Trial Outcomes & Findings for VEGF Trap in Treating Patients With Recurrent Stage III or Stage IV Melanoma That Cannot Be Removed by Surgery (NCT NCT00450255)

Last Updated: 2018-05-24

Results Overview

Using the RECIST v1.0 criteria for target lesions assessed by CT or MRI: 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.",

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

41 participants

Primary outcome timeframe

Start of treatment to disease progression/recurrence, up to 5 years

Results posted on

2018-05-24

Participant Flow

Participant milestones

Participant milestones
Measure	Arm I Patients receive Aflibercept IV at 4 mg/kg over 1 hour on day 1. Treatment repeats every 14 days for at least 6 courses in the absence of disease progression or unacceptable toxicity. ziv-aflibercept: Given IV pharmacological study: Correlative studies
Overall Study STARTED	41
Overall Study COMPLETED	40
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm I Patients receive Aflibercept IV at 4 mg/kg over 1 hour on day 1. Treatment repeats every 14 days for at least 6 courses in the absence of disease progression or unacceptable toxicity. ziv-aflibercept: Given IV pharmacological study: Correlative studies
Overall Study Prior RFA ablation of liver	1

Baseline Characteristics

VEGF Trap in Treating Patients With Recurrent Stage III or Stage IV Melanoma That Cannot Be Removed by Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm I n=41 Participants Patients receive Aflibercept IV at 4 mg/kg over 1 hour on day 1. Treatment repeats every 14 days for at least 6 courses in the absence of disease progression or unacceptable toxicity. ziv-aflibercept: Given IV pharmacological study: Correlative studies
Age, Continuous	57 years n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants
Sex: Female, Male Male	26 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	41 participants n=5 Participants
Region of Enrollment United States	41 participants n=5 Participants

PRIMARY outcome

Timeframe: Start of treatment to disease progression/recurrence, up to 5 years

Outcome measures

Outcome measures
Measure	Arm I n=40 Participants Patients receive Aflibercept IV at 4 mg/kg 1 hour on day 1. Treatment repeats every 14 days for at least 6 courses in the absence of disease progression or unacceptable toxicity. ziv-aflibercept: Given IV pharmacological study: Correlative studies
Objective Response Rate (CR + PR)	7.5 percentage of participants Interval 2.0 to 20.0

PRIMARY outcome

Timeframe: 4 months

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.

Outcome measures

Outcome measures
Measure	Arm I n=40 Participants Patients receive Aflibercept IV at 4 mg/kg 1 hour on day 1. Treatment repeats every 14 days for at least 6 courses in the absence of disease progression or unacceptable toxicity. ziv-aflibercept: Given IV pharmacological study: Correlative studies
4 Month Progression-free Survival	50 percentage of patients Interval 34.0 to 66.0

SECONDARY outcome

Timeframe: From the initial date of treatment to the recorded date of death, assessed up to 5 years

Will be estimated by the Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	Arm I n=40 Participants Patients receive Aflibercept IV at 4 mg/kg 1 hour on day 1. Treatment repeats every 14 days for at least 6 courses in the absence of disease progression or unacceptable toxicity. ziv-aflibercept: Given IV pharmacological study: Correlative studies
Overall Survival	16.3 Months Interval 9.2 to The upper limit of the 95% confidence interval was not calculable because an insufficient number of participants reached the event at the final time point for assessment.

SECONDARY outcome

Timeframe: Up to 5 years

The descriptions and grading scales found in the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 were utilized for AE grading and reporting. Grade 3 and higher adverse events considered possibly, probably or definitely related to aflibercept are summarized.

Outcome measures

Outcome measures
Measure	Arm I n=41 Participants Patients receive Aflibercept IV at 4 mg/kg 1 hour on day 1. Treatment repeats every 14 days for at least 6 courses in the absence of disease progression or unacceptable toxicity. ziv-aflibercept: Given IV pharmacological study: Correlative studies
Number of Participants With Toxicities Grade 3 : Thrombocytopenia	1 Participants
Number of Participants With Toxicities Grade 3 : Hypertension	9 Participants
Number of Participants With Toxicities Grade 3 : Hypotension	1 Participants
Number of Participants With Toxicities Grade 3 : LV Diastolic Dys	1 Participants
Number of Participants With Toxicities Grade 3 : GI Bleed	1 Participants
Number of Participants With Toxicities Grade 3 : Cerebrovascular ischemia	0 Participants
Number of Participants With Toxicities Grade 3 : Headache	1 Participants
Number of Participants With Toxicities Grade 3 : Extraocular muscle paresis	1 Participants
Number of Participants With Toxicities Grade 3 : Fatigue	1 Participants
Number of Participants With Toxicities Grade 3 : Hyponatremia	2 Participants
Number of Participants With Toxicities Grade 3 : Osteonecrosis of mandibular bone	1 Participants
Number of Participants With Toxicities Grade 3 : Back Pain	1 Participants
Number of Participants With Toxicities Grade 3 : Chest Pain	1 Participants
Number of Participants With Toxicities Grade 3 : Increased creatinine	1 Participants
Number of Participants With Toxicities Grade 3 : Proteinuria	6 Participants
Number of Participants With Toxicities Grade 4 : Thrombocytopenia	0 Participants
Number of Participants With Toxicities Grade 4 : Hypertension	0 Participants
Number of Participants With Toxicities Grade 4 : Hypotension	0 Participants
Number of Participants With Toxicities Grade 4 : LV Diastolic Dys	0 Participants
Number of Participants With Toxicities Grade 4 : GI Bleed	0 Participants
Number of Participants With Toxicities Grade 4 : Cerebrovascular ischemia	1 Participants
Number of Participants With Toxicities Grade 4 : Headache	0 Participants
Number of Participants With Toxicities Grade 4 : Extraocular muscle paresis	0 Participants
Number of Participants With Toxicities Grade 4 : Fatigue	0 Participants
Number of Participants With Toxicities Grade 4 : Hyponatremia	0 Participants
Number of Participants With Toxicities Grade 4 : Osteonecrosis of mandibular bone	0 Participants
Number of Participants With Toxicities Grade 4 : Back Pain	0 Participants
Number of Participants With Toxicities Grade 4 : Increased creatinine	0 Participants
Number of Participants With Toxicities Grade 4 : Proteinuria	0 Participants
Number of Participants With Toxicities Grade 4 : Chest Pain	0 Participants

SECONDARY outcome

Timeframe: Up to 5 years

Population: Laboratory Correlate data were not collected.

Outcome measures

Outcome data not reported

Adverse Events

Arm I

Serious events: 13 serious events

Other events: 41 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Arm I n=41 participants at risk Patients receive Aflibercept IV at 4 mg/kg over 1 hour on day 1. Treatment repeats every 14 days for at least 6 courses in the absence of disease progression or unacceptable toxicity. ziv-aflibercept: Given IV pharmacological study: Correlative studies
Cardiac disorders Left ventricular dysfunction	2.4% 1/41 • Number of events 1 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Eye disorders Extraocular muscle paresis	2.4% 1/41 • Number of events 1 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Colonic hemorrhage	2.4% 1/41 • Number of events 1 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Gastrointestinal disorder	2.4% 1/41 • Number of events 1 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Peritoneal pain	2.4% 1/41 • Number of events 1 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Disease progression	2.4% 1/41 • Number of events 1 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Fatigue	2.4% 1/41 • Number of events 1 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Gingival infection	2.4% 1/41 • Number of events 1 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Creatinine increased	2.4% 1/41 • Number of events 1 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Weight loss	2.4% 1/41 • Number of events 1 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Anorexia	2.4% 1/41 • Number of events 1 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Serum calcium decreased	2.4% 1/41 • Number of events 1 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Serum potassium increased	2.4% 1/41 • Number of events 1 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Serum sodium decreased	2.4% 1/41 • Number of events 1 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Back pain	2.4% 1/41 • Number of events 1 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Chest wall pain	2.4% 1/41 • Number of events 1 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Osteonecrosis	2.4% 1/41 • Number of events 1 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Pain in extremity	2.4% 1/41 • Number of events 1 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Headache	4.9% 2/41 • Number of events 2 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Ischemia cerebrovascular	2.4% 1/41 • Number of events 1 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Memory impairment	2.4% 1/41 • Number of events 1 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Psychiatric disorders Confusion	2.4% 1/41 • Number of events 1 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Psychiatric disorders Psychosis	2.4% 1/41 • Number of events 1 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Renal and urinary disorders Renal failure	4.9% 2/41 • Number of events 2 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Dyspnea	2.4% 1/41 • Number of events 1 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Pleural effusion	2.4% 1/41 • Number of events 1 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Respiratory disorder	2.4% 1/41 • Number of events 1 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Vascular disorders Hypertension	2.4% 1/41 • Number of events 1 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.

Other adverse events

Other adverse events
Measure	Arm I n=41 participants at risk Patients receive Aflibercept IV at 4 mg/kg over 1 hour on day 1. Treatment repeats every 14 days for at least 6 courses in the absence of disease progression or unacceptable toxicity. ziv-aflibercept: Given IV pharmacological study: Correlative studies
Blood and lymphatic system disorders Hemoglobin decreased	14.6% 6/41 • Number of events 9 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Cardiac disorders Atrial fibrillation	2.4% 1/41 • Number of events 4 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Cardiac disorders Sinus bradycardia	2.4% 1/41 • Number of events 1 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Cardiac disorders Sinus tachycardia	2.4% 1/41 • Number of events 3 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Ear and labyrinth disorders External ear pain	2.4% 1/41 • Number of events 1 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Ear and labyrinth disorders Hearing loss	2.4% 1/41 • Number of events 2 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Ear and labyrinth disorders Hearing test abnormal	2.4% 1/41 • Number of events 1 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Eye disorders Cataract	2.4% 1/41 • Number of events 1 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Eye disorders Eye pain	2.4% 1/41 • Number of events 2 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Eye disorders Photophobia	2.4% 1/41 • Number of events 2 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Eye disorders Vision blurred	4.9% 2/41 • Number of events 3 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Abdominal distension	4.9% 2/41 • Number of events 2 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Abdominal pain	19.5% 8/41 • Number of events 13 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Constipation	17.1% 7/41 • Number of events 9 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Diarrhea	14.6% 6/41 • Number of events 7 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Dry mouth	7.3% 3/41 • Number of events 3 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Dyspepsia	2.4% 1/41 • Number of events 1 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Dysphagia	2.4% 1/41 • Number of events 1 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Ear, nose and throat examination abnormal	7.3% 3/41 • Number of events 6 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Esophagitis	4.9% 2/41 • Number of events 2 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Gastrointestinal disorder	2.4% 1/41 • Number of events 1 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Gingival pain	2.4% 1/41 • Number of events 1 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Hemorrhoids	2.4% 1/41 • Number of events 3 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Lower gastrointestinal hemorrhage	2.4% 1/41 • Number of events 1 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Mucositis oral	4.9% 2/41 • Number of events 2 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Nausea	29.3% 12/41 • Number of events 18 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Oral hemorrhage	2.4% 1/41 • Number of events 1 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Oral pain	22.0% 9/41 • Number of events 13 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Rectal hemorrhage	4.9% 2/41 • Number of events 2 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Toothache	2.4% 1/41 • Number of events 2 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Upper gastrointestinal hemorrhage	2.4% 1/41 • Number of events 1 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Vomiting	19.5% 8/41 • Number of events 10 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Chest pain	4.9% 2/41 • Number of events 4 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Chills	2.4% 1/41 • Number of events 1 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Disease progression	56.1% 23/41 • Number of events 23 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Edema limbs	24.4% 10/41 • Number of events 18 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Facial pain	4.9% 2/41 • Number of events 3 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Fatigue	56.1% 23/41 • Number of events 37 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Fever	7.3% 3/41 • Number of events 4 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders General symptom	2.4% 1/41 • Number of events 2 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Localized edema	2.4% 1/41 • Number of events 1 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Pain	17.1% 7/41 • Number of events 26 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Immune system disorders Immune system disorder	2.4% 1/41 • Number of events 1 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Bladder infection	2.4% 1/41 • Number of events 1 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Gingival infection	4.9% 2/41 • Number of events 2 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Infection	9.8% 4/41 • Number of events 5 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Sinusitis	12.2% 5/41 • Number of events 7 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Skin infection	4.9% 2/41 • Number of events 2 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Tooth infection	7.3% 3/41 • Number of events 4 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Upper aerodigestive tract infection	2.4% 1/41 • Number of events 1 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Upper respiratory infection	2.4% 1/41 • Number of events 1 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Urinary tract infection	7.3% 3/41 • Number of events 4 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Vaginal infection	2.4% 1/41 • Number of events 1 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Injury, poisoning and procedural complications Intraoperative respiratory injury - Nasal cavity	2.4% 1/41 • Number of events 1 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Injury, poisoning and procedural complications Stomal ulcer	2.4% 1/41 • Number of events 1 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Injury, poisoning and procedural complications Thermal burn	2.4% 1/41 • Number of events 1 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Activated partial thromboplastin time prolonged	2.4% 1/41 • Number of events 1 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Alanine aminotransferase increased	24.4% 10/41 • Number of events 23 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Alkaline phosphatase increased	29.3% 12/41 • Number of events 26 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Aspartate aminotransferase increased	31.7% 13/41 • Number of events 37 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Bilirubin increased	4.9% 2/41 • Number of events 9 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Creatine phosphokinase increased	4.9% 2/41 • Number of events 5 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Creatinine increased	22.0% 9/41 • Number of events 18 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Laboratory test abnormal	22.0% 9/41 • Number of events 21 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Leukocyte count decreased	2.4% 1/41 • Number of events 2 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Lymphocyte count decreased	19.5% 8/41 • Number of events 21 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Neutrophil count decreased	2.4% 1/41 • Number of events 4 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Platelet count decreased	7.3% 3/41 • Number of events 7 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Weight loss	9.8% 4/41 • Number of events 6 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Anorexia	12.2% 5/41 • Number of events 6 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Blood glucose increased	24.4% 10/41 • Number of events 34 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Serum albumin decreased	12.2% 5/41 • Number of events 13 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Serum calcium decreased	7.3% 3/41 • Number of events 4 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Serum glucose decreased	4.9% 2/41 • Number of events 3 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Serum phosphate decreased	2.4% 1/41 • Number of events 1 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Serum potassium decreased	2.4% 1/41 • Number of events 1 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Serum potassium increased	19.5% 8/41 • Number of events 12 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Serum sodium decreased	34.1% 14/41 • Number of events 32 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Back pain	12.2% 5/41 • Number of events 8 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Bone pain	2.4% 1/41 • Number of events 1 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Chest wall pain	7.3% 3/41 • Number of events 3 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Joint pain	19.5% 8/41 • Number of events 12 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Muscle weakness lower limb	2.4% 1/41 • Number of events 1 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Musculoskeletal disorder	2.4% 1/41 • Number of events 1 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Myalgia	7.3% 3/41 • Number of events 4 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Neck pain	4.9% 2/41 • Number of events 3 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Pain in extremity	22.0% 9/41 • Number of events 11 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Upper extremity dysfunction	2.4% 1/41 • Number of events 3 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Dizziness	14.6% 6/41 • Number of events 8 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Headache	51.2% 21/41 • Number of events 37 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Nystagmus	2.4% 1/41 • Number of events 1 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Peripheral motor neuropathy	2.4% 1/41 • Number of events 1 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Peripheral sensory neuropathy	2.4% 1/41 • Number of events 1 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Sinus pain	2.4% 1/41 • Number of events 1 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Taste alteration	7.3% 3/41 • Number of events 3 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Psychiatric disorders Agitation	2.4% 1/41 • Number of events 2 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Psychiatric disorders Anxiety	4.9% 2/41 • Number of events 3 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Psychiatric disorders Confusion	2.4% 1/41 • Number of events 1 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Psychiatric disorders Depression	4.9% 2/41 • Number of events 2 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Psychiatric disorders Insomnia	17.1% 7/41 • Number of events 11 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Renal and urinary disorders Glomerular filtration rate decreased	2.4% 1/41 • Number of events 1 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Renal and urinary disorders Hemoglobin urine positive	2.4% 1/41 • Number of events 1 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Renal and urinary disorders Hemorrhage urinary tract	4.9% 2/41 • Number of events 6 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Renal and urinary disorders Protein urine positive	31.7% 13/41 • Number of events 34 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Renal and urinary disorders Urinary frequency	2.4% 1/41 • Number of events 1 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Renal and urinary disorders Urinary incontinence	4.9% 2/41 • Number of events 2 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Renal and urinary disorders Urinary retention	2.4% 1/41 • Number of events 1 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Renal and urinary disorders Urogenital disorder	2.4% 1/41 • Number of events 1 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Reproductive system and breast disorders Irregular menstruation	2.4% 1/41 • Number of events 1 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Reproductive system and breast disorders Testicular pain	2.4% 1/41 • Number of events 1 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Reproductive system and breast disorders Uterine hemorrhage	2.4% 1/41 • Number of events 3 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Bronchopulmonary hemorrhage	2.4% 1/41 • Number of events 1 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Bronchospasm	2.4% 1/41 • Number of events 1 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Cough	22.0% 9/41 • Number of events 17 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Dyspnea	4.9% 2/41 • Number of events 2 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Hemorrhage nasal	24.4% 10/41 • Number of events 21 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal pain	17.1% 7/41 • Number of events 25 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Respiratory disorder	7.3% 3/41 • Number of events 3 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Voice alteration	31.7% 13/41 • Number of events 30 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Alopecia	2.4% 1/41 • Number of events 1 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Hand-and-foot syndrome	2.4% 1/41 • Number of events 1 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Pruritus	7.3% 3/41 • Number of events 3 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Rash desquamating	22.0% 9/41 • Number of events 12 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Skin disorder	12.2% 5/41 • Number of events 22 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Skin hyperpigmentation	4.9% 2/41 • Number of events 4 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Skin hypopigmentation	2.4% 1/41 • Number of events 1 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Skin ulceration	4.9% 2/41 • Number of events 2 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Sweating	12.2% 5/41 • Number of events 6 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Vascular disorders Flushing	2.4% 1/41 • Number of events 1 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Vascular disorders Hemorrhage	2.4% 1/41 • Number of events 1 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Vascular disorders Hypertension	73.2% 30/41 • Number of events 55 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Vascular disorders Hypotension	2.4% 1/41 • Number of events 1 • Adverse events took place over a period of 1 year and 4 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.

Additional Information

DCC Project Administrator

California Cancer Consortium

Phone: 626-256-4673

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60