (2.86%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Progressive Disease, Death NOS * 1  1/45 (2.22%)  1 0/35 (0.00%)  0
Progressive disease * 1  1/45 (2.22%)  1 0/35 (0.00%)  0
non-small cell lung cancer * 1  0/45 (0.00%)  0 1/35 (2.86%)  1
Nervous system disorders     
Ataxia * 1  0/45 (0.00%)  0 1/35 (2.86%)  1
Headache * 1  0/45 (0.00%)  0 2/35 (5.71%)  2
Transient ischemic attacks * 1  1/45 (2.22%)  1 0/35 (0.00%)  0
Psychiatric disorders     
Confusion * 1  0/45 (0.00%)  0 1/35 (2.86%)  1
Reproductive system and breast disorders     
Vaginal dryness * 1  0/45 (0.00%)  0 1/35 (2.86%)  1
Respiratory, thoracic and mediastinal disorders     
Bronchopulmonary hemorrhage * 1  0/45 (0.00%)  0 1/35 (2.86%)  1
Dyspnea * 1  5/45 (11.11%)  5 2/35 (5.71%)  2
Hypoxia * 1  3/45 (6.67%)  3 2/35 (5.71%)  2
Pleural effusion * 1  1/45 (2.22%)  1 0/35 (0.00%)  0
Respiratory failure * 1  1/45 (2.22%)  1 1/35 (2.86%)  1
Skin and subcutaneous tissue disorders     
Dry skin * 1  0/45 (0.00%)  0 1/35 (2.86%)  1
Erythema multiforme * 1  0/45 (0.00%)  0 1/35 (2.86%)  1
Ingrown hair (eyelashes) * 1  0/45 (0.00%)  0 1/35 (2.86%)  1
Pruritus * 1  0/45 (0.00%)  0 1/35 (2.86%)  1
Rash acneiform * 1  1/45 (2.22%)  2 0/35 (0.00%)  0
Rash maculo-papular * 1  1/45 (2.22%)  1 0/35 (0.00%)  0
Skin ulceration * 1  1/45 (2.22%)  1 0/35 (0.00%)  0
skin discoloration (green, gray) * 1  0/45 (0.00%)  0 1/35 (2.86%)  1
Vascular disorders     
Thromboembolic event * 1  2/45 (4.44%)  2 0/35 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE 4.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
EGFR-Mutated Tumors EGFR Wild-Type Tumors
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   45/45 (100.00%)      35/35 (100.00%)    
Blood and lymphatic system disorders     
Anemia * 1  17/45 (37.78%)  46 19/35 (54.29%)  79
Aortic Aneurysm * 1  0/45 (0.00%)  0 1/35 (2.86%)  8
Aortic aneurysm * 1  0/45 (0.00%)  0 1/35 (2.86%)  1
Ascending aortic aneurysm * 1  0/45 (0.00%)  0 1/35 (2.86%)  1
Cardiac disorders     
Aortic valve disease * 1  0/45 (0.00%)  0 1/35 (2.86%)  2
Heart failure * 1  0/45 (0.00%)  0 1/35 (2.86%)  2
Palpitations * 1  0/45 (0.00%)  0 1/35 (2.86%)  1
Pericardial effusion * 1  1/45 (2.22%)  1 0/35 (0.00%)  0
Sinus tachycardia * 1  4/45 (8.89%)  4 2/35 (5.71%)  4
Ear and labyrinth disorders     
Ear pain * 1  0/45 (0.00%)  0 2/35 (5.71%)  5
Hearing impaired * 1  1/45 (2.22%)  1 0/35 (0.00%)  0
Tinnitus * 1  1/45 (2.22%)  2 1/35 (2.86%)  2
Vertigo * 1  0/45 (0.00%)  0 1/35 (2.86%)  1
fluid in ear * 1  1/45 (2.22%)  1 0/35 (0.00%)  0
Eye disorders     
Blepharitis * 1  0/45 (0.00%)  0 1/35 (2.86%)  1
Blurred vision * 1  1/45 (2.22%)  3 1/35 (2.86%)  1
Blurry Vision * 1  1/45 (2.22%)  1 0/35 (0.00%)  0
Cataract * 1  0/45 (0.00%)  0 1/35 (2.86%)  3
Conjunctivitis * 1  3/45 (6.67%)  5 0/35 (0.00%)  0
Dry eye * 1  8/45 (17.78%)  33 3/35 (8.57%)  8
Eye pain * 1  1/45 (2.22%)  1 1/35 (2.86%)  2
Ingrown eyelashes * 1  0/45 (0.00%)  0 1/35 (2.86%)  2
Redness Irritation * 1  1/45 (2.22%)  1 0/35 (0.00%)  0
Sensitivity to sun * 1  0/45 (0.00%)  0 1/35 (2.86%)  1
Watery Eyes * 1  1/45 (2.22%)  1 0/35 (0.00%)  0
eye irritation * 1  0/45 (0.00%)  0 1/35 (2.86%)  2
Gastrointestinal disorders     
Abdominal pain * 1  7/45 (15.56%)  11 6/35 (17.14%)  17
Bloating * 1  1/45 (2.22%)  2 0/35 (0.00%)  0
Constipation * 1  10/45 (22.22%)  21 10/35 (28.57%)  35
Diarrhea * 1  36/45 (80.00%)  123 27/35 (77.14%)  114
Dry mouth * 1  9/45 (20.00%)  21 5/35 (14.29%)  7
Dyspepsia * 1  3/45 (6.67%)  5 0/35 (0.00%)  0
Dysphagia * 1  3/45 (6.67%)  5 1/35 (2.86%)  1
Flatulence * 1  2/45 (4.44%)  3 2/35 (5.71%)  3
Gastritis * 1  2/45 (4.44%)  11 0/35 (0.00%)  0
Gastroesophageal reflux disease * 1  2/45 (4.44%)  8 3/35 (8.57%)  5
Hemorrhoidal hemorrhage * 1  1/45 (2.22%)  2 1/35 (2.86%)  2
Hemorrhoids * 1  2/45 (4.44%)  5 1/35 (2.86%)  3
Intermittent stomach aches * 1  0/45 (0.00%)  0 1/35 (2.86%)  2
Mucositis oral * 1  22/45 (48.89%)  44 10/35 (28.57%)  21
Nausea * 1  12/45 (26.67%)  25 14/35 (40.00%)  26
Oral hemorrhage * 1  0/45 (0.00%)  0 1/35 (2.86%)  3
Oral pain * 1  2/45 (4.44%)  2 2/35 (5.71%)  5
Rectal hemorrhage * 1  1/45 (2.22%)  3 2/35 (5.71%)  2
Stomach Flu * 1  0/45 (0.00%)  0 1/35 (2.86%)  1
Stomach pain * 1  1/45 (2.22%)  2 2/35 (5.71%)  2
Vomiting * 1  10/45 (22.22%)  14 8/35 (22.86%)  10
rough in mouth/sips * 1  0/45 (0.00%)  0 1/35 (2.86%)  1
General disorders     
Chills * 1  4/45 (8.89%)  5 6/35 (17.14%)  6
Death NOS * 1  11/45 (24.44%)  11 10/35 (28.57%)  10
Edema face * 1  0/45 (0.00%)  0 1/35 (2.86%)  2
Edema limbs * 1  7/45 (15.56%)  11 6/35 (17.14%)  12
Fatigue * 1  35/45 (77.78%)  115 30/35 (85.71%)  101
Fever * 1  5/45 (11.11%)  7 2/35 (5.71%)  2
Gait disturbance * 1  0/45 (0.00%)  0 2/35 (5.71%)  2
Malaise * 1  1/45 (2.22%)  1 0/35 (0.00%)  0
Neck edema * 1  1/45 (2.22%)  2 0/35 (0.00%)  0
Non-cardiac chest pain * 1  3/45 (6.67%)  10 4/35 (11.43%)  16
Pain * 1  0/45 (0.00%)  0 1/35 (2.86%)  1
Immune system disorders     
Allergic reaction * 1  1/45 (2.22%)  2 1/35 (2.86%)  1
Infections and infestations     
Bronchial infection * 1  0/45 (0.00%)  0 1/35 (2.86%)  3
Infected abrasion * 1  0/45 (0.00%)  0 1/35 (2.86%)  1
Infected abrasion wound * 1  0/45 (0.00%)  0 1/35 (2.86%)  1
Lung infection * 1  2/45 (4.44%)  4 1/35 (2.86%)  1
Nail infection * 1  1/45 (2.22%)  5 1/35 (2.86%)  14
Otitis externa * 1  0/45 (0.00%)  0 1/35 (2.86%)  2
Otitis media * 1  1/45 (2.22%)  2 1/35 (2.86%)  3
Paronychia * 1  9/45 (20.00%)  20 5/35 (14.29%)  25
Pharyngitis * 1  1/45 (2.22%)  1 0/35 (0.00%)  0
Rash pustular * 1  1/45 (2.22%)  1 0/35 (0.00%)  0
Sinus * 1  0/45 (0.00%)  0 1/35 (2.86%)  1
Sinusitis * 1  1/45 (2.22%)  3 2/35 (5.71%)  7
Skin infection * 1  0/45 (0.00%)  0 2/35 (5.71%)  5
Upper respiratory infection * 1  2/45 (4.44%)  2 4/35 (11.43%)  8
Urinary tract infection * 1  1/45 (2.22%)  1 4/35 (11.43%)  5
Vaginal infection * 1  0/45 (0.00%)  0 1/35 (2.86%)  2
Vulval infection * 1  1/45 (2.22%)  3 0/35 (0.00%)  0
Yeast Infection * 1  1/45 (2.22%)  1 0/35 (0.00%)  0
oral thrush * 1  0/45 (0.00%)  0 1/35 (2.86%)  2
Injury, poisoning and procedural complications     
Burn * 1  0/45 (0.00%)  0 1/35 (2.86%)  2
Fall * 1  0/45 (0.00%)  0 2/35 (5.71%)  5
Investigations     
Activated partial thromboplastin time pr * 1  2/45 (4.44%)  2 1/35 (2.86%)  13
Alanine aminotransferase increased * 1  7/45 (15.56%)  10 5/35 (14.29%)  17
Alkaline phosphatase increased * 1  14/45 (31.11%)  34 7/35 (20.00%)  20
Aspartate aminotransferase increased * 1  11/45 (24.44%)  21 9/35 (25.71%)  43
Blood bilirubin increased * 1  13/45 (28.89%)  39 6/35 (17.14%)  23
Cholesterol high * 1  1/45 (2.22%)  3 1/35 (2.86%)  6
Creatinine increased * 1  7/45 (15.56%)  34 12/35 (34.29%)  75
INR increased * 1  2/45 (4.44%)  2 2/35 (5.71%)  39
Lymphocyte count decreased * 1  14/45 (31.11%)  46 15/35 (42.86%)  56
Neutrophil count decreased * 1  3/45 (6.67%)  7 0/35 (0.00%)  0
Platelet count decreased * 1  0/45 (0.00%)  0 1/35 (2.86%)  2
Right bundle branch block * 1  1/45 (2.22%)  1 0/35 (0.00%)  0
Weight loss * 1  11/45 (24.44%)  35 13/35 (37.14%)  71
White blood cell decreased * 1  7/45 (15.56%)  35 4/35 (11.43%)  8
Metabolism and nutrition disorders     
Anorexia * 1  23/45 (51.11%)  47 21/35 (60.00%)  53
Dehydration * 1  3/45 (6.67%)  5 4/35 (11.43%)  4
Glucose intolerance * 1  0/45 (0.00%)  0 1/35 (2.86%)  6
Hypercalcemia * 1  0/45 (0.00%)  0 3/35 (8.57%)  3
Hyperglycemia * 1  14/45 (31.11%)  54 12/35 (34.29%)  26
Hyperkalemia * 1  0/45 (0.00%)  0 3/35 (8.57%)  9
Hypernatremia * 1  4/45 (8.89%)  9 3/35 (8.57%)  6
Hypertriglyceridemia * 1  0/45 (0.00%)  0 1/35 (2.86%)  2
Hypoalbuminemia * 1  16/45 (35.56%)  28 10/35 (28.57%)  66
Hypocalcemia * 1  8/45 (17.78%)  24 8/35 (22.86%)  14
Hypoglycemia * 1  5/45 (11.11%)  22 5/35 (14.29%)  10
Hypokalemia * 1  8/45 (17.78%)  16 5/35 (14.29%)  7
Hypomagnesemia * 1  1/45 (2.22%)  1 3/35 (8.57%)  8
Hyponatremia * 1  12/45 (26.67%)  21 11/35 (31.43%)  13
Hypophosphatemia * 1  9/45 (20.00%)  15 5/35 (14.29%)  10
LDH Increased * 1  1/45 (2.22%)  2 0/35 (0.00%)  0
Obesity * 1  5/45 (11.11%)  25 5/35 (14.29%)  12
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  5/45 (11.11%)  10 2/35 (5.71%)  4
Arthritis * 1  1/45 (2.22%)  2 0/35 (0.00%)  0
Back pain * 1  6/45 (13.33%)  25 8/35 (22.86%)  16
Back spasms * 1  1/45 (2.22%)  1 0/35 (0.00%)  0
Bone pain * 1  6/45 (13.33%)  18 5/35 (14.29%)  9
Chest wall pain * 1  4/45 (8.89%)  12 1/35 (2.86%)  3
Flank pain * 1  1/45 (2.22%)  4 1/35 (2.86%)  10
Generalized muscle weakness * 1  5/45 (11.11%)  6 4/35 (11.43%)  8
Joint Pain * 1  0/45 (0.00%)  0 1/35 (2.86%)  2
Joint range of motion decreased * 1  1/45 (2.22%)  1 1/35 (2.86%)  3
Muscle spasms * 1  0/45 (0.00%)  0 1/35 (2.86%)  2
Muscle weakness lower limb * 1  1/45 (2.22%)  2 2/35 (5.71%)  4
Muscle weakness upper limb * 1  1/45 (2.22%)  2 0/35 (0.00%)  0
Myalgia * 1  6/45 (13.33%)  19 4/35 (11.43%)  11
Neck pain * 1  3/45 (6.67%)  3 1/35 (2.86%)  1
Pain in extremity * 1  5/45 (11.11%)  7 4/35 (11.43%)  9
hand cramps * 1  0/45 (0.00%)  0 1/35 (2.86%)  2
leg cramps * 1  1/45 (2.22%)  2 0/35 (0.00%)  0
muscle cramps * 1  0/45 (0.00%)  0 1/35 (2.86%)  2
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Disease Progression * 1  22/45 (48.89%)  22 20/35 (57.14%)  20
Tumor pain * 1  0/45 (0.00%)  0 1/35 (2.86%)  1
Nervous system disorders     
Ataxia * 1  3/45 (6.67%)  11 1/35 (2.86%)  11
Dizziness * 1  6/45 (13.33%)  10 4/35 (11.43%)  6
Dysarthria * 1  1/45 (2.22%)  1 1/35 (2.86%)  1
Dysgeusia * 1  16/45 (35.56%)  48 11/35 (31.43%)  27
Dysphasia * 1  1/45 (2.22%)  1 0/35 (0.00%)  0
Headache * 1  6/45 (13.33%)  14 4/35 (11.43%)  8
Hydrocephalus * 1  0/45 (0.00%)  0 1/35 (2.86%)  1
Lethargy * 1  1/45 (2.22%)  1 1/35 (2.86%)  1
Memory impairment * 1  1/45 (2.22%)  2 4/35 (11.43%)  13
Paresthesia * 1  2/45 (4.44%)  9 4/35 (11.43%)  8
Peripheral motor neuropathy * 1  0/45 (0.00%)  0 1/35 (2.86%)  1
Peripheral sensory neuropathy * 1  5/45 (11.11%)  14 4/35 (11.43%)  25
sciatic like pain * 1  1/45 (2.22%)  1 0/35 (0.00%)  0
Psychiatric disorders     
Agitation * 1  0/45 (0.00%)  0 1/35 (2.86%)  2
Anxiety * 1  3/45 (6.67%)  12 2/35 (5.71%)  3
Confusion * 1  4/45 (8.89%)  5 1/35 (2.86%)  1
Crying spells * 1  0/45 (0.00%)  0 1/35 (2.86%)  1
Delirium * 1  1/45 (2.22%)  1 0/35 (0.00%)  0
Depression * 1  2/45 (4.44%)  11 3/35 (8.57%)  5
Hallucinations * 1  1/45 (2.22%)  2 0/35 (0.00%)  0
Insomnia * 1  3/45 (6.67%)  20 3/35 (8.57%)  11
Renal and urinary disorders     
Acute kidney injury * 1  1/45 (2.22%)  1 1/35 (2.86%)  1
Acute tubular necrosis * 1  1/45 (2.22%)  1 0/35 (0.00%)  0
Chronic kidney disease * 1  0/45 (0.00%)  0 1/35 (2.86%)  17
Hematuria * 1  2/45 (4.44%)  2 1/35 (2.86%)  1
Proteinuria * 1  1/45 (2.22%)  1 1/35 (2.86%)  6
Urinary incontinence * 1  0/45 (0.00%)  0 2/35 (5.71%)  2
Urinary tract pain * 1  0/45 (0.00%)  0 1/35 (2.86%)  2
Reproductive system and breast disorders     
Vaginal dryness * 1  1/45 (2.22%)  2 1/35 (2.86%)  2
Respiratory, thoracic and mediastinal disorders     
Allergic rhinitis * 1  4/45 (8.89%)  20 5/35 (14.29%)  10
Blood Streaked Sputum * 1  1/45 (2.22%)  1 0/35 (0.00%)  0
Bronchopulmonary hemorrhage * 1  0/45 (0.00%)  0 1/35 (2.86%)  1
Chest congestion, possible infection * 1  1/45 (2.22%)  1 0/35 (0.00%)  0
Cough * 1  20/45 (44.44%)  66 14/35 (40.00%)  67
Diminished Breath Sounds * 1  0/45 (0.00%)  0 1/35 (2.86%)  1
Dry Throat * 1  1/45 (2.22%)  1 0/35 (0.00%)  0
Dyspnea * 1  17/45 (37.78%)  34 15/35 (42.86%)  35
Epistaxis * 1  3/45 (6.67%)  6 4/35 (11.43%)  10
Hoarseness * 1  2/45 (4.44%)  2 2/35 (5.71%)  3
Laryngeal inflammation * 1  0/45 (0.00%)  0 1/35 (2.86%)  1
Nasal congestion * 1  2/45 (4.44%)  6 1/35 (2.86%)  4
Pharyngolaryngeal pain * 1  1/45 (2.22%)  1 0/35 (0.00%)  0
Postnasal drip * 1  2/45 (4.44%)  3 1/35 (2.86%)  2
Productive cough * 1  3/45 (6.67%)  3 6/35 (17.14%)  8
Respiratory failure * 1  0/45 (0.00%)  0 1/35 (2.86%)  1
Respiratory illness * 1  1/45 (2.22%)  1 0/35 (0.00%)  0
Rhinitis * 1  0/45 (0.00%)  0 1/35 (2.86%)  2
Runny nose * 1  0/45 (0.00%)  0 1/35 (2.86%)  1
Sore throat * 1  3/45 (6.67%)  9 4/35 (11.43%)  5
Upper Respiratory Infection * 1  0/45 (0.00%)  0 1/35 (2.86%)  1
Wheezing * 1  2/45 (4.44%)  5 3/35 (8.57%)  10
chest congestion * 1  1/45 (2.22%)  1 0/35 (0.00%)  0
chest tightness * 1  0/45 (0.00%)  0 1/35 (2.86%)  2
Skin and subcutaneous tissue disorders     
Alopecia * 1  3/45 (6.67%)  11 5/35 (14.29%)  26
Bullous dermatitis * 1  0/45 (0.00%)  0 1/35 (2.86%)  3
Cracked skin on feet * 1  1/45 (2.22%)  1 0/35 (0.00%)  0
Decadron rash * 1  0/45 (0.00%)  0 1/35 (2.86%)  1
Dermatitis * 1  0/45 (0.00%)  0 1/35 (2.86%)  3
Desquamation * 1  0/45 (0.00%)  0 1/35 (2.86%)  1
Desquamation of lips * 1  0/45 (0.00%)  0 1/35 (2.86%)  2
Desquamation right palm/fingers * 1  0/45 (0.00%)  0 1/35 (2.86%)  1
Dry desquamation * 1  0/45 (0.00%)  0 1/35 (2.86%)  1
Dry skin * 1  26/45 (57.78%)  119 24/35 (68.57%)  115
Erythema multiforme * 1  5/45 (11.11%)  17 3/35 (8.57%)  4
Erythematous scaly rash * 1  0/45 (0.00%)  0 1/35 (2.86%)  1
Finger Cracks * 1  0/45 (0.00%)  0 1/35 (2.86%)  1
Finger tip cracks * 1  0/45 (0.00%)  0 1/35 (2.86%)  3
Hand Food Syndrome * 1  0/45 (0.00%)  0 1/35 (2.86%)  1
Hand-Foot Skin Reaction * 1  0/45 (0.00%)  0 1/35 (2.86%)  1
Hirsutism * 1  0/45 (0.00%)  0 1/35 (2.86%)  9
Hypertrichosis * 1  2/45 (4.44%)  5 1/35 (2.86%)  3
In grown toenail * 1  1/45 (2.22%)  2 0/35 (0.00%)  0
Ingrown toe nail * 1  0/45 (0.00%)  0 1/35 (2.86%)  1
Ingrown toe nail - right foot * 1  0/45 (0.00%)  0 1/35 (2.86%)  1
Ingrown toenail * 1  1/45 (2.22%)  1 0/35 (0.00%)  0
Mottle rash * 1  0/45 (0.00%)  0 1/35 (2.86%)  1
Nail loss * 1  1/45 (2.22%)  2 2/35 (5.71%)  5
Nail ridging * 1  1/45 (2.22%)  3 2/35 (5.71%)  30
Palmar-plantar erythrodysesthesia syndro * 1  0/45 (0.00%)  0 2/35 (5.71%)  4
Peeling @ bottoms of feet * 1  0/45 (0.00%)  0 1/35 (2.86%)  1
Peeling @bottoms of feet * 1  0/45 (0.00%)  0 1/35 (2.86%)  1
Pruritus * 1  16/45 (35.56%)  59 15/35 (42.86%)  39
Rash acneiform * 1  22/45 (48.89%)  80 13/35 (37.14%)  54
Rash maculo-papular * 1  23/45 (51.11%)  92 17/35 (48.57%)  86
Scaling on toes * 1  1/45 (2.22%)  1 0/35 (0.00%)  0
Scalp pain * 1  1/45 (2.22%)  1 0/35 (0.00%)  0
Skin hyperpigmentation * 1  2/45 (4.44%)  8 2/35 (5.71%)  3
Skin hypopigmentation * 1  0/45 (0.00%)  0 1/35 (2.86%)  1
Skin ulceration * 1  2/45 (4.44%)  5 1/35 (2.86%)  2
Urticaria * 1  1/45 (2.22%)  1 0/35 (0.00%)  0
cracks on feet * 1  1/45 (2.22%)  1 0/35 (0.00%)  0
decadron rash * 1  0/45 (0.00%)  0 1/35 (2.86%)  3
desquamation of palm/fingers * 1  0/45 (0.00%)  0 1/35 (2.86%)  1
desquamation of r palm/fingers * 1  0/45 (0.00%)  0 1/35 (2.86%)  1
desquamation, right palm/fingers * 1  0/45 (0.00%)  0 1/35 (2.86%)  2
dry desquamation * 1  0/45 (0.00%)  0 1/35 (2.86%)  2
finger cracks * 1  0/45 (0.00%)  0 1/35 (2.86%)  2
finger tip cracks * 1  0/45 (0.00%)  0 1/35 (2.86%)  6
ingrown toenail * 1  1/45 (2.22%)  3 0/35 (0.00%)  0
scaling on toes * 1  1/45 (2.22%)  2 0/35 (0.00%)  0
skin cracks * 1  1/45 (2.22%)  1 0/35 (0.00%)  0
subcutaneous lesion in elbow * 1  0/45 (0.00%)  0 1/35 (2.86%)  1
Vascular disorders     
Hot flashes * 1  0/45 (0.00%)  0 1/35 (2.86%)  2
Hypertension * 1  17/45 (37.78%)  85 12/35 (34.29%)  45
Hypotension * 1  1/45 (2.22%)  1 0/35 (0.00%)  0
Thromboembolic event * 1  2/45 (4.44%)  2 1/35 (2.86%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE 4.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: DCC Project Administrator
Organization: California Cancer Consortium
Phone: 626-256-4673 ext 60094
EMail: CCCP@coh.org
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01294306     History of Changes
Other Study ID Numbers: NCI-2011-02578
NCI-2011-02578 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000695056
CHNMC-PHII-108
PhII-108 ( Other Identifier: City of Hope Comprehensive Cancer Center )
8698 ( Other Identifier: CTEP )
N01CM00038 ( U.S. NIH Grant/Contract )
N01CM00071 ( U.S. NIH Grant/Contract )
N01CM62209 ( U.S. NIH Grant/Contract )
P30CA033572 ( U.S. NIH Grant/Contract )
First Submitted: February 10, 2011
First Posted: February 11, 2011
Results First Submitted: August 23, 2016
Results First Posted: October 17, 2016
Last Update Posted: November 29, 2016