Trial Outcomes & Findings for LCCC 1128: Open Label Phase II Trial of the BRAF Inhibitor (Dabrafenib) and the MEK Inhibitor (Trametinib) in Unresectable Stage III and Stage IV BRAF Mutant Melanoma; Correlation of Resistance With the Kinome and Functional Mutations (NCT NCT01726738)
NCT ID: NCT01726738
Last Updated: 2020-11-23
Results Overview
The primary outcome of this study is to identify kinases that are differentially expressed pre- and post-treatment with BRAF (dabrafenib) and MEK (trametinib) inhibitors. The kinases will be profiled using Multiplexed Inhibitor Beads (MIBs) coupled with mass spectrometry (MS) and reported as a sum of the Log 2 Fold Change between baseline and one year post treatment across all patients
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
17 participants
Primary outcome timeframe
Baseline and One year post treatment
Results posted on
2020-11-23
Participant Flow
A total of 17 participants were recruited from University of North Carolina Hospitals (Chapel Hill, NC) between January 2013 and July 2016
In addition to the 17 patients who were enrolled and participated in the trial, 6 additional patients consented, but were found to be ineligible and 1 additional patient withdrew consent prior to starting the study.
Participant milestones
| Measure |
BRAF (Dabrafenib) and MEK (Trametinib) Inhibitors
BRAF inhibitor dabrafenib and MEK inhibitor trametinib: Patients received the BRAF inhibitor dabrafenib and MEK inhibitor trametinib orally at the Recommend Phase 2 Dose (RP2D) determined in the Phase I/II study (BRF113220): trametinib 2mg once a day (QD) and dabrafenib 150 mg twice a day (BID) on a continuous basis. A cycle is defined as 3 weeks in duration. Cycles were repeated until disease progression (clinical or radiological). Patients could remain on treatment after progression (at the discretion of the investigator) as long as they are still experiencing clinical benefit.
|
|---|---|
|
Overall Study
STARTED
|
17
|
|
Overall Study
COMPLETED
|
17
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
LCCC 1128: Open Label Phase II Trial of the BRAF Inhibitor (Dabrafenib) and the MEK Inhibitor (Trametinib) in Unresectable Stage III and Stage IV BRAF Mutant Melanoma; Correlation of Resistance With the Kinome and Functional Mutations
Baseline characteristics by cohort
| Measure |
BRAF (Dabrafenib) and MEK (Trametinib) Inhibitors
n=17 Participants
BRAF inhibitor dabrafenib and MEK inhibitor trametinib: Patients received the BRAF inhibitor dabrafenib and MEK inhibitor trametinib orally at the RP2D determined in the Phase I/II study (BRF113220): trametinib 2mg QD and dabrafenib 150 mg BID on a continuous basis. A cycle is defined as 3 weeks in duration. Cycles were repeated until disease progression (clinical or radiological). Patients could remain on treatment after progression (at the discretion of the investigator) as long as they are still experiencing clinical benefit.
|
|---|---|
|
Age, Continuous
|
54 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
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
|
17 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
|
|
Region of Enrollment
United States
|
17 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and One year post treatmentPopulation: Progression samples were not available for 7 participants; 3 additional participants did not have samples that were evaluable by MIB/MS
The primary outcome of this study is to identify kinases that are differentially expressed pre- and post-treatment with BRAF (dabrafenib) and MEK (trametinib) inhibitors. The kinases will be profiled using Multiplexed Inhibitor Beads (MIBs) coupled with mass spectrometry (MS) and reported as a sum of the Log 2 Fold Change between baseline and one year post treatment across all patients
Outcome measures
| Measure |
BRAF (Dabrafenib) and MEK (Trametinib) Inhibitors
n=7 Participants
BRAF inhibitor dabrafenib and MEK inhibitor trametinib: Patients received the BRAF inhibitor dabrafenib and MEK inhibitor trametinib orally at the RP2D determined in the Phase I/II study (BRF113220): trametinib 2mg QD and dabrafenib 150 mg BID on a continuous basis. A cycle is defined as 3 weeks in duration. Cycles were repeated until disease progression (clinical or radiological). Patients could remain on treatment after progression (at the discretion of the investigator) as long as they are still experiencing clinical benefit.
|
|---|---|
|
Change in Kinase Expression
PI4K2B
|
-7.66173 Sum Log 2 Fold Change Kinase Expression
|
|
Change in Kinase Expression
PKMYT1
|
-11.3527 Sum Log 2 Fold Change Kinase Expression
|
|
Change in Kinase Expression
MAP4K3
|
-9.8909 Sum Log 2 Fold Change Kinase Expression
|
|
Change in Kinase Expression
WEE1
|
-9.61838 Sum Log 2 Fold Change Kinase Expression
|
|
Change in Kinase Expression
TEC
|
-10.15407 Sum Log 2 Fold Change Kinase Expression
|
|
Change in Kinase Expression
CSNK1D
|
-9.57122 Sum Log 2 Fold Change Kinase Expression
|
|
Change in Kinase Expression
EPHA4
|
-9.5134 Sum Log 2 Fold Change Kinase Expression
|
|
Change in Kinase Expression
AURKB
|
-5.70255 Sum Log 2 Fold Change Kinase Expression
|
|
Change in Kinase Expression
ZAK
|
-9.14964 Sum Log 2 Fold Change Kinase Expression
|
|
Change in Kinase Expression
LIMK2
|
-7.86008 Sum Log 2 Fold Change Kinase Expression
|
|
Change in Kinase Expression
ADCK4
|
-8.56373 Sum Log 2 Fold Change Kinase Expression
|
|
Change in Kinase Expression
NME4
|
-5.34905 Sum Log 2 Fold Change Kinase Expression
|
|
Change in Kinase Expression
RIPK2
|
-20.87259 Sum Log 2 Fold Change Kinase Expression
|
|
Change in Kinase Expression
PTK6
|
-19.64376 Sum Log 2 Fold Change Kinase Expression
|
|
Change in Kinase Expression
BRAF
|
-16.41738 Sum Log 2 Fold Change Kinase Expression
|
|
Change in Kinase Expression
CDK1
|
-12.5401 Sum Log 2 Fold Change Kinase Expression
|
|
Change in Kinase Expression
PAK4
|
-12.31239 Sum Log 2 Fold Change Kinase Expression
|
|
Change in Kinase Expression
LIMK1
|
-12.38811 Sum Log 2 Fold Change Kinase Expression
|
|
Change in Kinase Expression
EIF2AK2
|
-12.51229 Sum Log 2 Fold Change Kinase Expression
|
|
Change in Kinase Expression
AURKA
|
-10.87395 Sum Log 2 Fold Change Kinase Expression
|
PRIMARY outcome
Timeframe: One year post treatmentPrediction analysis of microarrays (PAM) based on nearest shrunken centroid will also be carried out to identify a subset of kinases that predicts resistance to BRAF+MEK inhibition.
Outcome measures
| Measure |
BRAF (Dabrafenib) and MEK (Trametinib) Inhibitors
n=7 Participants
BRAF inhibitor dabrafenib and MEK inhibitor trametinib: Patients received the BRAF inhibitor dabrafenib and MEK inhibitor trametinib orally at the RP2D determined in the Phase I/II study (BRF113220): trametinib 2mg QD and dabrafenib 150 mg BID on a continuous basis. A cycle is defined as 3 weeks in duration. Cycles were repeated until disease progression (clinical or radiological). Patients could remain on treatment after progression (at the discretion of the investigator) as long as they are still experiencing clinical benefit.
|
|---|---|
|
Kinome Signature Predictive of Resistance
|
0 predictive kinase signatures
|
SECONDARY outcome
Timeframe: One yearPopulation: Progression samples were not available for 7 participants; 3 additional participants did not have samples that were evaluable by MIB/MS
The secondary outcome measure is to explore whether resistance to BRAF and MEK inhibition is associated with new functional mutations in the approximately 150 oncogenes / tumor suppressor genes that are assessed in more than 10% of the tumors (using Next Generation (NextGen) DNA sequencing technology) in the subset of patients who co-enroll in a correlative study, with particular focus on one of five established resistance genes (BRAF, NRAS, MEK1, Mitogen-Activated Protein Kinase Kinase Kinase 8 (MAP3K8) or Cancer Osaka Thyroid (COT), and PTEN).
Outcome measures
| Measure |
BRAF (Dabrafenib) and MEK (Trametinib) Inhibitors
n=7 Participants
BRAF inhibitor dabrafenib and MEK inhibitor trametinib: Patients received the BRAF inhibitor dabrafenib and MEK inhibitor trametinib orally at the RP2D determined in the Phase I/II study (BRF113220): trametinib 2mg QD and dabrafenib 150 mg BID on a continuous basis. A cycle is defined as 3 weeks in duration. Cycles were repeated until disease progression (clinical or radiological). Patients could remain on treatment after progression (at the discretion of the investigator) as long as they are still experiencing clinical benefit.
|
|---|---|
|
BRAF and MEK Inhibition Associated With New Functional Mutations in the Approximately 150 Oncogenes
|
0 Functional mutation predictors
|
SECONDARY outcome
Timeframe: One year post treatmentTo determine the disease overall response rate (ORR: complete response (CR) + partial response (PR)/total number of patients) as measured radiographically via Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions. CR is defined as the disappearance of all target lesions; PR is a \>=30% decrease in the sum of the longest diameter of target lesions
Outcome measures
| Measure |
BRAF (Dabrafenib) and MEK (Trametinib) Inhibitors
n=17 Participants
BRAF inhibitor dabrafenib and MEK inhibitor trametinib: Patients received the BRAF inhibitor dabrafenib and MEK inhibitor trametinib orally at the RP2D determined in the Phase I/II study (BRF113220): trametinib 2mg QD and dabrafenib 150 mg BID on a continuous basis. A cycle is defined as 3 weeks in duration. Cycles were repeated until disease progression (clinical or radiological). Patients could remain on treatment after progression (at the discretion of the investigator) as long as they are still experiencing clinical benefit.
|
|---|---|
|
Overall Response Rate (ORR)
|
76 percentage of patients with response
Interval 50.0 to 93.0
|
SECONDARY outcome
Timeframe: One year post treatmentDuration of overall response is defined as the time from documentation of response (Complete or Partial) to time of disease progression or death. Response was measured radiographically using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions. Complete Response is defined as the disappearance of all target lesions; Partial Response as a \>=30% decrease in the sum of the longest diameter of target lesions, and Progressive Disease as a 20% increase in the sum of the longest diameter of target lesions or the appearance of new lesions.
Outcome measures
| Measure |
BRAF (Dabrafenib) and MEK (Trametinib) Inhibitors
n=17 Participants
BRAF inhibitor dabrafenib and MEK inhibitor trametinib: Patients received the BRAF inhibitor dabrafenib and MEK inhibitor trametinib orally at the RP2D determined in the Phase I/II study (BRF113220): trametinib 2mg QD and dabrafenib 150 mg BID on a continuous basis. A cycle is defined as 3 weeks in duration. Cycles were repeated until disease progression (clinical or radiological). Patients could remain on treatment after progression (at the discretion of the investigator) as long as they are still experiencing clinical benefit.
|
|---|---|
|
Duration of Overall Response
|
13 Months
Interval 1.4 to 22.0
|
SECONDARY outcome
Timeframe: One year post treatmentPFS is defined as the time from Day 1 of protocol treatment to the date of progression as measured radiographically using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) or to the date of death. Per RECIST, Progressive Disease as a 20% increase in the sum of the longest diameter of target lesions or the appearance of new lesions.
Outcome measures
| Measure |
BRAF (Dabrafenib) and MEK (Trametinib) Inhibitors
n=17 Participants
BRAF inhibitor dabrafenib and MEK inhibitor trametinib: Patients received the BRAF inhibitor dabrafenib and MEK inhibitor trametinib orally at the RP2D determined in the Phase I/II study (BRF113220): trametinib 2mg QD and dabrafenib 150 mg BID on a continuous basis. A cycle is defined as 3 weeks in duration. Cycles were repeated until disease progression (clinical or radiological). Patients could remain on treatment after progression (at the discretion of the investigator) as long as they are still experiencing clinical benefit.
|
|---|---|
|
Progression Free Survival (PFS)
|
17 Months
Interval 4.1 to 25.4
|
SECONDARY outcome
Timeframe: One year post treatmentThe rate of overall survival is defined as the percentage of patients still alive at one year from Day 1 of protocol treatment
Outcome measures
| Measure |
BRAF (Dabrafenib) and MEK (Trametinib) Inhibitors
n=17 Participants
BRAF inhibitor dabrafenib and MEK inhibitor trametinib: Patients received the BRAF inhibitor dabrafenib and MEK inhibitor trametinib orally at the RP2D determined in the Phase I/II study (BRF113220): trametinib 2mg QD and dabrafenib 150 mg BID on a continuous basis. A cycle is defined as 3 weeks in duration. Cycles were repeated until disease progression (clinical or radiological). Patients could remain on treatment after progression (at the discretion of the investigator) as long as they are still experiencing clinical benefit.
|
|---|---|
|
Rate of Overall Survival (OS) at 12 Months
|
70 percentage of patients alive at 1 year
Interval 42.0 to 86.0
|
Adverse Events
BRAF (Dabrafenib) and MEK (Trametinib) Inhibitors
Serious events: 11 serious events
Other events: 17 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
BRAF (Dabrafenib) and MEK (Trametinib) Inhibitors
n=17 participants at risk
BRAF inhibitor dabrafenib and MEK inhibitor trametinib: Patients received the BRAF inhibitor dabrafenib and MEK inhibitor trametinib orally at the RP2D determined in the Phase I/II study (BRF113220): trametinib 2mg QD and dabrafenib 150 mg BID on a continuous basis. A cycle is defined as 3 weeks in duration. Cycles were repeated until disease progression (clinical or radiological). Patients could remain on treatment after progression (at the discretion of the investigator) as long as they are still experiencing clinical benefit.
|
|---|---|
|
Investigations
Alanine Aminotransferase Increased
|
5.9%
1/17 • From start of treatment through 30 days after end of treatment
|
|
Investigations
Aspartate Aminotransferase Increased
|
5.9%
1/17 • From start of treatment through 30 days after end of treatment
|
|
Gastrointestinal disorders
Diarrhea
|
5.9%
1/17 • From start of treatment through 30 days after end of treatment
|
|
Endocrine disorders
Endocrine Disorders - Other, Specify
|
5.9%
1/17 • From start of treatment through 30 days after end of treatment
|
|
General disorders
Fatigue
|
5.9%
1/17 • From start of treatment through 30 days after end of treatment
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
5.9%
1/17 • From start of treatment through 30 days after end of treatment
|
|
General disorders
Fever
|
11.8%
2/17 • From start of treatment through 30 days after end of treatment
|
|
General disorders
Flu Like Symptoms
|
5.9%
1/17 • From start of treatment through 30 days after end of treatment
|
|
Gastrointestinal disorders
Gastrointestinal Disorders - Other, Specify
|
5.9%
1/17 • From start of treatment through 30 days after end of treatment
|
|
General disorders
General Disorders And Administration Site Conditions - Other, Specify
|
5.9%
1/17 • From start of treatment through 30 days after end of treatment
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
5.9%
1/17 • From start of treatment through 30 days after end of treatment
|
|
Metabolism and nutrition disorders
Hyponatremia
|
5.9%
1/17 • From start of treatment through 30 days after end of treatment
|
|
Nervous system disorders
Intracranial Hemorrhage
|
5.9%
1/17 • From start of treatment through 30 days after end of treatment
|
|
General disorders
Multi-Organ Failure
|
5.9%
1/17 • From start of treatment through 30 days after end of treatment
|
|
Gastrointestinal disorders
Nausea
|
5.9%
1/17 • From start of treatment through 30 days after end of treatment
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-Papular
|
5.9%
1/17 • From start of treatment through 30 days after end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
5.9%
1/17 • From start of treatment through 30 days after end of treatment
|
|
Infections and infestations
Sepsis
|
5.9%
1/17 • From start of treatment through 30 days after end of treatment
|
|
Cardiac disorders
Sinus Tachycardia
|
5.9%
1/17 • From start of treatment through 30 days after end of treatment
|
|
Skin and subcutaneous tissue disorders
Skin And Subcutaneous Tissue Disorders - Other, Specify
|
5.9%
1/17 • From start of treatment through 30 days after end of treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Treatment Related Secondary Malignancy
|
5.9%
1/17 • From start of treatment through 30 days after end of treatment
|
|
Gastrointestinal disorders
Vomiting
|
5.9%
1/17 • From start of treatment through 30 days after end of treatment
|
Other adverse events
| Measure |
BRAF (Dabrafenib) and MEK (Trametinib) Inhibitors
n=17 participants at risk
BRAF inhibitor dabrafenib and MEK inhibitor trametinib: Patients received the BRAF inhibitor dabrafenib and MEK inhibitor trametinib orally at the RP2D determined in the Phase I/II study (BRF113220): trametinib 2mg QD and dabrafenib 150 mg BID on a continuous basis. A cycle is defined as 3 weeks in duration. Cycles were repeated until disease progression (clinical or radiological). Patients could remain on treatment after progression (at the discretion of the investigator) as long as they are still experiencing clinical benefit.
|
|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
23.5%
4/17 • From start of treatment through 30 days after end of treatment
|
|
Investigations
Alanine Aminotransferase Increased
|
76.5%
13/17 • From start of treatment through 30 days after end of treatment
|
|
Investigations
Alkaline Phosphatase Increased
|
23.5%
4/17 • From start of treatment through 30 days after end of treatment
|
|
Immune system disorders
Allergic Reaction
|
5.9%
1/17 • From start of treatment through 30 days after end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Allergic Rhinitis
|
11.8%
2/17 • From start of treatment through 30 days after end of treatment
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
11.8%
2/17 • From start of treatment through 30 days after end of treatment
|
|
Blood and lymphatic system disorders
Anemia
|
64.7%
11/17 • From start of treatment through 30 days after end of treatment
|
|
Metabolism and nutrition disorders
Anorexia
|
23.5%
4/17 • From start of treatment through 30 days after end of treatment
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
47.1%
8/17 • From start of treatment through 30 days after end of treatment
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
5.9%
1/17 • From start of treatment through 30 days after end of treatment
|
|
Investigations
Aspartate Aminotransferase Increased
|
76.5%
13/17 • From start of treatment through 30 days after end of treatment
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
17.6%
3/17 • From start of treatment through 30 days after end of treatment
|
|
Investigations
Blood Bilirubin Increased
|
5.9%
1/17 • From start of treatment through 30 days after end of treatment
|
|
Injury, poisoning and procedural complications
Bruising
|
11.8%
2/17 • From start of treatment through 30 days after end of treatment
|
|
Eye disorders
Cataract
|
5.9%
1/17 • From start of treatment through 30 days after end of treatment
|
|
General disorders
Chills
|
64.7%
11/17 • From start of treatment through 30 days after end of treatment
|
|
Renal and urinary disorders
Chronic Kidney Disease
|
5.9%
1/17 • From start of treatment through 30 days after end of treatment
|
|
Psychiatric disorders
Confusion
|
11.8%
2/17 • From start of treatment through 30 days after end of treatment
|
|
Gastrointestinal disorders
Constipation
|
41.2%
7/17 • From start of treatment through 30 days after end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
29.4%
5/17 • From start of treatment through 30 days after end of treatment
|
|
Investigations
Cpk Increased
|
11.8%
2/17 • From start of treatment through 30 days after end of treatment
|
|
Investigations
Creatinine Increased
|
35.3%
6/17 • From start of treatment through 30 days after end of treatment
|
|
Metabolism and nutrition disorders
Dehydration
|
11.8%
2/17 • From start of treatment through 30 days after end of treatment
|
|
Psychiatric disorders
Depression
|
11.8%
2/17 • From start of treatment through 30 days after end of treatment
|
|
Gastrointestinal disorders
Diarrhea
|
58.8%
10/17 • From start of treatment through 30 days after end of treatment
|
|
Nervous system disorders
Dizziness
|
29.4%
5/17 • From start of treatment through 30 days after end of treatment
|
|
Gastrointestinal disorders
Dry Mouth
|
5.9%
1/17 • From start of treatment through 30 days after end of treatment
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
23.5%
4/17 • From start of treatment through 30 days after end of treatment
|
|
Nervous system disorders
Dysgeusia
|
5.9%
1/17 • From start of treatment through 30 days after end of treatment
|
|
Reproductive system and breast disorders
Dysmenorrhea
|
5.9%
1/17 • From start of treatment through 30 days after end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
23.5%
4/17 • From start of treatment through 30 days after end of treatment
|
|
General disorders
Edema Face
|
5.9%
1/17 • From start of treatment through 30 days after end of treatment
|
|
General disorders
Edema Limbs
|
29.4%
5/17 • From start of treatment through 30 days after end of treatment
|
|
Investigations
Ejection Fraction Decreased
|
11.8%
2/17 • From start of treatment through 30 days after end of treatment
|
|
Endocrine disorders
Endocrine Disorders - Other, Specify
|
5.9%
1/17 • From start of treatment through 30 days after end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.9%
1/17 • From start of treatment through 30 days after end of treatment
|
|
Skin and subcutaneous tissue disorders
Erythema Multiforme
|
5.9%
1/17 • From start of treatment through 30 days after end of treatment
|
|
Eye disorders
Eye Disorders - Other, Specify
|
17.6%
3/17 • From start of treatment through 30 days after end of treatment
|
|
Eye disorders
Eye Pain
|
5.9%
1/17 • From start of treatment through 30 days after end of treatment
|
|
General disorders
Fatigue
|
76.5%
13/17 • From start of treatment through 30 days after end of treatment
|
|
General disorders
Fever
|
70.6%
12/17 • From start of treatment through 30 days after end of treatment
|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
5.9%
1/17 • From start of treatment through 30 days after end of treatment
|
|
Gastrointestinal disorders
Flatulence
|
5.9%
1/17 • From start of treatment through 30 days after end of treatment
|
|
Eye disorders
Floaters
|
5.9%
1/17 • From start of treatment through 30 days after end of treatment
|
|
General disorders
Flu Like Symptoms
|
47.1%
8/17 • From start of treatment through 30 days after end of treatment
|
|
Vascular disorders
Flushing
|
11.8%
2/17 • From start of treatment through 30 days after end of treatment
|
|
Injury, poisoning and procedural complications
Fracture
|
5.9%
1/17 • From start of treatment through 30 days after end of treatment
|
|
General disorders
Gait Disturbance
|
5.9%
1/17 • From start of treatment through 30 days after end of treatment
|
|
Gastrointestinal disorders
Gastroesophageal Reflux Disease
|
11.8%
2/17 • From start of treatment through 30 days after end of treatment
|
|
Gastrointestinal disorders
Gastrointestinal Disorders - Other, Specify
|
23.5%
4/17 • From start of treatment through 30 days after end of treatment
|
|
General disorders
General Disorders And Administration Site Conditions - Other, Specify
|
17.6%
3/17 • From start of treatment through 30 days after end of treatment
|
|
General disorders
Generalized Muscle Weakness
|
11.8%
2/17 • From start of treatment through 30 days after end of treatment
|
|
Investigations
Ggt Increased
|
23.5%
4/17 • From start of treatment through 30 days after end of treatment
|
|
Infections and infestations
Gum Infection
|
5.9%
1/17 • From start of treatment through 30 days after end of treatment
|
|
Nervous system disorders
Headache
|
47.1%
8/17 • From start of treatment through 30 days after end of treatment
|
|
Gastrointestinal disorders
Hemorrhoids
|
5.9%
1/17 • From start of treatment through 30 days after end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
5.9%
1/17 • From start of treatment through 30 days after end of treatment
|
|
Vascular disorders
Hot Flashes
|
11.8%
2/17 • From start of treatment through 30 days after end of treatment
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
5.9%
1/17 • From start of treatment through 30 days after end of treatment
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
29.4%
5/17 • From start of treatment through 30 days after end of treatment
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
41.2%
7/17 • From start of treatment through 30 days after end of treatment
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
11.8%
2/17 • From start of treatment through 30 days after end of treatment
|
|
Metabolism and nutrition disorders
Hypernatremia
|
11.8%
2/17 • From start of treatment through 30 days after end of treatment
|
|
Vascular disorders
Hypertension
|
41.2%
7/17 • From start of treatment through 30 days after end of treatment
|
|
Endocrine disorders
Hyperthyroidism
|
5.9%
1/17 • From start of treatment through 30 days after end of treatment
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
76.5%
13/17 • From start of treatment through 30 days after end of treatment
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
47.1%
8/17 • From start of treatment through 30 days after end of treatment
|
|
Metabolism and nutrition disorders
Hypokalemia
|
17.6%
3/17 • From start of treatment through 30 days after end of treatment
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
41.2%
7/17 • From start of treatment through 30 days after end of treatment
|
|
Metabolism and nutrition disorders
Hyponatremia
|
52.9%
9/17 • From start of treatment through 30 days after end of treatment
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
17.6%
3/17 • From start of treatment through 30 days after end of treatment
|
|
Vascular disorders
Hypotension
|
11.8%
2/17 • From start of treatment through 30 days after end of treatment
|
|
Endocrine disorders
Hypothyroidism
|
11.8%
2/17 • From start of treatment through 30 days after end of treatment
|
|
Infections and infestations
Infections And Infestations - Other, Specify
|
5.9%
1/17 • From start of treatment through 30 days after end of treatment
|
|
Psychiatric disorders
Insomnia
|
5.9%
1/17 • From start of treatment through 30 days after end of treatment
|
|
Nervous system disorders
Intracranial Hemorrhage
|
5.9%
1/17 • From start of treatment through 30 days after end of treatment
|
|
Psychiatric disorders
Libido Decreased
|
5.9%
1/17 • From start of treatment through 30 days after end of treatment
|
|
Investigations
Lipase Increased
|
11.8%
2/17 • From start of treatment through 30 days after end of treatment
|
|
Investigations
Lymphocyte Count Decreased
|
94.1%
16/17 • From start of treatment through 30 days after end of treatment
|
|
Investigations
Lymphocyte Count Increased
|
5.9%
1/17 • From start of treatment through 30 days after end of treatment
|
|
General disorders
Malaise
|
17.6%
3/17 • From start of treatment through 30 days after end of treatment
|
|
Nervous system disorders
Memory Impairment
|
5.9%
1/17 • From start of treatment through 30 days after end of treatment
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal And Connective Tissue Disorder - Other, Specify
|
17.6%
3/17 • From start of treatment through 30 days after end of treatment
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
17.6%
3/17 • From start of treatment through 30 days after end of treatment
|
|
Skin and subcutaneous tissue disorders
Nail Loss
|
5.9%
1/17 • From start of treatment through 30 days after end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
17.6%
3/17 • From start of treatment through 30 days after end of treatment
|
|
Gastrointestinal disorders
Nausea
|
58.8%
10/17 • From start of treatment through 30 days after end of treatment
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
17.6%
3/17 • From start of treatment through 30 days after end of treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms Benign, Malignant And Unspecified (Incl Cysts And Polyps) -
|
5.9%
1/17 • From start of treatment through 30 days after end of treatment
|
|
Investigations
Neutrophil Count Decreased
|
58.8%
10/17 • From start of treatment through 30 days after end of treatment
|
|
General disorders
Non-Cardiac Chest Pain
|
11.8%
2/17 • From start of treatment through 30 days after end of treatment
|
|
General disorders
Pain
|
29.4%
5/17 • From start of treatment through 30 days after end of treatment
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
11.8%
2/17 • From start of treatment through 30 days after end of treatment
|
|
Skin and subcutaneous tissue disorders
Pain Of Skin
|
17.6%
3/17 • From start of treatment through 30 days after end of treatment
|
|
Skin and subcutaneous tissue disorders
Palmar-Plantar Erythrodysesthesia Syndrome
|
5.9%
1/17 • From start of treatment through 30 days after end of treatment
|
|
Infections and infestations
Papulopustular Rash
|
5.9%
1/17 • From start of treatment through 30 days after end of treatment
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
5.9%
1/17 • From start of treatment through 30 days after end of treatment
|
|
Psychiatric disorders
Personality Change
|
5.9%
1/17 • From start of treatment through 30 days after end of treatment
|
|
Skin and subcutaneous tissue disorders
Photosensitivity
|
5.9%
1/17 • From start of treatment through 30 days after end of treatment
|
|
Investigations
Platelet Count Decreased
|
52.9%
9/17 • From start of treatment through 30 days after end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal Drip
|
5.9%
1/17 • From start of treatment through 30 days after end of treatment
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
29.4%
5/17 • From start of treatment through 30 days after end of treatment
|
|
Psychiatric disorders
Psychiatric Disorders - Other, Specify
|
5.9%
1/17 • From start of treatment through 30 days after end of treatment
|
|
Skin and subcutaneous tissue disorders
Rash Acneiform
|
11.8%
2/17 • From start of treatment through 30 days after end of treatment
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-Papular
|
52.9%
9/17 • From start of treatment through 30 days after end of treatment
|
|
Reproductive system and breast disorders
Reproductive System And Breast Disorders - Other, Specify
|
11.8%
2/17 • From start of treatment through 30 days after end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
5.9%
1/17 • From start of treatment through 30 days after end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, Thoracic And Mediastinal Disorders - Other, Specify
|
5.9%
1/17 • From start of treatment through 30 days after end of treatment
|
|
Nervous system disorders
Seizure
|
5.9%
1/17 • From start of treatment through 30 days after end of treatment
|
|
Nervous system disorders
Sinus Pain
|
11.8%
2/17 • From start of treatment through 30 days after end of treatment
|
|
Infections and infestations
Sinusitis
|
11.8%
2/17 • From start of treatment through 30 days after end of treatment
|
|
Skin and subcutaneous tissue disorders
Skin And Subcutaneous Tissue Disorders - Other, Specify
|
76.5%
13/17 • From start of treatment through 30 days after end of treatment
|
|
Skin and subcutaneous tissue disorders
Skin Induration
|
5.9%
1/17 • From start of treatment through 30 days after end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Sore Throat
|
17.6%
3/17 • From start of treatment through 30 days after end of treatment
|
|
Gastrointestinal disorders
Stomach Pain
|
11.8%
2/17 • From start of treatment through 30 days after end of treatment
|
|
Infections and infestations
Tooth Infection
|
5.9%
1/17 • From start of treatment through 30 days after end of treatment
|
|
Nervous system disorders
Tremor
|
5.9%
1/17 • From start of treatment through 30 days after end of treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor Pain
|
5.9%
1/17 • From start of treatment through 30 days after end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Infection
|
11.8%
2/17 • From start of treatment through 30 days after end of treatment
|
|
Renal and urinary disorders
Urinary Incontinence
|
5.9%
1/17 • From start of treatment through 30 days after end of treatment
|
|
Infections and infestations
Urinary Tract Infection
|
5.9%
1/17 • From start of treatment through 30 days after end of treatment
|
|
Renal and urinary disorders
Urinary Tract Pain
|
11.8%
2/17 • From start of treatment through 30 days after end of treatment
|
|
Infections and infestations
Vaginal Infection
|
5.9%
1/17 • From start of treatment through 30 days after end of treatment
|
|
Reproductive system and breast disorders
Vaginal Pain
|
11.8%
2/17 • From start of treatment through 30 days after end of treatment
|
|
Gastrointestinal disorders
Vomiting
|
52.9%
9/17 • From start of treatment through 30 days after end of treatment
|
|
Eye disorders
Watering Eyes
|
5.9%
1/17 • From start of treatment through 30 days after end of treatment
|
|
Investigations
Weight Gain
|
5.9%
1/17 • From start of treatment through 30 days after end of treatment
|
|
Investigations
Weight Loss
|
11.8%
2/17 • From start of treatment through 30 days after end of treatment
|
|
Investigations
White Blood Cell Decreased
|
76.5%
13/17 • From start of treatment through 30 days after end of treatment
|
|
Infections and infestations
Wound Infection
|
5.9%
1/17 • From start of treatment through 30 days after end of treatment
|
Additional Information
Robin 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