Trial Outcomes & Findings for BAY 43-9006 (Sorafenib) to Treat Relapsed Non-Small Cell Lung Cancer (NCT NCT00098254)
NCT ID: NCT00098254
Last Updated: 2012-05-02
Results Overview
Percentage of participants with response rate = CR + PR. Response will be evaluated by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. CR (complete response) is the disappearance of all target lesions; PR (partial response) is a 30% decrease in the sum of the longest diameter of target lesions; PD (progressive disease) is a 20% increase in the sum of the longest diameter of target lesions; and SD (stable disease) are small changes that do not meet the above criteria. Please see the Protocol Link module for additional information about RECIST if desired.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
37 participants
Primary outcome timeframe
17 months
Results posted on
2012-05-02
Participant Flow
Participant milestones
| Measure |
BAY 43-9006 (Sorafenib)
Self administered oral doses at 400 mg twice a day with 250 ml (8 oz.) of water each morning and evening (i.e., 12-hourly) continuously in a 28 day cycle. Tablets may be taken with or without food.
|
|---|---|
|
Overall Study
STARTED
|
37
|
|
Overall Study
COMPLETED
|
34
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
BAY 43-9006 (Sorafenib)
Self administered oral doses at 400 mg twice a day with 250 ml (8 oz.) of water each morning and evening (i.e., 12-hourly) continuously in a 28 day cycle. Tablets may be taken with or without food.
|
|---|---|
|
Overall Study
Adverse Event
|
2
|
|
Overall Study
Death
|
1
|
Baseline Characteristics
BAY 43-9006 (Sorafenib) to Treat Relapsed Non-Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
BAY 43-9006 (Sorafenib)
n=37 Participants
Self administered oral doses at 400 mg twice a day with 250 ml (8 oz.) of water each morning and evening (i.e., 12-hourly) continuously in a 28 day cycle. Tablets may be taken with or without food.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
17 Participants
n=5 Participants
|
|
Age Continuous
|
61.9 years
STANDARD_DEVIATION 12.19 • n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
4 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
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
26 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
37 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 17 monthsPercentage of participants with response rate = CR + PR. Response will be evaluated by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. CR (complete response) is the disappearance of all target lesions; PR (partial response) is a 30% decrease in the sum of the longest diameter of target lesions; PD (progressive disease) is a 20% increase in the sum of the longest diameter of target lesions; and SD (stable disease) are small changes that do not meet the above criteria. Please see the Protocol Link module for additional information about RECIST if desired.
Outcome measures
| Measure |
BAY 43-9006 (Sorafenib)
n=34 Participants
Self administered oral doses at 400 mg twice a day with 250 ml (8 oz.) of water each morning and evening (i.e., 12-hourly) continuously in a 28 day cycle. Tablets may be taken with or without food.
|
|---|---|
|
Response Rate
|
6 percentage of participants
Interval 1.0 to 20.0
|
PRIMARY outcome
Timeframe: 17 monthsTime between the first day of treatment to the day of disease progression. Progressive disease is at least a 20% increase in the sum of the longest diameter of target lesions. Appearance of one or more new lesions and/or unequivocal progressions of existing non-target lesions.
Outcome measures
| Measure |
BAY 43-9006 (Sorafenib)
n=34 Participants
Self administered oral doses at 400 mg twice a day with 250 ml (8 oz.) of water each morning and evening (i.e., 12-hourly) continuously in a 28 day cycle. Tablets may be taken with or without food.
|
|---|---|
|
Progression Free Survival
|
3.4 months
Interval 1.9 to 3.7
|
PRIMARY outcome
Timeframe: 5 1/2 yearsHere are the total number of participants with adverse events. For the detailed list of adverse events see the adverse event module.
Outcome measures
| Measure |
BAY 43-9006 (Sorafenib)
n=37 Participants
Self administered oral doses at 400 mg twice a day with 250 ml (8 oz.) of water each morning and evening (i.e., 12-hourly) continuously in a 28 day cycle. Tablets may be taken with or without food.
|
|---|---|
|
The Number of Participants With Adverse Events
|
37 Participants
|
SECONDARY outcome
Timeframe: 17 monthsTime between the first day of treatment to the days of death.
Outcome measures
| Measure |
BAY 43-9006 (Sorafenib)
n=34 Participants
Self administered oral doses at 400 mg twice a day with 250 ml (8 oz.) of water each morning and evening (i.e., 12-hourly) continuously in a 28 day cycle. Tablets may be taken with or without food.
|
|---|---|
|
Overall Survival
|
11.6 months
Interval 9.2 to 16.4
|
SECONDARY outcome
Timeframe: 58 monthsPopulation: The analysis for this outcome measure was not performed. Endpoint lost interest when mutation analysis was felt to be more important.
All patients will be genotyped for CYP3A4/5 and 5 polymorphisms.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 17 monthsDifference in placental derived growth factor (PLGF) between day 28 and day 0 of \< 11 pg/ml vs. \> 12 pg/ml.
Outcome measures
| Measure |
BAY 43-9006 (Sorafenib)
n=37 Participants
Self administered oral doses at 400 mg twice a day with 250 ml (8 oz.) of water each morning and evening (i.e., 12-hourly) continuously in a 28 day cycle. Tablets may be taken with or without food.
|
|---|---|
|
Overall Survival Reported Separately for Participants With a Change in PLGF Below 11 pg/ml and Above 12 pg/ml
PLGF ,< 11 pg/ml
|
6.6 months
Interval 4.9 to 9.2
|
|
Overall Survival Reported Separately for Participants With a Change in PLGF Below 11 pg/ml and Above 12 pg/ml
PLGF > 12 pg/ml
|
15.6 months
Interval 9.4 to 22.5
|
SECONDARY outcome
Timeframe: 54 daysSerial plasma samples were collected from all patients and cytokine levels were measured. The concentrations of the cytokines were determined with recombinant standards and expressed as picograms per milliliter (pg/ml).
Outcome measures
| Measure |
BAY 43-9006 (Sorafenib)
n=37 Participants
Self administered oral doses at 400 mg twice a day with 250 ml (8 oz.) of water each morning and evening (i.e., 12-hourly) continuously in a 28 day cycle. Tablets may be taken with or without food.
|
|---|---|
|
Cytokine Levels
VEGF
|
101 pg/ml
Interval 69.0 to 204.0
|
|
Cytokine Levels
sVEGFRI
|
115 pg/ml
Interval 91.0 to 198.0
|
|
Cytokine Levels
PLGF
|
19 pg/ml
Interval 12.0 to 29.0
|
|
Cytokine Levels
bFGF
|
6 pg/ml
Interval 2.9 to 14.0
|
SECONDARY outcome
Timeframe: 42 monthsPopulation: 11/34 KRAS positive; 23/34 KRAS negative 5/23 EGFR positive; 18/23 EGFR negative
Mutational analysis of these genes was performed on paraffin-imbedded tissue blocks from prior pathologic specimens. Disease control rate was correlated with KRAS mutational status. Disease control rate was defined as complete remission (CR) + partial remission (PR)+ stable disease (SD).
Outcome measures
| Measure |
BAY 43-9006 (Sorafenib)
n=37 Participants
Self administered oral doses at 400 mg twice a day with 250 ml (8 oz.) of water each morning and evening (i.e., 12-hourly) continuously in a 28 day cycle. Tablets may be taken with or without food.
|
|---|---|
|
Correlation of Response to Treatment With KRAS Mutational Status
DCR observed in KRAS mutant participants
|
60 percentage of participants
|
|
Correlation of Response to Treatment With KRAS Mutational Status
DCR observed in KRAS wild-type participants
|
71 percentage of participants
|
|
Correlation of Response to Treatment With KRAS Mutational Status
DCR observed in EGFR mutant participants
|
40 percentage of participants
|
|
Correlation of Response to Treatment With KRAS Mutational Status
DCR observed in EGFR wild-type participants
|
69 percentage of participants
|
SECONDARY outcome
Timeframe: 42 monthsPopulation: 14 patients with day 28 FGF \>6 and 14 patients with FGF \<6.
Serum plasma is collected at the beginning of each cycle during the course of the study and analyzed by the enzyme-linked immunosorbent assay (ELISA).
Outcome measures
| Measure |
BAY 43-9006 (Sorafenib)
n=14 Participants
Self administered oral doses at 400 mg twice a day with 250 ml (8 oz.) of water each morning and evening (i.e., 12-hourly) continuously in a 28 day cycle. Tablets may be taken with or without food.
|
|---|---|
|
Overall Survival Associated With Basic Fibroblast Growth Factor (bFGF)
Overall survival for bFGF day 0<6 pg/ml
|
15.4 months
Interval 9.2 to 31.2
|
|
Overall Survival Associated With Basic Fibroblast Growth Factor (bFGF)
Overall survival for bFGF day 0>6 pg/ml
|
5.5 months
Interval 3.1 to 16.4
|
SECONDARY outcome
Timeframe: 17 monthsSerum plasma is collected at the beginning of each cycle during the course of the study and analyzed by the enzyme-linked immunosorbent assay (ELISA).
Outcome measures
| Measure |
BAY 43-9006 (Sorafenib)
n=14 Participants
Self administered oral doses at 400 mg twice a day with 250 ml (8 oz.) of water each morning and evening (i.e., 12-hourly) continuously in a 28 day cycle. Tablets may be taken with or without food.
|
|---|---|
|
Progression Free Survival Associated With Basic Fibroblast Growth Factor (bFGF)
Progression free survival for bFGF day 28<6 pg/ml
|
4.4 months
Interval 3.1 to 5.5
|
|
Progression Free Survival Associated With Basic Fibroblast Growth Factor (bFGF)
Progression free survival for bFGF day 28>6 pg/ml
|
1.8 months
Interval 1.4 to 3.7
|
SECONDARY outcome
Timeframe: 59 monthsDCE-MRI was used to evaluate changes (e.g. decrease/increase in Ve, Ktrans, Kep value) in vascularity and quality of index lesions to provide early indication of treatment effect before changes in size can be perceived on CT. Changes were reflected in a decrease/increase of Ve, Ktrans, or Kep (Kep, Ve, Ktrans measurements at day 0, day 14 and the difference between the day 14 and the day 0 measurements (day 14-day 0).
Outcome measures
| Measure |
BAY 43-9006 (Sorafenib)
n=37 Participants
Self administered oral doses at 400 mg twice a day with 250 ml (8 oz.) of water each morning and evening (i.e., 12-hourly) continuously in a 28 day cycle. Tablets may be taken with or without food.
|
|---|---|
|
Percentage of Participants With an Increase or Decrease in the Reverse Contrast Transfer Rate (Kep), Forward Contrast Transfer Rate (Ktrans), and Extravascular Fraction (Ve) With the Dynamic Contrast Enhanced Magnetic Resonance Imaging (DCE-MRI)
percentage of pts with an increase in Ktrans orKep
|
19 Percentage of participants
|
|
Percentage of Participants With an Increase or Decrease in the Reverse Contrast Transfer Rate (Kep), Forward Contrast Transfer Rate (Ktrans), and Extravascular Fraction (Ve) With the Dynamic Contrast Enhanced Magnetic Resonance Imaging (DCE-MRI)
percentage of pts with an decrease in Ktrans orKep
|
81 Percentage of participants
|
|
Percentage of Participants With an Increase or Decrease in the Reverse Contrast Transfer Rate (Kep), Forward Contrast Transfer Rate (Ktrans), and Extravascular Fraction (Ve) With the Dynamic Contrast Enhanced Magnetic Resonance Imaging (DCE-MRI)
Percentage of pts with an increase or decrease-Ve
|
0 Percentage of participants
|
SECONDARY outcome
Timeframe: 59 monthsPopulation: The analysis for this outcome measure was not performed. Endpoint lost interest when mutation analysis was felt to br more important.
Immunohistochemical analysis performed by using state specific antibodies against Raf, methyl ethyl ketone (MEK), extracellular-signal regulated kinase (ERK), and two downstream substrates of ERK, E twenty-six (ETS)-like transcription factor 1 (ELK-1) and p90Ribosomal S6 kinase (p90RSK).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 60 monthsPopulation: The analysis for this outcome measure was not performed. Endpoint lost interest when mutation analysis was felt to be more important.
Serial plasma samples were collected from all patients at pretreatment (baseline - day 0), and on days 14, 28, and 54. The concentrations of the cytokines were determined with recombinant standards and expressed as picograms per milliliter (pg/ml).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 60 monthsPopulation: The analysis for this outcome measure was not performed. Endpoint lost interest when mutation analysis was felt to be more important.
Extracted DNA was subjected to an initial PCR using a single primer set encompassing codom V600. Pyrosequencing was carried out on a Qiagen PyroMaark Q24 system.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 60 monthsPopulation: The analysis for this outcome measure was not performed. Endpoint lost interest when mutation analysis was felt to be more important.
Pharmacoproteomic modulation targets (AKT, p-AKT, ERK 1/2, MEK, Cyclin D, p-ERK 1/2, p-MEK, pMEK, eNOA, p-eNOA, Cleaved PARP, PDGFRbeta, p-PDGFRbeta,Cyclin D, CD31, PARP. Caspase 9, Caspase 3, Cleaved Caspase-9 Cleaved Caspase 3)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 60 monthsPopulation: The analysis for this outcome measure was not performed. Endpoint lost interest when mutation analysis was felt to be more important.
Secondary pharmacoproteomic modulation targets (mTOR, EGFR, Src, NFkB, STAT1, TGFa, p38, Jak 1, lkB, IGFR, p-mTOR, p-EGFR, p-Src, p-NFkB, p-STAT1, Phospho-p38, p-Jak1, p-lkB,Pyk2, p-Pyk2, VEGFR-2, GSK3beta, p-GSK3beta, p-bad, p-Bcl-2, PCNA, Fos, Raf, CREB, Rho, avbeta3complex, Bad, CD34, VEGFR-1, bfGF, vWF, Factor VIII, Annexin V, Bcl-2).
Outcome measures
Outcome data not reported
Adverse Events
BAY 43-9006 (Sorafenib)
Serious events: 11 serious events
Other events: 37 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
BAY 43-9006 (Sorafenib)
n=37 participants at risk
Self administered oral doses at 400 mg twice a day with 250 ml (8 oz.) of water each morning and evening (i.e., 12-hourly) continuously in a 28 day cycle. Tablets may be taken with or without food.
|
|---|---|
|
Investigations
Alanine aminotransferase increased
|
2.7%
1/37 • Number of events 2 • 5 years, 6 months, and 21 days
|
|
Investigations
Alkaline phosphatase increased
|
2.7%
1/37 • Number of events 1 • 5 years, 6 months, and 21 days
|
|
Blood and lymphatic system disorders
Anemia
|
2.7%
1/37 • Number of events 4 • 5 years, 6 months, and 21 days
|
|
Investigations
Aspartate aminotransferase increased
|
2.7%
1/37 • Number of events 2 • 5 years, 6 months, and 21 days
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary hemorrhage
|
2.7%
1/37 • Number of events 1 • 5 years, 6 months, and 21 days
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
2.7%
1/37 • Number of events 1 • 5 years, 6 months, and 21 days
|
|
Psychiatric disorders
Confusion
|
2.7%
1/37 • Number of events 1 • 5 years, 6 months, and 21 days
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.7%
1/37 • Number of events 1 • 5 years, 6 months, and 21 days
|
|
General disorders
Death NOS
|
2.7%
1/37 • Number of events 1 • 5 years, 6 months, and 21 days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
10.8%
4/37 • Number of events 5 • 5 years, 6 months, and 21 days
|
|
General disorders
Fatigue
|
2.7%
1/37 • Number of events 1 • 5 years, 6 months, and 21 days
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
2.7%
1/37 • Number of events 1 • 5 years, 6 months, and 21 days
|
|
Vascular disorders
Hypertension
|
2.7%
1/37 • Number of events 2 • 5 years, 6 months, and 21 days
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
2.7%
1/37 • Number of events 3 • 5 years, 6 months, and 21 days
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
2.7%
1/37 • Number of events 2 • 5 years, 6 months, and 21 days
|
|
Metabolism and nutrition disorders
Hyponatremia
|
2.7%
1/37 • Number of events 1 • 5 years, 6 months, and 21 days
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
5.4%
2/37 • Number of events 2 • 5 years, 6 months, and 21 days
|
|
Infections and infestations
Lung infection
|
5.4%
2/37 • Number of events 4 • 5 years, 6 months, and 21 days
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
2.7%
1/37 • Number of events 3 • 5 years, 6 months, and 21 days
|
|
Investigations
Platelet count decreased
|
2.7%
1/37 • Number of events 4 • 5 years, 6 months, and 21 days
|
|
Vascular disorders
Vasculitis
|
2.7%
1/37 • Number of events 1 • 5 years, 6 months, and 21 days
|
Other adverse events
| Measure |
BAY 43-9006 (Sorafenib)
n=37 participants at risk
Self administered oral doses at 400 mg twice a day with 250 ml (8 oz.) of water each morning and evening (i.e., 12-hourly) continuously in a 28 day cycle. Tablets may be taken with or without food.
|
|---|---|
|
Investigations
Activated partial thromboplasstin time prolonged
|
37.8%
14/37 • Number of events 20 • 5 years, 6 months, and 21 days
|
|
Investigations
Alanine aminotransferase increased
|
32.4%
12/37 • Number of events 17 • 5 years, 6 months, and 21 days
|
|
Investigations
Alkaline phosphatase increased
|
24.3%
9/37 • Number of events 12 • 5 years, 6 months, and 21 days
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
2.7%
1/37 • Number of events 1 • 5 years, 6 months, and 21 days
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
8.1%
3/37 • Number of events 3 • 5 years, 6 months, and 21 days
|
|
Investigations
Creatinine increased
|
2.7%
1/37 • Number of events 1 • 5 years, 6 months, and 21 days
|
|
Blood and lymphatic system disorders
Anemia
|
35.1%
13/37 • Number of events 23 • 5 years, 6 months, and 21 days
|
|
Metabolism and nutrition disorders
Anorexia
|
24.3%
9/37 • Number of events 12 • 5 years, 6 months, and 21 days
|
|
Psychiatric disorders
Anxiety
|
2.7%
1/37 • Number of events 1 • 5 years, 6 months, and 21 days
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.7%
1/37 • Number of events 1 • 5 years, 6 months, and 21 days
|
|
Investigations
Aspartate aminotransferase increased
|
48.6%
18/37 • Number of events 42 • 5 years, 6 months, and 21 days
|
|
Nervous system disorders
Ataxia
|
2.7%
1/37 • Number of events 1 • 5 years, 6 months, and 21 days
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.1%
3/37 • Number of events 4 • 5 years, 6 months, and 21 days
|
|
Investigations
Blood bilirubin increased
|
18.9%
7/37 • Number of events 11 • 5 years, 6 months, and 21 days
|
|
Investigations
Blood prolactin abnormal
|
2.7%
1/37 • Number of events 1 • 5 years, 6 months, and 21 days
|
|
Eye disorders
Blurred vision
|
8.1%
3/37 • Number of events 3 • 5 years, 6 months, and 21 days
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulomonary hemorrhage
|
5.4%
2/37 • Number of events 2 • 5 years, 6 months, and 21 days
|
|
Investigations
CPK increased
|
10.8%
4/37 • Number of events 7 • 5 years, 6 months, and 21 days
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
5.4%
2/37 • Number of events 2 • 5 years, 6 months, and 21 days
|
|
General disorders
Chills
|
8.1%
3/37 • Number of events 3 • 5 years, 6 months, and 21 days
|
|
Psychiatric disorders
Confusion
|
2.7%
1/37 • Number of events 1 • 5 years, 6 months, and 21 days
|
|
Gastrointestinal disorders
Constipation
|
8.1%
3/37 • Number of events 3 • 5 years, 6 months, and 21 days
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
27.0%
10/37 • Number of events 14 • 5 years, 6 months, and 21 days
|
|
Metabolism and nutrition disorders
Dehydration
|
5.4%
2/37 • Number of events 2 • 5 years, 6 months, and 21 days
|
|
Gastrointestinal disorders
Diarrhea
|
40.5%
15/37 • Number of events 29 • 5 years, 6 months, and 21 days
|
|
Nervous system disorders
Dizziness
|
10.8%
4/37 • Number of events 4 • 5 years, 6 months, and 21 days
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
18.9%
7/37 • Number of events 7 • 5 years, 6 months, and 21 days
|
|
Nervous system disorders
Dysgeusia
|
2.7%
1/37 • Number of events 1 • 5 years, 6 months, and 21 days
|
|
Gastrointestinal disorders
Dyspepsia
|
5.4%
2/37 • Number of events 2 • 5 years, 6 months, and 21 days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
16.2%
6/37 • Number of events 9 • 5 years, 6 months, and 21 days
|
|
General disorders
Edema limbs
|
5.4%
2/37 • Number of events 2 • 5 years, 6 months, and 21 days
|
|
Infections and infestations
Enterocolitis infections
|
2.7%
1/37 • Number of events 1 • 5 years, 6 months, and 21 days
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.7%
1/37 • Number of events 1 • 5 years, 6 months, and 21 days
|
|
General disorders
Fatigue
|
29.7%
11/37 • Number of events 13 • 5 years, 6 months, and 21 days
|
|
General disorders
Fever
|
5.4%
2/37 • Number of events 3 • 5 years, 6 months, and 21 days
|
|
Eye disorders
Flashing lights
|
2.7%
1/37 • Number of events 1 • 5 years, 6 months, and 21 days
|
|
Vascular disorders
Flushing
|
5.4%
2/37 • Number of events 2 • 5 years, 6 months, and 21 days
|
|
Nervous system disorders
Headache
|
13.5%
5/37 • Number of events 8 • 5 years, 6 months, and 21 days
|
|
Renal and urinary disorders
Hemoglobinuria
|
2.7%
1/37 • Number of events 1 • 5 years, 6 months, and 21 days
|
|
Vascular disorders
Hot flashes
|
2.7%
1/37 • Number of events 1 • 5 years, 6 months, and 21 days
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
16.2%
6/37 • Number of events 7 • 5 years, 6 months, and 21 days
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
27.0%
10/37 • Number of events 22 • 5 years, 6 months, and 21 days
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
2.7%
1/37 • Number of events 1 • 5 years, 6 months, and 21 days
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
32.4%
12/37 • Number of events 22 • 5 years, 6 months, and 21 days
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
32.4%
12/37 • Number of events 17 • 5 years, 6 months, and 21 days
|
|
Metabolism and nutrition disorders
Hypernatremia
|
2.7%
1/37 • Number of events 2 • 5 years, 6 months, and 21 days
|
|
Vascular disorders
Hypertension
|
40.5%
15/37 • Number of events 20 • 5 years, 6 months, and 21 days
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
5.4%
2/37 • Number of events 4 • 5 years, 6 months, and 21 days
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
54.1%
20/37 • Number of events 35 • 5 years, 6 months, and 21 days
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
10.8%
4/37 • Number of events 12 • 5 years, 6 months, and 21 days
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
8.1%
3/37 • Number of events 3 • 5 years, 6 months, and 21 days
|
|
Metabolism and nutrition disorders
Hypokalemia
|
13.5%
5/37 • Number of events 7 • 5 years, 6 months, and 21 days
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
27.0%
10/37 • Number of events 15 • 5 years, 6 months, and 21 days
|
|
Metabolism and nutrition disorders
Hyponatremia
|
45.9%
17/37 • Number of events 41 • 5 years, 6 months, and 21 days
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
54.1%
20/37 • Number of events 44 • 5 years, 6 months, and 21 days
|
|
Vascular disorders
Hypotension
|
2.7%
1/37 • Number of events 1 • 5 years, 6 months, and 21 days
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.7%
1/37 • Number of events 1 • 5 years, 6 months, and 21 days
|
|
Investigations
INR increased
|
2.7%
1/37 • Number of events 1 • 5 years, 6 months, and 21 days
|
|
Psychiatric disorders
Insomnia
|
8.1%
3/37 • Number of events 3 • 5 years, 6 months, and 21 days
|
|
Investigations
Investigations-Other, specify
|
2.7%
1/37 • Number of events 1 • 5 years, 6 months, and 21 days
|
|
Investigations
Lipase increased
|
8.1%
3/37 • Number of events 4 • 5 years, 6 months, and 21 days
|
|
Infections and infestations
Lung infection
|
8.1%
3/37 • Number of events 3 • 5 years, 6 months, and 21 days
|
|
Investigations
Lymphocyte count decreased
|
43.2%
16/37 • Number of events 37 • 5 years, 6 months, and 21 days
|
|
Gastrointestinal disorders
Mucositis oral
|
18.9%
7/37 • Number of events 13 • 5 years, 6 months, and 21 days
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
13.5%
5/37 • Number of events 6 • 5 years, 6 months, and 21 days
|
|
Gastrointestinal disorders
Nausea
|
21.6%
8/37 • Number of events 13 • 5 years, 6 months, and 21 days
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
2.7%
1/37 • Number of events 1 • 5 years, 6 months, and 21 days
|
|
Nervous system disorders
Nervous system disorders-Other, specify
|
2.7%
1/37 • Number of events 1 • 5 years, 6 months, and 21 days
|
|
Investigations
Neutrophil count decreased
|
8.1%
3/37 • Number of events 10 • 5 years, 6 months, and 21 days
|
|
General disorders
Non-cardiac chest pain
|
5.4%
2/37 • Number of events 3 • 5 years, 6 months, and 21 days
|
|
Ear and labyrinth disorders
Otitis externa
|
2.7%
1/37 • Number of events 1 • 5 years, 6 months, and 21 days
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
13.5%
5/37 • Number of events 5 • 5 years, 6 months, and 21 days
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodyesthesia syndrome
|
62.2%
23/37 • Number of events 69 • 5 years, 6 months, and 21 days
|
|
Cardiac disorders
Pericardial effusion
|
2.7%
1/37 • Number of events 1 • 5 years, 6 months, and 21 days
|
|
Nervous system disorders
Peripheral motor neuropathy
|
2.7%
1/37 • Number of events 1 • 5 years, 6 months, and 21 days
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
13.5%
5/37 • Number of events 5 • 5 years, 6 months, and 21 days
|
|
Infections and infestations
Pharyngitis
|
2.7%
1/37 • Number of events 1 • 5 years, 6 months, and 21 days
|
|
Investigations
Platelet count decreased
|
29.7%
11/37 • Number of events 15 • 5 years, 6 months, and 21 days
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
5.4%
2/37 • Number of events 2 • 5 years, 6 months, and 21 days
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
18.9%
7/37 • Number of events 8 • 5 years, 6 months, and 21 days
|
|
Skin and subcutaneous tissue disorders
Rash maculopaular
|
54.1%
20/37 • Number of events 30 • 5 years, 6 months, and 21 days
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders-Other, specify
|
2.7%
1/37 • Number of events 1 • 5 years, 6 months, and 21 days
|
|
Eye disorders
Retinopathy
|
2.7%
1/37 • Number of events 1 • 5 years, 6 months, and 21 days
|
|
Cardiac disorders
Sinus tachycardia
|
5.4%
2/37 • Number of events 2 • 5 years, 6 months, and 21 days
|
|
Infections and infestations
Sinusitis
|
2.7%
1/37 • Number of events 1 • 5 years, 6 months, and 21 days
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders-Other, specify
|
2.7%
1/37 • Number of events 1 • 5 years, 6 months, and 21 days
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
2.7%
1/37 • Number of events 1 • 5 years, 6 months, and 21 days
|
|
Vascular disorders
Thromboembolic event
|
2.7%
1/37 • Number of events 1 • 5 years, 6 months, and 21 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Treatment related secondary malignancy
|
2.7%
1/37 • Number of events 1 • 5 years, 6 months, and 21 days
|
|
Nervous system disorders
Tremor
|
2.7%
1/37 • Number of events 1 • 5 years, 6 months, and 21 days
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
5.4%
2/37 • Number of events 2 • 5 years, 6 months, and 21 days
|
|
Renal and urinary disorders
Urinary frequency
|
2.7%
1/37 • Number of events 1 • 5 years, 6 months, and 21 days
|
|
Reproductive system and breast disorders
Uterine hemorrhage
|
2.7%
1/37 • Number of events 1 • 5 years, 6 months, and 21 days
|
|
Infections and infestations
Vaginal infection
|
2.7%
1/37 • Number of events 1 • 5 years, 6 months, and 21 days
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
2.7%
1/37 • Number of events 4 • 5 years, 6 months, and 21 days
|
|
Nervous system disorders
Syncope
|
2.7%
1/37 • Number of events 1 • 5 years, 6 months, and 21 days
|
|
Investigations
Serum amylase increased
|
8.1%
3/37 • Number of events 6 • 5 years, 6 months, and 21 days
|
|
Gastrointestinal disorders
Vomiting
|
8.1%
3/37 • Number of events 6 • 5 years, 6 months, and 21 days
|
|
Investigations
Weight loss
|
13.5%
5/37 • Number of events 9 • 5 years, 6 months, and 21 days
|
|
Investigations
White blood cell decreased
|
18.9%
7/37 • Number of events 15 • 5 years, 6 months, and 21 days
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
2.7%
1/37 • Number of events 1 • 5 years, 6 months, and 21 days
|
Additional Information
Giuseppe Giaccone, M.D., PH.D.
National Cancer Institute
Phone: 301-496-4916
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place