Trial Outcomes & Findings for Sunitinib in Treating Patients With Recurrent and/or Metastatic Head and Neck Cancer (NCT NCT00387335)

NCT ID: NCT00387335

Last Updated: 2014-07-25

Results Overview

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; Overall Response (OR) = CR + PR

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 22 participants
• Primary outcome timeframe: While patient remains on treatment, up to 30 weeks
• Results posted on: 2014-07-25

Participant Flow

Participant milestones

Measure	Sunitinib -- Cohort A Patients receive oral sunitinib malate once daily on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. ECOG Performance Status 0 -1.	Sunitinib -- Cohort B Patients receive oral sunitinib malate once daily on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.ECOG Performance Status 2.
Overall Study STARTED	15	7
Overall Study COMPLETED	15	7
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Sunitinib in Treating Patients With Recurrent and/or Metastatic Head and Neck Cancer

Baseline characteristics by cohort

Measure	Sunitinib -- Cohort A n=15 Participants Patients receive oral sunitinib malate once daily on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. ECOG Performance Status 0 -1.	Sunitinib -- Cohort B n=7 Participants Patients receive oral sunitinib malate once daily on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. ECOG Performance Status 2.	Total n=22 Participants Total of all reporting groups
Age, Continuous	55 years FULL_RANGE 43-78 • n=5 Participants	60 years n=7 Participants	57 years n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	1 Participants n=7 Participants	7 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	6 Participants n=7 Participants	15 Participants n=5 Participants
Region of Enrollment United States	15 participants n=5 Participants	7 participants n=7 Participants	22 participants n=5 Participants

PRIMARY outcome

Timeframe: While patient remains on treatment, up to 30 weeks

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; Overall Response (OR) = CR + PR

Outcome measures

Measure	Sunitinib -- Cohort A n=15 Participants Patients receive oral sunitinib malate once daily on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.	Sunitinib -- Cohort B n=7 Participants Patients receive oral sunitinib malate once daily on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
Objective Tumor Response Rate (Complete Response [CR] and Partial Response [PR]) Using RECIST Criteria	6.7 percentage of participants Interval 0.2 to 31.9	0 percentage of participants Interval 0.0 to 41.0

PRIMARY outcome

Timeframe: While patient remains on treatment, up to 30 weeks

Ability to remain on treatment without dose reduction

Outcome measures

Measure	Sunitinib -- Cohort A n=15 Participants Patients receive oral sunitinib malate once daily on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.	Sunitinib -- Cohort B n=7 Participants Patients receive oral sunitinib malate once daily on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
Feasibility of Treatment	80.0 percentage of participants Interval 51.9 to 95.7	71.4 percentage of participants Interval 29.0 to 96.3

SECONDARY outcome

Timeframe: Up to 2 years

Time to 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.

Outcome measures

Measure	Sunitinib -- Cohort A n=15 Participants Patients receive oral sunitinib malate once daily on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.	Sunitinib -- Cohort B n=7 Participants Patients receive oral sunitinib malate once daily on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
Progression-free Survival	8.4 weeks Interval 3.0 to 26.0	10.5 weeks Interval 3.0 to 30.0

SECONDARY outcome

Timeframe: Up to two years

Time from start of treatment until death from any cause.

Outcome measures

Measure	Sunitinib -- Cohort A n=15 Participants Patients receive oral sunitinib malate once daily on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.	Sunitinib -- Cohort B n=7 Participants Patients receive oral sunitinib malate once daily on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
Overall Survival	21.1 weeks Interval 4.0 to 96.0	19.1 weeks Interval 2.0 to 70.0

Adverse Events

Sunitinib -- Cohort A

Serious events: 3 serious events

Other events: 14 other events

Deaths: 0 deaths

Sunitinib -- Cohort B

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Measure	Sunitinib -- Cohort A n=15 participants at risk Patients receive oral sunitinib malate once daily on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. ECOG Performance Status 0 -1.	Sunitinib -- Cohort B n=7 participants at risk Patients receive oral sunitinib malate once daily on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. ECOG Performance Status 2.
Infections and infestations Sudden death from sepsis	6.7% 1/15 • Up to two years Common Terminology Criteria for Adverse Events (CTCAE v3.0). Reported are grade 1 or higher adverse events.	0.00% 0/7 • Up to two years Common Terminology Criteria for Adverse Events (CTCAE v3.0). Reported are grade 1 or higher adverse events.
Cardiac disorders Sudden cardiac death	0.00% 0/15 • Up to two years Common Terminology Criteria for Adverse Events (CTCAE v3.0). Reported are grade 1 or higher adverse events.	14.3% 1/7 • Up to two years Common Terminology Criteria for Adverse Events (CTCAE v3.0). Reported are grade 1 or higher adverse events.
Respiratory, thoracic and mediastinal disorders Pulmonary hemorrhage	6.7% 1/15 • Up to two years Common Terminology Criteria for Adverse Events (CTCAE v3.0). Reported are grade 1 or higher adverse events.	0.00% 0/7 • Up to two years Common Terminology Criteria for Adverse Events (CTCAE v3.0). Reported are grade 1 or higher adverse events.
Infections and infestations Pneumonia	6.7% 1/15 • Up to two years Common Terminology Criteria for Adverse Events (CTCAE v3.0). Reported are grade 1 or higher adverse events.	0.00% 0/7 • Up to two years Common Terminology Criteria for Adverse Events (CTCAE v3.0). Reported are grade 1 or higher adverse events.

Other adverse events

Measure	Sunitinib -- Cohort A n=15 participants at risk Patients receive oral sunitinib malate once daily on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. ECOG Performance Status 0 -1.	Sunitinib -- Cohort B n=7 participants at risk Patients receive oral sunitinib malate once daily on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. ECOG Performance Status 2.
Investigations Neutrophil count decreased	20.0% 3/15 • Up to two years Common Terminology Criteria for Adverse Events (CTCAE v3.0). Reported are grade 1 or higher adverse events.	14.3% 1/7 • Up to two years Common Terminology Criteria for Adverse Events (CTCAE v3.0). Reported are grade 1 or higher adverse events.
Blood and lymphatic system disorders Leukocytes	40.0% 6/15 • Up to two years Common Terminology Criteria for Adverse Events (CTCAE v3.0). Reported are grade 1 or higher adverse events.	14.3% 1/7 • Up to two years Common Terminology Criteria for Adverse Events (CTCAE v3.0). Reported are grade 1 or higher adverse events.
Blood and lymphatic system disorders Lymphopenia	40.0% 6/15 • Up to two years Common Terminology Criteria for Adverse Events (CTCAE v3.0). Reported are grade 1 or higher adverse events.	0.00% 0/7 • Up to two years Common Terminology Criteria for Adverse Events (CTCAE v3.0). Reported are grade 1 or higher adverse events.
Blood and lymphatic system disorders Platelet count decreased	33.3% 5/15 • Up to two years Common Terminology Criteria for Adverse Events (CTCAE v3.0). Reported are grade 1 or higher adverse events.	42.9% 3/7 • Up to two years Common Terminology Criteria for Adverse Events (CTCAE v3.0). Reported are grade 1 or higher adverse events.
General disorders Fatigue	73.3% 11/15 • Up to two years Common Terminology Criteria for Adverse Events (CTCAE v3.0). Reported are grade 1 or higher adverse events.	42.9% 3/7 • Up to two years Common Terminology Criteria for Adverse Events (CTCAE v3.0). Reported are grade 1 or higher adverse events.
Metabolism and nutrition disorders Anorexia	40.0% 6/15 • Up to two years Common Terminology Criteria for Adverse Events (CTCAE v3.0). Reported are grade 1 or higher adverse events.	28.6% 2/7 • Up to two years Common Terminology Criteria for Adverse Events (CTCAE v3.0). Reported are grade 1 or higher adverse events.
Gastrointestinal disorders Nausea	33.3% 5/15 • Up to two years Common Terminology Criteria for Adverse Events (CTCAE v3.0). Reported are grade 1 or higher adverse events.	42.9% 3/7 • Up to two years Common Terminology Criteria for Adverse Events (CTCAE v3.0). Reported are grade 1 or higher adverse events.
Gastrointestinal disorders Mucositis	33.3% 5/15 • Up to two years Common Terminology Criteria for Adverse Events (CTCAE v3.0). Reported are grade 1 or higher adverse events.	28.6% 2/7 • Up to two years Common Terminology Criteria for Adverse Events (CTCAE v3.0). Reported are grade 1 or higher adverse events.
Gastrointestinal disorders Vomiting	33.3% 5/15 • Up to two years Common Terminology Criteria for Adverse Events (CTCAE v3.0). Reported are grade 1 or higher adverse events.	42.9% 3/7 • Up to two years Common Terminology Criteria for Adverse Events (CTCAE v3.0). Reported are grade 1 or higher adverse events.
Respiratory, thoracic and mediastinal disorders Hypertension	20.0% 3/15 • Up to two years Common Terminology Criteria for Adverse Events (CTCAE v3.0). Reported are grade 1 or higher adverse events.	28.6% 2/7 • Up to two years Common Terminology Criteria for Adverse Events (CTCAE v3.0). Reported are grade 1 or higher adverse events.
Metabolism and nutrition disorders Hyponatremia	26.7% 4/15 • Up to two years Common Terminology Criteria for Adverse Events (CTCAE v3.0). Reported are grade 1 or higher adverse events.	0.00% 0/7 • Up to two years Common Terminology Criteria for Adverse Events (CTCAE v3.0). Reported are grade 1 or higher adverse events.
Nervous system disorders Headache	20.0% 3/15 • Up to two years Common Terminology Criteria for Adverse Events (CTCAE v3.0). Reported are grade 1 or higher adverse events.	14.3% 1/7 • Up to two years Common Terminology Criteria for Adverse Events (CTCAE v3.0). Reported are grade 1 or higher adverse events.
Metabolism and nutrition disorders Hypocalcemia	20.0% 3/15 • Up to two years Common Terminology Criteria for Adverse Events (CTCAE v3.0). Reported are grade 1 or higher adverse events.	28.6% 2/7 • Up to two years Common Terminology Criteria for Adverse Events (CTCAE v3.0). Reported are grade 1 or higher adverse events.
Respiratory, thoracic and mediastinal disorders Pulmonary hemorrhage	6.7% 1/15 • Up to two years Common Terminology Criteria for Adverse Events (CTCAE v3.0). Reported are grade 1 or higher adverse events.	0.00% 0/7 • Up to two years Common Terminology Criteria for Adverse Events (CTCAE v3.0). Reported are grade 1 or higher adverse events.
Gastrointestinal disorders Gastrointestinal hemorrhage	6.7% 1/15 • Up to two years Common Terminology Criteria for Adverse Events (CTCAE v3.0). Reported are grade 1 or higher adverse events.	14.3% 1/7 • Up to two years Common Terminology Criteria for Adverse Events (CTCAE v3.0). Reported are grade 1 or higher adverse events.
Respiratory, thoracic and mediastinal disorders Tumor hemorrhage	0.00% 0/15 • Up to two years Common Terminology Criteria for Adverse Events (CTCAE v3.0). Reported are grade 1 or higher adverse events.	14.3% 1/7 • Up to two years Common Terminology Criteria for Adverse Events (CTCAE v3.0). Reported are grade 1 or higher adverse events.
Blood and lymphatic system disorders Hemoglobin	20.0% 3/15 • Up to two years Common Terminology Criteria for Adverse Events (CTCAE v3.0). Reported are grade 1 or higher adverse events.	14.3% 1/7 • Up to two years Common Terminology Criteria for Adverse Events (CTCAE v3.0). Reported are grade 1 or higher adverse events.
Gastrointestinal disorders Diarrhea	6.7% 1/15 • Up to two years Common Terminology Criteria for Adverse Events (CTCAE v3.0). Reported are grade 1 or higher adverse events.	28.6% 2/7 • Up to two years Common Terminology Criteria for Adverse Events (CTCAE v3.0). Reported are grade 1 or higher adverse events.
Respiratory, thoracic and mediastinal disorders Epistaxis	13.3% 2/15 • Up to two years Common Terminology Criteria for Adverse Events (CTCAE v3.0). Reported are grade 1 or higher adverse events.	14.3% 1/7 • Up to two years Common Terminology Criteria for Adverse Events (CTCAE v3.0). Reported are grade 1 or higher adverse events.
Investigations Alanine aminotransferase increased	13.3% 2/15 • Up to two years Common Terminology Criteria for Adverse Events (CTCAE v3.0). Reported are grade 1 or higher adverse events.	0.00% 0/7 • Up to two years Common Terminology Criteria for Adverse Events (CTCAE v3.0). Reported are grade 1 or higher adverse events.
Investigations Aspartate aminotransferase increased	13.3% 2/15 • Up to two years Common Terminology Criteria for Adverse Events (CTCAE v3.0). Reported are grade 1 or higher adverse events.	14.3% 1/7 • Up to two years Common Terminology Criteria for Adverse Events (CTCAE v3.0). Reported are grade 1 or higher adverse events.
Gastrointestinal disorders Abdominal pain	13.3% 2/15 • Up to two years Common Terminology Criteria for Adverse Events (CTCAE v3.0). Reported are grade 1 or higher adverse events.	0.00% 0/7 • Up to two years Common Terminology Criteria for Adverse Events (CTCAE v3.0). Reported are grade 1 or higher adverse events.
Investigations Alkaline phosphatase increased	13.3% 2/15 • Up to two years Common Terminology Criteria for Adverse Events (CTCAE v3.0). Reported are grade 1 or higher adverse events.	14.3% 1/7 • Up to two years Common Terminology Criteria for Adverse Events (CTCAE v3.0). Reported are grade 1 or higher adverse events.
Skin and subcutaneous tissue disorders Alopecia	6.7% 1/15 • Up to two years Common Terminology Criteria for Adverse Events (CTCAE v3.0). Reported are grade 1 or higher adverse events.	0.00% 0/7 • Up to two years Common Terminology Criteria for Adverse Events (CTCAE v3.0). Reported are grade 1 or higher adverse events.
Gastrointestinal disorders Anal pain	6.7% 1/15 • Up to two years Common Terminology Criteria for Adverse Events (CTCAE v3.0). Reported are grade 1 or higher adverse events.	0.00% 0/7 • Up to two years Common Terminology Criteria for Adverse Events (CTCAE v3.0). Reported are grade 1 or higher adverse events.
Cardiac disorders Chest pain	6.7% 1/15 • Up to two years Common Terminology Criteria for Adverse Events (CTCAE v3.0). Reported are grade 1 or higher adverse events.	14.3% 1/7 • Up to two years Common Terminology Criteria for Adverse Events (CTCAE v3.0). Reported are grade 1 or higher adverse events.
Nervous system disorders Confusion	6.7% 1/15 • Up to two years Common Terminology Criteria for Adverse Events (CTCAE v3.0). Reported are grade 1 or higher adverse events.	0.00% 0/7 • Up to two years Common Terminology Criteria for Adverse Events (CTCAE v3.0). Reported are grade 1 or higher adverse events.
Gastrointestinal disorders Constipation	6.7% 1/15 • Up to two years Common Terminology Criteria for Adverse Events (CTCAE v3.0). Reported are grade 1 or higher adverse events.	14.3% 1/7 • Up to two years Common Terminology Criteria for Adverse Events (CTCAE v3.0). Reported are grade 1 or higher adverse events.
Metabolism and nutrition disorders Dehydration	20.0% 3/15 • Up to two years Common Terminology Criteria for Adverse Events (CTCAE v3.0). Reported are grade 1 or higher adverse events.	28.6% 2/7 • Up to two years Common Terminology Criteria for Adverse Events (CTCAE v3.0). Reported are grade 1 or higher adverse events.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/15 • Up to two years Common Terminology Criteria for Adverse Events (CTCAE v3.0). Reported are grade 1 or higher adverse events.	14.3% 1/7 • Up to two years Common Terminology Criteria for Adverse Events (CTCAE v3.0). Reported are grade 1 or higher adverse events.
Nervous system disorders Dizziness	13.3% 2/15 • Up to two years Common Terminology Criteria for Adverse Events (CTCAE v3.0). Reported are grade 1 or higher adverse events.	0.00% 0/7 • Up to two years Common Terminology Criteria for Adverse Events (CTCAE v3.0). Reported are grade 1 or higher adverse events.
Gastrointestinal disorders Dry mouth	13.3% 2/15 • Up to two years Common Terminology Criteria for Adverse Events (CTCAE v3.0). Reported are grade 1 or higher adverse events.	0.00% 0/7 • Up to two years Common Terminology Criteria for Adverse Events (CTCAE v3.0). Reported are grade 1 or higher adverse events.
Skin and subcutaneous tissue disorders Dry skin	6.7% 1/15 • Up to two years Common Terminology Criteria for Adverse Events (CTCAE v3.0). Reported are grade 1 or higher adverse events.	0.00% 0/7 • Up to two years Common Terminology Criteria for Adverse Events (CTCAE v3.0). Reported are grade 1 or higher adverse events.
Gastrointestinal disorders Dyspepsia	6.7% 1/15 • Up to two years Common Terminology Criteria for Adverse Events (CTCAE v3.0). Reported are grade 1 or higher adverse events.	0.00% 0/7 • Up to two years Common Terminology Criteria for Adverse Events (CTCAE v3.0). Reported are grade 1 or higher adverse events.
Gastrointestinal disorders Dysphagia	13.3% 2/15 • Up to two years Common Terminology Criteria for Adverse Events (CTCAE v3.0). Reported are grade 1 or higher adverse events.	14.3% 1/7 • Up to two years Common Terminology Criteria for Adverse Events (CTCAE v3.0). Reported are grade 1 or higher adverse events.
Respiratory, thoracic and mediastinal disorders Dyspnea	13.3% 2/15 • Up to two years Common Terminology Criteria for Adverse Events (CTCAE v3.0). Reported are grade 1 or higher adverse events.	0.00% 0/7 • Up to two years Common Terminology Criteria for Adverse Events (CTCAE v3.0). Reported are grade 1 or higher adverse events.
Ear and labyrinth disorders Ear pain	26.7% 4/15 • Up to two years Common Terminology Criteria for Adverse Events (CTCAE v3.0). Reported are grade 1 or higher adverse events.	14.3% 1/7 • Up to two years Common Terminology Criteria for Adverse Events (CTCAE v3.0). Reported are grade 1 or higher adverse events.
Respiratory, thoracic and mediastinal disorders Edema limbs	6.7% 1/15 • Up to two years Common Terminology Criteria for Adverse Events (CTCAE v3.0). Reported are grade 1 or higher adverse events.	0.00% 0/7 • Up to two years Common Terminology Criteria for Adverse Events (CTCAE v3.0). Reported are grade 1 or higher adverse events.
Respiratory, thoracic and mediastinal disorders Edema: head and neck	13.3% 2/15 • Up to two years Common Terminology Criteria for Adverse Events (CTCAE v3.0). Reported are grade 1 or higher adverse events.	0.00% 0/7 • Up to two years Common Terminology Criteria for Adverse Events (CTCAE v3.0). Reported are grade 1 or higher adverse events.
Gastrointestinal disorders Esophageal pain	0.00% 0/15 • Up to two years Common Terminology Criteria for Adverse Events (CTCAE v3.0). Reported are grade 1 or higher adverse events.	14.3% 1/7 • Up to two years Common Terminology Criteria for Adverse Events (CTCAE v3.0). Reported are grade 1 or higher adverse events.
Skin and subcutaneous tissue disorders Hand-and-foot syndrome	6.7% 1/15 • Up to two years Common Terminology Criteria for Adverse Events (CTCAE v3.0). Reported are grade 1 or higher adverse events.	0.00% 0/7 • Up to two years Common Terminology Criteria for Adverse Events (CTCAE v3.0). Reported are grade 1 or higher adverse events.
Metabolism and nutrition disorders Hypercalcemia	13.3% 2/15 • Up to two years Common Terminology Criteria for Adverse Events (CTCAE v3.0). Reported are grade 1 or higher adverse events.	0.00% 0/7 • Up to two years Common Terminology Criteria for Adverse Events (CTCAE v3.0). Reported are grade 1 or higher adverse events.
Metabolism and nutrition disorders Hyperglycemia	13.3% 2/15 • Up to two years Common Terminology Criteria for Adverse Events (CTCAE v3.0). Reported are grade 1 or higher adverse events.	0.00% 0/7 • Up to two years Common Terminology Criteria for Adverse Events (CTCAE v3.0). Reported are grade 1 or higher adverse events.
Metabolism and nutrition disorders Hyperkalemia	6.7% 1/15 • Up to two years Common Terminology Criteria for Adverse Events (CTCAE v3.0). Reported are grade 1 or higher adverse events.	0.00% 0/7 • Up to two years Common Terminology Criteria for Adverse Events (CTCAE v3.0). Reported are grade 1 or higher adverse events.
Metabolism and nutrition disorders Hypernatremia	6.7% 1/15 • Up to two years Common Terminology Criteria for Adverse Events (CTCAE v3.0). Reported are grade 1 or higher adverse events.	0.00% 0/7 • Up to two years Common Terminology Criteria for Adverse Events (CTCAE v3.0). Reported are grade 1 or higher adverse events.
Metabolism and nutrition disorders Hypoalbuminemia	13.3% 2/15 • Up to two years Common Terminology Criteria for Adverse Events (CTCAE v3.0). Reported are grade 1 or higher adverse events.	14.3% 1/7 • Up to two years Common Terminology Criteria for Adverse Events (CTCAE v3.0). Reported are grade 1 or higher adverse events.
Metabolism and nutrition disorders Hypokalemia	6.7% 1/15 • Up to two years Common Terminology Criteria for Adverse Events (CTCAE v3.0). Reported are grade 1 or higher adverse events.	0.00% 0/7 • Up to two years Common Terminology Criteria for Adverse Events (CTCAE v3.0). Reported are grade 1 or higher adverse events.
Metabolism and nutrition disorders Hypomagnesemia	6.7% 1/15 • Up to two years Common Terminology Criteria for Adverse Events (CTCAE v3.0). Reported are grade 1 or higher adverse events.	0.00% 0/7 • Up to two years Common Terminology Criteria for Adverse Events (CTCAE v3.0). Reported are grade 1 or higher adverse events.
Metabolism and nutrition disorders Hypophosphatemia	6.7% 1/15 • Up to two years Common Terminology Criteria for Adverse Events (CTCAE v3.0). Reported are grade 1 or higher adverse events.	0.00% 0/7 • Up to two years Common Terminology Criteria for Adverse Events (CTCAE v3.0). Reported are grade 1 or higher adverse events.
Endocrine disorders Hypothyroidism	6.7% 1/15 • Up to two years Common Terminology Criteria for Adverse Events (CTCAE v3.0). Reported are grade 1 or higher adverse events.	0.00% 0/7 • Up to two years Common Terminology Criteria for Adverse Events (CTCAE v3.0). Reported are grade 1 or higher adverse events.
Respiratory, thoracic and mediastinal disorders Hypoxia	6.7% 1/15 • Up to two years Common Terminology Criteria for Adverse Events (CTCAE v3.0). Reported are grade 1 or higher adverse events.	0.00% 0/7 • Up to two years Common Terminology Criteria for Adverse Events (CTCAE v3.0). Reported are grade 1 or higher adverse events.
Blood and lymphatic system disorders INR increased	6.7% 1/15 • Up to two years Common Terminology Criteria for Adverse Events (CTCAE v3.0). Reported are grade 1 or higher adverse events.	0.00% 0/7 • Up to two years Common Terminology Criteria for Adverse Events (CTCAE v3.0). Reported are grade 1 or higher adverse events.
Musculoskeletal and connective tissue disorders Muscle weakness	6.7% 1/15 • Up to two years Common Terminology Criteria for Adverse Events (CTCAE v3.0). Reported are grade 1 or higher adverse events.	14.3% 1/7 • Up to two years Common Terminology Criteria for Adverse Events (CTCAE v3.0). Reported are grade 1 or higher adverse events.
Respiratory, thoracic and mediastinal disorders Oral hemorrhage	6.7% 1/15 • Up to two years Common Terminology Criteria for Adverse Events (CTCAE v3.0). Reported are grade 1 or higher adverse events.	0.00% 0/7 • Up to two years Common Terminology Criteria for Adverse Events (CTCAE v3.0). Reported are grade 1 or higher adverse events.
Respiratory, thoracic and mediastinal disorders Oral pain	6.7% 1/15 • Up to two years Common Terminology Criteria for Adverse Events (CTCAE v3.0). Reported are grade 1 or higher adverse events.	0.00% 0/7 • Up to two years Common Terminology Criteria for Adverse Events (CTCAE v3.0). Reported are grade 1 or higher adverse events.
Skin and subcutaneous tissue disorders Neck soft tissue necrosis	0.00% 0/15 • Up to two years Common Terminology Criteria for Adverse Events (CTCAE v3.0). Reported are grade 1 or higher adverse events.	14.3% 1/7 • Up to two years Common Terminology Criteria for Adverse Events (CTCAE v3.0). Reported are grade 1 or higher adverse events.
Infections and infestations Pneumonia	6.7% 1/15 • Up to two years Common Terminology Criteria for Adverse Events (CTCAE v3.0). Reported are grade 1 or higher adverse events.	28.6% 2/7 • Up to two years Common Terminology Criteria for Adverse Events (CTCAE v3.0). Reported are grade 1 or higher adverse events.
Skin and subcutaneous tissue disorders Rash desquamating	6.7% 1/15 • Up to two years Common Terminology Criteria for Adverse Events (CTCAE v3.0). Reported are grade 1 or higher adverse events.	0.00% 0/7 • Up to two years Common Terminology Criteria for Adverse Events (CTCAE v3.0). Reported are grade 1 or higher adverse events.
General disorders Sweating	6.7% 1/15 • Up to two years Common Terminology Criteria for Adverse Events (CTCAE v3.0). Reported are grade 1 or higher adverse events.	0.00% 0/7 • Up to two years Common Terminology Criteria for Adverse Events (CTCAE v3.0). Reported are grade 1 or higher adverse events.
Respiratory, thoracic and mediastinal disorders Sinus pain	0.00% 0/15 • Up to two years Common Terminology Criteria for Adverse Events (CTCAE v3.0). Reported are grade 1 or higher adverse events.	14.3% 1/7 • Up to two years Common Terminology Criteria for Adverse Events (CTCAE v3.0). Reported are grade 1 or higher adverse events.
General disorders Taste alteration	6.7% 1/15 • Up to two years Common Terminology Criteria for Adverse Events (CTCAE v3.0). Reported are grade 1 or higher adverse events.	0.00% 0/7 • Up to two years Common Terminology Criteria for Adverse Events (CTCAE v3.0). Reported are grade 1 or higher adverse events.
Ear and labyrinth disorders Tinnitus	6.7% 1/15 • Up to two years Common Terminology Criteria for Adverse Events (CTCAE v3.0). Reported are grade 1 or higher adverse events.	0.00% 0/7 • Up to two years Common Terminology Criteria for Adverse Events (CTCAE v3.0). Reported are grade 1 or higher adverse events.
Musculoskeletal and connective tissue disorders Trismus	6.7% 1/15 • Up to two years Common Terminology Criteria for Adverse Events (CTCAE v3.0). Reported are grade 1 or higher adverse events.	0.00% 0/7 • Up to two years Common Terminology Criteria for Adverse Events (CTCAE v3.0). Reported are grade 1 or higher adverse events.
Respiratory, thoracic and mediastinal disorders Upper respiratory infection	0.00% 0/15 • Up to two years Common Terminology Criteria for Adverse Events (CTCAE v3.0). Reported are grade 1 or higher adverse events.	14.3% 1/7 • Up to two years Common Terminology Criteria for Adverse Events (CTCAE v3.0). Reported are grade 1 or higher adverse events.
Metabolism and nutrition disorders Weight loss	20.0% 3/15 • Up to two years Common Terminology Criteria for Adverse Events (CTCAE v3.0). Reported are grade 1 or higher adverse events.	14.3% 1/7 • Up to two years Common Terminology Criteria for Adverse Events (CTCAE v3.0). Reported are grade 1 or higher adverse events.

Additional Information

Ezra Cohen

University of Chicago

Phone: 773-702-4137

Email: ecohen@medicine.bsd.uchicago.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60