Trial Outcomes & Findings for Everolimus in Treating Patients With Newly Diagnosed Localized Prostate Cancer (NCT NCT00526591)
NCT ID: NCT00526591
Last Updated: 2018-12-06
Results Overview
Specimens are fixed in formalin for 24 hours.Specimens are the cut at 3 mm intervals perpendicular to the rectal surface and the sections are examined grossly and microscopically on routine Hematoxylin and Eosin stain (H\&E) (pathologic complete response or P0) will be defined as responders.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
17 participants
Primary outcome timeframe
After 8 weeks of therapy at the time of prostatectomy
Results posted on
2018-12-06
Participant Flow
Participant milestones
| Measure |
Low-dose Cohort
Patients will receive 5.0mg P.O. daily continuously for 8 weeks
everolimus: Low-dose Cohort: Patients will receive 5.0mg P.O. daily continuously for 8 weeks; High-dose Cohort: Patients will receive 10mg P.O. daily continuously for 8 weeks
conventional surgery: Radical prostatectomy with bilateral pelvic lymphadenectomy will be performed within 10 days of the completion of week 8 on RAD-001 (Everolimus).
|
High-dose Cohort
Patients will receive 10mg P.O. daily continuously for 8 weeks
everolimus: Low-dose Cohort: Patients will receive 5.0mg P.O. daily continuously for 8 weeks; High-dose Cohort: Patients will receive 10mg P.O. daily continuously for 8 weeks
conventional surgery: Radical prostatectomy with bilateral pelvic lymphadenectomy will be performed within 10 days of the completion of week 8 on RAD-001 (Everolimus).
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
9
|
|
Overall Study
COMPLETED
|
8
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Everolimus in Treating Patients With Newly Diagnosed Localized Prostate Cancer
Baseline characteristics by cohort
| Measure |
Low-dose Cohort
n=8 Participants
Patients will receive 5.0mg P.O. daily continuously for 8 weeks
everolimus: Low-dose Cohort: Patients will receive 5.0mg P.O. daily continuously for 8 weeks; High-dose Cohort: Patients will receive 10mg P.O. daily continuously for 8 weeks
conventional surgery: Radical prostatectomy with bilateral pelvic lymphadenectomy will be performed within 10 days of the completion of week 8 on RAD-001 (Everolimus).
|
High-dose Cohort
n=9 Participants
Patients will receive 10mg P.O. daily continuously for 8 weeks
everolimus: Low-dose Cohort: Patients will receive 5.0mg P.O. daily continuously for 8 weeks; High-dose Cohort: Patients will receive 10mg P.O. daily continuously for 8 weeks
conventional surgery: Radical prostatectomy with bilateral pelvic lymphadenectomy will be performed within 10 days of the completion of week 8 on RAD-001 (Everolimus).
|
Total
n=17 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58 years
STANDARD_DEVIATION 7.9 • n=5 Participants
|
59 years
STANDARD_DEVIATION 4.5 • n=7 Participants
|
59 years
STANDARD_DEVIATION 6.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=5 Participants
|
9 participants
n=7 Participants
|
17 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: After 8 weeks of therapy at the time of prostatectomyPopulation: Intention to treat
Specimens are fixed in formalin for 24 hours.Specimens are the cut at 3 mm intervals perpendicular to the rectal surface and the sections are examined grossly and microscopically on routine Hematoxylin and Eosin stain (H\&E) (pathologic complete response or P0) will be defined as responders.
Outcome measures
| Measure |
Low-dose Cohort
n=8 Participants
Patients will receive 5.0mg P.O. daily continuously for 8 weeks
everolimus: Low-dose Cohort: Patients will receive 5.0mg P.O. daily continuously for 8 weeks; High-dose Cohort: Patients will receive 10mg P.O. daily continuously for 8 weeks
conventional surgery: Radical prostatectomy with bilateral pelvic lymphadenectomy will be performed within 10 days of the completion of week 8 on RAD-001 (Everolimus).
|
High-dose Cohort
n=9 Participants
Patients will receive 10mg P.O. daily continuously for 8 weeks
everolimus: Low-dose Cohort: Patients will receive 5.0mg P.O. daily continuously for 8 weeks; High-dose Cohort: Patients will receive 10mg P.O. daily continuously for 8 weeks
conventional surgery: Radical prostatectomy with bilateral pelvic lymphadenectomy will be performed within 10 days of the completion of week 8 on RAD-001 (Everolimus).
|
|---|---|---|
|
Proportion of Patients Who Are P0 (i.e., no Clinically Detectable Tumor in the Pathologic Specimen) at Surgery
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: at daily dose for 8 weeksPopulation: intention to treat
Toxicity will be assessed using the NIH-NCI Common Terminology Criteria for Adverse Events, version 3.0 (CTCAEv3.0)
Outcome measures
| Measure |
Low-dose Cohort
n=8 Participants
Patients will receive 5.0mg P.O. daily continuously for 8 weeks
everolimus: Low-dose Cohort: Patients will receive 5.0mg P.O. daily continuously for 8 weeks; High-dose Cohort: Patients will receive 10mg P.O. daily continuously for 8 weeks
conventional surgery: Radical prostatectomy with bilateral pelvic lymphadenectomy will be performed within 10 days of the completion of week 8 on RAD-001 (Everolimus).
|
High-dose Cohort
n=9 Participants
Patients will receive 10mg P.O. daily continuously for 8 weeks
everolimus: Low-dose Cohort: Patients will receive 5.0mg P.O. daily continuously for 8 weeks; High-dose Cohort: Patients will receive 10mg P.O. daily continuously for 8 weeks
conventional surgery: Radical prostatectomy with bilateral pelvic lymphadenectomy will be performed within 10 days of the completion of week 8 on RAD-001 (Everolimus).
|
|---|---|---|
|
Toxicity Profile of Each Dose (Number of Patients With Worst Grade Toxicity)
Patients with Grade 3 toxicity
|
2 participants
|
1 participants
|
|
Toxicity Profile of Each Dose (Number of Patients With Worst Grade Toxicity)
Patients with Grade 4 toxicity
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Up to 16 weeks after start of studyPopulation: One patient in the high dose cohort was not analyzed for change in PSA because they withdrew early due to progressive disease
Time-to-event data, such as change in PSA will be summarized using the method of Kaplan and Meier.
Outcome measures
| Measure |
Low-dose Cohort
n=8 Participants
Patients will receive 5.0mg P.O. daily continuously for 8 weeks
everolimus: Low-dose Cohort: Patients will receive 5.0mg P.O. daily continuously for 8 weeks; High-dose Cohort: Patients will receive 10mg P.O. daily continuously for 8 weeks
conventional surgery: Radical prostatectomy with bilateral pelvic lymphadenectomy will be performed within 10 days of the completion of week 8 on RAD-001 (Everolimus).
|
High-dose Cohort
n=8 Participants
Patients will receive 10mg P.O. daily continuously for 8 weeks
everolimus: Low-dose Cohort: Patients will receive 5.0mg P.O. daily continuously for 8 weeks; High-dose Cohort: Patients will receive 10mg P.O. daily continuously for 8 weeks
conventional surgery: Radical prostatectomy with bilateral pelvic lymphadenectomy will be performed within 10 days of the completion of week 8 on RAD-001 (Everolimus).
|
|---|---|---|
|
Change in PSA
|
3.5 ng/mL
Interval -0.8 to 21.6
|
3.04 ng/mL
Interval -4.2 to 58.4
|
OTHER_PRE_SPECIFIED outcome
Timeframe: After 8 weeks of therapyImmunohistochemical Staining of Cellular and Molecular Markers in Prostate Tumor Tissue
Outcome measures
Outcome data not reported
Adverse Events
Low-dose Cohort
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
High-dose Cohort
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Low-dose Cohort
n=8 participants at risk
Patients will receive 5.0mg P.O. daily continuously for 8 weeks
everolimus: Low-dose Cohort: Patients will receive 5.0mg P.O. daily continuously for 8 weeks; High-dose Cohort: Patients will receive 10mg P.O. daily continuously for 8 weeks
conventional surgery: Radical prostatectomy with bilateral pelvic lymphadenectomy will be performed within 10 days of the completion of week 8 on RAD-001 (Everolimus).
|
High-dose Cohort
n=9 participants at risk
Patients will receive 10mg P.O. daily continuously for 8 weeks
everolimus: Low-dose Cohort: Patients will receive 5.0mg P.O. daily continuously for 8 weeks; High-dose Cohort: Patients will receive 10mg P.O. daily continuously for 8 weeks
conventional surgery: Radical prostatectomy with bilateral pelvic lymphadenectomy will be performed within 10 days of the completion of week 8 on RAD-001 (Everolimus).
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
12.5%
1/8 • Number of events 1 • At daily dose for 8 weeks
|
0.00%
0/9 • At daily dose for 8 weeks
|
Other adverse events
| Measure |
Low-dose Cohort
n=8 participants at risk
Patients will receive 5.0mg P.O. daily continuously for 8 weeks
everolimus: Low-dose Cohort: Patients will receive 5.0mg P.O. daily continuously for 8 weeks; High-dose Cohort: Patients will receive 10mg P.O. daily continuously for 8 weeks
conventional surgery: Radical prostatectomy with bilateral pelvic lymphadenectomy will be performed within 10 days of the completion of week 8 on RAD-001 (Everolimus).
|
High-dose Cohort
n=9 participants at risk
Patients will receive 10mg P.O. daily continuously for 8 weeks
everolimus: Low-dose Cohort: Patients will receive 5.0mg P.O. daily continuously for 8 weeks; High-dose Cohort: Patients will receive 10mg P.O. daily continuously for 8 weeks
conventional surgery: Radical prostatectomy with bilateral pelvic lymphadenectomy will be performed within 10 days of the completion of week 8 on RAD-001 (Everolimus).
|
|---|---|---|
|
Metabolism and nutrition disorders
Anorexia
|
12.5%
1/8 • Number of events 2 • At daily dose for 8 weeks
|
33.3%
3/9 • Number of events 3 • At daily dose for 8 weeks
|
|
Investigations
Aspartate aminotransferase
|
50.0%
4/8 • Number of events 4 • At daily dose for 8 weeks
|
22.2%
2/9 • Number of events 2 • At daily dose for 8 weeks
|
|
Investigations
hemoglobin
|
12.5%
1/8 • Number of events 1 • At daily dose for 8 weeks
|
55.6%
5/9 • Number of events 5 • At daily dose for 8 weeks
|
|
Investigations
Cholesterol high
|
62.5%
5/8 • Number of events 7 • At daily dose for 8 weeks
|
44.4%
4/9 • Number of events 4 • At daily dose for 8 weeks
|
|
Gastrointestinal disorders
Constipation
|
12.5%
1/8 • Number of events 1 • At daily dose for 8 weeks
|
0.00%
0/9 • At daily dose for 8 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.0%
2/8 • Number of events 2 • At daily dose for 8 weeks
|
0.00%
0/9 • At daily dose for 8 weeks
|
|
Investigations
Creatinine
|
12.5%
1/8 • Number of events 1 • At daily dose for 8 weeks
|
11.1%
1/9 • Number of events 1 • At daily dose for 8 weeks
|
|
Metabolism and nutrition disorders
Dehydration
|
12.5%
1/8 • Number of events 2 • At daily dose for 8 weeks
|
0.00%
0/9 • At daily dose for 8 weeks
|
|
General disorders
Sensation of coldness
|
12.5%
1/8 • Number of events 1 • At daily dose for 8 weeks
|
0.00%
0/9 • At daily dose for 8 weeks
|
|
Skin and subcutaneous tissue disorders
dry skin
|
12.5%
1/8 • Number of events 1 • At daily dose for 8 weeks
|
11.1%
1/9 • Number of events 1 • At daily dose for 8 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
12.5%
1/8 • Number of events 1 • At daily dose for 8 weeks
|
11.1%
1/9 • Number of events 1 • At daily dose for 8 weeks
|
|
Skin and subcutaneous tissue disorders
Furuncle
|
12.5%
1/8 • Number of events 1 • At daily dose for 8 weeks
|
0.00%
0/9 • At daily dose for 8 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
12.5%
1/8 • Number of events 1 • At daily dose for 8 weeks
|
11.1%
1/9 • Number of events 1 • At daily dose for 8 weeks
|
|
Gastrointestinal disorders
Distension/bloating, abdominal
|
12.5%
1/8 • Number of events 1 • At daily dose for 8 weeks
|
0.00%
0/9 • At daily dose for 8 weeks
|
|
Nervous system disorders
Dizziness
|
12.5%
1/8 • Number of events 1 • At daily dose for 8 weeks
|
0.00%
0/9 • At daily dose for 8 weeks
|
|
Eye disorders
Dry eye syndrome
|
25.0%
2/8 • Number of events 2 • At daily dose for 8 weeks
|
0.00%
0/9 • At daily dose for 8 weeks
|
|
Gastrointestinal disorders
Dry mouth/salivary gland (xerostomia)
|
12.5%
1/8 • Number of events 1 • At daily dose for 8 weeks
|
0.00%
0/9 • At daily dose for 8 weeks
|
|
General disorders
Edema: limb
|
12.5%
1/8 • Number of events 1 • At daily dose for 8 weeks
|
33.3%
3/9 • Number of events 5 • At daily dose for 8 weeks
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
37.5%
3/8 • Number of events 3 • At daily dose for 8 weeks
|
11.1%
1/9 • Number of events 1 • At daily dose for 8 weeks
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
62.5%
5/8 • Number of events 6 • At daily dose for 8 weeks
|
33.3%
3/9 • Number of events 5 • At daily dose for 8 weeks
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
62.5%
5/8 • Number of events 7 • At daily dose for 8 weeks
|
22.2%
2/9 • Number of events 2 • At daily dose for 8 weeks
|
|
Gastrointestinal disorders
Heartburn/dyspepsia
|
12.5%
1/8 • Number of events 1 • At daily dose for 8 weeks
|
11.1%
1/9 • Number of events 1 • At daily dose for 8 weeks
|
|
Gastrointestinal disorders
Hemorrhage, GI - Rectum
|
12.5%
1/8 • Number of events 1 • At daily dose for 8 weeks
|
0.00%
0/9 • At daily dose for 8 weeks
|
|
Gastrointestinal disorders
Hemorrhoids
|
12.5%
1/8 • Number of events 1 • At daily dose for 8 weeks
|
0.00%
0/9 • At daily dose for 8 weeks
|
|
Renal and urinary disorders
Incontinence, urinary
|
87.5%
7/8 • Number of events 8 • At daily dose for 8 weeks
|
44.4%
4/9 • Number of events 4 • At daily dose for 8 weeks
|
|
Infections and infestations
infection
|
12.5%
1/8 • Number of events 1 • At daily dose for 8 weeks
|
0.00%
0/9 • At daily dose for 8 weeks
|
|
Infections and infestations
Pharyngitis
|
12.5%
1/8 • Number of events 1 • At daily dose for 8 weeks
|
0.00%
0/9 • At daily dose for 8 weeks
|
|
Infections and infestations
Stabbing rectal pain Infection with normal ANC
|
12.5%
1/8 • Number of events 1 • At daily dose for 8 weeks
|
0.00%
0/9 • At daily dose for 8 weeks
|
|
Psychiatric disorders
insominia
|
12.5%
1/8 • Number of events 1 • At daily dose for 8 weeks
|
0.00%
0/9 • At daily dose for 8 weeks
|
|
Psychiatric disorders
libido
|
12.5%
1/8 • Number of events 1 • At daily dose for 8 weeks
|
0.00%
0/9 • At daily dose for 8 weeks
|
|
Gastrointestinal disorders
Mucositis/stomatitis (clinical exam) - Oral cavity
|
62.5%
5/8 • Number of events 11 • At daily dose for 8 weeks
|
77.8%
7/9 • Number of events 12 • At daily dose for 8 weeks
|
|
Gastrointestinal disorders
Nausea
|
37.5%
3/8 • Number of events 3 • At daily dose for 8 weeks
|
11.1%
1/9 • Number of events 1 • At daily dose for 8 weeks
|
|
Gastrointestinal disorders
abdominal pain
|
25.0%
2/8 • Number of events 2 • At daily dose for 8 weeks
|
0.00%
0/9 • At daily dose for 8 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain - Back
|
12.5%
1/8 • Number of events 1 • At daily dose for 8 weeks
|
0.00%
0/9 • At daily dose for 8 weeks
|
|
General disorders
Pain - Chest/thorax NOS
|
25.0%
2/8 • Number of events 2 • At daily dose for 8 weeks
|
0.00%
0/9 • At daily dose for 8 weeks
|
|
Nervous system disorders
Pain - Head/headache
|
37.5%
3/8 • Number of events 3 • At daily dose for 8 weeks
|
33.3%
3/9 • Number of events 4 • At daily dose for 8 weeks
|
|
Gastrointestinal disorders
Pain broken tooth
|
12.5%
1/8 • Number of events 1 • At daily dose for 8 weeks
|
0.00%
0/9 • At daily dose for 8 weeks
|
|
Metabolism and nutrition disorders
Phosphate, serum-low (hypophosphatemia)
|
12.5%
1/8 • Number of events 2 • At daily dose for 8 weeks
|
55.6%
5/9 • Number of events 5 • At daily dose for 8 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
12.5%
1/8 • Number of events 1 • At daily dose for 8 weeks
|
22.2%
2/9 • Number of events 2 • At daily dose for 8 weeks
|
|
Respiratory, thoracic and mediastinal disorders
bronchial mucous
|
12.5%
1/8 • Number of events 1 • At daily dose for 8 weeks
|
0.00%
0/9 • At daily dose for 8 weeks
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
25.0%
2/8 • Number of events 2 • At daily dose for 8 weeks
|
33.3%
3/9 • Number of events 3 • At daily dose for 8 weeks
|
|
Metabolism and nutrition disorders
Triglyceride, serum-high (hypertriglyceridemia)
|
37.5%
3/8 • Number of events 5 • At daily dose for 8 weeks
|
55.6%
5/9 • Number of events 5 • At daily dose for 8 weeks
|
|
Metabolism and nutrition disorders
Uric acid, serum-high (hyperuricemia)
|
0.00%
0/8 • At daily dose for 8 weeks
|
11.1%
1/9 • Number of events 1 • At daily dose for 8 weeks
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
12.5%
1/8 • Number of events 1 • At daily dose for 8 weeks
|
11.1%
1/9 • Number of events 1 • At daily dose for 8 weeks
|
|
Renal and urinary disorders
Urinary retention (including neurogenic bladder)
|
12.5%
1/8 • Number of events 1 • At daily dose for 8 weeks
|
0.00%
0/9 • At daily dose for 8 weeks
|
|
Investigations
Weight loss
|
12.5%
1/8 • Number of events 1 • At daily dose for 8 weeks
|
11.1%
1/9 • Number of events 1 • At daily dose for 8 weeks
|
|
Injury, poisoning and procedural complications
Wound complication, non-infectious
|
25.0%
2/8 • Number of events 2 • At daily dose for 8 weeks
|
0.00%
0/9 • At daily dose for 8 weeks
|
|
Investigations
ALT, SGPT (serum glutamic pyruvic transaminase)
|
0.00%
0/8 • At daily dose for 8 weeks
|
11.1%
1/9 • Number of events 1 • At daily dose for 8 weeks
|
|
Investigations
Bicarbonate, serum-low
|
0.00%
0/8 • At daily dose for 8 weeks
|
11.1%
1/9 • Number of events 1 • At daily dose for 8 weeks
|
|
Injury, poisoning and procedural complications
Bruising (in absence of Grade 3 or 4 thrombocytopenia)
|
0.00%
0/8 • At daily dose for 8 weeks
|
11.1%
1/9 • Number of events 1 • At daily dose for 8 weeks
|
|
Metabolism and nutrition disorders
Calcium, serum-low (hypocalcemia)
|
0.00%
0/8 • At daily dose for 8 weeks
|
11.1%
1/9 • Number of events 1 • At daily dose for 8 weeks
|
|
Skin and subcutaneous tissue disorders
Hair Color change
|
0.00%
0/8 • At daily dose for 8 weeks
|
11.1%
1/9 • Number of events 1 • At daily dose for 8 weeks
|
|
General disorders
Flu-like syndrome
|
0.00%
0/8 • At daily dose for 8 weeks
|
11.1%
1/9 • Number of events 1 • At daily dose for 8 weeks
|
|
Vascular disorders
Hot flashes/flushes
|
0.00%
0/8 • At daily dose for 8 weeks
|
11.1%
1/9 • Number of events 1 • At daily dose for 8 weeks
|
|
Infections and infestations
Infection, lower lip
|
0.00%
0/8 • At daily dose for 8 weeks
|
11.1%
1/9 • Number of events 1 • At daily dose for 8 weeks
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
0.00%
0/8 • At daily dose for 8 weeks
|
55.6%
5/9 • Number of events 5 • At daily dose for 8 weeks
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/8 • At daily dose for 8 weeks
|
44.4%
4/9 • Number of events 5 • At daily dose for 8 weeks
|
|
Investigations
Neutrophils/granulocytes (ANC/AGC)
|
0.00%
0/8 • At daily dose for 8 weeks
|
22.2%
2/9 • Number of events 2 • At daily dose for 8 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain, left heel
|
0.00%
0/8 • At daily dose for 8 weeks
|
11.1%
1/9 • Number of events 1 • At daily dose for 8 weeks
|
|
Reproductive system and breast disorders
Pain, left groin
|
0.00%
0/8 • At daily dose for 8 weeks
|
11.1%
1/9 • Number of events 1 • At daily dose for 8 weeks
|
|
Renal and urinary disorders
Pain and burning while urinating
|
0.00%
0/8 • At daily dose for 8 weeks
|
11.1%
1/9 • Number of events 1 • At daily dose for 8 weeks
|
|
Investigations
Pain at surgery site
|
0.00%
0/8 • At daily dose for 8 weeks
|
11.1%
1/9 • Number of events 1 • At daily dose for 8 weeks
|
|
Reproductive system and breast disorders
pain,left groin
|
0.00%
0/8 • At daily dose for 8 weeks
|
11.1%
1/9 • Number of events 1 • At daily dose for 8 weeks
|
|
Gastrointestinal disorders
pain/rectal
|
0.00%
0/8 • At daily dose for 8 weeks
|
11.1%
1/9 • Number of events 1 • At daily dose for 8 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pain, throat
|
0.00%
0/8 • At daily dose for 8 weeks
|
11.1%
1/9 • Number of events 1 • At daily dose for 8 weeks
|
|
Investigations
Platelets
|
0.00%
0/8 • At daily dose for 8 weeks
|
55.6%
5/9 • Number of events 6 • At daily dose for 8 weeks
|
|
Metabolism and nutrition disorders
Potassium, serum-high (hyperkalemia)
|
0.00%
0/8 • At daily dose for 8 weeks
|
44.4%
4/9 • Number of events 4 • At daily dose for 8 weeks
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
0.00%
0/8 • At daily dose for 8 weeks
|
33.3%
3/9 • Number of events 3 • At daily dose for 8 weeks
|
|
Renal and urinary disorders
nocturia
|
0.00%
0/8 • At daily dose for 8 weeks
|
33.3%
3/9 • Number of events 3 • At daily dose for 8 weeks
|
|
General disorders
Rigors/chills
|
0.00%
0/8 • At daily dose for 8 weeks
|
11.1%
1/9 • Number of events 1 • At daily dose for 8 weeks
|
|
General disorders
Sweating (diaphoresis)
|
0.00%
0/8 • At daily dose for 8 weeks
|
11.1%
1/9 • Number of events 1 • At daily dose for 8 weeks
|
|
Nervous system disorders
Taste alteration (dysgeusia)
|
0.00%
0/8 • At daily dose for 8 weeks
|
22.2%
2/9 • Number of events 2 • At daily dose for 8 weeks
|
Additional Information
Dr. Jorge Garcia
Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
Phone: 216-444-7774
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place