Trial Outcomes & Findings for Dovitinib in BCG Refractory Urothelial Carcinoma With FGFR3 Mutations or Over-expression (NCT NCT01732107)
NCT ID: NCT01732107
Last Updated: 2022-07-11
Results Overview
The 6-month complete response rate is defined as the proportion of patients treated with dovitinib with no evidence of any remaining urothelial carcinoma tumors of any T-stage (including Tis) present within the bladder as assessed by standard of care cystoscopic examination with transurethral resection of bladder tumor (TURBT) and urine cytology performed at 6 months after initiation of study therapy.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
13 participants
Primary outcome timeframe
6 months
Results posted on
2022-07-11
Participant Flow
Participant milestones
| Measure |
Dovitinib
Dovitinib will be administered 500mg orally in a 5 days on, 2 days off dosing schedule.
Dovitinib: Dovitinib will be administered 500mg orally in a 5 days on, 2 days off dosing schedule. Day 12 assessments are intended to be performed on the last dosing day of the 2nd week in cycle 1 and cycle 2 and day 26 assessments are intended to be performed on the last dosing day of the 4th week in cycle 1 and cycle 2.
|
|---|---|
|
Overall Study
STARTED
|
13
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
13
|
Reasons for withdrawal
| Measure |
Dovitinib
Dovitinib will be administered 500mg orally in a 5 days on, 2 days off dosing schedule.
Dovitinib: Dovitinib will be administered 500mg orally in a 5 days on, 2 days off dosing schedule. Day 12 assessments are intended to be performed on the last dosing day of the 2nd week in cycle 1 and cycle 2 and day 26 assessments are intended to be performed on the last dosing day of the 4th week in cycle 1 and cycle 2.
|
|---|---|
|
Overall Study
Adverse Event
|
2
|
|
Overall Study
Disease Progression
|
8
|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
Baseline Characteristics
Dovitinib in BCG Refractory Urothelial Carcinoma With FGFR3 Mutations or Over-expression
Baseline characteristics by cohort
| Measure |
Dovitinib
n=13 Participants
Dovitinib will be administered 500mg orally in a 5 days on, 2 days off dosing schedule.
Dovitinib: Dovitinib will be administered 500mg orally in a 5 days on, 2 days off dosing schedule. Day 12 assessments are intended to be performed on the last dosing day of the 2nd week in cycle 1 and cycle 2 and day 26 assessments are intended to be performed on the last dosing day of the 4th week in cycle 1 and cycle 2.
|
|---|---|
|
Age, Continuous
|
70 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 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
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsThe 6-month complete response rate is defined as the proportion of patients treated with dovitinib with no evidence of any remaining urothelial carcinoma tumors of any T-stage (including Tis) present within the bladder as assessed by standard of care cystoscopic examination with transurethral resection of bladder tumor (TURBT) and urine cytology performed at 6 months after initiation of study therapy.
Outcome measures
| Measure |
Dovitinib
n=13 Participants
Dovitinib will be administered 500mg orally in a 5 days on, 2 days off dosing schedule.
Dovitinib: Dovitinib will be administered 500mg orally in a 5 days on, 2 days off dosing schedule. Day 12 assessments are intended to be performed on the last dosing day of the 2nd week in cycle 1 and cycle 2 and day 26 assessments are intended to be performed on the last dosing day of the 4th week in cycle 1 and cycle 2.
|
|---|---|
|
Determine 6-Month Complete Response Rate
|
8 percentage of participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Data for this outcome measure was neither collected or analyzed due to the early termination of the study.
The 1-year relapse free survival rate is defined as the proportion of patients treated with dovitinib with no evidence of any remaining urothelial carcinoma tumors at 12 months of follow-up.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 monthsPopulation: Data for this outcome measure was neither collected or analyzed due to the early termination of the study.
The rate of progression to muscle-invasive stage for dovitinib is defined as the proportion of patients with clinical or pathologic progression to muscle-invasive stages (i.e., T2-T4) at any time point on study.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 monthsPopulation: Data for this outcome measure was neither collected or analyzed due to the early termination of the study.
The 3- and 6-month partial response rates are defined as the proportion of patients treated with persistent but reduced T-stage tumors on post-therapy TURBT (i.e., T1 ≥ Ta; T1+Tis ≥ T1).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 monthsTreatment-related toxicity rates will be assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All grade 3-4 adverse events and other adverse events occurring in more than 20% of patients are reported.
Outcome measures
| Measure |
Dovitinib
n=13 Participants
Dovitinib will be administered 500mg orally in a 5 days on, 2 days off dosing schedule.
Dovitinib: Dovitinib will be administered 500mg orally in a 5 days on, 2 days off dosing schedule. Day 12 assessments are intended to be performed on the last dosing day of the 2nd week in cycle 1 and cycle 2 and day 26 assessments are intended to be performed on the last dosing day of the 4th week in cycle 1 and cycle 2.
|
|---|---|
|
Characterize Treatment-related Toxicity Rates
Constipation (Grade 2)
|
2 participants
|
|
Characterize Treatment-related Toxicity Rates
Diarrhea (Grade 1)
|
8 participants
|
|
Characterize Treatment-related Toxicity Rates
Diarrhea (Grade 2)
|
2 participants
|
|
Characterize Treatment-related Toxicity Rates
Anorexia (Grade 1)
|
4 participants
|
|
Characterize Treatment-related Toxicity Rates
Anorexia (Grade 2)
|
1 participants
|
|
Characterize Treatment-related Toxicity Rates
Weight loss (Grade 1)
|
4 participants
|
|
Characterize Treatment-related Toxicity Rates
Dysgeusia (Grade 1)
|
5 participants
|
|
Characterize Treatment-related Toxicity Rates
Dysgeusia (Grade 2)
|
2 participants
|
|
Characterize Treatment-related Toxicity Rates
Nausea/Emesis (Grade 1)
|
6 participants
|
|
Characterize Treatment-related Toxicity Rates
Emesis (Grade 1)
|
4 participants
|
|
Characterize Treatment-related Toxicity Rates
Other gastrointestinal (Grade 1)
|
2 participants
|
|
Characterize Treatment-related Toxicity Rates
Other gastrointestinal (Grade 2)
|
3 participants
|
|
Characterize Treatment-related Toxicity Rates
Stomatitis (Grade 3)
|
1 participants
|
|
Characterize Treatment-related Toxicity Rates
Rash (Grade 1)
|
4 participants
|
|
Characterize Treatment-related Toxicity Rates
Rash (Grade 2)
|
1 participants
|
|
Characterize Treatment-related Toxicity Rates
Rash (Grade 3)
|
1 participants
|
|
Characterize Treatment-related Toxicity Rates
Hand-foot syndrome (Grade 1)
|
2 participants
|
|
Characterize Treatment-related Toxicity Rates
Hand-foot syndrome (Grade 2)
|
1 participants
|
|
Characterize Treatment-related Toxicity Rates
Dry mouth (Grade 1)
|
4 participants
|
|
Characterize Treatment-related Toxicity Rates
Other skin (Grade 1)
|
6 participants
|
|
Characterize Treatment-related Toxicity Rates
Other skin (Grade 2)
|
2 participants
|
|
Characterize Treatment-related Toxicity Rates
Bladder spasms (Grade 2)
|
3 participants
|
|
Characterize Treatment-related Toxicity Rates
Other urinary (Grade 1)
|
7 participants
|
|
Characterize Treatment-related Toxicity Rates
Other urinary (Grade 2)
|
1 participants
|
|
Characterize Treatment-related Toxicity Rates
Fever (Grade 1)
|
4 participants
|
|
Characterize Treatment-related Toxicity Rates
Infection (Grade 2)
|
8 participants
|
|
Characterize Treatment-related Toxicity Rates
Hoarseness (Grade 1)
|
3 participants
|
|
Characterize Treatment-related Toxicity Rates
Other pulmonary (Grade 1)
|
4 participants
|
|
Characterize Treatment-related Toxicity Rates
Other pulmonary (Grade 2)
|
2 participants
|
|
Characterize Treatment-related Toxicity Rates
Arthralgia/Myalgia (Grade 1)
|
4 participants
|
|
Characterize Treatment-related Toxicity Rates
Arthralgia/Myalgia (Grade 2)
|
2 participants
|
|
Characterize Treatment-related Toxicity Rates
Hypertriglyceridemia (Grade 1)
|
1 participants
|
|
Characterize Treatment-related Toxicity Rates
Hypertriglyceridemia (Grade 2)
|
2 participants
|
|
Characterize Treatment-related Toxicity Rates
Hypertriglyceridemia (Grade 3)
|
1 participants
|
|
Characterize Treatment-related Toxicity Rates
Hypertriglyceridemia (Grade 4)
|
1 participants
|
|
Characterize Treatment-related Toxicity Rates
Elevated alkaline phosphatase (Grade 1)
|
2 participants
|
|
Characterize Treatment-related Toxicity Rates
Elevated alkaline phosphatase (Grade 2)
|
1 participants
|
|
Characterize Treatment-related Toxicity Rates
Elevated GGT (Grade 2)
|
1 participants
|
|
Characterize Treatment-related Toxicity Rates
Elevated GGT (Grade 3)
|
2 participants
|
|
Characterize Treatment-related Toxicity Rates
Hypoalbuminemia (Grade 1)
|
2 participants
|
|
Characterize Treatment-related Toxicity Rates
Hypoalbuminemia (Grade 2)
|
1 participants
|
|
Characterize Treatment-related Toxicity Rates
Elevated lipase (Grade 3)
|
2 participants
|
|
Characterize Treatment-related Toxicity Rates
Other metabolic (Grade 1)
|
6 participants
|
|
Characterize Treatment-related Toxicity Rates
Anemia (Grade 1)
|
4 participants
|
|
Characterize Treatment-related Toxicity Rates
Constipation (Grade 1)
|
2 participants
|
|
Characterize Treatment-related Toxicity Rates
Fatigue (Grade 1)
|
5 participants
|
|
Characterize Treatment-related Toxicity Rates
Fatigue (Grade 2)
|
4 participants
|
|
Characterize Treatment-related Toxicity Rates
Fatigue (Grade 3)
|
2 participants
|
|
Characterize Treatment-related Toxicity Rates
Pain (Grade 1)
|
6 participants
|
|
Characterize Treatment-related Toxicity Rates
Pain (Grade 2)
|
6 participants
|
|
Characterize Treatment-related Toxicity Rates
Other Constitutional (Grade 1)
|
3 participants
|
|
Characterize Treatment-related Toxicity Rates
Other Constitutional (Grade 2)
|
2 participants
|
|
Characterize Treatment-related Toxicity Rates
Fall (Grade 3)
|
1 participants
|
|
Characterize Treatment-related Toxicity Rates
Hypertension (Grade 2)
|
2 participants
|
|
Characterize Treatment-related Toxicity Rates
Hypertension (Grade 3)
|
2 participants
|
|
Characterize Treatment-related Toxicity Rates
Headache (Grade 1)
|
5 participants
|
|
Characterize Treatment-related Toxicity Rates
Headache (Grade 2)
|
1 participants
|
|
Characterize Treatment-related Toxicity Rates
Headache (Grade 3)
|
1 participants
|
|
Characterize Treatment-related Toxicity Rates
Intracranial Hemmorage (Grade 3)
|
1 participants
|
|
Characterize Treatment-related Toxicity Rates
GERD (Grade 1)
|
2 participants
|
|
Characterize Treatment-related Toxicity Rates
GERD (Grade 2)
|
3 participants
|
|
Characterize Treatment-related Toxicity Rates
GERD (Grade 3)
|
2 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 monthsPopulation: Data for this outcome measure was neither collected or analyzed due to the early termination of the study.
Pre- and post-treatment bladder tumor FGFR pathway phosphorylation changes will be assessed by bladder tumor tissue immunohistochemistry utilizing commercially available antibodies including, but not limited to, the following: fibroblast growth factor receptors (FGFR3, pFGFR3), vascular endothelial growth factor receptors (VEGFR2, pVEGFR2), fibroblast growth factor receptor substrates (2FRS2, pFRS2), extracellular signal-regulated kinases (ERK), phosphorylated extracellular signal-related kinase (pERK).
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 monthsPopulation: Data for this outcome measure was neither collected or analyzed due to the early termination of the study.
Pre-treatment germline FGFR SNPs will be assessed by testing extracted Deoxyribonucleic acid (DNA) from patient peripheral blood mononuclear cells (PBMC's) (collected prior to initiating dovitinib therapy) with validated commercial probes.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 monthsPopulation: Data for this outcome measure was neither collected or analyzed due to the early termination of the study.
Pre- and post-treatment bladder tumor VEGFR pathway phosphorylation changes will be assessed by bladder tumor tissue immunohistochemistry utilizing commercially available antibodies including, but not limited to, the following: FGFR3, pFGFR3, VEGFR2, pVEGFR2, FRS2, pFRS2, ERK, pERK.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 monthsPopulation: Data for this outcome measure was neither collected or analyzed due to the early termination of the study.
Pre-treatment germline VEGFR SNPs will be assessed by testing extracted DNA from patient PBMC's (collected prior to initiating dovitinib therapy) with validated commercial probes.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 monthsPopulation: Data for this outcome measure was neither collected or analyzed due to the early termination of the study.
Hypertension will be defined as a systolic blood pressure (SBP) of \> 140 mmHg or a diastolic blood pressure (DBP) of \> 90 mm Hg recorded at any time after dovitinib therapy is initiated.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 monthsPopulation: Data for this outcome measure was neither collected or analyzed due to the early termination of the study.
Presence of FGFR3 mutations within patient free plasma will be assessed by polymerase chain reaction (PCR) amplification of the target regions and sequencing.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 monthsPopulation: 9 subjects had sufficient tissue available to measure dovitinib tissue concentration
Post-treatment bladder tissue dovitinib concentrations will be assessed by TURBT fresh frozen tissue obtained at the 3-month cystoscopy
Outcome measures
| Measure |
Dovitinib
n=9 Participants
Dovitinib will be administered 500mg orally in a 5 days on, 2 days off dosing schedule.
Dovitinib: Dovitinib will be administered 500mg orally in a 5 days on, 2 days off dosing schedule. Day 12 assessments are intended to be performed on the last dosing day of the 2nd week in cycle 1 and cycle 2 and day 26 assessments are intended to be performed on the last dosing day of the 4th week in cycle 1 and cycle 2.
|
|---|---|
|
Characterize Post-treatment Bladder Tissue Dovitinib Concentrations.
Subject 2
|
1603 nmol/L
|
|
Characterize Post-treatment Bladder Tissue Dovitinib Concentrations.
Subject 3
|
159 nmol/L
|
|
Characterize Post-treatment Bladder Tissue Dovitinib Concentrations.
Subject 6
|
5813 nmol/L
|
|
Characterize Post-treatment Bladder Tissue Dovitinib Concentrations.
Subject 7
|
812 nmol/L
|
|
Characterize Post-treatment Bladder Tissue Dovitinib Concentrations.
Subject 8
|
726 nmol/L
|
|
Characterize Post-treatment Bladder Tissue Dovitinib Concentrations.
Subject 10
|
1135 nmol/L
|
|
Characterize Post-treatment Bladder Tissue Dovitinib Concentrations.
Subject 11
|
94 nmol/L
|
|
Characterize Post-treatment Bladder Tissue Dovitinib Concentrations.
Subject 12
|
2115 nmol/L
|
|
Characterize Post-treatment Bladder Tissue Dovitinib Concentrations.
Subject 13
|
2483 nmol/L
|
Adverse Events
Dovitinib
Serious events: 3 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dovitinib
n=13 participants at risk
Dovitinib will be administered 500mg orally in a 5 days on, 2 days off dosing schedule.
Dovitinib: Dovitinib will be administered 500mg orally in a 5 days on, 2 days off dosing schedule. Day 12 assessments are intended to be performed on the last dosing day of the 2nd week in cycle 1 and cycle 2 and day 26 assessments are intended to be performed on the last dosing day of the 4th week in cycle 1 and cycle 2.
|
|---|---|
|
Renal and urinary disorders
ACUTE KIDNEY INJURY
|
7.7%
1/13 • Number of events 1 • Duration of participation of the treatment portion of the study, up to six cycles (6 Months).
|
|
Gastrointestinal disorders
CONSTIPATION
|
7.7%
1/13 • Number of events 1 • Duration of participation of the treatment portion of the study, up to six cycles (6 Months).
|
|
Nervous system disorders
INTRACRANIAL HEMORRHAGE
|
7.7%
1/13 • Number of events 1 • Duration of participation of the treatment portion of the study, up to six cycles (6 Months).
|
Other adverse events
| Measure |
Dovitinib
n=13 participants at risk
Dovitinib will be administered 500mg orally in a 5 days on, 2 days off dosing schedule.
Dovitinib: Dovitinib will be administered 500mg orally in a 5 days on, 2 days off dosing schedule. Day 12 assessments are intended to be performed on the last dosing day of the 2nd week in cycle 1 and cycle 2 and day 26 assessments are intended to be performed on the last dosing day of the 4th week in cycle 1 and cycle 2.
|
|---|---|
|
Gastrointestinal disorders
ABDOMINAL DISTENSION
|
7.7%
1/13 • Number of events 1 • Duration of participation of the treatment portion of the study, up to six cycles (6 Months).
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
15.4%
2/13 • Number of events 3 • Duration of participation of the treatment portion of the study, up to six cycles (6 Months).
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
7.7%
1/13 • Number of events 3 • Duration of participation of the treatment portion of the study, up to six cycles (6 Months).
|
|
Investigations
ALKALINE PHOSPHATASE INCREASED
|
23.1%
3/13 • Number of events 5 • Duration of participation of the treatment portion of the study, up to six cycles (6 Months).
|
|
Blood and lymphatic system disorders
ANEMIA
|
46.2%
6/13 • Number of events 9 • Duration of participation of the treatment portion of the study, up to six cycles (6 Months).
|
|
Metabolism and nutrition disorders
ANOREXIA
|
38.5%
5/13 • Number of events 6 • Duration of participation of the treatment portion of the study, up to six cycles (6 Months).
|
|
Psychiatric disorders
ANXIETY
|
15.4%
2/13 • Number of events 2 • Duration of participation of the treatment portion of the study, up to six cycles (6 Months).
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
7.7%
1/13 • Number of events 1 • Duration of participation of the treatment portion of the study, up to six cycles (6 Months).
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
7.7%
1/13 • Number of events 4 • Duration of participation of the treatment portion of the study, up to six cycles (6 Months).
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
30.8%
4/13 • Number of events 4 • Duration of participation of the treatment portion of the study, up to six cycles (6 Months).
|
|
Renal and urinary disorders
BLADDER SPASM
|
30.8%
4/13 • Number of events 7 • Duration of participation of the treatment portion of the study, up to six cycles (6 Months).
|
|
Eye disorders
BLURRED VISION
|
7.7%
1/13 • Number of events 1 • Duration of participation of the treatment portion of the study, up to six cycles (6 Months).
|
|
Injury, poisoning and procedural complications
BRUISING
|
7.7%
1/13 • Number of events 1 • Duration of participation of the treatment portion of the study, up to six cycles (6 Months).
|
|
Cardiac disorders
CARDIAC DISORDERS
|
7.7%
1/13 • Number of events 1 • Duration of participation of the treatment portion of the study, up to six cycles (6 Months).
|
|
Eye disorders
CATARACT
|
7.7%
1/13 • Number of events 2 • Duration of participation of the treatment portion of the study, up to six cycles (6 Months).
|
|
Cardiac disorders
CHEST PAIN - CARDIAC
|
7.7%
1/13 • Number of events 2 • Duration of participation of the treatment portion of the study, up to six cycles (6 Months).
|
|
General disorders
CHILLS
|
7.7%
1/13 • Number of events 1 • Duration of participation of the treatment portion of the study, up to six cycles (6 Months).
|
|
Investigations
CHOLESTEROL HIGH
|
23.1%
3/13 • Number of events 6 • Duration of participation of the treatment portion of the study, up to six cycles (6 Months).
|
|
Cardiac disorders
CONDUCTION DISORDER
|
7.7%
1/13 • Number of events 1 • Duration of participation of the treatment portion of the study, up to six cycles (6 Months).
|
|
Eye disorders
CONJUNCTIVITIS
|
7.7%
1/13 • Number of events 1 • Duration of participation of the treatment portion of the study, up to six cycles (6 Months).
|
|
Gastrointestinal disorders
CONSTIPATION
|
46.2%
6/13 • Number of events 8 • Duration of participation of the treatment portion of the study, up to six cycles (6 Months).
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
7.7%
1/13 • Number of events 1 • Duration of participation of the treatment portion of the study, up to six cycles (6 Months).
|
|
Investigations
CREATININE INCREASED
|
7.7%
1/13 • Number of events 1 • Duration of participation of the treatment portion of the study, up to six cycles (6 Months).
|
|
Renal and urinary disorders
CYSTITIS NONINFECTIVE
|
7.7%
1/13 • Number of events 1 • Duration of participation of the treatment portion of the study, up to six cycles (6 Months).
|
|
Psychiatric disorders
DEPRESSION
|
15.4%
2/13 • Number of events 2 • Duration of participation of the treatment portion of the study, up to six cycles (6 Months).
|
|
Gastrointestinal disorders
DIARRHEA
|
76.9%
10/13 • Number of events 15 • Duration of participation of the treatment portion of the study, up to six cycles (6 Months).
|
|
Nervous system disorders
DIZZINESS
|
15.4%
2/13 • Number of events 2 • Duration of participation of the treatment portion of the study, up to six cycles (6 Months).
|
|
Gastrointestinal disorders
DRY MOUTH
|
30.8%
4/13 • Number of events 4 • Duration of participation of the treatment portion of the study, up to six cycles (6 Months).
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
7.7%
1/13 • Number of events 1 • Duration of participation of the treatment portion of the study, up to six cycles (6 Months).
|
|
Nervous system disorders
DYSARTHRIA
|
7.7%
1/13 • Number of events 1 • Duration of participation of the treatment portion of the study, up to six cycles (6 Months).
|
|
Nervous system disorders
DYSGEUSIA
|
53.8%
7/13 • Number of events 9 • Duration of participation of the treatment portion of the study, up to six cycles (6 Months).
|
|
Gastrointestinal disorders
DYSPEPSIA
|
15.4%
2/13 • Number of events 2 • Duration of participation of the treatment portion of the study, up to six cycles (6 Months).
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNEA
|
7.7%
1/13 • Number of events 1 • Duration of participation of the treatment portion of the study, up to six cycles (6 Months).
|
|
Ear and labyrinth disorders
EAR AND LABYRINTH DISORDERS
|
7.7%
1/13 • Number of events 1 • Duration of participation of the treatment portion of the study, up to six cycles (6 Months).
|
|
Gastrointestinal disorders
ESOPHAGEAL PAIN
|
7.7%
1/13 • Number of events 1 • Duration of participation of the treatment portion of the study, up to six cycles (6 Months).
|
|
Infections and infestations
EYE INFECTION
|
7.7%
1/13 • Number of events 1 • Duration of participation of the treatment portion of the study, up to six cycles (6 Months).
|
|
Injury, poisoning and procedural complications
FALL
|
7.7%
1/13 • Number of events 2 • Duration of participation of the treatment portion of the study, up to six cycles (6 Months).
|
|
General disorders
FATIGUE
|
84.6%
11/13 • Number of events 18 • Duration of participation of the treatment portion of the study, up to six cycles (6 Months).
|
|
Gastrointestinal disorders
FECAL INCONTINENCE
|
7.7%
1/13 • Number of events 1 • Duration of participation of the treatment portion of the study, up to six cycles (6 Months).
|
|
General disorders
FEVER
|
30.8%
4/13 • Number of events 7 • Duration of participation of the treatment portion of the study, up to six cycles (6 Months).
|
|
Gastrointestinal disorders
FLATULENCE
|
15.4%
2/13 • Number of events 2 • Duration of participation of the treatment portion of the study, up to six cycles (6 Months).
|
|
General disorders
FLU LIKE SYMPTOMS
|
7.7%
1/13 • Number of events 1 • Duration of participation of the treatment portion of the study, up to six cycles (6 Months).
|
|
Gastrointestinal disorders
GASTROESOPHAGEAL REFLUX DISEASE
|
15.4%
2/13 • Number of events 3 • Duration of participation of the treatment portion of the study, up to six cycles (6 Months).
|
|
Gastrointestinal disorders
GASTROINTESTINAL DISORDERS
|
7.7%
1/13 • Number of events 1 • Duration of participation of the treatment portion of the study, up to six cycles (6 Months).
|
|
Investigations
GGT INCREASED
|
23.1%
3/13 • Number of events 12 • Duration of participation of the treatment portion of the study, up to six cycles (6 Months).
|
|
Nervous system disorders
HEADACHE
|
61.5%
8/13 • Number of events 10 • Duration of participation of the treatment portion of the study, up to six cycles (6 Months).
|
|
Ear and labyrinth disorders
HEARING IMPAIRED
|
7.7%
1/13 • Number of events 1 • Duration of participation of the treatment portion of the study, up to six cycles (6 Months).
|
|
Renal and urinary disorders
HEMATURIA
|
23.1%
3/13 • Number of events 3 • Duration of participation of the treatment portion of the study, up to six cycles (6 Months).
|
|
Hepatobiliary disorders
HEPATOBILIARY DISORDERS
|
7.7%
1/13 • Number of events 2 • Duration of participation of the treatment portion of the study, up to six cycles (6 Months).
|
|
Respiratory, thoracic and mediastinal disorders
HOARSENESS
|
23.1%
3/13 • Number of events 3 • Duration of participation of the treatment portion of the study, up to six cycles (6 Months).
|
|
Metabolism and nutrition disorders
HYPERCALCEMIA
|
7.7%
1/13 • Number of events 1 • Duration of participation of the treatment portion of the study, up to six cycles (6 Months).
|
|
Metabolism and nutrition disorders
HYPERGLYCEMIA
|
23.1%
3/13 • Number of events 3 • Duration of participation of the treatment portion of the study, up to six cycles (6 Months).
|
|
Metabolism and nutrition disorders
HYPERNATREMIA
|
7.7%
1/13 • Number of events 1 • Duration of participation of the treatment portion of the study, up to six cycles (6 Months).
|
|
Vascular disorders
HYPERTENSION
|
46.2%
6/13 • Number of events 27 • Duration of participation of the treatment portion of the study, up to six cycles (6 Months).
|
|
Metabolism and nutrition disorders
HYPERTRIGLYCERIDEMIA
|
38.5%
5/13 • Number of events 17 • Duration of participation of the treatment portion of the study, up to six cycles (6 Months).
|
|
Metabolism and nutrition disorders
HYPOALBUMINEMIA
|
23.1%
3/13 • Number of events 3 • Duration of participation of the treatment portion of the study, up to six cycles (6 Months).
|
|
Metabolism and nutrition disorders
HYPOKALEMIA
|
15.4%
2/13 • Number of events 2 • Duration of participation of the treatment portion of the study, up to six cycles (6 Months).
|
|
Metabolism and nutrition disorders
HYPOMAGNESEMIA
|
15.4%
2/13 • Number of events 4 • Duration of participation of the treatment portion of the study, up to six cycles (6 Months).
|
|
Metabolism and nutrition disorders
HYPOPHOSPHATEMIA
|
7.7%
1/13 • Number of events 1 • Duration of participation of the treatment portion of the study, up to six cycles (6 Months).
|
|
Injury, poisoning and procedural complications
INJURY, POISONING AND PROCEDURAL COMPLICATIONS
|
7.7%
1/13 • Number of events 1 • Duration of participation of the treatment portion of the study, up to six cycles (6 Months).
|
|
Psychiatric disorders
INSOMNIA
|
15.4%
2/13 • Number of events 2 • Duration of participation of the treatment portion of the study, up to six cycles (6 Months).
|
|
Investigations
INVESTIGATIONS
|
7.7%
1/13 • Number of events 1 • Duration of participation of the treatment portion of the study, up to six cycles (6 Months).
|
|
Investigations
LIPASE INCREASED
|
23.1%
3/13 • Number of events 5 • Duration of participation of the treatment portion of the study, up to six cycles (6 Months).
|
|
Investigations
LYMPHOCYTE COUNT DECREASED
|
7.7%
1/13 • Number of events 1 • Duration of participation of the treatment portion of the study, up to six cycles (6 Months).
|
|
General disorders
MALAISE
|
7.7%
1/13 • Number of events 3 • Duration of participation of the treatment portion of the study, up to six cycles (6 Months).
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDER
|
7.7%
1/13 • Number of events 1 • Duration of participation of the treatment portion of the study, up to six cycles (6 Months).
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
15.4%
2/13 • Number of events 2 • Duration of participation of the treatment portion of the study, up to six cycles (6 Months).
|
|
Respiratory, thoracic and mediastinal disorders
NASAL CONGESTION
|
7.7%
1/13 • Number of events 1 • Duration of participation of the treatment portion of the study, up to six cycles (6 Months).
|
|
Gastrointestinal disorders
NAUSEA
|
46.2%
6/13 • Number of events 8 • Duration of participation of the treatment portion of the study, up to six cycles (6 Months).
|
|
Investigations
NEUTROPHIL COUNT DECREASED
|
7.7%
1/13 • Number of events 3 • Duration of participation of the treatment portion of the study, up to six cycles (6 Months).
|
|
Gastrointestinal disorders
ORAL PAIN
|
7.7%
1/13 • Number of events 2 • Duration of participation of the treatment portion of the study, up to six cycles (6 Months).
|
|
General disorders
PAIN
|
15.4%
2/13 • Number of events 3 • Duration of participation of the treatment portion of the study, up to six cycles (6 Months).
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
15.4%
2/13 • Number of events 2 • Duration of participation of the treatment portion of the study, up to six cycles (6 Months).
|
|
Skin and subcutaneous tissue disorders
PAIN OF SKIN
|
7.7%
1/13 • Number of events 1 • Duration of participation of the treatment portion of the study, up to six cycles (6 Months).
|
|
Infections and infestations
PAPULOPUSTULAR RASH
|
7.7%
1/13 • Number of events 1 • Duration of participation of the treatment portion of the study, up to six cycles (6 Months).
|
|
Nervous system disorders
PARESTHESIA
|
7.7%
1/13 • Number of events 1 • Duration of participation of the treatment portion of the study, up to six cycles (6 Months).
|
|
Nervous system disorders
PERIPHERAL SENSORY NEUROPATHY
|
23.1%
3/13 • Number of events 3 • Duration of participation of the treatment portion of the study, up to six cycles (6 Months).
|
|
Investigations
PLATELET COUNT DECREASED
|
15.4%
2/13 • Number of events 2 • Duration of participation of the treatment portion of the study, up to six cycles (6 Months).
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
7.7%
1/13 • Number of events 1 • Duration of participation of the treatment portion of the study, up to six cycles (6 Months).
|
|
Psychiatric disorders
PSYCHIATRIC DISORDERS
|
7.7%
1/13 • Number of events 1 • Duration of participation of the treatment portion of the study, up to six cycles (6 Months).
|
|
Skin and subcutaneous tissue disorders
RASH ACNEIFORM
|
23.1%
3/13 • Number of events 4 • Duration of participation of the treatment portion of the study, up to six cycles (6 Months).
|
|
Skin and subcutaneous tissue disorders
RASH MACULO-PAPULAR
|
30.8%
4/13 • Number of events 4 • Duration of participation of the treatment portion of the study, up to six cycles (6 Months).
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
|
7.7%
1/13 • Number of events 1 • Duration of participation of the treatment portion of the study, up to six cycles (6 Months).
|
|
Investigations
SERUM AMYLASE INCREASED
|
7.7%
1/13 • Number of events 1 • Duration of participation of the treatment portion of the study, up to six cycles (6 Months).
|
|
Cardiac disorders
SINUS BRADYCARDIA
|
7.7%
1/13 • Number of events 1 • Duration of participation of the treatment portion of the study, up to six cycles (6 Months).
|
|
Infections and infestations
SINUSITIS
|
7.7%
1/13 • Number of events 1 • Duration of participation of the treatment portion of the study, up to six cycles (6 Months).
|
|
Skin and subcutaneous tissue disorders
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
|
15.4%
2/13 • Number of events 4 • Duration of participation of the treatment portion of the study, up to six cycles (6 Months).
|
|
Skin and subcutaneous tissue disorders
SKIN HYPOPIGMENTATION
|
7.7%
1/13 • Number of events 1 • Duration of participation of the treatment portion of the study, up to six cycles (6 Months).
|
|
Infections and infestations
SKIN INFECTION
|
7.7%
1/13 • Number of events 1 • Duration of participation of the treatment portion of the study, up to six cycles (6 Months).
|
|
Skin and subcutaneous tissue disorders
SKIN ULCERATION
|
7.7%
1/13 • Number of events 1 • Duration of participation of the treatment portion of the study, up to six cycles (6 Months).
|
|
Respiratory, thoracic and mediastinal disorders
SORE THROAT
|
7.7%
1/13 • Number of events 1 • Duration of participation of the treatment portion of the study, up to six cycles (6 Months).
|
|
Gastrointestinal disorders
STOMACH PAIN
|
15.4%
2/13 • Number of events 2 • Duration of participation of the treatment portion of the study, up to six cycles (6 Months).
|
|
Gastrointestinal disorders
TOOTHACHE
|
7.7%
1/13 • Number of events 1 • Duration of participation of the treatment portion of the study, up to six cycles (6 Months).
|
|
Infections and infestations
UPPER RESPIRATORY INFECTION
|
7.7%
1/13 • Number of events 1 • Duration of participation of the treatment portion of the study, up to six cycles (6 Months).
|
|
Renal and urinary disorders
URINARY FREQUENCY
|
46.2%
6/13 • Number of events 6 • Duration of participation of the treatment portion of the study, up to six cycles (6 Months).
|
|
Infections and infestations
URINARY TRACT INFECTION
|
30.8%
4/13 • Number of events 4 • Duration of participation of the treatment portion of the study, up to six cycles (6 Months).
|
|
Renal and urinary disorders
URINARY TRACT PAIN
|
7.7%
1/13 • Number of events 1 • Duration of participation of the treatment portion of the study, up to six cycles (6 Months).
|
|
Renal and urinary disorders
URINARY URGENCY
|
7.7%
1/13 • Number of events 1 • Duration of participation of the treatment portion of the study, up to six cycles (6 Months).
|
|
Respiratory, thoracic and mediastinal disorders
VOICE ALTERATION
|
7.7%
1/13 • Number of events 1 • Duration of participation of the treatment portion of the study, up to six cycles (6 Months).
|
|
Gastrointestinal disorders
VOMITING
|
30.8%
4/13 • Number of events 4 • Duration of participation of the treatment portion of the study, up to six cycles (6 Months).
|
|
Eye disorders
WATERING EYES
|
7.7%
1/13 • Number of events 1 • Duration of participation of the treatment portion of the study, up to six cycles (6 Months).
|
|
Investigations
WEIGHT LOSS
|
30.8%
4/13 • Number of events 4 • Duration of participation of the treatment portion of the study, up to six cycles (6 Months).
|
Additional Information
Clinical Data Coordinator
Hoosier Cancer Research Network
Phone: 317-921-2050
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place