Trial Outcomes & Findings for Cixutumumab in Treating Patients With Metastatic Melanoma of the Eye (NCT NCT01413191)

Last Updated: 2020-02-19

Results Overview

Response rate is the percentage of subjects with a confirmed complete or partial response using revised Response Evaluation Criteria in Solid Tumors (RECIST) where changes in only the largest diameter (unidimensional measurement) of the tumor lesions are used in the RECIST criteria: Complete Response (CR): Disappearance all target lesions; pathological lymph nodes reduction in short axis to \<10 mm. Partial Response (PR): 30% or \> decrease in sum diameters of target lesions, reference baseline sum diameters. Progressive Disease (PD): 20% or \> increase in sum diameters of target lesions, reference smallest sum on study (includes baseline sum if smallest on study); and sum must demonstrate absolute increase of 5+ mm. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, reference smallest sum diameters while on study.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

18 participants

Primary outcome timeframe

Baseline to 2 years

Results posted on

2020-02-19

Participant Flow

Recruitment Period: August 02, 2011 to August 23, 2012. Recruitment was done at The University of Texas MD Anderson Cancer Center (MD Anderson) and The Thomas Jefferson University.

Participant milestones

Participant milestones
Measure	CixutumumabTreatment Cixutumumab 10 mg/kg intravenous (IV) over 1 hour on days 1 and 15 for 4 week courses.
Overall Study STARTED	18
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	11

Reasons for withdrawal

Reasons for withdrawal
Measure	CixutumumabTreatment Cixutumumab 10 mg/kg intravenous (IV) over 1 hour on days 1 and 15 for 4 week courses.
Overall Study Lost to Follow-up	5
Overall Study Disease Progression	5
Overall Study Death	1

Baseline Characteristics

Cixutumumab in Treating Patients With Metastatic Melanoma of the Eye

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CixutumumabTreatment n=18 Participants Cixutumumab 10 mg/kg intravenous (IV) over 1 hour on days 1 and 15 for 4 week courses.
Age, Continuous	67 years n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Region of Enrollment United States	18 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to 2 years

Population: One participant was not evaluable for response assessment.

Outcome measures

Outcome measures
Measure	CixutumumabTreatment n=17 Participants Cixutumumab 10 mg/kg intravenous (IV) over 1 hour on days 1 and 15 for 4 week courses.
Number of Participants With Response CR	0 participants
Number of Participants With Response PR	0 participants
Number of Participants With Response PD	8 participants
Number of Participants With Response SD	9 participants

SECONDARY outcome

Timeframe: Up to 2 years

Disease Control Rate is the proportion of subjects with a confirmed complete or partial response of any duration or stable disease ≥3 months in duration.

Outcome measures

Outcome measures
Measure	CixutumumabTreatment n=18 Participants Cixutumumab 10 mg/kg intravenous (IV) over 1 hour on days 1 and 15 for 4 week courses.
Disease Control Rate PR	0 Participants
Disease Control Rate CR	0 Participants
Disease Control Rate SD	9 Participants

SECONDARY outcome

Timeframe: From the date criteria are first met for complete or partial response until the first date of documented progression, assessed up to 2 years

Population: Duration of response could not be calculated, as there were no responders.

Duration of response will be summarized by using descriptive statistics. Median duration of response will be estimated by using the Kaplan-Meier method.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 2 years

Outcome measures

Outcome measures
Measure	CixutumumabTreatment n=18 Participants Cixutumumab 10 mg/kg intravenous (IV) over 1 hour on days 1 and 15 for 4 week courses.
Progression-free Survival (PFS)	12.21 WEEKS Interval 0.0 to 23.2

SECONDARY outcome

Timeframe: Up to 2 years

Outcome measures

Outcome measures
Measure	CixutumumabTreatment n=18 Participants Cixutumumab 10 mg/kg intravenous (IV) over 1 hour on days 1 and 15 for 4 week courses.
Overall Survival (OS)	59.71 WEEKS Interval 0.0 to 109.6

SECONDARY outcome

Timeframe: Up to 2 years

Durable Response Rate is the proportion of subjects with a confirmed complete or partial response ≥ 6 months in duration.

Outcome measures

Outcome measures
Measure	CixutumumabTreatment n=17 Participants Cixutumumab 10 mg/kg intravenous (IV) over 1 hour on days 1 and 15 for 4 week courses.
Durable Response Rate	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 2 years

Population: No participants was evaluable due to progression.

Outcome measures

Outcome data not reported

Adverse Events

CixutumumabTreatment

Serious events: 1 serious events

Other events: 18 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	CixutumumabTreatment n=18 participants at risk Cixutumumab 10 mg/kg intravenous (IV) over 1 hour on days 1 and 15 for 4 week courses.
Gastrointestinal disorders Dehydration	5.6% 1/18 • Adverse Events reporting includes occurrences within 30 days of the last investigational agent/intervention. Overall study period: August 2011 to May 2014.

Other adverse events

Other adverse events
Measure	CixutumumabTreatment n=18 participants at risk Cixutumumab 10 mg/kg intravenous (IV) over 1 hour on days 1 and 15 for 4 week courses.
Gastrointestinal disorders Abdominal pain	50.0% 9/18 • Number of events 14 • Adverse Events reporting includes occurrences within 30 days of the last investigational agent/intervention. Overall study period: August 2011 to May 2014.
Metabolism and nutrition disorders Alanine aminotransferase increased	11.1% 2/18 • Number of events 4 • Adverse Events reporting includes occurrences within 30 days of the last investigational agent/intervention. Overall study period: August 2011 to May 2014.
Metabolism and nutrition disorders Alkaline phosphatase increased	16.7% 3/18 • Number of events 3 • Adverse Events reporting includes occurrences within 30 days of the last investigational agent/intervention. Overall study period: August 2011 to May 2014.
Immune system disorders Allergic rhinitis	11.1% 2/18 • Number of events 2 • Adverse Events reporting includes occurrences within 30 days of the last investigational agent/intervention. Overall study period: August 2011 to May 2014.
Skin and subcutaneous tissue disorders Alopecia	5.6% 1/18 • Number of events 1 • Adverse Events reporting includes occurrences within 30 days of the last investigational agent/intervention. Overall study period: August 2011 to May 2014.
Blood and lymphatic system disorders Anemia	55.6% 10/18 • Number of events 15 • Adverse Events reporting includes occurrences within 30 days of the last investigational agent/intervention. Overall study period: August 2011 to May 2014.
Gastrointestinal disorders Anorexia	61.1% 11/18 • Number of events 13 • Adverse Events reporting includes occurrences within 30 days of the last investigational agent/intervention. Overall study period: August 2011 to May 2014.
Nervous system disorders Anxiety	5.6% 1/18 • Number of events 1 • Adverse Events reporting includes occurrences within 30 days of the last investigational agent/intervention. Overall study period: August 2011 to May 2014.
Cardiac disorders Arthralgia	11.1% 2/18 • Number of events 2 • Adverse Events reporting includes occurrences within 30 days of the last investigational agent/intervention. Overall study period: August 2011 to May 2014.
Metabolism and nutrition disorders Aspartate aminotransferase increased	44.4% 8/18 • Number of events 9 • Adverse Events reporting includes occurrences within 30 days of the last investigational agent/intervention. Overall study period: August 2011 to May 2014.
Cardiac disorders Atrial fibrillation	5.6% 1/18 • Number of events 1 • Adverse Events reporting includes occurrences within 30 days of the last investigational agent/intervention. Overall study period: August 2011 to May 2014.
Musculoskeletal and connective tissue disorders Back pain	22.2% 4/18 • Number of events 5 • Adverse Events reporting includes occurrences within 30 days of the last investigational agent/intervention. Overall study period: August 2011 to May 2014.
Metabolism and nutrition disorders Blood bilirubin increased	16.7% 3/18 • Number of events 3 • Adverse Events reporting includes occurrences within 30 days of the last investigational agent/intervention. Overall study period: August 2011 to May 2014.
Eye disorders Blurred vision	11.1% 2/18 • Number of events 2 • Adverse Events reporting includes occurrences within 30 days of the last investigational agent/intervention. Overall study period: August 2011 to May 2014.
Musculoskeletal and connective tissue disorders Bone pain	5.6% 1/18 • Number of events 1 • Adverse Events reporting includes occurrences within 30 days of the last investigational agent/intervention. Overall study period: August 2011 to May 2014.
Skin and subcutaneous tissue disorders Bruising	5.6% 1/18 • Number of events 1 • Adverse Events reporting includes occurrences within 30 days of the last investigational agent/intervention. Overall study period: August 2011 to May 2014.
Respiratory, thoracic and mediastinal disorders Chest wall pain	5.6% 1/18 • Number of events 1 • Adverse Events reporting includes occurrences within 30 days of the last investigational agent/intervention. Overall study period: August 2011 to May 2014.
Metabolism and nutrition disorders Cholesterol high	44.4% 8/18 • Number of events 15 • Adverse Events reporting includes occurrences within 30 days of the last investigational agent/intervention. Overall study period: August 2011 to May 2014.
Nervous system disorders Confusion	5.6% 1/18 • Number of events 1 • Adverse Events reporting includes occurrences within 30 days of the last investigational agent/intervention. Overall study period: August 2011 to May 2014.
Eye disorders Conjunctivitis	5.6% 1/18 • Number of events 2 • Adverse Events reporting includes occurrences within 30 days of the last investigational agent/intervention. Overall study period: August 2011 to May 2014.
Gastrointestinal disorders Constipation	38.9% 7/18 • Number of events 9 • Adverse Events reporting includes occurrences within 30 days of the last investigational agent/intervention. Overall study period: August 2011 to May 2014.
Respiratory, thoracic and mediastinal disorders Cough	11.1% 2/18 • Number of events 3 • Adverse Events reporting includes occurrences within 30 days of the last investigational agent/intervention. Overall study period: August 2011 to May 2014.
Metabolism and nutrition disorders Creatinine increased	16.7% 3/18 • Number of events 4 • Adverse Events reporting includes occurrences within 30 days of the last investigational agent/intervention. Overall study period: August 2011 to May 2014.
Gastrointestinal disorders Dehydration	11.1% 2/18 • Number of events 2 • Adverse Events reporting includes occurrences within 30 days of the last investigational agent/intervention. Overall study period: August 2011 to May 2014.
Nervous system disorders Depression	5.6% 1/18 • Number of events 1 • Adverse Events reporting includes occurrences within 30 days of the last investigational agent/intervention. Overall study period: August 2011 to May 2014.
Gastrointestinal disorders Diarrhea	27.8% 5/18 • Number of events 19 • Adverse Events reporting includes occurrences within 30 days of the last investigational agent/intervention. Overall study period: August 2011 to May 2014.
Nervous system disorders Dizziness	27.8% 5/18 • Number of events 7 • Adverse Events reporting includes occurrences within 30 days of the last investigational agent/intervention. Overall study period: August 2011 to May 2014.
Eye disorders Dry eye	5.6% 1/18 • Number of events 1 • Adverse Events reporting includes occurrences within 30 days of the last investigational agent/intervention. Overall study period: August 2011 to May 2014.
Gastrointestinal disorders Dry mouth	11.1% 2/18 • Number of events 2 • Adverse Events reporting includes occurrences within 30 days of the last investigational agent/intervention. Overall study period: August 2011 to May 2014.
Skin and subcutaneous tissue disorders Dry skin	33.3% 6/18 • Number of events 7 • Adverse Events reporting includes occurrences within 30 days of the last investigational agent/intervention. Overall study period: August 2011 to May 2014.
Nervous system disorders Dysesthesia	5.6% 1/18 • Number of events 1 • Adverse Events reporting includes occurrences within 30 days of the last investigational agent/intervention. Overall study period: August 2011 to May 2014.
Gastrointestinal disorders Dysgeusia	16.7% 3/18 • Number of events 4 • Adverse Events reporting includes occurrences within 30 days of the last investigational agent/intervention. Overall study period: August 2011 to May 2014.
Gastrointestinal disorders Dyspepsia	5.6% 1/18 • Number of events 1 • Adverse Events reporting includes occurrences within 30 days of the last investigational agent/intervention. Overall study period: August 2011 to May 2014.
Gastrointestinal disorders Dysphagia	11.1% 2/18 • Number of events 2 • Adverse Events reporting includes occurrences within 30 days of the last investigational agent/intervention. Overall study period: August 2011 to May 2014.
Nervous system disorders Dysphasia	5.6% 1/18 • Number of events 1 • Adverse Events reporting includes occurrences within 30 days of the last investigational agent/intervention. Overall study period: August 2011 to May 2014.
Respiratory, thoracic and mediastinal disorders Dyspnea	5.6% 1/18 • Number of events 1 • Adverse Events reporting includes occurrences within 30 days of the last investigational agent/intervention. Overall study period: August 2011 to May 2014.
Ear and labyrinth disorders Ear and labyrinth disorders, Other	22.2% 4/18 • Number of events 4 • Adverse Events reporting includes occurrences within 30 days of the last investigational agent/intervention. Overall study period: August 2011 to May 2014.
Musculoskeletal and connective tissue disorders Edema limbs	5.6% 1/18 • Number of events 1 • Adverse Events reporting includes occurrences within 30 days of the last investigational agent/intervention. Overall study period: August 2011 to May 2014.
General disorders Epistaxis	5.6% 1/18 • Number of events 1 • Adverse Events reporting includes occurrences within 30 days of the last investigational agent/intervention. Overall study period: August 2011 to May 2014.
Eye disorders Eye disorders, Other	11.1% 2/18 • Number of events 2 • Adverse Events reporting includes occurrences within 30 days of the last investigational agent/intervention. Overall study period: August 2011 to May 2014.
Eye disorders Eye pain	11.1% 2/18 • Number of events 2 • Adverse Events reporting includes occurrences within 30 days of the last investigational agent/intervention. Overall study period: August 2011 to May 2014.
General disorders Fatigue	94.4% 17/18 • Number of events 26 • Adverse Events reporting includes occurrences within 30 days of the last investigational agent/intervention. Overall study period: August 2011 to May 2014.
Eye disorders Floaters	50.0% 9/18 • Number of events 9 • Adverse Events reporting includes occurrences within 30 days of the last investigational agent/intervention. Overall study period: August 2011 to May 2014.
Gastrointestinal disorders Gastroesophageal reflux disease	5.6% 1/18 • Number of events 1 • Adverse Events reporting includes occurrences within 30 days of the last investigational agent/intervention. Overall study period: August 2011 to May 2014.
Gastrointestinal disorders Gastrointestinal disorders - (Other)	5.6% 1/18 • Number of events 1 • Adverse Events reporting includes occurrences within 30 days of the last investigational agent/intervention. Overall study period: August 2011 to May 2014.
General disorders Pain NOS	5.6% 1/18 • Number of events 1 • Adverse Events reporting includes occurrences within 30 days of the last investigational agent/intervention. Overall study period: August 2011 to May 2014.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	5.6% 1/18 • Number of events 1 • Adverse Events reporting includes occurrences within 30 days of the last investigational agent/intervention. Overall study period: August 2011 to May 2014.
Endocrine disorders Glucose intolerance	5.6% 1/18 • Number of events 1 • Adverse Events reporting includes occurrences within 30 days of the last investigational agent/intervention. Overall study period: August 2011 to May 2014.
Nervous system disorders Headache	22.2% 4/18 • Number of events 7 • Adverse Events reporting includes occurrences within 30 days of the last investigational agent/intervention. Overall study period: August 2011 to May 2014.
Metabolism and nutrition disorders Hypercalcemia	5.6% 1/18 • Number of events 1 • Adverse Events reporting includes occurrences within 30 days of the last investigational agent/intervention. Overall study period: August 2011 to May 2014.
Metabolism and nutrition disorders Hyperglycemia	50.0% 9/18 • Number of events 29 • Adverse Events reporting includes occurrences within 30 days of the last investigational agent/intervention. Overall study period: August 2011 to May 2014.
Metabolism and nutrition disorders Hyperkalemia	27.8% 5/18 • Number of events 6 • Adverse Events reporting includes occurrences within 30 days of the last investigational agent/intervention. Overall study period: August 2011 to May 2014.
Cardiac disorders Hypertension	66.7% 12/18 • Number of events 45 • Adverse Events reporting includes occurrences within 30 days of the last investigational agent/intervention. Overall study period: August 2011 to May 2014.
Metabolism and nutrition disorders Hypertriglyceridemia	50.0% 9/18 • Number of events 20 • Adverse Events reporting includes occurrences within 30 days of the last investigational agent/intervention. Overall study period: August 2011 to May 2014.
Metabolism and nutrition disorders Hyperuricemia	27.8% 5/18 • Number of events 8 • Adverse Events reporting includes occurrences within 30 days of the last investigational agent/intervention. Overall study period: August 2011 to May 2014.
Metabolism and nutrition disorders Hypoalbuminemia	11.1% 2/18 • Number of events 4 • Adverse Events reporting includes occurrences within 30 days of the last investigational agent/intervention. Overall study period: August 2011 to May 2014.
Metabolism and nutrition disorders Hypocalcemia	16.7% 3/18 • Number of events 4 • Adverse Events reporting includes occurrences within 30 days of the last investigational agent/intervention. Overall study period: August 2011 to May 2014.
Metabolism and nutrition disorders Hypoglycemia	5.6% 1/18 • Number of events 1 • Adverse Events reporting includes occurrences within 30 days of the last investigational agent/intervention. Overall study period: August 2011 to May 2014.
Metabolism and nutrition disorders Hyponatremia	5.6% 1/18 • Number of events 1 • Adverse Events reporting includes occurrences within 30 days of the last investigational agent/intervention. Overall study period: August 2011 to May 2014.
Cardiac disorders Hypotension	11.1% 2/18 • Number of events 3 • Adverse Events reporting includes occurrences within 30 days of the last investigational agent/intervention. Overall study period: August 2011 to May 2014.
General disorders Hypothermia	11.1% 2/18 • Number of events 4 • Adverse Events reporting includes occurrences within 30 days of the last investigational agent/intervention. Overall study period: August 2011 to May 2014.
Infections and infestations Infections and infestations - (Other)	16.7% 3/18 • Number of events 4 • Adverse Events reporting includes occurrences within 30 days of the last investigational agent/intervention. Overall study period: August 2011 to May 2014.
Investigations Investigations - (Other)	5.6% 1/18 • Number of events 1 • Adverse Events reporting includes occurrences within 30 days of the last investigational agent/intervention. Overall study period: August 2011 to May 2014.
General disorders Lethargy	5.6% 1/18 • Number of events 1 • Adverse Events reporting includes occurrences within 30 days of the last investigational agent/intervention. Overall study period: August 2011 to May 2014.
Metabolism and nutrition disorders Lipase increased	33.3% 6/18 • Number of events 7 • Adverse Events reporting includes occurrences within 30 days of the last investigational agent/intervention. Overall study period: August 2011 to May 2014.
Blood and lymphatic system disorders Lymphocyte count decreased	11.1% 2/18 • Number of events 3 • Adverse Events reporting includes occurrences within 30 days of the last investigational agent/intervention. Overall study period: August 2011 to May 2014.
Gastrointestinal disorders Mucositis oral	11.1% 2/18 • Number of events 2 • Adverse Events reporting includes occurrences within 30 days of the last investigational agent/intervention. Overall study period: August 2011 to May 2014.
Musculoskeletal and connective tissue disorders Muscle weakness upper limb	5.6% 1/18 • Number of events 1 • Adverse Events reporting includes occurrences within 30 days of the last investigational agent/intervention. Overall study period: August 2011 to May 2014.
Respiratory, thoracic and mediastinal disorders Nasal congestion	16.7% 3/18 • Number of events 3 • Adverse Events reporting includes occurrences within 30 days of the last investigational agent/intervention. Overall study period: August 2011 to May 2014.
Gastrointestinal disorders Nausea	44.4% 8/18 • Number of events 20 • Adverse Events reporting includes occurrences within 30 days of the last investigational agent/intervention. Overall study period: August 2011 to May 2014.
Musculoskeletal and connective tissue disorders Neck pain	5.6% 1/18 • Number of events 1 • Adverse Events reporting includes occurrences within 30 days of the last investigational agent/intervention. Overall study period: August 2011 to May 2014.
Nervous system disorders Nervous system disorders - (Other)	5.6% 1/18 • Number of events 1 • Adverse Events reporting includes occurrences within 30 days of the last investigational agent/intervention. Overall study period: August 2011 to May 2014.
Blood and lymphatic system disorders Neutrophil count decreased	11.1% 2/18 • Number of events 3 • Adverse Events reporting includes occurrences within 30 days of the last investigational agent/intervention. Overall study period: August 2011 to May 2014.
General disorders Pain	38.9% 7/18 • Number of events 12 • Adverse Events reporting includes occurrences within 30 days of the last investigational agent/intervention. Overall study period: August 2011 to May 2014.
Musculoskeletal and connective tissue disorders Pain in extremity	16.7% 3/18 • Number of events 6 • Adverse Events reporting includes occurrences within 30 days of the last investigational agent/intervention. Overall study period: August 2011 to May 2014.
Hepatobiliary disorders Pancreatitis	5.6% 1/18 • Number of events 1 • Adverse Events reporting includes occurrences within 30 days of the last investigational agent/intervention. Overall study period: August 2011 to May 2014.
Nervous system disorders Paresthesia	27.8% 5/18 • Number of events 5 • Adverse Events reporting includes occurrences within 30 days of the last investigational agent/intervention. Overall study period: August 2011 to May 2014.
Reproductive system and breast disorders Penile infection	5.6% 1/18 • Number of events 1 • Adverse Events reporting includes occurrences within 30 days of the last investigational agent/intervention. Overall study period: August 2011 to May 2014.
Nervous system disorders Peripheral sensory neuropathy	5.6% 1/18 • Number of events 1 • Adverse Events reporting includes occurrences within 30 days of the last investigational agent/intervention. Overall study period: August 2011 to May 2014.
Blood and lymphatic system disorders Platelet count decreased	38.9% 7/18 • Number of events 12 • Adverse Events reporting includes occurrences within 30 days of the last investigational agent/intervention. Overall study period: August 2011 to May 2014.
Respiratory, thoracic and mediastinal disorders Pleural effusion	5.6% 1/18 • Number of events 1 • Adverse Events reporting includes occurrences within 30 days of the last investigational agent/intervention. Overall study period: August 2011 to May 2014.
Respiratory, thoracic and mediastinal disorders Postnasal drip	11.1% 2/18 • Number of events 2 • Adverse Events reporting includes occurrences within 30 days of the last investigational agent/intervention. Overall study period: August 2011 to May 2014.
Respiratory, thoracic and mediastinal disorders Productive cough	5.6% 1/18 • Number of events 1 • Adverse Events reporting includes occurrences within 30 days of the last investigational agent/intervention. Overall study period: August 2011 to May 2014.
Skin and subcutaneous tissue disorders Pruritus	33.3% 6/18 • Number of events 8 • Adverse Events reporting includes occurrences within 30 days of the last investigational agent/intervention. Overall study period: August 2011 to May 2014.
Psychiatric disorders Psychiatric disorders - (Other)	5.6% 1/18 • Number of events 1 • Adverse Events reporting includes occurrences within 30 days of the last investigational agent/intervention. Overall study period: August 2011 to May 2014.
Skin and subcutaneous tissue disorders Rash acneiform	5.6% 1/18 • Number of events 1 • Adverse Events reporting includes occurrences within 30 days of the last investigational agent/intervention. Overall study period: August 2011 to May 2014.
Skin and subcutaneous tissue disorders Rash maculo-papular	16.7% 3/18 • Number of events 3 • Adverse Events reporting includes occurrences within 30 days of the last investigational agent/intervention. Overall study period: August 2011 to May 2014.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - (Other)	5.6% 1/18 • Number of events 1 • Adverse Events reporting includes occurrences within 30 days of the last investigational agent/intervention. Overall study period: August 2011 to May 2014.
Metabolism and nutrition disorders Serum amylase increased	16.7% 3/18 • Number of events 8 • Adverse Events reporting includes occurrences within 30 days of the last investigational agent/intervention. Overall study period: August 2011 to May 2014.
Cardiac disorders Sinus bradycardia	5.6% 1/18 • Number of events 1 • Adverse Events reporting includes occurrences within 30 days of the last investigational agent/intervention. Overall study period: August 2011 to May 2014.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - (Other)	16.7% 3/18 • Number of events 3 • Adverse Events reporting includes occurrences within 30 days of the last investigational agent/intervention. Overall study period: August 2011 to May 2014.
Nervous system disorders Somnolence	5.6% 1/18 • Number of events 1 • Adverse Events reporting includes occurrences within 30 days of the last investigational agent/intervention. Overall study period: August 2011 to May 2014.
Skin and subcutaneous tissue disorders Telangiectasia	16.7% 3/18 • Number of events 3 • Adverse Events reporting includes occurrences within 30 days of the last investigational agent/intervention. Overall study period: August 2011 to May 2014.
Ear and labyrinth disorders Tinnitus	5.6% 1/18 • Number of events 1 • Adverse Events reporting includes occurrences within 30 days of the last investigational agent/intervention. Overall study period: August 2011 to May 2014.
Renal and urinary disorders Urinary tract infection	5.6% 1/18 • Number of events 1 • Adverse Events reporting includes occurrences within 30 days of the last investigational agent/intervention. Overall study period: August 2011 to May 2014.
Reproductive system and breast disorders Vaginal dryness	5.6% 1/18 • Number of events 1 • Adverse Events reporting includes occurrences within 30 days of the last investigational agent/intervention. Overall study period: August 2011 to May 2014.
Gastrointestinal disorders Vomiting	22.2% 4/18 • Number of events 6 • Adverse Events reporting includes occurrences within 30 days of the last investigational agent/intervention. Overall study period: August 2011 to May 2014.
General disorders Weight loss	44.4% 8/18 • Number of events 14 • Adverse Events reporting includes occurrences within 30 days of the last investigational agent/intervention. Overall study period: August 2011 to May 2014.
Blood and lymphatic system disorders White blood cell decreased	16.7% 3/18 • Number of events 5 • Adverse Events reporting includes occurrences within 30 days of the last investigational agent/intervention. Overall study period: August 2011 to May 2014.

Additional Information

Dr. Sapna Patel, MD - Associate Professor, Melanoma Medical Oncology

UT MD Anderson Cancer Center

Phone: 713-792-2921

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60