Trial Outcomes & Findings for Trial of Cabozantinib (XL184) in Non-Small Cell Lung Cancer With Brain Metastases (NCT NCT02132598)
NCT ID: NCT02132598
Last Updated: 2021-03-10
Results Overview
The proportion of response-evaluable patients who achieve Complete Response (CR) or Partial Response (PR) as best response by RECIST v1.1 criteria. Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.
TERMINATED
PHASE2
5 participants
Up to 12 months
2021-03-10
Participant Flow
Participant milestones
| Measure |
Cabozantinib (XL184)
Cabozantinib - 60 mg orally, once daily (4 weeks treatment cycles)
Treatment until disease progression, death or unacceptable adverse events.
|
|---|---|
|
Overall Study
STARTED
|
5
|
|
Overall Study
COMPLETED
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Trial of Cabozantinib (XL184) in Non-Small Cell Lung Cancer With Brain Metastases
Baseline characteristics by cohort
| Measure |
Cabozantinib (XL184)
n=5 Participants
Cabozantinib - 60 mg orally, once daily (4 weeks treatment cycles)
Treatment until disease progression, death or unacceptable adverse events.
|
|---|---|
|
Age, Continuous
|
62.6 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 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
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
c-MET amplification
Negative
|
3 Participants
n=5 Participants
|
|
c-MET amplification
Positive
|
2 Participants
n=5 Participants
|
|
Histology
ADENOCARCINOMA IN SITU, NOS
|
1 Participants
n=5 Participants
|
|
Histology
ADENOCARCINOMA, NOS
|
2 Participants
n=5 Participants
|
|
Histology
NON-SMALL CELL CA
|
2 Participants
n=5 Participants
|
|
Stage of Disease
Stage IV
|
5 Participants
n=5 Participants
|
|
Stage of Disease
Stage l-III
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 12 monthsPopulation: Patients evaluable for response: Received at least one dose of study drug, and, underwent at least one radiologic scan follow-up.
The proportion of response-evaluable patients who achieve Complete Response (CR) or Partial Response (PR) as best response by RECIST v1.1 criteria. Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.
Outcome measures
| Measure |
Cabozantinib (XL184)
n=4 Participants
Cabozantinib - 60 mg orally, once daily (4 weeks treatment cycles)
Treatment until disease progression, death or unacceptable adverse events.
|
|---|---|
|
Overall Response
|
0.25 proportion of participants
Interval 0.006 to 0.806
|
SECONDARY outcome
Timeframe: Up to 16 weeksPopulation: As no patients who received at least one dose of study drug and underwent at least one follow-up radiologic scan were able to be evaluated later than 15 weeks, this endpoint cannot be assessed.
Proportion of response-evaluable patients that experienced Complete Response (CR) + Partial Response (PR) + Stable Disease (SD) as best response (RECIST v1.1 criteria) per the total study population criteria. Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. Stable Disease (SD) is defined as, neither sufficient shrinkage (compared to baseline) to qualify for partial or complete response (CR or PR) nor sufficient increase (taking as reference the smallest sum of diameters at baseline or while on study, whichever is smallest) to qualify for progressive disease (PD).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: Only one patient was assessed as having disease progression.
Progression-free survival is the time measured from the initial date of treatment to the date of documented progression, or the date of death (in the absence of progression), whichever occurs first, with progression defined by RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.
Outcome measures
| Measure |
Cabozantinib (XL184)
n=1 Participants
Cabozantinib - 60 mg orally, once daily (4 weeks treatment cycles)
Treatment until disease progression, death or unacceptable adverse events.
|
|---|---|
|
Progression-free Survival (PFS)
|
45 days
|
SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: "All patients" includes all 5 of the patients for whom survival data were available, regardless of c-MET status. "c-MET positive patients" (only) does not include patients for who c-MET status was not positive.
The length of time from the start of treatment that patients remain alive, until death from any cause.
Outcome measures
| Measure |
Cabozantinib (XL184)
n=5 Participants
Cabozantinib - 60 mg orally, once daily (4 weeks treatment cycles)
Treatment until disease progression, death or unacceptable adverse events.
|
|---|---|
|
Overall Survival (OS)
All patients
|
4.07 months
Interval 3.09 to
Upper bound of 95% CI not reached
|
|
Overall Survival (OS)
c-MET positive patients (only)
|
2.25 months
Interval 0.43 to
Upper bound of 95% CI not reached
|
SECONDARY outcome
Timeframe: Until disease progression; Up to 2 yearsPopulation: Only one participant experienced disease progression.
Time from initiation of study treatment to disease progression per RECIST v1.1, excluding death from causes unrelated to the disease. As defined by RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.
Outcome measures
| Measure |
Cabozantinib (XL184)
n=1 Participants
Cabozantinib - 60 mg orally, once daily (4 weeks treatment cycles)
Treatment until disease progression, death or unacceptable adverse events.
|
|---|---|
|
Time to Progression (TTP)
|
45 days
|
SECONDARY outcome
Timeframe: From baseline up to 20 weeksPopulation: Patients that received at least one dose of study drug.
Worst Grade of Adverse Events Reported as assessed by the investigator. Severity/grade defined by the Cancer Therapy Evaluation Program (CTEP) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Subjects monitored continuously for Adverse Events (AE's) throughout the study and for 30 days after the last dose of study treatment.
Outcome measures
| Measure |
Cabozantinib (XL184)
n=5 Participants
Cabozantinib - 60 mg orally, once daily (4 weeks treatment cycles)
Treatment until disease progression, death or unacceptable adverse events.
|
|---|---|
|
Worst Grade of Adverse Events Reported
Grade 1
|
0 Participants
|
|
Worst Grade of Adverse Events Reported
Grade 2
|
0 Participants
|
|
Worst Grade of Adverse Events Reported
Grade 3
|
4 Participants
|
|
Worst Grade of Adverse Events Reported
Grade 4
|
0 Participants
|
|
Worst Grade of Adverse Events Reported
Grade 5
|
1 Participants
|
SECONDARY outcome
Timeframe: From baseline up to 20 weeksPopulation: Patients that received at least one dose of study drug.
Worst Grade of Adverse Events Reported as assessed by the investigator. Severity/grade defined by the Cancer Therapy Evaluation Program (CTEP) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Subjects monitored continuously for Adverse Events (AE's) throughout the study and for 30 days after the last dose of study treatment.
Outcome measures
| Measure |
Cabozantinib (XL184)
n=5 Participants
Cabozantinib - 60 mg orally, once daily (4 weeks treatment cycles)
Treatment until disease progression, death or unacceptable adverse events.
|
|---|---|
|
Worst Grade of AE at Least Possibly Related to Treatment Reported
Grade 3
|
5 Participants
|
|
Worst Grade of AE at Least Possibly Related to Treatment Reported
Grade 4
|
0 Participants
|
|
Worst Grade of AE at Least Possibly Related to Treatment Reported
Grade 5
|
0 Participants
|
|
Worst Grade of AE at Least Possibly Related to Treatment Reported
Grade 1
|
0 Participants
|
|
Worst Grade of AE at Least Possibly Related to Treatment Reported
Grade 2
|
0 Participants
|
SECONDARY outcome
Timeframe: From baseline up to 20 weeksPopulation: Patients that received at least one dose of study drug.
Worst Grade of Adverse Events Reported as assessed by the investigator. Severity/grade defined by the Cancer Therapy Evaluation Program (CTEP) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Subjects monitored continuously for Adverse Events (AE's) throughout the study and for 30 days after the last dose of study treatment.
Outcome measures
| Measure |
Cabozantinib (XL184)
n=4 Participants
Cabozantinib - 60 mg orally, once daily (4 weeks treatment cycles)
Treatment until disease progression, death or unacceptable adverse events.
|
|---|---|
|
Worst Grade of AE at Least Probably Related to Treatment Reported
Grade 1
|
0 Participants
|
|
Worst Grade of AE at Least Probably Related to Treatment Reported
Grade 2
|
0 Participants
|
|
Worst Grade of AE at Least Probably Related to Treatment Reported
Grade 3
|
4 Participants
|
|
Worst Grade of AE at Least Probably Related to Treatment Reported
Grade 4
|
0 Participants
|
|
Worst Grade of AE at Least Probably Related to Treatment Reported
Grade 5
|
0 Participants
|
SECONDARY outcome
Timeframe: From baseline up to 20 weeksPopulation: Patients that received at least one dose of study drug.
Worst Grade of Adverse Events Reported as assessed by the investigator. Severity/grade defined by the Cancer Therapy Evaluation Program (CTEP) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Subjects monitored continuously for Adverse Events (AE's) throughout the study and for 30 days after the last dose of study treatment.
Outcome measures
| Measure |
Cabozantinib (XL184)
n=1 Participants
Cabozantinib - 60 mg orally, once daily (4 weeks treatment cycles)
Treatment until disease progression, death or unacceptable adverse events.
|
|---|---|
|
Worst Grade of AE Definitely Related to Treatment Reported:
Grade 1
|
0 Participants
|
|
Worst Grade of AE Definitely Related to Treatment Reported:
Grade 2
|
0 Participants
|
|
Worst Grade of AE Definitely Related to Treatment Reported:
Grade 3
|
1 Participants
|
|
Worst Grade of AE Definitely Related to Treatment Reported:
Grade 4
|
0 Participants
|
|
Worst Grade of AE Definitely Related to Treatment Reported:
Grade 5
|
0 Participants
|
Adverse Events
Cabozantinib (XL184)
Serious adverse events
| Measure |
Cabozantinib (XL184)
n=5 participants at risk
Cabozantinib - 60 mg orally, once daily (4 weeks treatment cycles)
Treatment until disease progression, death or unacceptable adverse events.
|
|---|---|
|
General disorders
Fatigue
|
40.0%
2/5 • Up to 30 days after discontinuation of treatment.
Serious Adverse Events are defined as grade 3 and higher toxicity events, per CTCAE v4.0
|
|
Infections and infestations
Infections and infestations - Other, specify
|
20.0%
1/5 • Up to 30 days after discontinuation of treatment.
Serious Adverse Events are defined as grade 3 and higher toxicity events, per CTCAE v4.0
|
|
Infections and infestations
Urinary tract infection
|
20.0%
1/5 • Up to 30 days after discontinuation of treatment.
Serious Adverse Events are defined as grade 3 and higher toxicity events, per CTCAE v4.0
|
|
Investigations
Alkaline phosphatase increased
|
20.0%
1/5 • Up to 30 days after discontinuation of treatment.
Serious Adverse Events are defined as grade 3 and higher toxicity events, per CTCAE v4.0
|
|
Investigations
Blood bilirubin increased
|
40.0%
2/5 • Up to 30 days after discontinuation of treatment.
Serious Adverse Events are defined as grade 3 and higher toxicity events, per CTCAE v4.0
|
|
Investigations
GGT increased
|
20.0%
1/5 • Up to 30 days after discontinuation of treatment.
Serious Adverse Events are defined as grade 3 and higher toxicity events, per CTCAE v4.0
|
|
Investigations
Lymphocyte count decreased
|
20.0%
1/5 • Up to 30 days after discontinuation of treatment.
Serious Adverse Events are defined as grade 3 and higher toxicity events, per CTCAE v4.0
|
|
Investigations
Platelet count decreased
|
20.0%
1/5 • Up to 30 days after discontinuation of treatment.
Serious Adverse Events are defined as grade 3 and higher toxicity events, per CTCAE v4.0
|
|
Metabolism and nutrition disorders
Anorexia
|
20.0%
1/5 • Up to 30 days after discontinuation of treatment.
Serious Adverse Events are defined as grade 3 and higher toxicity events, per CTCAE v4.0
|
|
Metabolism and nutrition disorders
Dehydration
|
20.0%
1/5 • Up to 30 days after discontinuation of treatment.
Serious Adverse Events are defined as grade 3 and higher toxicity events, per CTCAE v4.0
|
|
Metabolism and nutrition disorders
Hyponatremia
|
20.0%
1/5 • Up to 30 days after discontinuation of treatment.
Serious Adverse Events are defined as grade 3 and higher toxicity events, per CTCAE v4.0
|
|
Psychiatric disorders
Confusion
|
20.0%
1/5 • Up to 30 days after discontinuation of treatment.
Serious Adverse Events are defined as grade 3 and higher toxicity events, per CTCAE v4.0
|
|
Renal and urinary disorders
Proteinuria
|
20.0%
1/5 • Up to 30 days after discontinuation of treatment.
Serious Adverse Events are defined as grade 3 and higher toxicity events, per CTCAE v4.0
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
20.0%
1/5 • Up to 30 days after discontinuation of treatment.
Serious Adverse Events are defined as grade 3 and higher toxicity events, per CTCAE v4.0
|
|
Vascular disorders
Hypertension
|
40.0%
2/5 • Up to 30 days after discontinuation of treatment.
Serious Adverse Events are defined as grade 3 and higher toxicity events, per CTCAE v4.0
|
Other adverse events
| Measure |
Cabozantinib (XL184)
n=5 participants at risk
Cabozantinib - 60 mg orally, once daily (4 weeks treatment cycles)
Treatment until disease progression, death or unacceptable adverse events.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
20.0%
1/5 • Up to 30 days after discontinuation of treatment.
Serious Adverse Events are defined as grade 3 and higher toxicity events, per CTCAE v4.0
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
20.0%
1/5 • Up to 30 days after discontinuation of treatment.
Serious Adverse Events are defined as grade 3 and higher toxicity events, per CTCAE v4.0
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
20.0%
1/5 • Up to 30 days after discontinuation of treatment.
Serious Adverse Events are defined as grade 3 and higher toxicity events, per CTCAE v4.0
|
|
Cardiac disorders
Sinus tachycardia
|
40.0%
2/5 • Up to 30 days after discontinuation of treatment.
Serious Adverse Events are defined as grade 3 and higher toxicity events, per CTCAE v4.0
|
|
Endocrine disorders
Hypothyroidism
|
20.0%
1/5 • Up to 30 days after discontinuation of treatment.
Serious Adverse Events are defined as grade 3 and higher toxicity events, per CTCAE v4.0
|
|
Gastrointestinal disorders
Abdominal pain
|
20.0%
1/5 • Up to 30 days after discontinuation of treatment.
Serious Adverse Events are defined as grade 3 and higher toxicity events, per CTCAE v4.0
|
|
Gastrointestinal disorders
Constipation
|
40.0%
2/5 • Up to 30 days after discontinuation of treatment.
Serious Adverse Events are defined as grade 3 and higher toxicity events, per CTCAE v4.0
|
|
Gastrointestinal disorders
Diarrhea
|
60.0%
3/5 • Up to 30 days after discontinuation of treatment.
Serious Adverse Events are defined as grade 3 and higher toxicity events, per CTCAE v4.0
|
|
Gastrointestinal disorders
Dyspepsia
|
20.0%
1/5 • Up to 30 days after discontinuation of treatment.
Serious Adverse Events are defined as grade 3 and higher toxicity events, per CTCAE v4.0
|
|
Gastrointestinal disorders
Dysphagia
|
20.0%
1/5 • Up to 30 days after discontinuation of treatment.
Serious Adverse Events are defined as grade 3 and higher toxicity events, per CTCAE v4.0
|
|
Gastrointestinal disorders
Nausea
|
20.0%
1/5 • Up to 30 days after discontinuation of treatment.
Serious Adverse Events are defined as grade 3 and higher toxicity events, per CTCAE v4.0
|
|
Gastrointestinal disorders
Vomiting
|
20.0%
1/5 • Up to 30 days after discontinuation of treatment.
Serious Adverse Events are defined as grade 3 and higher toxicity events, per CTCAE v4.0
|
|
General disorders
Chills
|
20.0%
1/5 • Up to 30 days after discontinuation of treatment.
Serious Adverse Events are defined as grade 3 and higher toxicity events, per CTCAE v4.0
|
|
General disorders
Edema limbs
|
20.0%
1/5 • Up to 30 days after discontinuation of treatment.
Serious Adverse Events are defined as grade 3 and higher toxicity events, per CTCAE v4.0
|
|
General disorders
Fatigue
|
100.0%
5/5 • Up to 30 days after discontinuation of treatment.
Serious Adverse Events are defined as grade 3 and higher toxicity events, per CTCAE v4.0
|
|
General disorders
Fever
|
20.0%
1/5 • Up to 30 days after discontinuation of treatment.
Serious Adverse Events are defined as grade 3 and higher toxicity events, per CTCAE v4.0
|
|
General disorders
Gait disturbance
|
20.0%
1/5 • Up to 30 days after discontinuation of treatment.
Serious Adverse Events are defined as grade 3 and higher toxicity events, per CTCAE v4.0
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
20.0%
1/5 • Up to 30 days after discontinuation of treatment.
Serious Adverse Events are defined as grade 3 and higher toxicity events, per CTCAE v4.0
|
|
General disorders
Pain
|
20.0%
1/5 • Up to 30 days after discontinuation of treatment.
Serious Adverse Events are defined as grade 3 and higher toxicity events, per CTCAE v4.0
|
|
Infections and infestations
Infections and infestations - Other, specify
|
20.0%
1/5 • Up to 30 days after discontinuation of treatment.
Serious Adverse Events are defined as grade 3 and higher toxicity events, per CTCAE v4.0
|
|
Infections and infestations
Urinary tract infection
|
20.0%
1/5 • Up to 30 days after discontinuation of treatment.
Serious Adverse Events are defined as grade 3 and higher toxicity events, per CTCAE v4.0
|
|
Injury, poisoning and procedural complications
Fracture
|
20.0%
1/5 • Up to 30 days after discontinuation of treatment.
Serious Adverse Events are defined as grade 3 and higher toxicity events, per CTCAE v4.0
|
|
Investigations
Activated partial thromboplastin time prolonged
|
20.0%
1/5 • Up to 30 days after discontinuation of treatment.
Serious Adverse Events are defined as grade 3 and higher toxicity events, per CTCAE v4.0
|
|
Investigations
Alanine aminotransferase increased
|
40.0%
2/5 • Up to 30 days after discontinuation of treatment.
Serious Adverse Events are defined as grade 3 and higher toxicity events, per CTCAE v4.0
|
|
Investigations
Alkaline phosphatase increased
|
40.0%
2/5 • Up to 30 days after discontinuation of treatment.
Serious Adverse Events are defined as grade 3 and higher toxicity events, per CTCAE v4.0
|
|
Investigations
Aspartate aminotransferase increased
|
60.0%
3/5 • Up to 30 days after discontinuation of treatment.
Serious Adverse Events are defined as grade 3 and higher toxicity events, per CTCAE v4.0
|
|
Investigations
Blood bilirubin increased
|
60.0%
3/5 • Up to 30 days after discontinuation of treatment.
Serious Adverse Events are defined as grade 3 and higher toxicity events, per CTCAE v4.0
|
|
Investigations
GGT increased
|
20.0%
1/5 • Up to 30 days after discontinuation of treatment.
Serious Adverse Events are defined as grade 3 and higher toxicity events, per CTCAE v4.0
|
|
Investigations
Investigations - Other, specify
|
40.0%
2/5 • Up to 30 days after discontinuation of treatment.
Serious Adverse Events are defined as grade 3 and higher toxicity events, per CTCAE v4.0
|
|
Investigations
Lipase increased
|
20.0%
1/5 • Up to 30 days after discontinuation of treatment.
Serious Adverse Events are defined as grade 3 and higher toxicity events, per CTCAE v4.0
|
|
Investigations
Lymphocyte count decreased
|
20.0%
1/5 • Up to 30 days after discontinuation of treatment.
Serious Adverse Events are defined as grade 3 and higher toxicity events, per CTCAE v4.0
|
|
Investigations
Platelet count decreased
|
40.0%
2/5 • Up to 30 days after discontinuation of treatment.
Serious Adverse Events are defined as grade 3 and higher toxicity events, per CTCAE v4.0
|
|
Investigations
Serum amylase increased
|
40.0%
2/5 • Up to 30 days after discontinuation of treatment.
Serious Adverse Events are defined as grade 3 and higher toxicity events, per CTCAE v4.0
|
|
Investigations
White blood cell decreased
|
20.0%
1/5 • Up to 30 days after discontinuation of treatment.
Serious Adverse Events are defined as grade 3 and higher toxicity events, per CTCAE v4.0
|
|
Metabolism and nutrition disorders
Anorexia
|
20.0%
1/5 • Up to 30 days after discontinuation of treatment.
Serious Adverse Events are defined as grade 3 and higher toxicity events, per CTCAE v4.0
|
|
Metabolism and nutrition disorders
Dehydration
|
20.0%
1/5 • Up to 30 days after discontinuation of treatment.
Serious Adverse Events are defined as grade 3 and higher toxicity events, per CTCAE v4.0
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
40.0%
2/5 • Up to 30 days after discontinuation of treatment.
Serious Adverse Events are defined as grade 3 and higher toxicity events, per CTCAE v4.0
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
20.0%
1/5 • Up to 30 days after discontinuation of treatment.
Serious Adverse Events are defined as grade 3 and higher toxicity events, per CTCAE v4.0
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
60.0%
3/5 • Up to 30 days after discontinuation of treatment.
Serious Adverse Events are defined as grade 3 and higher toxicity events, per CTCAE v4.0
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
20.0%
1/5 • Up to 30 days after discontinuation of treatment.
Serious Adverse Events are defined as grade 3 and higher toxicity events, per CTCAE v4.0
|
|
Metabolism and nutrition disorders
Hypokalemia
|
40.0%
2/5 • Up to 30 days after discontinuation of treatment.
Serious Adverse Events are defined as grade 3 and higher toxicity events, per CTCAE v4.0
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
80.0%
4/5 • Up to 30 days after discontinuation of treatment.
Serious Adverse Events are defined as grade 3 and higher toxicity events, per CTCAE v4.0
|
|
Metabolism and nutrition disorders
Hyponatremia
|
60.0%
3/5 • Up to 30 days after discontinuation of treatment.
Serious Adverse Events are defined as grade 3 and higher toxicity events, per CTCAE v4.0
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
20.0%
1/5 • Up to 30 days after discontinuation of treatment.
Serious Adverse Events are defined as grade 3 and higher toxicity events, per CTCAE v4.0
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify
|
60.0%
3/5 • Up to 30 days after discontinuation of treatment.
Serious Adverse Events are defined as grade 3 and higher toxicity events, per CTCAE v4.0
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
20.0%
1/5 • Up to 30 days after discontinuation of treatment.
Serious Adverse Events are defined as grade 3 and higher toxicity events, per CTCAE v4.0
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
20.0%
1/5 • Up to 30 days after discontinuation of treatment.
Serious Adverse Events are defined as grade 3 and higher toxicity events, per CTCAE v4.0
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
20.0%
1/5 • Up to 30 days after discontinuation of treatment.
Serious Adverse Events are defined as grade 3 and higher toxicity events, per CTCAE v4.0
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
20.0%
1/5 • Up to 30 days after discontinuation of treatment.
Serious Adverse Events are defined as grade 3 and higher toxicity events, per CTCAE v4.0
|
|
Nervous system disorders
Dizziness
|
20.0%
1/5 • Up to 30 days after discontinuation of treatment.
Serious Adverse Events are defined as grade 3 and higher toxicity events, per CTCAE v4.0
|
|
Nervous system disorders
Dysgeusia
|
20.0%
1/5 • Up to 30 days after discontinuation of treatment.
Serious Adverse Events are defined as grade 3 and higher toxicity events, per CTCAE v4.0
|
|
Nervous system disorders
Headache
|
40.0%
2/5 • Up to 30 days after discontinuation of treatment.
Serious Adverse Events are defined as grade 3 and higher toxicity events, per CTCAE v4.0
|
|
Nervous system disorders
Ischemia cerebrovascular
|
20.0%
1/5 • Up to 30 days after discontinuation of treatment.
Serious Adverse Events are defined as grade 3 and higher toxicity events, per CTCAE v4.0
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
20.0%
1/5 • Up to 30 days after discontinuation of treatment.
Serious Adverse Events are defined as grade 3 and higher toxicity events, per CTCAE v4.0
|
|
Psychiatric disorders
Confusion
|
20.0%
1/5 • Up to 30 days after discontinuation of treatment.
Serious Adverse Events are defined as grade 3 and higher toxicity events, per CTCAE v4.0
|
|
Renal and urinary disorders
Proteinuria
|
20.0%
1/5 • Up to 30 days after discontinuation of treatment.
Serious Adverse Events are defined as grade 3 and higher toxicity events, per CTCAE v4.0
|
|
Renal and urinary disorders
Urine discoloration
|
20.0%
1/5 • Up to 30 days after discontinuation of treatment.
Serious Adverse Events are defined as grade 3 and higher toxicity events, per CTCAE v4.0
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
40.0%
2/5 • Up to 30 days after discontinuation of treatment.
Serious Adverse Events are defined as grade 3 and higher toxicity events, per CTCAE v4.0
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
20.0%
1/5 • Up to 30 days after discontinuation of treatment.
Serious Adverse Events are defined as grade 3 and higher toxicity events, per CTCAE v4.0
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
20.0%
1/5 • Up to 30 days after discontinuation of treatment.
Serious Adverse Events are defined as grade 3 and higher toxicity events, per CTCAE v4.0
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
20.0%
1/5 • Up to 30 days after discontinuation of treatment.
Serious Adverse Events are defined as grade 3 and higher toxicity events, per CTCAE v4.0
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
20.0%
1/5 • Up to 30 days after discontinuation of treatment.
Serious Adverse Events are defined as grade 3 and higher toxicity events, per CTCAE v4.0
|
|
Vascular disorders
Hypertension
|
40.0%
2/5 • Up to 30 days after discontinuation of treatment.
Serious Adverse Events are defined as grade 3 and higher toxicity events, per CTCAE v4.0
|
Additional Information
Barbara Stadterman, MPH MCCR
UPMC Hillman Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place