Trial Outcomes & Findings for Temsirolimus With or Without Cetuximab in Patients With Recurrent and/or Metastatic Head and Neck Cancer Who Did Not Respond to Previous Therapy (NCT NCT01256385)
NCT ID: NCT01256385
Last Updated: 2017-03-27
Results Overview
Progression determined using RECIST criteria: \>=20% increase in the sum of the longest diameters of target lesions from nadir, occurrence of new lesions, or progression of non-target lesions.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
86 participants
Primary outcome timeframe
From start of treatment to time of progression or death from any cause, assessed up to 5 years
Results posted on
2017-03-27
Participant Flow
Participant milestones
| Measure |
Arm A (Cetuximab and Temsirolimus)
Patients receive temsirolimus IV over 30-60 minutes and cetuximab IV over 1-2 hours once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
|
Arm B (Temsirolimus)
Patients receive temsirolimus as in Arm A. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may cross over to Arm A.
|
|---|---|---|
|
Overall Study
STARTED
|
43
|
43
|
|
Overall Study
Crossover From Arm B to Arm A
|
0
|
15
|
|
Overall Study
COMPLETED
|
40
|
40
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
Reasons for withdrawal
| Measure |
Arm A (Cetuximab and Temsirolimus)
Patients receive temsirolimus IV over 30-60 minutes and cetuximab IV over 1-2 hours once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
|
Arm B (Temsirolimus)
Patients receive temsirolimus as in Arm A. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may cross over to Arm A.
|
|---|---|---|
|
Overall Study
Physician Decision
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
Baseline Characteristics
Temsirolimus With or Without Cetuximab in Patients With Recurrent and/or Metastatic Head and Neck Cancer Who Did Not Respond to Previous Therapy
Baseline characteristics by cohort
| Measure |
Arm A (Cetuximab and Temsirolimus)
n=40 Participants
Patients receive temsirolimus IV over 30-60 minutes and cetuximab IV over 1-2 hours once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
|
Arm B (Temsirolimus)
n=40 Participants
Patients receive temsirolimus as in Arm A. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may cross over to Arm A.
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63 years
n=5 Participants
|
63 years
n=7 Participants
|
63 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
40 participants
n=5 Participants
|
40 participants
n=7 Participants
|
80 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From start of treatment to time of progression or death from any cause, assessed up to 5 yearsProgression determined using RECIST criteria: \>=20% increase in the sum of the longest diameters of target lesions from nadir, occurrence of new lesions, or progression of non-target lesions.
Outcome measures
| Measure |
Arm A (Cetuximab and Temsirolimus)
n=40 Participants
Patients receive temsirolimus IV over 30-60 minutes and cetuximab IV over 1-2 hours once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
|
Arm B (Temsirolimus)
n=40 Participants
Patients receive temsirolimus as in Arm A. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may cross over to Arm A.
|
|---|---|---|
|
Progression-free Survival (PFS)
|
105 days
Interval 70.0 to 136.0
|
105 days
Interval 77.0 to 147.0
|
SECONDARY outcome
Timeframe: Up to 5 yearsTime from randomization until death from any cause
Outcome measures
| Measure |
Arm A (Cetuximab and Temsirolimus)
n=40 Participants
Patients receive temsirolimus IV over 30-60 minutes and cetuximab IV over 1-2 hours once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
|
Arm B (Temsirolimus)
n=40 Participants
Patients receive temsirolimus as in Arm A. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may cross over to Arm A.
|
|---|---|---|
|
Overall Survival (OS)
|
177 days
Interval 146.0 to 247.0
|
176 days
Interval 131.0 to 316.0
|
SECONDARY outcome
Timeframe: Up to 5 yearsPer Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and 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; Statistics reported are for Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
Arm A (Cetuximab and Temsirolimus)
n=40 Participants
Patients receive temsirolimus IV over 30-60 minutes and cetuximab IV over 1-2 hours once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
|
Arm B (Temsirolimus)
n=40 Participants
Patients receive temsirolimus as in Arm A. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may cross over to Arm A.
|
|---|---|---|
|
Overall Response Rates (OR)
|
12.5 percentage of participants
Interval 4.2 to 26.8
|
2.5 percentage of participants
Interval 0.1 to 13.2
|
SECONDARY outcome
Timeframe: From start of treatment to time of progression or death of any cause, assessed at 4 monthsPopulation: Note: Each arm is separately compared to an historical rate of 21.4%, based on a one-sided test at the 0.05 significant level. Since the 90% CIs each exclude 21.4%, the 4-month PFS rate in both arms exceeds the fixed historical control rate.
PFS at 4 months in Arm A and Arm B will each be compared with a 4-month historical control rate of 21.4%. The historical data appears in two publications, an ASCO abstract: Abidoye, ASCO Annual Meeting 2006: 5568 and de Souza, Davis, et al, Clin Cancer Res 2012; 18(8):2336-2343.
Outcome measures
| Measure |
Arm A (Cetuximab and Temsirolimus)
n=40 Participants
Patients receive temsirolimus IV over 30-60 minutes and cetuximab IV over 1-2 hours once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
|
Arm B (Temsirolimus)
n=40 Participants
Patients receive temsirolimus as in Arm A. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may cross over to Arm A.
|
|---|---|---|
|
PFS vs. Historical Control Cohort
|
41.3 percentage of participants
Interval 28.3 to 54.3
|
36.4 percentage of participants
Interval 22.6 to 50.2
|
SECONDARY outcome
Timeframe: Up to 5 yearsIncidence of hematological toxicities at least possibly related to study drug, graded based on Common Terminology Criteria for Adverse Events version 4
Outcome measures
| Measure |
Arm A (Cetuximab and Temsirolimus)
n=40 Participants
Patients receive temsirolimus IV over 30-60 minutes and cetuximab IV over 1-2 hours once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
|
Arm B (Temsirolimus)
n=40 Participants
Patients receive temsirolimus as in Arm A. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may cross over to Arm A.
|
|---|---|---|
|
Grade 3 or Higher Hematological Toxicity
|
17.5 percentage of participants
Interval 7.3 to 32.8
|
25 percentage of participants
Interval 12.7 to 41.1
|
SECONDARY outcome
Timeframe: Up to 5 yearsPercentage of responses (if any) after crossover from the control arm to the combination arm will be evaluated qualitatively. This is includes complete and partial responses, and is different from Outcome Measure 8 below, which includes complete and partial responses as well as stable disease.
Outcome measures
| Measure |
Arm A (Cetuximab and Temsirolimus)
Patients receive temsirolimus IV over 30-60 minutes and cetuximab IV over 1-2 hours once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
|
Arm B (Temsirolimus)
n=15 Participants
Patients receive temsirolimus as in Arm A. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may cross over to Arm A.
|
|---|---|---|
|
Percentage of Responses After Crossover From Control Arm to the Combination Arm, Assessed According to RECIST
|
—
|
0 percentage of participants
Interval 0.0 to 21.8
|
SECONDARY outcome
Timeframe: From start of treatment to time of progression or death of any cause, assessed up to 5 yearsPopulation: Myofibroblast status was not determined. Concerns about the validity/technical feasibility as well as availability of the assay led us to decide to not perform the assay. We do not intend to perform this assay anymore.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 5 yearsAssessed according to RECIST. This is includes complete and partial responses as well as stable disease, and is different from Outcome Measure 6 above, which includes only complete and partial responses.
Outcome measures
| Measure |
Arm A (Cetuximab and Temsirolimus)
Patients receive temsirolimus IV over 30-60 minutes and cetuximab IV over 1-2 hours once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
|
Arm B (Temsirolimus)
n=15 Participants
Patients receive temsirolimus as in Arm A. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may cross over to Arm A.
|
|---|---|---|
|
Percentage of Responses/Disease Stabilization for Patients Crossing Over to the Combination Therapy After Progressing on Arm B.
|
—
|
26.7 percentage of participants
Interval 7.8 to 55.1
|
Adverse Events
Arm A (Cetuximab and Temsirolimus)
Serious events: 14 serious events
Other events: 39 other events
Deaths: 0 deaths
Arm B (Temsirolimus)
Serious events: 19 serious events
Other events: 37 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm A (Cetuximab and Temsirolimus)
n=40 participants at risk
Patients receive temsirolimus IV over 30-60 minutes and cetuximab IV over 1-2 hours once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
|
Arm B (Temsirolimus)
n=40 participants at risk
Patients receive temsirolimus as in Arm A. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may cross over to Arm A.
|
|---|---|---|
|
Renal and urinary disorders
Acute kidney injury
|
2.5%
1/40
|
0.00%
0/40
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/40
|
5.0%
2/40
|
|
Infections and infestations
Anorectal infection
|
0.00%
0/40
|
2.5%
1/40
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
2.5%
1/40
|
0.00%
0/40
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.5%
1/40
|
0.00%
0/40
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
2.5%
1/40
|
0.00%
0/40
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary hemorrhage
|
2.5%
1/40
|
0.00%
0/40
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/40
|
7.5%
3/40
|
|
General disorders
Death NOS
|
2.5%
1/40
|
0.00%
0/40
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/40
|
2.5%
1/40
|
|
Nervous system disorders
Dizziness
|
0.00%
0/40
|
2.5%
1/40
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.5%
1/40
|
17.5%
7/40
|
|
General disorders
Edema face
|
0.00%
0/40
|
5.0%
2/40
|
|
General disorders
Fatigue
|
2.5%
1/40
|
0.00%
0/40
|
|
General disorders
Fever
|
2.5%
1/40
|
2.5%
1/40
|
|
General disorders
General disorders and administration site conditions - Other
|
0.00%
0/40
|
5.0%
2/40
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
2.5%
1/40
|
0.00%
0/40
|
|
Cardiac disorders
Heart failure
|
0.00%
0/40
|
2.5%
1/40
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
2.5%
1/40
|
5.0%
2/40
|
|
Metabolism and nutrition disorders
Hypernatremia
|
2.5%
1/40
|
5.0%
2/40
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
2.5%
1/40
|
0.00%
0/40
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/40
|
2.5%
1/40
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.5%
1/40
|
2.5%
1/40
|
|
Infections and infestations
Infections and infestations - Other
|
2.5%
1/40
|
0.00%
0/40
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal edema
|
2.5%
1/40
|
0.00%
0/40
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal obstruction
|
0.00%
0/40
|
2.5%
1/40
|
|
Infections and infestations
Lung infection
|
7.5%
3/40
|
2.5%
1/40
|
|
Investigations
Lymphocyte count decreased
|
2.5%
1/40
|
0.00%
0/40
|
|
General disorders
Multi-organ failure
|
2.5%
1/40
|
0.00%
0/40
|
|
Cardiac disorders
Myocardial infarction
|
2.5%
1/40
|
0.00%
0/40
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/40
|
2.5%
1/40
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other
|
0.00%
0/40
|
5.0%
2/40
|
|
General disorders
Non-cardiac chest pain
|
2.5%
1/40
|
2.5%
1/40
|
|
General disorders
Pain
|
2.5%
1/40
|
2.5%
1/40
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal hemorrhage
|
2.5%
1/40
|
2.5%
1/40
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/40
|
5.0%
2/40
|
|
Infections and infestations
Pleural infection
|
0.00%
0/40
|
2.5%
1/40
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/40
|
2.5%
1/40
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.5%
1/40
|
0.00%
0/40
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
2.5%
1/40
|
2.5%
1/40
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
2.5%
1/40
|
0.00%
0/40
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/40
|
7.5%
3/40
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other
|
0.00%
0/40
|
2.5%
1/40
|
|
Infections and infestations
Scrotal infection
|
2.5%
1/40
|
0.00%
0/40
|
|
Infections and infestations
Sinusitis
|
0.00%
0/40
|
2.5%
1/40
|
|
Infections and infestations
Skin infection
|
2.5%
1/40
|
5.0%
2/40
|
|
Respiratory, thoracic and mediastinal disorders
Stridor
|
0.00%
0/40
|
2.5%
1/40
|
|
Injury, poisoning and procedural complications
Tracheal hemorrhage
|
0.00%
0/40
|
2.5%
1/40
|
|
Injury, poisoning and procedural complications
Tracheostomy site bleeding
|
0.00%
0/40
|
2.5%
1/40
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/40
|
2.5%
1/40
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/40
|
2.5%
1/40
|
|
Infections and infestations
Wound infection
|
5.0%
2/40
|
0.00%
0/40
|
Other adverse events
| Measure |
Arm A (Cetuximab and Temsirolimus)
n=40 participants at risk
Patients receive temsirolimus IV over 30-60 minutes and cetuximab IV over 1-2 hours once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
|
Arm B (Temsirolimus)
n=40 participants at risk
Patients receive temsirolimus as in Arm A. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may cross over to Arm A.
|
|---|---|---|
|
Investigations
Alanine aminotransferase increased
|
27.5%
11/40
|
25.0%
10/40
|
|
Investigations
Alkaline phosphatase increased
|
25.0%
10/40
|
17.5%
7/40
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
5.0%
2/40
|
5.0%
2/40
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
7.5%
3/40
|
2.5%
1/40
|
|
Blood and lymphatic system disorders
Anemia
|
60.0%
24/40
|
65.0%
26/40
|
|
Metabolism and nutrition disorders
Anorexia
|
27.5%
11/40
|
37.5%
15/40
|
|
Psychiatric disorders
Anxiety
|
5.0%
2/40
|
7.5%
3/40
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.5%
3/40
|
10.0%
4/40
|
|
Investigations
Aspartate aminotransferase increased
|
22.5%
9/40
|
17.5%
7/40
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.0%
4/40
|
7.5%
3/40
|
|
Eye disorders
Blurred vision
|
5.0%
2/40
|
2.5%
1/40
|
|
Investigations
CD4 lymphocytes decreased
|
7.5%
3/40
|
0.00%
0/40
|
|
General disorders
Chills
|
7.5%
3/40
|
5.0%
2/40
|
|
Investigations
Cholesterol high
|
22.5%
9/40
|
25.0%
10/40
|
|
Gastrointestinal disorders
Constipation
|
35.0%
14/40
|
35.0%
14/40
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.0%
10/40
|
35.0%
14/40
|
|
Investigations
Creatinine increased
|
5.0%
2/40
|
15.0%
6/40
|
|
Metabolism and nutrition disorders
Dehydration
|
7.5%
3/40
|
5.0%
2/40
|
|
Psychiatric disorders
Depression
|
2.5%
1/40
|
20.0%
8/40
|
|
Gastrointestinal disorders
Diarrhea
|
25.0%
10/40
|
12.5%
5/40
|
|
Nervous system disorders
Dizziness
|
12.5%
5/40
|
10.0%
4/40
|
|
Gastrointestinal disorders
Dry mouth
|
10.0%
4/40
|
7.5%
3/40
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
37.5%
15/40
|
7.5%
3/40
|
|
Nervous system disorders
Dysgeusia
|
15.0%
6/40
|
12.5%
5/40
|
|
Gastrointestinal disorders
Dyspepsia
|
5.0%
2/40
|
5.0%
2/40
|
|
Gastrointestinal disorders
Dysphagia
|
12.5%
5/40
|
22.5%
9/40
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
17.5%
7/40
|
27.5%
11/40
|
|
Ear and labyrinth disorders
Ear pain
|
2.5%
1/40
|
5.0%
2/40
|
|
General disorders
Edema face
|
17.5%
7/40
|
15.0%
6/40
|
|
General disorders
Edema limbs
|
10.0%
4/40
|
10.0%
4/40
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
12.5%
5/40
|
5.0%
2/40
|
|
Eye disorders
Eye disorders - Other
|
5.0%
2/40
|
2.5%
1/40
|
|
General disorders
Facial pain
|
5.0%
2/40
|
7.5%
3/40
|
|
General disorders
Fatigue
|
70.0%
28/40
|
75.0%
30/40
|
|
General disorders
Fever
|
17.5%
7/40
|
20.0%
8/40
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
5.0%
2/40
|
5.0%
2/40
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
7.5%
3/40
|
5.0%
2/40
|
|
Nervous system disorders
Headache
|
17.5%
7/40
|
17.5%
7/40
|
|
Ear and labyrinth disorders
Hearing impaired
|
0.00%
0/40
|
5.0%
2/40
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
5.0%
2/40
|
0.00%
0/40
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
2.5%
1/40
|
5.0%
2/40
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
45.0%
18/40
|
47.5%
19/40
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/40
|
5.0%
2/40
|
|
Vascular disorders
Hypertension
|
7.5%
3/40
|
7.5%
3/40
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
20.0%
8/40
|
25.0%
10/40
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
32.5%
13/40
|
27.5%
11/40
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
30.0%
12/40
|
17.5%
7/40
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
10.0%
4/40
|
0.00%
0/40
|
|
Metabolism and nutrition disorders
Hypokalemia
|
37.5%
15/40
|
17.5%
7/40
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
55.0%
22/40
|
5.0%
2/40
|
|
Metabolism and nutrition disorders
Hyponatremia
|
12.5%
5/40
|
17.5%
7/40
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
30.0%
12/40
|
20.0%
8/40
|
|
Vascular disorders
Hypotension
|
5.0%
2/40
|
2.5%
1/40
|
|
Investigations
INR increased
|
0.00%
0/40
|
7.5%
3/40
|
|
Infections and infestations
Infections and infestations - Other
|
12.5%
5/40
|
12.5%
5/40
|
|
Psychiatric disorders
Insomnia
|
17.5%
7/40
|
17.5%
7/40
|
|
Blood and lymphatic system disorders
Leukocytosis
|
2.5%
1/40
|
5.0%
2/40
|
|
Infections and infestations
Lung infection
|
0.00%
0/40
|
5.0%
2/40
|
|
Vascular disorders
Lymphedema
|
2.5%
1/40
|
5.0%
2/40
|
|
Investigations
Lymphocyte count decreased
|
35.0%
14/40
|
42.5%
17/40
|
|
Gastrointestinal disorders
Mucositis oral
|
40.0%
16/40
|
30.0%
12/40
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.5%
1/40
|
5.0%
2/40
|
|
Infections and infestations
Nail infection
|
7.5%
3/40
|
0.00%
0/40
|
|
Gastrointestinal disorders
Nausea
|
37.5%
15/40
|
35.0%
14/40
|
|
General disorders
Neck edema
|
2.5%
1/40
|
7.5%
3/40
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
5.0%
2/40
|
15.0%
6/40
|
|
Investigations
Neutrophil count decreased
|
7.5%
3/40
|
10.0%
4/40
|
|
General disorders
Non-cardiac chest pain
|
2.5%
1/40
|
17.5%
7/40
|
|
Gastrointestinal disorders
Oral dysesthesia
|
5.0%
2/40
|
7.5%
3/40
|
|
Gastrointestinal disorders
Oral pain
|
12.5%
5/40
|
2.5%
1/40
|
|
General disorders
Pain
|
17.5%
7/40
|
30.0%
12/40
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.0%
2/40
|
0.00%
0/40
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
5.0%
2/40
|
2.5%
1/40
|
|
Infections and infestations
Papulopustular rash
|
5.0%
2/40
|
5.0%
2/40
|
|
Infections and infestations
Paronychia
|
7.5%
3/40
|
0.00%
0/40
|
|
Nervous system disorders
Peripheral motor neuropathy
|
7.5%
3/40
|
2.5%
1/40
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
12.5%
5/40
|
15.0%
6/40
|
|
Investigations
Platelet count decreased
|
40.0%
16/40
|
35.0%
14/40
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
10.0%
4/40
|
7.5%
3/40
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
5.0%
2/40
|
2.5%
1/40
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.5%
3/40
|
7.5%
3/40
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
47.5%
19/40
|
12.5%
5/40
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
15.0%
6/40
|
12.5%
5/40
|
|
Infections and infestations
Sinusitis
|
0.00%
0/40
|
5.0%
2/40
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other
|
10.0%
4/40
|
2.5%
1/40
|
|
Infections and infestations
Skin infection
|
15.0%
6/40
|
5.0%
2/40
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
7.5%
3/40
|
2.5%
1/40
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
2.5%
1/40
|
5.0%
2/40
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
0.00%
0/40
|
5.0%
2/40
|
|
Renal and urinary disorders
Urinary frequency
|
0.00%
0/40
|
5.0%
2/40
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
5.0%
2/40
|
0.00%
0/40
|
|
Gastrointestinal disorders
Vomiting
|
17.5%
7/40
|
15.0%
6/40
|
|
Investigations
Weight loss
|
20.0%
8/40
|
20.0%
8/40
|
|
Investigations
White blood cell decreased
|
25.0%
10/40
|
27.5%
11/40
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60