Trial Outcomes & Findings for PhII Trial Panitumumab, Nivolumab, Ipilimumab in Kras/Nras/BRAF Wild-type MSS Refractory mCRC (NCT NCT03442569)
NCT ID: NCT03442569
Last Updated: 2025-07-01
Results Overview
Overall Response Rate (ORR) = CR + PR Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
56 participants
Primary outcome timeframe
12 weeks
Results posted on
2025-07-01
Participant Flow
Subjects were recruited from 5 medical institutions between March 2018 and June 2020.
A total of 61 subjects were consented to the trial, but 5 were deemed to be ineligible during screening and therefore were not enrolled on the trial.
Participant milestones
| Measure |
Open-label, Single Arm, Phase II
Nivolumab and ipilimumab with panitumumab
Panitumumab: 6 mg/kg via IV every 2 weeks in combination with nivolumab and ipilimumab
Nivolumab: 240 mg via IV every 2 weeks in combination with panitumumab and ipilimumab
Ipilimumab: 1 mg/kg via IV every 6 weeks in combination with nivolumab and panitumumab
|
|---|---|
|
Overall Study
STARTED
|
56
|
|
Overall Study
Started Treatment
|
55
|
|
Overall Study
COMPLETED
|
55
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Open-label, Single Arm, Phase II
Nivolumab and ipilimumab with panitumumab
Panitumumab: 6 mg/kg via IV every 2 weeks in combination with nivolumab and ipilimumab
Nivolumab: 240 mg via IV every 2 weeks in combination with panitumumab and ipilimumab
Ipilimumab: 1 mg/kg via IV every 6 weeks in combination with nivolumab and panitumumab
|
|---|---|
|
Overall Study
Subject was ineligible after enrollment
|
1
|
Baseline Characteristics
PhII Trial Panitumumab, Nivolumab, Ipilimumab in Kras/Nras/BRAF Wild-type MSS Refractory mCRC
Baseline characteristics by cohort
| Measure |
Open-label, Single Arm, Phase II
n=56 Participants
Nivolumab and ipilimumab with panitumumab
Panitumumab: 6 mg/kg via IV every 2 weeks in combination with nivolumab and ipilimumab
Nivolumab: 240 mg via IV every 2 weeks in combination with panitumumab and ipilimumab
Ipilimumab: 1 mg/kg via IV every 6 weeks in combination with nivolumab and panitumumab
|
|---|---|
|
Age, Customized
Age · 30-39
|
1 Participants
n=5 Participants
|
|
Age, Customized
Age · 40-49
|
9 Participants
n=5 Participants
|
|
Age, Customized
Age · 50-59
|
25 Participants
n=5 Participants
|
|
Age, Customized
Age · 60-69
|
17 Participants
n=5 Participants
|
|
Age, Customized
Age · 70-79
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
54 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
44 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
56 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Seven participants were unevaluable for the primary endpoint at 12 weeks
Overall Response Rate (ORR) = CR + PR Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions
Outcome measures
| Measure |
Open-label, Single Arm, Phase II
n=49 Participants
Nivolumab and ipilimumab with panitumumab
Panitumumab: 6 mg/kg via IV every 2 weeks in combination with nivolumab and ipilimumab
Nivolumab: 240 mg via IV every 2 weeks in combination with panitumumab and ipilimumab
Ipilimumab: 1 mg/kg via IV every 6 weeks in combination with nivolumab and panitumumab
|
|---|---|
|
Overall Response Rate
|
32 percentage of participants
Interval 21.0 to 45.0
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Seven participants were unevaluable for the primary endpoint at 12 weeks
Overall Response Rate (ORR) = irCR + irPR Per immune-related Response Evaluation Criteria in Solid Tumors (irRECIST) for target and/or non-target lesions and assessed by imaging: Complete Response (irCR), Disappearance of all lesions, no new lesions, lymph nodes \< 10 mm in short axis; Partial Response (irPR), ≥30% decrease in the sum of target lesions and non-target lesions are irNN; Stable response (irSD), not meeting criteria for irCR, irPR, or irPD; Progressive Disease (irPD), ≥20% increase in tumor burden and minimum 5 mm absolute increase in compared to nadir; for no new non-target or (irNN) and where irPR or irPD are confirmed by a repeat, consecutive assessment no less than 4 weeks later
Outcome measures
| Measure |
Open-label, Single Arm, Phase II
n=49 Participants
Nivolumab and ipilimumab with panitumumab
Panitumumab: 6 mg/kg via IV every 2 weeks in combination with nivolumab and ipilimumab
Nivolumab: 240 mg via IV every 2 weeks in combination with panitumumab and ipilimumab
Ipilimumab: 1 mg/kg via IV every 6 weeks in combination with nivolumab and panitumumab
|
|---|---|
|
Overall Response Rate Per irRECIST
|
34 percentage of participants
Interval 23.0 to 47.0
|
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: Participants initiated the study and were assessed for disease progression or survival.
Median Progression Free Survival is the time at which 50% of the study population has experienced disease progression as defined by RECIST, irRECIST, or death from any cause.
Outcome measures
| Measure |
Open-label, Single Arm, Phase II
n=49 Participants
Nivolumab and ipilimumab with panitumumab
Panitumumab: 6 mg/kg via IV every 2 weeks in combination with nivolumab and ipilimumab
Nivolumab: 240 mg via IV every 2 weeks in combination with panitumumab and ipilimumab
Ipilimumab: 1 mg/kg via IV every 6 weeks in combination with nivolumab and panitumumab
|
|---|---|
|
Median Progression Free Survival
|
6 months
Interval 5.5 to 7.4
|
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: Participants initiated the study and were assessed for survival.
Time from the first day of treatment until death from any cause.
Outcome measures
| Measure |
Open-label, Single Arm, Phase II
n=49 Participants
Nivolumab and ipilimumab with panitumumab
Panitumumab: 6 mg/kg via IV every 2 weeks in combination with nivolumab and ipilimumab
Nivolumab: 240 mg via IV every 2 weeks in combination with panitumumab and ipilimumab
Ipilimumab: 1 mg/kg via IV every 6 weeks in combination with nivolumab and panitumumab
|
|---|---|
|
Median Overall Survival
|
17.4 months
Interval 14.2 to 27.5
|
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: Participants initiated the study and were assessed for response and disease progression.
Duration of response is the time from documentation of tumor response to disease progression.
Outcome measures
| Measure |
Open-label, Single Arm, Phase II
n=56 Participants
Nivolumab and ipilimumab with panitumumab
Panitumumab: 6 mg/kg via IV every 2 weeks in combination with nivolumab and ipilimumab
Nivolumab: 240 mg via IV every 2 weeks in combination with panitumumab and ipilimumab
Ipilimumab: 1 mg/kg via IV every 6 weeks in combination with nivolumab and panitumumab
|
|---|---|
|
Median Duration of Response
|
5 months
Interval 3.3 to 9.0
|
SECONDARY outcome
Timeframe: Up to 36 monthPopulation: Participants started to study the treatment.
The number of treatment-emergent grade 3 and 4 toxicities as defined by the National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI CTCAE v4.03) was reported.
Outcome measures
| Measure |
Open-label, Single Arm, Phase II
n=56 Participants
Nivolumab and ipilimumab with panitumumab
Panitumumab: 6 mg/kg via IV every 2 weeks in combination with nivolumab and ipilimumab
Nivolumab: 240 mg via IV every 2 weeks in combination with panitumumab and ipilimumab
Ipilimumab: 1 mg/kg via IV every 6 weeks in combination with nivolumab and panitumumab
|
|---|---|
|
Toxicity of Treatment
Thromboembolic event
|
2 Participants
|
|
Toxicity of Treatment
Blood and lymphatic system disorders - Other, specify
|
3 Participants
|
|
Toxicity of Treatment
Hemolysis
|
1 Participants
|
|
Toxicity of Treatment
Myocarditis
|
1 Participants
|
|
Toxicity of Treatment
Adrenal insufficiency
|
3 Participants
|
|
Toxicity of Treatment
Endocrine disorders - Other, specify
|
1 Participants
|
|
Toxicity of Treatment
Abdominal pain
|
2 Participants
|
|
Toxicity of Treatment
Colitis
|
1 Participants
|
|
Toxicity of Treatment
Colonic obstruction
|
1 Participants
|
|
Toxicity of Treatment
Constipation
|
1 Participants
|
|
Toxicity of Treatment
Diarrhea
|
3 Participants
|
|
Toxicity of Treatment
Gastrointestinal disorders - Other, specify
|
2 Participants
|
|
Toxicity of Treatment
Nausea
|
3 Participants
|
|
Toxicity of Treatment
Pancreatitis
|
1 Participants
|
|
Toxicity of Treatment
Rectal pain
|
1 Participants
|
|
Toxicity of Treatment
Small intestinal obstruction
|
1 Participants
|
|
Toxicity of Treatment
Vomiting
|
3 Participants
|
|
Toxicity of Treatment
Fatigue
|
2 Participants
|
|
Toxicity of Treatment
Cholecystitis
|
1 Participants
|
|
Toxicity of Treatment
Allergic reaction
|
1 Participants
|
|
Toxicity of Treatment
Autoimmune disorder
|
1 Participants
|
|
Toxicity of Treatment
Infections and infestations - Other, specify
|
2 Participants
|
|
Toxicity of Treatment
Papulopustular rash
|
1 Participants
|
|
Toxicity of Treatment
Paronychia
|
1 Participants
|
|
Toxicity of Treatment
Rash pustular
|
1 Participants
|
|
Toxicity of Treatment
Sepsis
|
2 Participants
|
|
Toxicity of Treatment
Soft tissue infection
|
1 Participants
|
|
Toxicity of Treatment
Alanine aminotransferase increased
|
3 Participants
|
|
Toxicity of Treatment
Aspartate aminotransferase increased
|
3 Participants
|
|
Toxicity of Treatment
Lipase increased
|
5 Participants
|
|
Toxicity of Treatment
Lymphocyte count decreased
|
4 Participants
|
|
Toxicity of Treatment
Neutrophil count decreased
|
1 Participants
|
|
Toxicity of Treatment
Platelet count decreased
|
1 Participants
|
|
Toxicity of Treatment
Serum amylase increased
|
4 Participants
|
|
Toxicity of Treatment
White blood cell decreased
|
2 Participants
|
|
Toxicity of Treatment
Anorexia
|
1 Participants
|
|
Toxicity of Treatment
Dehydration
|
1 Participants
|
|
Toxicity of Treatment
Hyperglycemia
|
1 Participants
|
|
Toxicity of Treatment
Hypocalcemia
|
2 Participants
|
|
Toxicity of Treatment
Hypokalemia
|
4 Participants
|
|
Toxicity of Treatment
Hypomagnesemia
|
8 Participants
|
|
Toxicity of Treatment
Hyponatremia
|
1 Participants
|
|
Toxicity of Treatment
Hypophosphatemia
|
4 Participants
|
|
Toxicity of Treatment
Pain in extremity
|
1 Participants
|
|
Toxicity of Treatment
Headache
|
1 Participants
|
|
Toxicity of Treatment
Delirium
|
2 Participants
|
|
Toxicity of Treatment
Psychiatric disorders - Other, specify
|
1 Participants
|
|
Toxicity of Treatment
Acute kidney injury
|
1 Participants
|
|
Toxicity of Treatment
Urinary retention
|
1 Participants
|
|
Toxicity of Treatment
Dyspnea
|
2 Participants
|
|
Toxicity of Treatment
Hypoxia
|
1 Participants
|
|
Toxicity of Treatment
Pneumonitis
|
1 Participants
|
|
Toxicity of Treatment
Rash acneiform
|
6 Participants
|
|
Toxicity of Treatment
Rash maculo-papular
|
3 Participants
|
|
Toxicity of Treatment
Skin and subcutaneous tissue disorders - Other, specify
|
1 Participants
|
|
Toxicity of Treatment
Stevens-Johnson syndrome
|
1 Participants
|
|
Toxicity of Treatment
Surgical and medical procedures - Other, specify
|
1 Participants
|
|
Toxicity of Treatment
Hypertension
|
6 Participants
|
|
Toxicity of Treatment
Hypotension
|
1 Participants
|
Adverse Events
Open-label, Single Arm, Phase II
Serious events: 21 serious events
Other events: 56 other events
Deaths: 27 deaths
Serious adverse events
| Measure |
Open-label, Single Arm, Phase II
n=56 participants at risk
Nivolumab and ipilimumab with panitumumab
Panitumumab: 6 mg/kg via IV every 2 weeks in combination with nivolumab and ipilimumab
Nivolumab: 240 mg via IV every 2 weeks in combination with panitumumab and ipilimumab
Ipilimumab: 1 mg/kg via IV every 6 weeks in combination with nivolumab and panitumumab
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
3.6%
2/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Renal and urinary disorders
Acute kidney injury
|
1.8%
1/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Endocrine disorders
Adrenal insufficiency
|
5.4%
3/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Investigations
Alanine aminotransferase increased
|
1.8%
1/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Investigations
Alkaline phosphatase increased
|
1.8%
1/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Metabolism and nutrition disorders
Anorexia
|
1.8%
1/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Investigations
Aspartate aminotransferase increased
|
3.6%
2/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
1.8%
1/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Investigations
Blood bilirubin increased
|
1.8%
1/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Cardiac disorders
Chest pain - cardiac
|
1.8%
1/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Gastrointestinal disorders
Colonic obstruction
|
1.8%
1/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Gastrointestinal disorders
Colonic perforation
|
1.8%
1/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Metabolism and nutrition disorders
Dehydration
|
1.8%
1/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Psychiatric disorders
Delirium
|
1.8%
1/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Gastrointestinal disorders
Diarrhea
|
5.4%
3/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
1.8%
1/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Endocrine disorders
Endocrine disorders - Other, specify
|
1.8%
1/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
General disorders
Fatigue
|
3.6%
2/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
General disorders
Flu like symptoms
|
1.8%
1/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
3.6%
2/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Nervous system disorders
Headache
|
1.8%
1/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Blood and lymphatic system disorders
Hemolysis
|
1.8%
1/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Vascular disorders
Hypotension
|
1.8%
1/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.8%
1/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Infections and infestations
Infections and infestations - Other, specify
|
3.6%
2/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Cardiac disorders
Myocarditis
|
1.8%
1/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Gastrointestinal disorders
Nausea
|
1.8%
1/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.8%
1/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
1.8%
1/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
1.8%
1/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Infections and infestations
Sepsis
|
1.8%
1/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
1.8%
1/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Skin and subcutaneous tissue disorders
Stevens-Johnson syndrome
|
1.8%
1/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Vascular disorders
Thromboembolic event
|
1.8%
1/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Renal and urinary disorders
Urinary retention
|
1.8%
1/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Gastrointestinal disorders
Vomiting
|
3.6%
2/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Gastrointestinal disorders
pancreatitis
|
1.8%
1/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
Other adverse events
| Measure |
Open-label, Single Arm, Phase II
n=56 participants at risk
Nivolumab and ipilimumab with panitumumab
Panitumumab: 6 mg/kg via IV every 2 weeks in combination with nivolumab and ipilimumab
Nivolumab: 240 mg via IV every 2 weeks in combination with panitumumab and ipilimumab
Ipilimumab: 1 mg/kg via IV every 6 weeks in combination with nivolumab and panitumumab
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
16.1%
9/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Renal and urinary disorders
Acute kidney injury
|
3.6%
2/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Endocrine disorders
Adrenal insufficiency
|
5.4%
3/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Nervous system disorders
Akathisia
|
1.8%
1/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Investigations
Alanine aminotransferase increased
|
30.4%
17/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Investigations
Alkaline phosphatase increased
|
26.8%
15/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Immune system disorders
Allergic reaction
|
1.8%
1/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
3.6%
2/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Gastrointestinal disorders
Anal hemorrhage
|
1.8%
1/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Blood and lymphatic system disorders
Anemia
|
28.6%
16/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Metabolism and nutrition disorders
Anorexia
|
33.9%
19/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Psychiatric disorders
Anxiety
|
1.8%
1/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.4%
3/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
3.6%
2/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Gastrointestinal disorders
Ascites
|
1.8%
1/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Investigations
Aspartate aminotransferase increased
|
35.7%
20/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Immune system disorders
Autoimmune disorder
|
1.8%
1/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.1%
4/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Gastrointestinal disorders
Bloating
|
1.8%
1/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
1.8%
1/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Investigations
Blood bilirubin increased
|
10.7%
6/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Eye disorders
Blurred vision
|
10.7%
6/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
1.8%
1/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
1.8%
1/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Gastrointestinal disorders
Cheilitis
|
1.8%
1/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
General disorders
Chills
|
7.1%
4/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Hepatobiliary disorders
Cholecystitis
|
1.8%
1/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Gastrointestinal disorders
Colitis
|
5.4%
3/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Eye disorders
Conjunctivitis
|
5.4%
3/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Gastrointestinal disorders
Constipation
|
28.6%
16/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
17.9%
10/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Investigations
Creatinine increased
|
1.8%
1/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Endocrine disorders
Cushingoid
|
1.8%
1/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Metabolism and nutrition disorders
Dehydration
|
5.4%
3/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Psychiatric disorders
Delirium
|
1.8%
1/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Psychiatric disorders
Depression
|
5.4%
3/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Gastrointestinal disorders
Diarrhea
|
32.1%
18/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Nervous system disorders
Dizziness
|
10.7%
6/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Eye disorders
Dry eye
|
5.4%
3/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Gastrointestinal disorders
Dry mouth
|
5.4%
3/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
30.4%
17/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Nervous system disorders
Dysesthesia
|
1.8%
1/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Nervous system disorders
Dysgeusia
|
5.4%
3/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Gastrointestinal disorders
Dyspepsia
|
5.4%
3/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Gastrointestinal disorders
Dysphagia
|
1.8%
1/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Nervous system disorders
Dysphasia
|
1.8%
1/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
7.1%
4/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Other, specify
|
1.8%
1/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Ear and labyrinth disorders
Ear pain
|
3.6%
2/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
General disorders
Edema limbs
|
10.7%
6/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Endocrine disorders
Endocrine disorders - Other, specify
|
3.6%
2/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.4%
3/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
3.6%
2/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Infections and infestations
Esophageal infection
|
1.8%
1/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Gastrointestinal disorders
Esophagitis
|
1.8%
1/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Ear and labyrinth disorders
External ear inflammation
|
1.8%
1/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Eye disorders
Eye disorders - Other, specify
|
3.6%
2/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Eye disorders
Eye pain
|
1.8%
1/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Eye disorders
Eyelid function disorder
|
3.6%
2/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
General disorders
Facial pain
|
1.8%
1/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
General disorders
Fatigue
|
42.9%
24/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Gastrointestinal disorders
Fecal incontinence
|
1.8%
1/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
General disorders
Fever
|
28.6%
16/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Gastrointestinal disorders
Flatulence
|
1.8%
1/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Eye disorders
Floaters
|
1.8%
1/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
General disorders
Flu like symptoms
|
5.4%
3/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Gastrointestinal disorders
Gastric ulcer
|
1.8%
1/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Gastrointestinal disorders
Gastritis
|
1.8%
1/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
3.6%
2/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
5.4%
3/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Gastrointestinal disorders
Gastroparesis
|
1.8%
1/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
7.1%
4/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
3.6%
2/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Nervous system disorders
Headache
|
17.9%
10/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Renal and urinary disorders
Hematuria
|
5.4%
3/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Investigations
Hemoglobin increased
|
1.8%
1/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Gastrointestinal disorders
Hemorrhoids
|
1.8%
1/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other, specify
|
1.8%
1/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
3.6%
2/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Skin and subcutaneous tissue disorders
Hirsutism
|
3.6%
2/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
3.6%
2/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
1.8%
1/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
12.5%
7/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
1.8%
1/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
3.6%
2/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
1.8%
1/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Metabolism and nutrition disorders
Hypernatremia
|
1.8%
1/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Vascular disorders
Hypertension
|
37.5%
21/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Endocrine disorders
Hyperthyroidism
|
12.5%
7/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Skin and subcutaneous tissue disorders
Hypertrichosis
|
1.8%
1/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
1.8%
1/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
25.0%
14/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
23.2%
13/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
1.8%
1/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Metabolism and nutrition disorders
Hypokalemia
|
35.7%
20/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
67.9%
38/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Metabolism and nutrition disorders
Hyponatremia
|
26.8%
15/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
21.4%
12/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Vascular disorders
Hypotension
|
5.4%
3/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Endocrine disorders
Hypothyroidism
|
26.8%
15/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
3.6%
2/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Investigations
INR increased
|
1.8%
1/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Infections and infestations
Infections and infestations - Other, specify
|
12.5%
7/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
General disorders
Infusion related reaction
|
7.1%
4/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Psychiatric disorders
Insomnia
|
8.9%
5/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Investigations
Investigations - Other, specify
|
14.3%
8/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Nervous system disorders
Lethargy
|
1.8%
1/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Investigations
Lipase increased
|
17.9%
10/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Investigations
Lymphocyte count decreased
|
37.5%
21/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
General disorders
Malaise
|
7.1%
4/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify
|
5.4%
3/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Ear and labyrinth disorders
Middle ear inflammation
|
1.8%
1/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Infections and infestations
Mucosal infection
|
3.6%
2/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Gastrointestinal disorders
Mucositis oral
|
23.2%
13/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
5.4%
3/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.1%
4/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Infections and infestations
Nail infection
|
1.8%
1/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Skin and subcutaneous tissue disorders
Nail loss
|
1.8%
1/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
3.6%
2/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Gastrointestinal disorders
Nausea
|
37.5%
21/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
1.8%
1/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Investigations
Neutrophil count decreased
|
12.5%
7/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Gastrointestinal disorders
Oral pain
|
1.8%
1/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
General disorders
Pain
|
16.1%
9/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.9%
5/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
1.8%
1/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
5.4%
3/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Infections and infestations
Papulopustular rash
|
1.8%
1/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Infections and infestations
Paronychia
|
19.6%
11/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Reproductive system and breast disorders
Penile pain
|
1.8%
1/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Nervous system disorders
Peripheral motor neuropathy
|
1.8%
1/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
3.6%
2/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Skin and subcutaneous tissue disorders
Photosensitivity
|
1.8%
1/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Investigations
Platelet count decreased
|
19.6%
11/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
5.4%
3/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Nervous system disorders
Presyncope
|
1.8%
1/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
1.8%
1/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
48.2%
27/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Psychiatric disorders
Psychiatric disorders - Other, specify
|
3.6%
2/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
1.8%
1/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
91.1%
51/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
12.5%
7/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Infections and infestations
Rash pustular
|
1.8%
1/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
5.4%
3/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Gastrointestinal disorders
Rectal pain
|
1.8%
1/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
1.8%
1/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Renal and urinary disorders
Renal calculi
|
1.8%
1/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders - Other, specify
|
1.8%
1/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
5.4%
3/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Skin and subcutaneous tissue disorders
Scalp pain
|
1.8%
1/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Eye disorders
Scleral disorder
|
1.8%
1/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Investigations
Serum amylase increased
|
14.3%
8/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Cardiac disorders
Sinus tachycardia
|
1.8%
1/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Infections and infestations
Sinusitis
|
1.8%
1/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
21.4%
12/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Infections and infestations
Skin infection
|
1.8%
1/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
3.6%
2/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
1.8%
1/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Skin and subcutaneous tissue disorders
Stevens-Johnson syndrome
|
1.8%
1/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Surgical and medical procedures
Surgical and medical procedures - Other, specify
|
1.8%
1/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Vascular disorders
Thromboembolic event
|
5.4%
3/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Infections and infestations
Upper respiratory infection
|
3.6%
2/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Renal and urinary disorders
Urinary frequency
|
7.1%
4/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Renal and urinary disorders
Urinary retention
|
1.8%
1/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Renal and urinary disorders
Urinary tract pain
|
1.8%
1/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Renal and urinary disorders
Urinary urgency
|
1.8%
1/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Renal and urinary disorders
Urine discoloration
|
3.6%
2/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Reproductive system and breast disorders
Vaginal discharge
|
1.8%
1/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Gastrointestinal disorders
Vomiting
|
37.5%
21/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Eye disorders
Watering eyes
|
1.8%
1/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Investigations
Weight loss
|
3.6%
2/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
|
Investigations
White blood cell decreased
|
16.1%
9/56 • From Day 1 of treatment up to 3 years after completion of treatment
|
Additional Information
Robin V. Johnson
University of North Carolina Lineberger Comprehensive Cancer Center
Phone: 919-966-1125
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place