Trial Outcomes & Findings for Neoadjuvant Dasatinib and Radical Cystectomy for Transitional Cell Carcinoma of the Bladder (NCT NCT00706641)
NCT ID: NCT00706641
Last Updated: 2016-01-15
Results Overview
Feasibility for this trial is defined as at least 60% (\>=14 of 23) of patients completing study therapy in the absence of Dose Limiting Toxicity (DLT)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
25 participants
Primary outcome timeframe
From enrollment to completion of radical cystectomy
Results posted on
2016-01-15
Participant Flow
Participant milestones
| Measure |
Experimental: Neoadjuvant Dasatinib + Radical Cystectomy
Dasatinib 100 mg PO qd x 4 weeks followed by radical cystectomy 8-24 hours post last administered dasatinib dose
Dasatinib: Dasatinib 100 mg administered orally once daily for 4 weeks duration (+/- 1 week)
Radical Cystectomy: Radical cystectomy should be performed no sooner than 8 hours but preferably within 24 hours of the last administered Dasatinib dose. All attempts should be made for the patient to have their surgery after 8 hours but within 24 hours of their last dose of dasatinib. If surgery delay is imperative, dasatinib therapy should continue until at least 24 hours before planned surgery.
|
|---|---|
|
Dasatinib Administration
STARTED
|
25
|
|
Dasatinib Administration
Toxicity Evaluation
|
24
|
|
Dasatinib Administration
COMPLETED
|
23
|
|
Dasatinib Administration
NOT COMPLETED
|
2
|
|
Radical Cystectomy
STARTED
|
23
|
|
Radical Cystectomy
COMPLETED
|
22
|
|
Radical Cystectomy
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Experimental: Neoadjuvant Dasatinib + Radical Cystectomy
Dasatinib 100 mg PO qd x 4 weeks followed by radical cystectomy 8-24 hours post last administered dasatinib dose
Dasatinib: Dasatinib 100 mg administered orally once daily for 4 weeks duration (+/- 1 week)
Radical Cystectomy: Radical cystectomy should be performed no sooner than 8 hours but preferably within 24 hours of the last administered Dasatinib dose. All attempts should be made for the patient to have their surgery after 8 hours but within 24 hours of their last dose of dasatinib. If surgery delay is imperative, dasatinib therapy should continue until at least 24 hours before planned surgery.
|
|---|---|
|
Dasatinib Administration
Withdrawal by Subject
|
1
|
|
Dasatinib Administration
Ineligible after start of therapy
|
1
|
|
Radical Cystectomy
Deemed unresectable upon exploration
|
1
|
Baseline Characteristics
Neoadjuvant Dasatinib and Radical Cystectomy for Transitional Cell Carcinoma of the Bladder
Baseline characteristics by cohort
| Measure |
Experimental: Neoadjuvant Dasatinib + Radical Cystectomy
n=25 Participants
Dasatinib 100 mg PO qd x 4 weeks followed by radical cystectomy 8-24 hours post last administered dasatinib dose
Dasatinib: Dasatinib 100 mg administered orally once daily for 4 weeks duration (+/- 1 week)
Radical Cystectomy: Radical cystectomy should be performed no sooner than 8 hours but preferably within 24 hours of the last administered Dasatinib dose. All attempts should be made for the patient to have their surgery after 8 hours but within 24 hours of their last dose of dasatinib. If surgery delay is imperative, dasatinib therapy should continue until at least 24 hours before planned surgery.
|
|---|---|
|
Age, Continuous
|
62 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
|
ECOG PS
ECOG PS 0
|
19 participants
n=5 Participants
|
|
ECOG PS
ECOG PS 1
|
6 participants
n=5 Participants
|
|
T-Stage at Study Entry
T2
|
17 participants
n=5 Participants
|
|
T-Stage at Study Entry
T3
|
7 participants
n=5 Participants
|
|
T-Stage at Study Entry
T4a
|
0 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From enrollment to completion of radical cystectomyPopulation: All patients who completed dasatinib
Feasibility for this trial is defined as at least 60% (\>=14 of 23) of patients completing study therapy in the absence of Dose Limiting Toxicity (DLT)
Outcome measures
| Measure |
Experimental: Neoadjuvant Dasatinib + Radical Cystectomy
n=23 Participants
Dasatinib 100 mg PO qd x 4 weeks followed by radical cystectomy 8-24 hours post last administered dasatinib dose
Dasatinib: Dasatinib 100 mg administered orally once daily for 4 weeks duration (+/- 1 week)
Radical Cystectomy: Radical cystectomy should be performed no sooner than 8 hours but preferably within 24 hours of the last administered Dasatinib dose. All attempts should be made for the patient to have their surgery after 8 hours but within 24 hours of their last dose of dasatinib. If surgery delay is imperative, dasatinib therapy should continue until at least 24 hours before planned surgery.
|
|---|---|
|
Feasibility
DLT
|
8 participants
|
|
Feasibility
Absence of DLT
|
15 participants
|
SECONDARY outcome
Timeframe: Time of consent through 30 days after treatment discontinuationPopulation: 24 patients received treatment, 1 patient ineligible due to small cell histology after starting dasatinib treatment and was not evaluable.
Report grade 3/4 toxicities during treatment with dasatinib prior to radical cystectomy in patients with muscle invasive transitional cell carcinoma of the bladder.
Outcome measures
| Measure |
Experimental: Neoadjuvant Dasatinib + Radical Cystectomy
n=24 Participants
Dasatinib 100 mg PO qd x 4 weeks followed by radical cystectomy 8-24 hours post last administered dasatinib dose
Dasatinib: Dasatinib 100 mg administered orally once daily for 4 weeks duration (+/- 1 week)
Radical Cystectomy: Radical cystectomy should be performed no sooner than 8 hours but preferably within 24 hours of the last administered Dasatinib dose. All attempts should be made for the patient to have their surgery after 8 hours but within 24 hours of their last dose of dasatinib. If surgery delay is imperative, dasatinib therapy should continue until at least 24 hours before planned surgery.
|
|---|---|
|
Grade 3/4 Toxicities
Anemia
|
4 percentage of particpants
|
|
Grade 3/4 Toxicities
Fatigue
|
8 percentage of particpants
|
|
Grade 3/4 Toxicities
Diarrhea
|
4 percentage of particpants
|
|
Grade 3/4 Toxicities
Nausea
|
4 percentage of particpants
|
|
Grade 3/4 Toxicities
Anorexia
|
4 percentage of particpants
|
|
Grade 3/4 Toxicities
Abdominal Pain
|
4 percentage of particpants
|
|
Grade 3/4 Toxicities
Dyspnea
|
8 percentage of particpants
|
|
Grade 3/4 Toxicities
Hematuria
|
4 percentage of particpants
|
|
Grade 3/4 Toxicities
Superventricular and Nodal Arrythmia
|
4 percentage of particpants
|
|
Grade 3/4 Toxicities
Enteric Fistula
|
8 percentage of particpants
|
|
Grade 3/4 Toxicities
Deep Vein Thrombosis \ Pulmonary Embolism
|
8 percentage of particpants
|
SECONDARY outcome
Timeframe: Baseline to post dasatinib therapyPopulation: Sufficient tumor suitable for Immuno-Histochemistry (IHC) analysis was available from 20 patients
pSFK levels were analyzed pre and post treatment
Outcome measures
| Measure |
Experimental: Neoadjuvant Dasatinib + Radical Cystectomy
n=20 Participants
Dasatinib 100 mg PO qd x 4 weeks followed by radical cystectomy 8-24 hours post last administered dasatinib dose
Dasatinib: Dasatinib 100 mg administered orally once daily for 4 weeks duration (+/- 1 week)
Radical Cystectomy: Radical cystectomy should be performed no sooner than 8 hours but preferably within 24 hours of the last administered Dasatinib dose. All attempts should be made for the patient to have their surgery after 8 hours but within 24 hours of their last dose of dasatinib. If surgery delay is imperative, dasatinib therapy should continue until at least 24 hours before planned surgery.
|
|---|---|
|
Reduced pSFK Expression
|
16 participants
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: 23 participants completed treatment and underwent radical cystectomy.
Pathologic complete response (pCR) rate is defined as no residual evidence of muscle-invasive disease at cystectomy (\< pT0).
Outcome measures
| Measure |
Experimental: Neoadjuvant Dasatinib + Radical Cystectomy
n=23 Participants
Dasatinib 100 mg PO qd x 4 weeks followed by radical cystectomy 8-24 hours post last administered dasatinib dose
Dasatinib: Dasatinib 100 mg administered orally once daily for 4 weeks duration (+/- 1 week)
Radical Cystectomy: Radical cystectomy should be performed no sooner than 8 hours but preferably within 24 hours of the last administered Dasatinib dose. All attempts should be made for the patient to have their surgery after 8 hours but within 24 hours of their last dose of dasatinib. If surgery delay is imperative, dasatinib therapy should continue until at least 24 hours before planned surgery.
|
|---|---|
|
Pathologic Complete Response (pCR) Rate
|
0 participants
|
SECONDARY outcome
Timeframe: Staged Post-Cystectomy and dasatinib treatmentTumor Node Metastasis (TNM) Staging. This system classifies tumors by size and extent of the primary tumor (T), involvement of regional lymph nodes (N), and the presence or absence of distant metastases (M) T0=No evidence of primary tumor, Tis=Carcinoma in situ, and T1, T2, T3, T4=Increasing size and/or local extension of the primary tumor, TX=Not assessed N0=No Regional lymph node metastases, N1, N2, N3=Increasing number or extent of regional lymph node involvement, NX=not assessed M0=No distant metastases, M1=Distant metastases present
Outcome measures
| Measure |
Experimental: Neoadjuvant Dasatinib + Radical Cystectomy
n=23 Participants
Dasatinib 100 mg PO qd x 4 weeks followed by radical cystectomy 8-24 hours post last administered dasatinib dose
Dasatinib: Dasatinib 100 mg administered orally once daily for 4 weeks duration (+/- 1 week)
Radical Cystectomy: Radical cystectomy should be performed no sooner than 8 hours but preferably within 24 hours of the last administered Dasatinib dose. All attempts should be made for the patient to have their surgery after 8 hours but within 24 hours of their last dose of dasatinib. If surgery delay is imperative, dasatinib therapy should continue until at least 24 hours before planned surgery.
|
|---|---|
|
Post-Cystectomy Pathologic Stage
T1\Tis
|
23 percentage of particpants
Interval 10.0 to 44.0
|
|
Post-Cystectomy Pathologic Stage
T4
|
9 percentage of particpants
Interval 1.0 to 29.0
|
|
Post-Cystectomy Pathologic Stage
Unresectable
|
5 percentage of particpants
Interval 0.0 to 24.0
|
|
Post-Cystectomy Pathologic Stage
T2
|
27 percentage of particpants
Interval 13.0 to 48.0
|
|
Post-Cystectomy Pathologic Stage
T3
|
41 percentage of particpants
Interval 23.0 to 61.0
|
SECONDARY outcome
Timeframe: Baseline to post dasatinib therapyPopulation: Sufficient tumor suitable for Immuno-Histochemistry (IHC) analysis was available from 20 patients
Ki-67 levels were analyzed pre and post treatment
Outcome measures
| Measure |
Experimental: Neoadjuvant Dasatinib + Radical Cystectomy
n=20 Participants
Dasatinib 100 mg PO qd x 4 weeks followed by radical cystectomy 8-24 hours post last administered dasatinib dose
Dasatinib: Dasatinib 100 mg administered orally once daily for 4 weeks duration (+/- 1 week)
Radical Cystectomy: Radical cystectomy should be performed no sooner than 8 hours but preferably within 24 hours of the last administered Dasatinib dose. All attempts should be made for the patient to have their surgery after 8 hours but within 24 hours of their last dose of dasatinib. If surgery delay is imperative, dasatinib therapy should continue until at least 24 hours before planned surgery.
|
|---|---|
|
Reduced Ki-67 Expression
|
4 participants
|
SECONDARY outcome
Timeframe: Baseline to post dasatinib therapyPopulation: Sufficient tumor suitable for Immuno-Histochemistry (IHC) analysis was available from 20 patients
Cas3 levels were analyzed pre and post treatment
Outcome measures
| Measure |
Experimental: Neoadjuvant Dasatinib + Radical Cystectomy
n=20 Participants
Dasatinib 100 mg PO qd x 4 weeks followed by radical cystectomy 8-24 hours post last administered dasatinib dose
Dasatinib: Dasatinib 100 mg administered orally once daily for 4 weeks duration (+/- 1 week)
Radical Cystectomy: Radical cystectomy should be performed no sooner than 8 hours but preferably within 24 hours of the last administered Dasatinib dose. All attempts should be made for the patient to have their surgery after 8 hours but within 24 hours of their last dose of dasatinib. If surgery delay is imperative, dasatinib therapy should continue until at least 24 hours before planned surgery.
|
|---|---|
|
Increase in Cas3 Expression
|
3 participants
|
Adverse Events
Experimental: Neoadjuvant Dasatinib + Radical Cystectomy
Serious events: 4 serious events
Other events: 24 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Experimental: Neoadjuvant Dasatinib + Radical Cystectomy
n=25 participants at risk
Dasatinib 100 mg PO qd x 4 weeks followed by radical cystectomy 8-24 hours post last administered dasatinib dose
Dasatinib: Dasatinib 100 mg administered orally once daily for 4 weeks duration (+/- 1 week)
Radical Cystectomy: Radical cystectomy should be performed no sooner than 8 hours but preferably within 24 hours of the last administered Dasatinib dose. All attempts should be made for the patient to have their surgery after 8 hours but within 24 hours of their last dose of dasatinib. If surgery delay is imperative, dasatinib therapy should continue until at least 24 hours before planned surgery.
|
|---|---|
|
Gastrointestinal disorders
ESOPHAGITIS
|
4.0%
1/25 • Number of events 1 • Duration of Study
|
|
Gastrointestinal disorders
FISTULA, GI / ANUS
|
4.0%
1/25 • Number of events 1 • Duration of Study
|
|
Gastrointestinal disorders
HEMORRHAGE, GI / PERITONEAL CAVITY
|
4.0%
1/25 • Number of events 1 • Duration of Study
|
|
Cardiac disorders
HYPERTENSION
|
4.0%
1/25 • Number of events 1 • Duration of Study
|
|
Cardiac disorders
HYPOTENSION
|
4.0%
1/25 • Number of events 1 • Duration of Study
|
|
Gastrointestinal disorders
LEAK (INCLUDING ANASTOMOTIC), GI / SMALL BOWEL
|
4.0%
1/25 • Number of events 1 • Duration of Study
|
|
Cardiac disorders
PALPITATIONS
|
4.0%
1/25 • Number of events 1 • Duration of Study
|
|
Cardiac disorders
SUPRAVENTRICULAR AND NODAL ARRHYTHMIA / ATRIAL FLUTTER
|
4.0%
1/25 • Number of events 1 • Duration of Study
|
|
Vascular disorders
THROMBOSIS/EMBOLISM (VASCULAR ACCESS-RELATED)
|
4.0%
1/25 • Number of events 1 • Duration of Study
|
|
Vascular disorders
THROMBOSIS/THROMBUS/EMBOLISM
|
4.0%
1/25 • Number of events 1 • Duration of Study
|
|
Skin and subcutaneous tissue disorders
WOUND COMPLICATION, NON-INFECTIOUS
|
4.0%
1/25 • Number of events 2 • Duration of Study
|
Other adverse events
| Measure |
Experimental: Neoadjuvant Dasatinib + Radical Cystectomy
n=25 participants at risk
Dasatinib 100 mg PO qd x 4 weeks followed by radical cystectomy 8-24 hours post last administered dasatinib dose
Dasatinib: Dasatinib 100 mg administered orally once daily for 4 weeks duration (+/- 1 week)
Radical Cystectomy: Radical cystectomy should be performed no sooner than 8 hours but preferably within 24 hours of the last administered Dasatinib dose. All attempts should be made for the patient to have their surgery after 8 hours but within 24 hours of their last dose of dasatinib. If surgery delay is imperative, dasatinib therapy should continue until at least 24 hours before planned surgery.
|
|---|---|
|
Investigations
ALBUMIN, SERUM-LOW (HYPOALBUMINEMIA)
|
8.0%
2/25 • Number of events 4 • Duration of Study
|
|
Investigations
ALKALINE PHOSPHATASE
|
4.0%
1/25 • Number of events 1 • Duration of Study
|
|
Immune system disorders
ALLERGIC RHINITIS (INCLUDING SNEEZING, NASAL STUFFINESS, POSTNASAL DRIP)
|
8.0%
2/25 • Number of events 2 • Duration of Study
|
|
Investigations
ALT, SGPT (SERUM GLUTAMIC PYRUVIC TRANSAMINASE)
|
4.0%
1/25 • Number of events 1 • Duration of Study
|
|
Gastrointestinal disorders
ANOREXIA
|
48.0%
12/25 • Number of events 15 • Duration of Study
|
|
Investigations
AST, SGOT(SERUM GLUTAMIC OXALOACETIC TRANSAMINASE)
|
4.0%
1/25 • Number of events 1 • Duration of Study
|
|
Nervous system disorders
ATAXIA (INCOORDINATION)
|
8.0%
2/25 • Number of events 2 • Duration of Study
|
|
Investigations
BICARBONATE, SERUM-LOW
|
8.0%
2/25 • Number of events 2 • Duration of Study
|
|
Renal and urinary disorders
BLADDER SPASMS
|
16.0%
4/25 • Number of events 4 • Duration of Study
|
|
Investigations
CALCIUM, SERUM-LOW (HYPOCALCEMIA)
|
4.0%
1/25 • Number of events 2 • Duration of Study
|
|
Cardiac disorders
CARDIAC GENERAL - OTHER (SPECIFY, __)
|
8.0%
2/25 • Number of events 3 • Duration of Study
|
|
Gastrointestinal disorders
CONSTIPATION
|
52.0%
13/25 • Number of events 17 • Duration of Study
|
|
General disorders
CONSTITUTIONAL SYMPTOMS - OTHER (SPECIFY, __)
|
4.0%
1/25 • Number of events 1 • Duration of Study
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
8.0%
2/25 • Number of events 2 • Duration of Study
|
|
Investigations
CREATININE
|
4.0%
1/25 • Number of events 1 • Duration of Study
|
|
Skin and subcutaneous tissue disorders
DERMATOLOGY/SKIN - OTHER (SPECIFY, __)
|
12.0%
3/25 • Number of events 3 • Duration of Study
|
|
Gastrointestinal disorders
DIARRHEA
|
52.0%
13/25 • Number of events 15 • Duration of Study
|
|
Gastrointestinal disorders
DISTENSION/BLOATING, ABDOMINAL
|
8.0%
2/25 • Number of events 2 • Duration of Study
|
|
Nervous system disorders
DIZZINESS
|
4.0%
1/25 • Number of events 1 • Duration of Study
|
|
Gastrointestinal disorders
DRY MOUTH/SALIVARY GLAND (XEROSTOMIA)
|
8.0%
2/25 • Number of events 2 • Duration of Study
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNEA (SHORTNESS OF BREATH)
|
20.0%
5/25 • Number of events 8 • Duration of Study
|
|
Blood and lymphatic system disorders
EDEMA: LIMB
|
8.0%
2/25 • Number of events 2 • Duration of Study
|
|
Reproductive system and breast disorders
ERECTILE DYSFUNCTION
|
4.0%
1/25 • Number of events 1 • Duration of Study
|
|
Gastrointestinal disorders
ESOPHAGITIS
|
4.0%
1/25 • Number of events 1 • Duration of Study
|
|
General disorders
FATIGUE (ASTHENIA, LETHARGY, MALAISE)
|
88.0%
22/25 • Number of events 32 • Duration of Study
|
|
General disorders
FEVER (IN THE ABSENCE OF NEUTROPENIA, WHERE NEUTROPENIA IS DEFINED AS ANC <1.0 X 10E9/L)
|
8.0%
2/25 • Number of events 3 • Duration of Study
|
|
Gastrointestinal disorders
FISTULA, GI / SMALL BOWEL NOS
|
4.0%
1/25 • Number of events 1 • Duration of Study
|
|
Skin and subcutaneous tissue disorders
FLUSHING
|
8.0%
2/25 • Number of events 2 • Duration of Study
|
|
Gastrointestinal disorders
GASTROINTESTINAL - OTHER (SPECIFY, __)
|
8.0%
2/25 • Number of events 2 • Duration of Study
|
|
Investigations
GLUCOSE, SERUM-HIGH (HYPERGLYCEMIA)
|
16.0%
4/25 • Number of events 4 • Duration of Study
|
|
Gastrointestinal disorders
HEARTBURN/DYSPEPSIA
|
44.0%
11/25 • Number of events 15 • Duration of Study
|
|
Blood and lymphatic system disorders
HEMOGLOBIN
|
24.0%
6/25 • Number of events 22 • Duration of Study
|
|
Investigations
HEMOGLOBINURIA
|
8.0%
2/25 • Number of events 2 • Duration of Study
|
|
Blood and lymphatic system disorders
HEMOLYSIS (E.G., IMMUNE HEMOLYTIC ANEMIA, DRUG-RELATED HEMOLYSIS)
|
4.0%
1/25 • Number of events 1 • Duration of Study
|
|
Gastrointestinal disorders
HEMORRHAGE, GU / BLADDER
|
16.0%
4/25 • Number of events 7 • Duration of Study
|
|
Renal and urinary disorders
HEMORRHAGE, GU / URINARY NOS
|
12.0%
3/25 • Number of events 5 • Duration of Study
|
|
General disorders
HEMORRHAGE/BLEEDING - OTHER (SPECIFY, __)
|
4.0%
1/25 • Number of events 1 • Duration of Study
|
|
Injury, poisoning and procedural complications
HEMORRHAGE/BLEEDING ASSOCIATED WITH SURGERY, INTRA-OPERATIVE OR POSTOPERATIVE
|
4.0%
1/25 • Number of events 1 • Duration of Study
|
|
Gastrointestinal disorders
HEMORRHOIDS
|
4.0%
1/25 • Number of events 1 • Duration of Study
|
|
Cardiac disorders
HYPERTENSION
|
16.0%
4/25 • Number of events 4 • Duration of Study
|
|
Infections and infestations
INFECTION WITH GRADE 3 OR 4 NEUTROPHILS (ANC <1.0 X 10E9/L) / BLADDER (URINARY)
|
4.0%
1/25 • Number of events 1 • Duration of Study
|
|
Infections and infestations
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / BLADDER (URINARY)
|
4.0%
1/25 • Number of events 1 • Duration of Study
|
|
Infections and infestations
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / URINARY TRACT NOS
|
12.0%
3/25 • Number of events 3 • Duration of Study
|
|
Infections and infestations
INFECTION WITH UNKNOWN ANC / PERITONEAL CAVITY
|
4.0%
1/25 • Number of events 1 • Duration of Study
|
|
Infections and infestations
INFECTION WITH UNKNOWN ANC / URINARY TRACT NOS
|
4.0%
1/25 • Number of events 1 • Duration of Study
|
|
Infections and infestations
INFECTION WITH UNKNOWN ANC / VAGINA
|
4.0%
1/25 • Number of events 1 • Duration of Study
|
|
General disorders
INSOMNIA
|
20.0%
5/25 • Number of events 6 • Duration of Study
|
|
Investigations
METABOLIC/LABORATORY - OTHER (SPECIFY, __)
|
4.0%
1/25 • Number of events 1 • Duration of Study
|
|
Psychiatric disorders
MOOD ALTERATION / ANXIETY
|
20.0%
5/25 • Number of events 5 • Duration of Study
|
|
Psychiatric disorders
MOOD ALTERATION / DEPRESSION
|
16.0%
4/25 • Number of events 4 • Duration of Study
|
|
Surgical and medical procedures
MUCOSITIS/STOMATITIS (CLINICAL EXAM) / ORAL CAVITY
|
12.0%
3/25 • Number of events 3 • Duration of Study
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL/SOFT TISSUE - OTHER (SPECIFY, __)
|
8.0%
2/25 • Number of events 2 • Duration of Study
|
|
Gastrointestinal disorders
NAUSEA
|
56.0%
14/25 • Number of events 26 • Duration of Study
|
|
Nervous system disorders
NEUROLOGY - OTHER (SPECIFY, __)
|
4.0%
1/25 • Number of events 2 • Duration of Study
|
|
Nervous system disorders
NEUROPATHY: SENSORY
|
12.0%
3/25 • Number of events 3 • Duration of Study
|
|
Blood and lymphatic system disorders
NEUTROPHILS/GRANULOCYTES (ANC/AGC)
|
4.0%
1/25 • Number of events 1 • Duration of Study
|
|
Renal and urinary disorders
OBSTRUCTION, GU / BLADDER
|
8.0%
2/25 • Number of events 2 • Duration of Study
|
|
Gastrointestinal disorders
PAIN / ABDOMEN NOS
|
32.0%
8/25 • Number of events 10 • Duration of Study
|
|
General disorders
PAIN / BACK
|
8.0%
2/25 • Number of events 2 • Duration of Study
|
|
Renal and urinary disorders
PAIN / BLADDER
|
24.0%
6/25 • Number of events 7 • Duration of Study
|
|
Musculoskeletal and connective tissue disorders
PAIN / BONE
|
4.0%
1/25 • Number of events 3 • Duration of Study
|
|
General disorders
PAIN / BUTTOCK
|
4.0%
1/25 • Number of events 1 • Duration of Study
|
|
Musculoskeletal and connective tissue disorders
PAIN / EXTREMITY-LIMB
|
8.0%
2/25 • Number of events 2 • Duration of Study
|
|
General disorders
PAIN / HEAD/HEADACHE
|
20.0%
5/25 • Number of events 6 • Duration of Study
|
|
Musculoskeletal and connective tissue disorders
PAIN / JOINT
|
12.0%
3/25 • Number of events 5 • Duration of Study
|
|
Musculoskeletal and connective tissue disorders
PAIN / MUSCLE
|
4.0%
1/25 • Number of events 2 • Duration of Study
|
|
General disorders
PAIN / PAIN NOS
|
8.0%
2/25 • Number of events 2 • Duration of Study
|
|
General disorders
PAIN / PELVIS
|
8.0%
2/25 • Number of events 2 • Duration of Study
|
|
Reproductive system and breast disorders
PAIN / PENIS
|
4.0%
1/25 • Number of events 1 • Duration of Study
|
|
Gastrointestinal disorders
PAIN / RECTUM
|
4.0%
1/25 • Number of events 2 • Duration of Study
|
|
Gastrointestinal disorders
PAIN / STOMACH
|
4.0%
1/25 • Number of events 1 • Duration of Study
|
|
Reproductive system and breast disorders
PAIN / TESTICLE
|
4.0%
1/25 • Number of events 1 • Duration of Study
|
|
Respiratory, thoracic and mediastinal disorders
PAIN / THROAT/PHARYNX/LARYNX
|
4.0%
1/25 • Number of events 1 • Duration of Study
|
|
General disorders
PAIN / TUMOR PAIN
|
8.0%
2/25 • Number of events 3 • Duration of Study
|
|
General disorders
PAIN - OTHER (SPECIFY, __)
|
28.0%
7/25 • Number of events 9 • Duration of Study
|
|
Cardiac disorders
PALPITATIONS
|
8.0%
2/25 • Number of events 2 • Duration of Study
|
|
Endocrine disorders
PANCREATIC ENDOCRINE: GLUCOSE INTOLERANCE
|
4.0%
1/25 • Number of events 1 • Duration of Study
|
|
Blood and lymphatic system disorders
PLATELETS
|
4.0%
1/25 • Number of events 1 • Duration of Study
|
|
Investigations
POTASSIUM, SERUM-HIGH (HYPERKALEMIA)
|
4.0%
1/25 • Number of events 1 • Duration of Study
|
|
Skin and subcutaneous tissue disorders
PRURITUS/ITCHING
|
24.0%
6/25 • Number of events 6 • Duration of Study
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY/UPPER RESPIRATORY - OTHER (SPECIFY, __)
|
8.0%
2/25 • Number of events 2 • Duration of Study
|
|
Skin and subcutaneous tissue disorders
RASH/DESQUAMATION
|
8.0%
2/25 • Number of events 2 • Duration of Study
|
|
Skin and subcutaneous tissue disorders
RASH: ACNE/ACNEIFORM
|
12.0%
3/25 • Number of events 3 • Duration of Study
|
|
Skin and subcutaneous tissue disorders
RASH: HAND-FOOT SKIN REACTION
|
8.0%
2/25 • Number of events 4 • Duration of Study
|
|
Renal and urinary disorders
RENAL FAILURE
|
4.0%
1/25 • Number of events 1 • Duration of Study
|
|
Renal and urinary disorders
RENAL/GENITOURINARY - OTHER (SPECIFY, __)
|
32.0%
8/25 • Number of events 12 • Duration of Study
|
|
General disorders
RIGORS/CHILLS
|
8.0%
2/25 • Number of events 2 • Duration of Study
|
|
Gastrointestinal disorders
SALIVARY GLAND CHANGES/SALIVA
|
4.0%
1/25 • Number of events 1 • Duration of Study
|
|
Skin and subcutaneous tissue disorders
SKIN BREAKDOWN/DECUBITUS ULCER
|
4.0%
1/25 • Number of events 1 • Duration of Study
|
|
Investigations
SODIUM, SERUM-LOW (HYPONATREMIA)
|
4.0%
1/25 • Number of events 1 • Duration of Study
|
|
Cardiac disorders
SUPRAVENTRICULAR AND NODAL ARRHYTHMIA / ATRIAL FIBRILLATION
|
4.0%
1/25 • Number of events 1 • Duration of Study
|
|
Cardiac disorders
SUPRAVENTRICULAR AND NODAL ARRHYTHMIA / SINUS TACHYCARDIA
|
4.0%
1/25 • Number of events 1 • Duration of Study
|
|
General disorders
SWEATING (DIAPHORESIS)
|
4.0%
1/25 • Number of events 1 • Duration of Study
|
|
Gastrointestinal disorders
TASTE ALTERATION (DYSGEUSIA)
|
24.0%
6/25 • Number of events 7 • Duration of Study
|
|
Renal and urinary disorders
URINARY FREQUENCY/URGENCY
|
28.0%
7/25 • Number of events 8 • Duration of Study
|
|
Renal and urinary disorders
URINARY RETENTION (INCLUDING NEUROGENIC BLADDER)
|
4.0%
1/25 • Number of events 2 • Duration of Study
|
|
Renal and urinary disorders
URINE COLOR CHANGE
|
4.0%
1/25 • Number of events 1 • Duration of Study
|
|
Skin and subcutaneous tissue disorders
URTICARIA (HIVES, WELTS, WHEALS)
|
4.0%
1/25 • Number of events 1 • Duration of Study
|
|
Gastrointestinal disorders
VOMITING
|
28.0%
7/25 • Number of events 8 • Duration of Study
|
|
General disorders
WEIGHT GAIN
|
4.0%
1/25 • Number of events 1 • Duration of Study
|
|
General disorders
WEIGHT LOSS
|
20.0%
5/25 • Number of events 7 • Duration of Study
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place