Trial Outcomes & Findings for Sunitinib in Never-Smokers With Lung Adenocarcinoma (NCT NCT01829217)
NCT ID: NCT01829217
Last Updated: 2018-10-31
Results Overview
Percentage of patients with evidence of complete or partial response per RECIST1.1 criteria.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
13 participants
Primary outcome timeframe
ORR was assessed at 6 weeks post-registration and every 6 weeks until date of documented disease progression or death, up to January 23, 2017 (approximately 44 months).
Results posted on
2018-10-31
Participant Flow
Participant milestones
| Measure |
Sunitinib
42 day cycle, taken orally every day for the first 28 days followed by 14 days off
Sunitinib
|
|---|---|
|
Overall Study
STARTED
|
13
|
|
Overall Study
COMPLETED
|
13
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Sunitinib in Never-Smokers With Lung Adenocarcinoma
Baseline characteristics by cohort
| Measure |
Sunitinib
n=13 Participants
42 day cycle, taken orally every day for the first 28 days followed by 14 days off
Sunitinib
|
|---|---|
|
Age, Continuous
|
67 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: ORR was assessed at 6 weeks post-registration and every 6 weeks until date of documented disease progression or death, up to January 23, 2017 (approximately 44 months).Percentage of patients with evidence of complete or partial response per RECIST1.1 criteria.
Outcome measures
| Measure |
Sunitinib
n=13 Participants
42 day cycle, taken orally every day for the first 28 days followed by 14 days off
Sunitinib
|
|---|---|
|
Objective Response Rate (ORR)
|
7.69 percentage of participants
Interval 0.22 to 36.05
|
Adverse Events
Sunitinib
Serious events: 0 serious events
Other events: 9 other events
Deaths: 7 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Sunitinib
n=13 participants at risk
42 day cycle, taken orally every day for the first 28 days followed by 14 days off
Sunitinib
|
|---|---|
|
Investigations
Alanine aminotransferase increased
|
7.7%
1/13 • Number of events 3 • Adverse events should be reported from start of study intervention through 30 days after the last dose of study treatment. AEs were assessed through January 23, 2017, approximately 44 months.
Because this drug is commercially available, only grade 3 adverse events are reported here.
|
|
Blood and lymphatic system disorders
Anemia
|
15.4%
2/13 • Number of events 6 • Adverse events should be reported from start of study intervention through 30 days after the last dose of study treatment. AEs were assessed through January 23, 2017, approximately 44 months.
Because this drug is commercially available, only grade 3 adverse events are reported here.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
7.7%
1/13 • Number of events 1 • Adverse events should be reported from start of study intervention through 30 days after the last dose of study treatment. AEs were assessed through January 23, 2017, approximately 44 months.
Because this drug is commercially available, only grade 3 adverse events are reported here.
|
|
Blood and lymphatic system disorders
Thrombotic thrombocytopenic purpura
|
23.1%
3/13 • Number of events 4 • Adverse events should be reported from start of study intervention through 30 days after the last dose of study treatment. AEs were assessed through January 23, 2017, approximately 44 months.
Because this drug is commercially available, only grade 3 adverse events are reported here.
|
|
Cardiac disorders
Palpitations
|
7.7%
1/13 • Number of events 1 • Adverse events should be reported from start of study intervention through 30 days after the last dose of study treatment. AEs were assessed through January 23, 2017, approximately 44 months.
Because this drug is commercially available, only grade 3 adverse events are reported here.
|
|
Endocrine disorders
Endocrine disorders - Other, specify
|
7.7%
1/13 • Number of events 3 • Adverse events should be reported from start of study intervention through 30 days after the last dose of study treatment. AEs were assessed through January 23, 2017, approximately 44 months.
Because this drug is commercially available, only grade 3 adverse events are reported here.
|
|
Endocrine disorders
Hyperthyroidism
|
23.1%
3/13 • Number of events 3 • Adverse events should be reported from start of study intervention through 30 days after the last dose of study treatment. AEs were assessed through January 23, 2017, approximately 44 months.
Because this drug is commercially available, only grade 3 adverse events are reported here.
|
|
Endocrine disorders
Hypothyroidism
|
7.7%
1/13 • Number of events 1 • Adverse events should be reported from start of study intervention through 30 days after the last dose of study treatment. AEs were assessed through January 23, 2017, approximately 44 months.
Because this drug is commercially available, only grade 3 adverse events are reported here.
|
|
Eye disorders
Dry eye
|
15.4%
2/13 • Number of events 3 • Adverse events should be reported from start of study intervention through 30 days after the last dose of study treatment. AEs were assessed through January 23, 2017, approximately 44 months.
Because this drug is commercially available, only grade 3 adverse events are reported here.
|
|
Eye disorders
Eye pain
|
7.7%
1/13 • Number of events 1 • Adverse events should be reported from start of study intervention through 30 days after the last dose of study treatment. AEs were assessed through January 23, 2017, approximately 44 months.
Because this drug is commercially available, only grade 3 adverse events are reported here.
|
|
Gastrointestinal disorders
Abdominal pain
|
7.7%
1/13 • Number of events 1 • Adverse events should be reported from start of study intervention through 30 days after the last dose of study treatment. AEs were assessed through January 23, 2017, approximately 44 months.
Because this drug is commercially available, only grade 3 adverse events are reported here.
|
|
Gastrointestinal disorders
Constipation
|
46.2%
6/13 • Number of events 8 • Adverse events should be reported from start of study intervention through 30 days after the last dose of study treatment. AEs were assessed through January 23, 2017, approximately 44 months.
Because this drug is commercially available, only grade 3 adverse events are reported here.
|
|
Gastrointestinal disorders
Diarrhea
|
38.5%
5/13 • Number of events 10 • Adverse events should be reported from start of study intervention through 30 days after the last dose of study treatment. AEs were assessed through January 23, 2017, approximately 44 months.
Because this drug is commercially available, only grade 3 adverse events are reported here.
|
|
Gastrointestinal disorders
Dry mouth
|
15.4%
2/13 • Number of events 2 • Adverse events should be reported from start of study intervention through 30 days after the last dose of study treatment. AEs were assessed through January 23, 2017, approximately 44 months.
Because this drug is commercially available, only grade 3 adverse events are reported here.
|
|
Gastrointestinal disorders
Dyspepsia
|
23.1%
3/13 • Number of events 3 • Adverse events should be reported from start of study intervention through 30 days after the last dose of study treatment. AEs were assessed through January 23, 2017, approximately 44 months.
Because this drug is commercially available, only grade 3 adverse events are reported here.
|
|
Gastrointestinal disorders
Dysphagia
|
7.7%
1/13 • Number of events 1 • Adverse events should be reported from start of study intervention through 30 days after the last dose of study treatment. AEs were assessed through January 23, 2017, approximately 44 months.
Because this drug is commercially available, only grade 3 adverse events are reported here.
|
|
Gastrointestinal disorders
Flatulence
|
7.7%
1/13 • Number of events 1 • Adverse events should be reported from start of study intervention through 30 days after the last dose of study treatment. AEs were assessed through January 23, 2017, approximately 44 months.
Because this drug is commercially available, only grade 3 adverse events are reported here.
|
|
Gastrointestinal disorders
Gastritis
|
7.7%
1/13 • Number of events 1 • Adverse events should be reported from start of study intervention through 30 days after the last dose of study treatment. AEs were assessed through January 23, 2017, approximately 44 months.
Because this drug is commercially available, only grade 3 adverse events are reported here.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
15.4%
2/13 • Number of events 2 • Adverse events should be reported from start of study intervention through 30 days after the last dose of study treatment. AEs were assessed through January 23, 2017, approximately 44 months.
Because this drug is commercially available, only grade 3 adverse events are reported here.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
15.4%
2/13 • Number of events 4 • Adverse events should be reported from start of study intervention through 30 days after the last dose of study treatment. AEs were assessed through January 23, 2017, approximately 44 months.
Because this drug is commercially available, only grade 3 adverse events are reported here.
|
|
Gastrointestinal disorders
Hemorrhoids
|
7.7%
1/13 • Number of events 1 • Adverse events should be reported from start of study intervention through 30 days after the last dose of study treatment. AEs were assessed through January 23, 2017, approximately 44 months.
Because this drug is commercially available, only grade 3 adverse events are reported here.
|
|
Gastrointestinal disorders
Mucositis oral
|
46.2%
6/13 • Number of events 11 • Adverse events should be reported from start of study intervention through 30 days after the last dose of study treatment. AEs were assessed through January 23, 2017, approximately 44 months.
Because this drug is commercially available, only grade 3 adverse events are reported here.
|
|
Gastrointestinal disorders
Nausea
|
46.2%
6/13 • Number of events 9 • Adverse events should be reported from start of study intervention through 30 days after the last dose of study treatment. AEs were assessed through January 23, 2017, approximately 44 months.
Because this drug is commercially available, only grade 3 adverse events are reported here.
|
|
Gastrointestinal disorders
Oral dysesthesia
|
7.7%
1/13 • Number of events 1 • Adverse events should be reported from start of study intervention through 30 days after the last dose of study treatment. AEs were assessed through January 23, 2017, approximately 44 months.
Because this drug is commercially available, only grade 3 adverse events are reported here.
|
|
Gastrointestinal disorders
Oral pain
|
7.7%
1/13 • Number of events 1 • Adverse events should be reported from start of study intervention through 30 days after the last dose of study treatment. AEs were assessed through January 23, 2017, approximately 44 months.
Because this drug is commercially available, only grade 3 adverse events are reported here.
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
7.7%
1/13 • Number of events 2 • Adverse events should be reported from start of study intervention through 30 days after the last dose of study treatment. AEs were assessed through January 23, 2017, approximately 44 months.
Because this drug is commercially available, only grade 3 adverse events are reported here.
|
|
Gastrointestinal disorders
Vomiting
|
30.8%
4/13 • Number of events 7 • Adverse events should be reported from start of study intervention through 30 days after the last dose of study treatment. AEs were assessed through January 23, 2017, approximately 44 months.
Because this drug is commercially available, only grade 3 adverse events are reported here.
|
|
General disorders
Edema limbs
|
23.1%
3/13 • Number of events 3 • Adverse events should be reported from start of study intervention through 30 days after the last dose of study treatment. AEs were assessed through January 23, 2017, approximately 44 months.
Because this drug is commercially available, only grade 3 adverse events are reported here.
|
|
General disorders
Flu like symptoms
|
7.7%
1/13 • Number of events 1 • Adverse events should be reported from start of study intervention through 30 days after the last dose of study treatment. AEs were assessed through January 23, 2017, approximately 44 months.
Because this drug is commercially available, only grade 3 adverse events are reported here.
|
|
General disorders
Localized edema
|
7.7%
1/13 • Number of events 1 • Adverse events should be reported from start of study intervention through 30 days after the last dose of study treatment. AEs were assessed through January 23, 2017, approximately 44 months.
Because this drug is commercially available, only grade 3 adverse events are reported here.
|
|
General disorders
Malaise
|
7.7%
1/13 • Number of events 1 • Adverse events should be reported from start of study intervention through 30 days after the last dose of study treatment. AEs were assessed through January 23, 2017, approximately 44 months.
Because this drug is commercially available, only grade 3 adverse events are reported here.
|
|
General disorders
Non-cardiac chest pain
|
15.4%
2/13 • Number of events 2 • Adverse events should be reported from start of study intervention through 30 days after the last dose of study treatment. AEs were assessed through January 23, 2017, approximately 44 months.
Because this drug is commercially available, only grade 3 adverse events are reported here.
|
|
General disorders
Pain
|
15.4%
2/13 • Number of events 3 • Adverse events should be reported from start of study intervention through 30 days after the last dose of study treatment. AEs were assessed through January 23, 2017, approximately 44 months.
Because this drug is commercially available, only grade 3 adverse events are reported here.
|
|
General disorders
Fatigue
|
69.2%
9/13 • Number of events 20 • Adverse events should be reported from start of study intervention through 30 days after the last dose of study treatment. AEs were assessed through January 23, 2017, approximately 44 months.
Because this drug is commercially available, only grade 3 adverse events are reported here.
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other, specify
|
7.7%
1/13 • Number of events 1 • Adverse events should be reported from start of study intervention through 30 days after the last dose of study treatment. AEs were assessed through January 23, 2017, approximately 44 months.
Because this drug is commercially available, only grade 3 adverse events are reported here.
|
|
Infections and infestations
Infections and infestations - Other, specify
|
7.7%
1/13 • Number of events 3 • Adverse events should be reported from start of study intervention through 30 days after the last dose of study treatment. AEs were assessed through January 23, 2017, approximately 44 months.
Because this drug is commercially available, only grade 3 adverse events are reported here.
|
|
Infections and infestations
Mucosal infection
|
7.7%
1/13 • Number of events 1 • Adverse events should be reported from start of study intervention through 30 days after the last dose of study treatment. AEs were assessed through January 23, 2017, approximately 44 months.
Because this drug is commercially available, only grade 3 adverse events are reported here.
|
|
Infections and infestations
Stoma site infection
|
7.7%
1/13 • Number of events 4 • Adverse events should be reported from start of study intervention through 30 days after the last dose of study treatment. AEs were assessed through January 23, 2017, approximately 44 months.
Because this drug is commercially available, only grade 3 adverse events are reported here.
|
|
Infections and infestations
Upper respiratory infection
|
7.7%
1/13 • Number of events 1 • Adverse events should be reported from start of study intervention through 30 days after the last dose of study treatment. AEs were assessed through January 23, 2017, approximately 44 months.
Because this drug is commercially available, only grade 3 adverse events are reported here.
|
|
Infections and infestations
Urinary tract infection
|
7.7%
1/13 • Number of events 1 • Adverse events should be reported from start of study intervention through 30 days after the last dose of study treatment. AEs were assessed through January 23, 2017, approximately 44 months.
Because this drug is commercially available, only grade 3 adverse events are reported here.
|
|
Injury, poisoning and procedural complications
Bruising
|
23.1%
3/13 • Number of events 3 • Adverse events should be reported from start of study intervention through 30 days after the last dose of study treatment. AEs were assessed through January 23, 2017, approximately 44 months.
Because this drug is commercially available, only grade 3 adverse events are reported here.
|
|
Investigations
Alkaline phosphatase increased
|
7.7%
1/13 • Number of events 1 • Adverse events should be reported from start of study intervention through 30 days after the last dose of study treatment. AEs were assessed through January 23, 2017, approximately 44 months.
Because this drug is commercially available, only grade 3 adverse events are reported here.
|
|
Investigations
Aspartate aminotransferase increased
|
30.8%
4/13 • Number of events 5 • Adverse events should be reported from start of study intervention through 30 days after the last dose of study treatment. AEs were assessed through January 23, 2017, approximately 44 months.
Because this drug is commercially available, only grade 3 adverse events are reported here.
|
|
Investigations
Blood bilirubin increased
|
7.7%
1/13 • Number of events 1 • Adverse events should be reported from start of study intervention through 30 days after the last dose of study treatment. AEs were assessed through January 23, 2017, approximately 44 months.
Because this drug is commercially available, only grade 3 adverse events are reported here.
|
|
Investigations
Creatinine increased
|
7.7%
1/13 • Number of events 1 • Adverse events should be reported from start of study intervention through 30 days after the last dose of study treatment. AEs were assessed through January 23, 2017, approximately 44 months.
Because this drug is commercially available, only grade 3 adverse events are reported here.
|
|
Investigations
Lymphocyte count decreased
|
7.7%
1/13 • Number of events 1 • Adverse events should be reported from start of study intervention through 30 days after the last dose of study treatment. AEs were assessed through January 23, 2017, approximately 44 months.
Because this drug is commercially available, only grade 3 adverse events are reported here.
|
|
Investigations
Neutrophil count decreased
|
38.5%
5/13 • Number of events 11 • Adverse events should be reported from start of study intervention through 30 days after the last dose of study treatment. AEs were assessed through January 23, 2017, approximately 44 months.
Because this drug is commercially available, only grade 3 adverse events are reported here.
|
|
Investigations
Platelet count decreased
|
23.1%
3/13 • Number of events 8 • Adverse events should be reported from start of study intervention through 30 days after the last dose of study treatment. AEs were assessed through January 23, 2017, approximately 44 months.
Because this drug is commercially available, only grade 3 adverse events are reported here.
|
|
Investigations
Weight loss
|
15.4%
2/13 • Number of events 4 • Adverse events should be reported from start of study intervention through 30 days after the last dose of study treatment. AEs were assessed through January 23, 2017, approximately 44 months.
Because this drug is commercially available, only grade 3 adverse events are reported here.
|
|
Investigations
White blood cell decreased
|
38.5%
5/13 • Number of events 11 • Adverse events should be reported from start of study intervention through 30 days after the last dose of study treatment. AEs were assessed through January 23, 2017, approximately 44 months.
Because this drug is commercially available, only grade 3 adverse events are reported here.
|
|
Metabolism and nutrition disorders
Anorexia
|
46.2%
6/13 • Number of events 9 • Adverse events should be reported from start of study intervention through 30 days after the last dose of study treatment. AEs were assessed through January 23, 2017, approximately 44 months.
Because this drug is commercially available, only grade 3 adverse events are reported here.
|
|
Metabolism and nutrition disorders
Dehydration
|
15.4%
2/13 • Number of events 3 • Adverse events should be reported from start of study intervention through 30 days after the last dose of study treatment. AEs were assessed through January 23, 2017, approximately 44 months.
Because this drug is commercially available, only grade 3 adverse events are reported here.
|
|
Metabolism and nutrition disorders
Glucose intolerance
|
7.7%
1/13 • Number of events 1 • Adverse events should be reported from start of study intervention through 30 days after the last dose of study treatment. AEs were assessed through January 23, 2017, approximately 44 months.
Because this drug is commercially available, only grade 3 adverse events are reported here.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
23.1%
3/13 • Number of events 6 • Adverse events should be reported from start of study intervention through 30 days after the last dose of study treatment. AEs were assessed through January 23, 2017, approximately 44 months.
Because this drug is commercially available, only grade 3 adverse events are reported here.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
7.7%
1/13 • Number of events 3 • Adverse events should be reported from start of study intervention through 30 days after the last dose of study treatment. AEs were assessed through January 23, 2017, approximately 44 months.
Because this drug is commercially available, only grade 3 adverse events are reported here.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
7.7%
1/13 • Number of events 1 • Adverse events should be reported from start of study intervention through 30 days after the last dose of study treatment. AEs were assessed through January 23, 2017, approximately 44 months.
Because this drug is commercially available, only grade 3 adverse events are reported here.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
23.1%
3/13 • Number of events 4 • Adverse events should be reported from start of study intervention through 30 days after the last dose of study treatment. AEs were assessed through January 23, 2017, approximately 44 months.
Because this drug is commercially available, only grade 3 adverse events are reported here.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
15.4%
2/13 • Number of events 2 • Adverse events should be reported from start of study intervention through 30 days after the last dose of study treatment. AEs were assessed through January 23, 2017, approximately 44 months.
Because this drug is commercially available, only grade 3 adverse events are reported here.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
15.4%
2/13 • Number of events 2 • Adverse events should be reported from start of study intervention through 30 days after the last dose of study treatment. AEs were assessed through January 23, 2017, approximately 44 months.
Because this drug is commercially available, only grade 3 adverse events are reported here.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
23.1%
3/13 • Number of events 6 • Adverse events should be reported from start of study intervention through 30 days after the last dose of study treatment. AEs were assessed through January 23, 2017, approximately 44 months.
Because this drug is commercially available, only grade 3 adverse events are reported here.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.7%
1/13 • Number of events 2 • Adverse events should be reported from start of study intervention through 30 days after the last dose of study treatment. AEs were assessed through January 23, 2017, approximately 44 months.
Because this drug is commercially available, only grade 3 adverse events are reported here.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
7.7%
1/13 • Number of events 1 • Adverse events should be reported from start of study intervention through 30 days after the last dose of study treatment. AEs were assessed through January 23, 2017, approximately 44 months.
Because this drug is commercially available, only grade 3 adverse events are reported here.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
15.4%
2/13 • Number of events 2 • Adverse events should be reported from start of study intervention through 30 days after the last dose of study treatment. AEs were assessed through January 23, 2017, approximately 44 months.
Because this drug is commercially available, only grade 3 adverse events are reported here.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
23.1%
3/13 • Number of events 3 • Adverse events should be reported from start of study intervention through 30 days after the last dose of study treatment. AEs were assessed through January 23, 2017, approximately 44 months.
Because this drug is commercially available, only grade 3 adverse events are reported here.
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
7.7%
1/13 • Number of events 1 • Adverse events should be reported from start of study intervention through 30 days after the last dose of study treatment. AEs were assessed through January 23, 2017, approximately 44 months.
Because this drug is commercially available, only grade 3 adverse events are reported here.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
7.7%
1/13 • Number of events 1 • Adverse events should be reported from start of study intervention through 30 days after the last dose of study treatment. AEs were assessed through January 23, 2017, approximately 44 months.
Because this drug is commercially available, only grade 3 adverse events are reported here.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
7.7%
1/13 • Number of events 1 • Adverse events should be reported from start of study intervention through 30 days after the last dose of study treatment. AEs were assessed through January 23, 2017, approximately 44 months.
Because this drug is commercially available, only grade 3 adverse events are reported here.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.7%
1/13 • Number of events 1 • Adverse events should be reported from start of study intervention through 30 days after the last dose of study treatment. AEs were assessed through January 23, 2017, approximately 44 months.
Because this drug is commercially available, only grade 3 adverse events are reported here.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
7.7%
1/13 • Number of events 1 • Adverse events should be reported from start of study intervention through 30 days after the last dose of study treatment. AEs were assessed through January 23, 2017, approximately 44 months.
Because this drug is commercially available, only grade 3 adverse events are reported here.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
15.4%
2/13 • Number of events 8 • Adverse events should be reported from start of study intervention through 30 days after the last dose of study treatment. AEs were assessed through January 23, 2017, approximately 44 months.
Because this drug is commercially available, only grade 3 adverse events are reported here.
|
|
Nervous system disorders
Ataxia
|
7.7%
1/13 • Number of events 1 • Adverse events should be reported from start of study intervention through 30 days after the last dose of study treatment. AEs were assessed through January 23, 2017, approximately 44 months.
Because this drug is commercially available, only grade 3 adverse events are reported here.
|
|
Nervous system disorders
Dizziness
|
15.4%
2/13 • Number of events 2 • Adverse events should be reported from start of study intervention through 30 days after the last dose of study treatment. AEs were assessed through January 23, 2017, approximately 44 months.
Because this drug is commercially available, only grade 3 adverse events are reported here.
|
|
Nervous system disorders
Dysgeusia
|
38.5%
5/13 • Number of events 6 • Adverse events should be reported from start of study intervention through 30 days after the last dose of study treatment. AEs were assessed through January 23, 2017, approximately 44 months.
Because this drug is commercially available, only grade 3 adverse events are reported here.
|
|
Nervous system disorders
Headache
|
15.4%
2/13 • Number of events 2 • Adverse events should be reported from start of study intervention through 30 days after the last dose of study treatment. AEs were assessed through January 23, 2017, approximately 44 months.
Because this drug is commercially available, only grade 3 adverse events are reported here.
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
7.7%
1/13 • Number of events 1 • Adverse events should be reported from start of study intervention through 30 days after the last dose of study treatment. AEs were assessed through January 23, 2017, approximately 44 months.
Because this drug is commercially available, only grade 3 adverse events are reported here.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
7.7%
1/13 • Number of events 1 • Adverse events should be reported from start of study intervention through 30 days after the last dose of study treatment. AEs were assessed through January 23, 2017, approximately 44 months.
Because this drug is commercially available, only grade 3 adverse events are reported here.
|
|
Psychiatric disorders
Anxiety
|
7.7%
1/13 • Number of events 1 • Adverse events should be reported from start of study intervention through 30 days after the last dose of study treatment. AEs were assessed through January 23, 2017, approximately 44 months.
Because this drug is commercially available, only grade 3 adverse events are reported here.
|
|
Psychiatric disorders
Insomnia
|
15.4%
2/13 • Number of events 2 • Adverse events should be reported from start of study intervention through 30 days after the last dose of study treatment. AEs were assessed through January 23, 2017, approximately 44 months.
Because this drug is commercially available, only grade 3 adverse events are reported here.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
7.7%
1/13 • Number of events 1 • Adverse events should be reported from start of study intervention through 30 days after the last dose of study treatment. AEs were assessed through January 23, 2017, approximately 44 months.
Because this drug is commercially available, only grade 3 adverse events are reported here.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary hemorrhage
|
7.7%
1/13 • Number of events 1 • Adverse events should be reported from start of study intervention through 30 days after the last dose of study treatment. AEs were assessed through January 23, 2017, approximately 44 months.
Because this drug is commercially available, only grade 3 adverse events are reported here.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
46.2%
6/13 • Number of events 8 • Adverse events should be reported from start of study intervention through 30 days after the last dose of study treatment. AEs were assessed through January 23, 2017, approximately 44 months.
Because this drug is commercially available, only grade 3 adverse events are reported here.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
53.8%
7/13 • Number of events 7 • Adverse events should be reported from start of study intervention through 30 days after the last dose of study treatment. AEs were assessed through January 23, 2017, approximately 44 months.
Because this drug is commercially available, only grade 3 adverse events are reported here.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
30.8%
4/13 • Number of events 4 • Adverse events should be reported from start of study intervention through 30 days after the last dose of study treatment. AEs were assessed through January 23, 2017, approximately 44 months.
Because this drug is commercially available, only grade 3 adverse events are reported here.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
7.7%
1/13 • Number of events 1 • Adverse events should be reported from start of study intervention through 30 days after the last dose of study treatment. AEs were assessed through January 23, 2017, approximately 44 months.
Because this drug is commercially available, only grade 3 adverse events are reported here.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
7.7%
1/13 • Number of events 1 • Adverse events should be reported from start of study intervention through 30 days after the last dose of study treatment. AEs were assessed through January 23, 2017, approximately 44 months.
Because this drug is commercially available, only grade 3 adverse events are reported here.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders
|
7.7%
1/13 • Number of events 1 • Adverse events should be reported from start of study intervention through 30 days after the last dose of study treatment. AEs were assessed through January 23, 2017, approximately 44 months.
Because this drug is commercially available, only grade 3 adverse events are reported here.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
23.1%
3/13 • Number of events 4 • Adverse events should be reported from start of study intervention through 30 days after the last dose of study treatment. AEs were assessed through January 23, 2017, approximately 44 months.
Because this drug is commercially available, only grade 3 adverse events are reported here.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
46.2%
6/13 • Number of events 11 • Adverse events should be reported from start of study intervention through 30 days after the last dose of study treatment. AEs were assessed through January 23, 2017, approximately 44 months.
Because this drug is commercially available, only grade 3 adverse events are reported here.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.7%
1/13 • Number of events 2 • Adverse events should be reported from start of study intervention through 30 days after the last dose of study treatment. AEs were assessed through January 23, 2017, approximately 44 months.
Because this drug is commercially available, only grade 3 adverse events are reported here.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
23.1%
3/13 • Number of events 3 • Adverse events should be reported from start of study intervention through 30 days after the last dose of study treatment. AEs were assessed through January 23, 2017, approximately 44 months.
Because this drug is commercially available, only grade 3 adverse events are reported here.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
7.7%
1/13 • Number of events 1 • Adverse events should be reported from start of study intervention through 30 days after the last dose of study treatment. AEs were assessed through January 23, 2017, approximately 44 months.
Because this drug is commercially available, only grade 3 adverse events are reported here.
|
|
Skin and subcutaneous tissue disorders
Skin/subcutaneous tissue disorders; Other, specify
|
23.1%
3/13 • Number of events 3 • Adverse events should be reported from start of study intervention through 30 days after the last dose of study treatment. AEs were assessed through January 23, 2017, approximately 44 months.
Because this drug is commercially available, only grade 3 adverse events are reported here.
|
|
Vascular disorders
Hypertension
|
23.1%
3/13 • Number of events 5 • Adverse events should be reported from start of study intervention through 30 days after the last dose of study treatment. AEs were assessed through January 23, 2017, approximately 44 months.
Because this drug is commercially available, only grade 3 adverse events are reported here.
|
Additional Information
Principal Investigator: Geoffrey Oxnard, MD
Dana-Farber Cancer Institute
Phone: 617-632-6049
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place