Trial Outcomes & Findings for ERBITUX® Followed by Adjuvant Treatment With Chemoradiation and ERBITUX® for Locally Advanced Head and Neck Squamous Cell Carcinoma (NCT NCT01218048)
NCT ID: NCT01218048
Last Updated: 2018-08-16
Results Overview
Cetuximab-mediated NK cell activation (percentage of activity) measures at pre-/post-cetuximab exposure for patients in peripheral blood lymphocytes (PBL) and tumor infiltrating lymphocytes (TIL) and in those patients that did and did not respond to treatment.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
40 participants
Primary outcome timeframe
Prior to each weekly cetuximab treatment (up to 4 weeks); at the time of surgery (at 3-4 weeks after first cetuximab treatments)
Results posted on
2018-08-16
Participant Flow
Participant milestones
| Measure |
Neo-Adjuvant Cetuximab
Patients with Head and Neck Squamous Cell Cancer (HNSCC) treated with Neo-Adjuvant Cetuximab + Surgery + Post-Surgical Radiation + Cisplatin (or Carboplatin)
NOTE: Based the results of surgery if the treating physician feels patient is not a candidate for chemotherapy, radiation can be given alone or with cetuximab.
Cetuximab: Pre-Surgery: IV, 400 mg/m\^2 day 1 then 250 mg/m\^2 alone days 8 and 15; Post-surgery: IV, 250 mg/m2 weekly concurrent with RT
Post-surgical radiation: Radiation (2 Gy/d) to min of 60 Gy + max of 66 Gy post-surgery
Cisplatin or carboplatin: Cisplatin 30 mg/m2 or carboplatin AUC 1.5-2/week weekly, Concurrent with radiotherapy
|
|---|---|
|
Overall Study
STARTED
|
40
|
|
Overall Study
COMPLETED
|
40
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
ERBITUX® Followed by Adjuvant Treatment With Chemoradiation and ERBITUX® for Locally Advanced Head and Neck Squamous Cell Carcinoma
Baseline characteristics by cohort
| Measure |
Neo-Adjuvant Cetuximab
n=40 Participants
Patients with Head and Neck Squamous Cell Cancer (HNSCC) treated with Neo-Adjuvant Cetuximab + Surgery + Post-Surgical Radiation + Cisplatin (or Carboplatin)
NOTE: Based the results of surgery if the treating physician feels patient is not a candidate for chemotherapy, radiation can be given alone or with cetuximab.
Cetuximab: Pre-Surgery: IV, 400 mg/m\^2 day 1 then 250 mg/m\^2 alone days 8 and 15; Post-surgery: IV, 250 mg/m2 weekly concurrent with RT
Post-surgical radiation: Radiation (2 Gy/d) to min of 60 Gy + max of 66 Gy post-surgery
Cisplatin or carboplatin: Cisplatin 30 mg/m2 or carboplatin AUC 1.5-2/week weekly, Concurrent with radiotherapy
|
|---|---|
|
Age, Continuous
|
58.6 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Prior to each weekly cetuximab treatment (up to 4 weeks); at the time of surgery (at 3-4 weeks after first cetuximab treatments)Population: Participants that received preoperative treatment with single-agent cetuximab for a minimum of 3-4 weeks.Patients defined as responders, demonstrated upregulation of CD137 on tumor infiltrating NK cells following cetuximab therapy compared with non-responders.
Cetuximab-mediated NK cell activation (percentage of activity) measures at pre-/post-cetuximab exposure for patients in peripheral blood lymphocytes (PBL) and tumor infiltrating lymphocytes (TIL) and in those patients that did and did not respond to treatment.
Outcome measures
| Measure |
Neo-Adjuvant Cetuximab
n=17 Participants
Patients with Head and Neck Squamous Cell Cancer (HNSCC) treated with Neo-Adjuvant Cetuximab + Surgery + Post-Surgical Radiation +/- Cisplatin (or Carboplatin): Intravenous Cetuximab (pre-surgery) 400 mg/m\^2 alone days 8 and 15; then 250mg/m\^2/week) for 3-4 weeks preoperatively, followed post-surgery by adjuvant chemoradiation with or without 250 mg/m\^2 weekly cetuximab.
|
|---|---|
|
NK Cell Activation
Percent NK cells (PBL): pre-cetuximab
|
19 percentage of activity
Interval 13.0 to 22.0
|
|
NK Cell Activation
Percent NK cells (PBL): post-cetuximab
|
20 percentage of activity
Interval 12.0 to 27.0
|
|
NK Cell Activation
Percent NK cells (TIL): pre-cetuximab
|
4 percentage of activity
Interval 2.0 to 7.0
|
|
NK Cell Activation
Percent NK cells (TIL): post-cetuximab
|
3 percentage of activity
Interval 1.0 to 4.0
|
|
NK Cell Activation
Percent CD16+ NK cells(PBL): pre-cetuximab
|
55 percentage of activity
Interval 40.0 to 66.0
|
|
NK Cell Activation
Percent CD16+ NK cells (PBL): post-cetuximab
|
49 percentage of activity
Interval 34.0 to 65.0
|
|
NK Cell Activation
Percent CD16+ NK cells (TIL): pre-cetuximab
|
10 percentage of activity
Interval 4.0 to 15.0
|
|
NK Cell Activation
Percent CD16+ NK cells (TIL): post-cetuximab
|
6 percentage of activity
Interval 4.0 to 9.0
|
|
NK Cell Activation
Percent Granzyme B+ cells (PBL): pre-cetuximab
|
54 percentage of activity
Interval 46.0 to 66.0
|
|
NK Cell Activation
Percent Granzyme B+ cells(PBL): post-cetuximab
|
64 percentage of activity
Interval 54.0 to 71.0
|
|
NK Cell Activation
Percent Granzyme B+ cells (TIL): pre-cetuximab
|
17 percentage of activity
Interval 1.0 to 20.0
|
|
NK Cell Activation
Percent Granzyme B+ cells (TIL): post-cetuximab
|
21 percentage of activity
Interval 10.0 to 31.0
|
|
NK Cell Activation
Percent Perforin+ cells (PBL): pre-cetuximab
|
50 percentage of activity
Interval 42.0 to 68.0
|
|
NK Cell Activation
Percent Perforin+ cells (PBL): post-cetuximab
|
60 percentage of activity
Interval 46.0 to 78.0
|
|
NK Cell Activation
Percent Perforin+ cells (TIL): pre-cetuximab
|
6 percentage of activity
Interval 1.0 to 14.0
|
|
NK Cell Activation
Percent Perforin+ cells (TIL): post-cetuximab
|
10 percentage of activity
Interval 2.0 to 14.0
|
|
NK Cell Activation
Percent CD107a+ cells (PBL): pre-cetuximab
|
1 percentage of activity
Interval 0.0 to 4.0
|
|
NK Cell Activation
Percent CD107a+ cells (PBL): post-cetuximab
|
0 percentage of activity
Interval 0.0 to 0.0
|
|
NK Cell Activation
Percent CD107a+ cells (TIL): pre-cetuximab
|
36 percentage of activity
Interval 23.0 to 56.0
|
|
NK Cell Activation
Percent CD107a+ cells (TIL): post-cetuximab
|
60 percentage of activity
Interval 38.0 to 69.0
|
|
NK Cell Activation
Percent CD137+ cells (PBL): pre-cetuximab
|
2 percentage of activity
Interval 1.0 to 3.0
|
|
NK Cell Activation
Percent CD137+ cells (PBL): post-cetuximab
|
0 percentage of activity
Interval 0.0 to 0.0
|
|
NK Cell Activation
Percent CD137+ cells (TIL): pre-cetuximab
|
6 percentage of activity
Interval 3.0 to 10.0
|
|
NK Cell Activation
Percent CD137+ cells (TIL): post-cetuximab
|
10 percentage of activity
Interval 8.0 to 13.0
|
PRIMARY outcome
Timeframe: Prior to each weekly cetuximab treatment (up to 4 weeks); at the time of surgery (at 3-4 weeks after first cetuximab treatments)Population: Participants that received preoperative treatment with single-agent cetuximab for a minimum of 3-4 weeks.
Serum cytokines levels measured at pre-/post-cetuximab, exposure measured in picogram per milliliter of plasma (pg/ml)
Outcome measures
| Measure |
Neo-Adjuvant Cetuximab
n=33 Participants
Patients with Head and Neck Squamous Cell Cancer (HNSCC) treated with Neo-Adjuvant Cetuximab + Surgery + Post-Surgical Radiation +/- Cisplatin (or Carboplatin): Intravenous Cetuximab (pre-surgery) 400 mg/m\^2 alone days 8 and 15; then 250mg/m\^2/week) for 3-4 weeks preoperatively, followed post-surgery by adjuvant chemoradiation with or without 250 mg/m\^2 weekly cetuximab.
|
|---|---|
|
Serum Cytokines Levels
Non-responders: pre-cetuximab GM-CSF
|
18.0 pg/ml
Interval 2.0 to 22.0
|
|
Serum Cytokines Levels
Responders: post-cetuximab GM-CSF
|
11.0 pg/ml
Interval 7.0 to 13.0
|
|
Serum Cytokines Levels
Non-responders: post-cetuximab GM-CSF
|
5.0 pg/ml
Interval 2.0 to 12.5
|
|
Serum Cytokines Levels
Non-responders: pre-cetuximab CCL2
|
500 pg/ml
Interval 100.0 to 1600.0
|
|
Serum Cytokines Levels
Responders: post-cetuximab CCL2
|
250 pg/ml
Interval 200.0 to 400.0
|
|
Serum Cytokines Levels
Non-responders: post-cetuximab CCL2
|
200 pg/ml
Interval 100.0 to 750.0
|
|
Serum Cytokines Levels
Responders: pre-cetuximab MP-1 alpha
|
6.0 pg/ml
Interval 5.0 to 9.5
|
|
Serum Cytokines Levels
Responders: post-cetuximab MP-1 alpha
|
7.0 pg/ml
Interval 4.0 to 11.0
|
|
Serum Cytokines Levels
Responders: pre-cetuximab GM-CSF
|
2.5 pg/ml
Interval 2.0 to 8.0
|
|
Serum Cytokines Levels
Responders: pre-cetuximab CCL2
|
260 pg/ml
Interval 175.0 to 500.0
|
|
Serum Cytokines Levels
Non-responders: pre-cetuximab MP-1 alpha
|
10.0 pg/ml
Interval 1.0 to 27.0
|
|
Serum Cytokines Levels
Non-responders: post-cetuximab MP-1 alpha
|
3.0 pg/ml
Interval 2.0 to 21.0
|
PRIMARY outcome
Timeframe: Prior to each weekly cetuximab treatment (up to 4 weeks); at the time of surgery (at 3-4 weeks after first cetuximab treatments)Population: Participants that received preoperative treatment with single-agent cetuximab for a minimum of 3-4 weeks.
T cell activation measured at pre-/post-cetuximab exposure
Outcome measures
| Measure |
Neo-Adjuvant Cetuximab
n=33 Participants
Patients with Head and Neck Squamous Cell Cancer (HNSCC) treated with Neo-Adjuvant Cetuximab + Surgery + Post-Surgical Radiation +/- Cisplatin (or Carboplatin): Intravenous Cetuximab (pre-surgery) 400 mg/m\^2 alone days 8 and 15; then 250mg/m\^2/week) for 3-4 weeks preoperatively, followed post-surgery by adjuvant chemoradiation with or without 250 mg/m\^2 weekly cetuximab.
|
|---|---|
|
T Cell Activation
Pre-cetuximab
|
0.25 percentage of T cell activation
Interval 0.2 to 0.3
|
|
T Cell Activation
Post-cetuximab
|
1.0 percentage of T cell activation
Interval 0.9 to 1.4
|
SECONDARY outcome
Timeframe: Prior to each weekly cetuximab treatment (up to 4 weeks); at the time of surgery (at 3-4 weeks after first cetuximab treatments)Difference in frequency of circulating EGFR-specific T cells between cetuximab-treated and cetuximab-naive patients
Outcome measures
| Measure |
Neo-Adjuvant Cetuximab
n=39 Participants
Patients with Head and Neck Squamous Cell Cancer (HNSCC) treated with Neo-Adjuvant Cetuximab + Surgery + Post-Surgical Radiation +/- Cisplatin (or Carboplatin): Intravenous Cetuximab (pre-surgery) 400 mg/m\^2 alone days 8 and 15; then 250mg/m\^2/week) for 3-4 weeks preoperatively, followed post-surgery by adjuvant chemoradiation with or without 250 mg/m\^2 weekly cetuximab.
|
|---|---|
|
Frequency of EGFR-specific T Cells (EGFR853-861 Peptide-specific Tetramer+ CD8+T Cells)
no cetuximab-treatment
|
45 EGFR+ T cells/10^4 T cells
Interval 0.0 to 150.0
|
|
Frequency of EGFR-specific T Cells (EGFR853-861 Peptide-specific Tetramer+ CD8+T Cells)
cetuximab-treatment
|
120 EGFR+ T cells/10^4 T cells
Interval 0.0 to 300.0
|
SECONDARY outcome
Timeframe: Up to 54 monthsThe length of time during and after study treatment that participants lived with disease that did not progress per RECIST 1.0. Progression per RECIST 1.0 is defined as a 20% increase the in longest dimension (LD) lesion from Nadir.
Outcome measures
| Measure |
Neo-Adjuvant Cetuximab
n=40 Participants
Patients with Head and Neck Squamous Cell Cancer (HNSCC) treated with Neo-Adjuvant Cetuximab + Surgery + Post-Surgical Radiation +/- Cisplatin (or Carboplatin): Intravenous Cetuximab (pre-surgery) 400 mg/m\^2 alone days 8 and 15; then 250mg/m\^2/week) for 3-4 weeks preoperatively, followed post-surgery by adjuvant chemoradiation with or without 250 mg/m\^2 weekly cetuximab.
|
|---|---|
|
Progression-free Survival (PFS)
|
24 months
Interval 1.0 to 54.0
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: All patients enrolled in the study.
Number of patients remaining alive.
Outcome measures
| Measure |
Neo-Adjuvant Cetuximab
n=40 Participants
Patients with Head and Neck Squamous Cell Cancer (HNSCC) treated with Neo-Adjuvant Cetuximab + Surgery + Post-Surgical Radiation +/- Cisplatin (or Carboplatin): Intravenous Cetuximab (pre-surgery) 400 mg/m\^2 alone days 8 and 15; then 250mg/m\^2/week) for 3-4 weeks preoperatively, followed post-surgery by adjuvant chemoradiation with or without 250 mg/m\^2 weekly cetuximab.
|
|---|---|
|
Overall Survival (OS)
|
40 participants
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Participant that where evaluable for response to treatment with cetuximab (400 mg/m2 then 250mg/m2/week) for 3-4 weeks preoperatively, followed by adjuvant chemoradiation with or without cetuximab.
The percentage of participants that experienced a response to study treatment, per RECIST 1.0: Number of participant with (Complete Response (CR) + number of participants with Partial Response (PR) / Total number of participants evaluable for response.
Outcome measures
| Measure |
Neo-Adjuvant Cetuximab
n=33 Participants
Patients with Head and Neck Squamous Cell Cancer (HNSCC) treated with Neo-Adjuvant Cetuximab + Surgery + Post-Surgical Radiation +/- Cisplatin (or Carboplatin): Intravenous Cetuximab (pre-surgery) 400 mg/m\^2 alone days 8 and 15; then 250mg/m\^2/week) for 3-4 weeks preoperatively, followed post-surgery by adjuvant chemoradiation with or without 250 mg/m\^2 weekly cetuximab.
|
|---|---|
|
Objective Response (Rate)
|
33 percentage of participants
|
SECONDARY outcome
Timeframe: 3 yearsPercentage of participants alive at 3 years that did not experience disease progression per RECIST 1.0. Progression per RECIST 1.0 is defined as a 20% increase the in longest dimension (LD) lesion from Nadir.
Outcome measures
| Measure |
Neo-Adjuvant Cetuximab
n=40 Participants
Patients with Head and Neck Squamous Cell Cancer (HNSCC) treated with Neo-Adjuvant Cetuximab + Surgery + Post-Surgical Radiation +/- Cisplatin (or Carboplatin): Intravenous Cetuximab (pre-surgery) 400 mg/m\^2 alone days 8 and 15; then 250mg/m\^2/week) for 3-4 weeks preoperatively, followed post-surgery by adjuvant chemoradiation with or without 250 mg/m\^2 weekly cetuximab.
|
|---|---|
|
3-year Progression-free Survival (PFS)
|
84 percentage of participants
Interval 71.0 to 98.0
|
SECONDARY outcome
Timeframe: Prior to each weekly cetuximab treatment (up to 4 weeks); at the time of surgery (at 3-4 weeks after first cetuximab treatments)Largest percent change (decrease) in tumor size before and after neoadjuvant cetuximab.
Outcome measures
| Measure |
Neo-Adjuvant Cetuximab
n=16 Participants
Patients with Head and Neck Squamous Cell Cancer (HNSCC) treated with Neo-Adjuvant Cetuximab + Surgery + Post-Surgical Radiation +/- Cisplatin (or Carboplatin): Intravenous Cetuximab (pre-surgery) 400 mg/m\^2 alone days 8 and 15; then 250mg/m\^2/week) for 3-4 weeks preoperatively, followed post-surgery by adjuvant chemoradiation with or without 250 mg/m\^2 weekly cetuximab.
|
|---|---|
|
Change in Tumor Size
|
10 percent
|
Adverse Events
Neo-Adjuvant Cetuximab
Serious events: 8 serious events
Other events: 32 other events
Deaths: 32 deaths
Serious adverse events
| Measure |
Neo-Adjuvant Cetuximab
n=40 participants at risk
Patients with Head and Neck Squamous Cell Cancer (HNSCC) treated with Neo-Adjuvant Cetuximab + Surgery + Post-Surgical Radiation +/- Cisplatin (or Carboplatin): Intravenous Cetuximab (pre-surgery) 400 mg/m\^2 alone days 8 and 15; then 250mg/m\^2/week) for 3-4 weeks preoperatively, followed post-surgery by adjuvant chemoradiation with or without 250 mg/m\^2 weekly cetuximab.
|
|---|---|
|
Endocrine disorders
Hypothyroidism
|
2.5%
1/40
|
|
Gastrointestinal disorders
Constipation
|
2.5%
1/40
|
|
Gastrointestinal disorders
Mucositis oral
|
5.0%
2/40
|
|
Infections and infestations
Infections and infestations - Other, specify
|
2.5%
1/40
|
|
Infections and infestations
Soft tissue infection
|
2.5%
1/40
|
|
Injury, poisoning and procedural complications
Fall
|
5.0%
2/40
|
|
Injury, poisoning and procedural complications
Postoperative hemorrhage
|
2.5%
1/40
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
2.5%
1/40
|
|
Metabolism and nutrition disorders
Dehydration
|
2.5%
1/40
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
2.5%
1/40
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
2.5%
1/40
|
|
Psychiatric disorders
Mania
|
2.5%
1/40
|
|
Vascular disorders
Thromboembolic event
|
2.5%
1/40
|
Other adverse events
| Measure |
Neo-Adjuvant Cetuximab
n=40 participants at risk
Patients with Head and Neck Squamous Cell Cancer (HNSCC) treated with Neo-Adjuvant Cetuximab + Surgery + Post-Surgical Radiation +/- Cisplatin (or Carboplatin): Intravenous Cetuximab (pre-surgery) 400 mg/m\^2 alone days 8 and 15; then 250mg/m\^2/week) for 3-4 weeks preoperatively, followed post-surgery by adjuvant chemoradiation with or without 250 mg/m\^2 weekly cetuximab.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
37.5%
15/40
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
12.5%
5/40
|
|
Blood and lymphatic system disorders
Leukocytosis
|
5.0%
2/40
|
|
Cardiac disorders
Sinus tachycardia
|
5.0%
2/40
|
|
Ear and labyrinth disorders
Hearing impaired
|
5.0%
2/40
|
|
Ear and labyrinth disorders
Tinnitus
|
7.5%
3/40
|
|
Endocrine disorders
Hypothyroidism
|
5.0%
2/40
|
|
Eye disorders
Dry eye
|
5.0%
2/40
|
|
Gastrointestinal disorders
Constipation
|
30.0%
12/40
|
|
Gastrointestinal disorders
Diarrhea
|
12.5%
5/40
|
|
Gastrointestinal disorders
Dry mouth
|
30.0%
12/40
|
|
Gastrointestinal disorders
Dysphagia
|
45.0%
18/40
|
|
Gastrointestinal disorders
Esophageal pain
|
5.0%
2/40
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
10.0%
4/40
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
27.5%
11/40
|
|
Gastrointestinal disorders
Mucositis oral
|
37.5%
15/40
|
|
Gastrointestinal disorders
Nausea
|
32.5%
13/40
|
|
Gastrointestinal disorders
Oral pain
|
17.5%
7/40
|
|
Gastrointestinal disorders
Vomiting
|
17.5%
7/40
|
|
General disorders
Chills
|
7.5%
3/40
|
|
General disorders
Edema face
|
5.0%
2/40
|
|
General disorders
Fatigue
|
32.5%
13/40
|
|
General disorders
Fever
|
7.5%
3/40
|
|
General disorders
Flu like symptoms
|
5.0%
2/40
|
|
General disorders
Pain
|
22.5%
9/40
|
|
Infections and infestations
Infections and infestations - Other, specify
|
15.0%
6/40
|
|
Infections and infestations
Skin infection
|
5.0%
2/40
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
7.5%
3/40
|
|
Injury, poisoning and procedural complications
Fall
|
7.5%
3/40
|
|
Investigations
Alanine aminotransferase increased
|
12.5%
5/40
|
|
Investigations
Alkaline phosphatase increased
|
10.0%
4/40
|
|
Investigations
Aspartate aminotransferase increased
|
15.0%
6/40
|
|
Investigations
Cholesterol high
|
10.0%
4/40
|
|
Investigations
Creatinine increased
|
5.0%
2/40
|
|
Investigations
Investigations - Other, specify
|
7.5%
3/40
|
|
Investigations
Lymphocyte count decreased
|
22.5%
9/40
|
|
Investigations
Neutrophil count decreased
|
12.5%
5/40
|
|
Investigations
Platelet count decreased
|
12.5%
5/40
|
|
Investigations
Weight loss
|
47.5%
19/40
|
|
Investigations
White blood cell decreased
|
22.5%
9/40
|
|
Metabolism and nutrition disorders
Anorexia
|
10.0%
4/40
|
|
Metabolism and nutrition disorders
Dehydration
|
22.5%
9/40
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
7.5%
3/40
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
40.0%
16/40
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
5.0%
2/40
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
10.0%
4/40
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
32.5%
13/40
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
10.0%
4/40
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
5.0%
2/40
|
|
Metabolism and nutrition disorders
Hypokalemia
|
15.0%
6/40
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
12.5%
5/40
|
|
Metabolism and nutrition disorders
Hyponatremia
|
27.5%
11/40
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
5.0%
2/40
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify
|
5.0%
2/40
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.0%
2/40
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
10.0%
4/40
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
7.5%
3/40
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
10.0%
4/40
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
5.0%
2/40
|
|
Nervous system disorders
Dizziness
|
7.5%
3/40
|
|
Nervous system disorders
Dysgeusia
|
12.5%
5/40
|
|
Nervous system disorders
Headache
|
40.0%
16/40
|
|
Psychiatric disorders
Anxiety
|
22.5%
9/40
|
|
Psychiatric disorders
Depression
|
12.5%
5/40
|
|
Psychiatric disorders
Insomnia
|
15.0%
6/40
|
|
Renal and urinary disorders
Renal calculi
|
5.0%
2/40
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.0%
2/40
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
10.0%
4/40
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
5.0%
2/40
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
5.0%
2/40
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
12.5%
5/40
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
5.0%
2/40
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
17.5%
7/40
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
17.5%
7/40
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
42.5%
17/40
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
7.5%
3/40
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
47.5%
19/40
|
|
Vascular disorders
Hypertension
|
25.0%
10/40
|
|
Vascular disorders
Hypotension
|
12.5%
5/40
|
Additional Information
Robert Ferris, MD, PhD
University of Pittsburgh Cancer Institute
Phone: 412-623-3205
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place