Trial Outcomes & Findings for Pazopanib Hydrochloride With or Without Bicalutamide in Treating Patients With Prostate Cancer That Did Not Respond to Hormone Therapy (NCT NCT00486642)
NCT ID: NCT00486642
Last Updated: 2017-05-24
Results Overview
Prostate-specific antigen (PSA) response rate (defined as a confirmed \> / = 50% decline (minimum 5ng/ml) in PSA from baseline maintained for \>4 weeks, and without other evidence of disease progression documented at time of confirmatory values).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
23 participants
Primary outcome timeframe
Up to 12 weeks
Results posted on
2017-05-24
Participant Flow
Participant milestones
| Measure |
Arm I (Pazopanib)
Arm I - Patients receive pazopanib hydrochloride PO QD on days 1-28.
Laboratory Biomarker Analysis: Correlative studies
Pazopanib Hydrochloride: Given PO
Pharmacological Study: Correlative studies
|
Arm II (Pazopanib & Bicalutamide)
Arm II - Patients receive pazopanib hydrochloride PO QD on days 1-28. Patients also receive bicalutamide PO QD on days 8-28 of course 1 and on days 1-28 in all subsequent courses.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
13
|
|
Overall Study
COMPLETED
|
10
|
13
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pazopanib Hydrochloride With or Without Bicalutamide in Treating Patients With Prostate Cancer That Did Not Respond to Hormone Therapy
Baseline characteristics by cohort
| Measure |
Arm A - Pazopanib
n=10 Participants
Patients receive pazopanib hydrochloride PO QD on days 1-28.
Laboratory Biomarker Analysis: Correlative studies
Pazopanib Hydrochloride: Given PO
Pharmacological Study: Correlative studies
|
Arm B - Pazopanib + Bicalutamide
n=13 Participants
Patients receive pazopanib hydrochloride PO QD on days 1-28. Patients also receive bicalutamide PO QD on days 8-28 of course 1 and on days 1-28 in all subsequent courses.
Laboratory Biomarker Analysis: Correlative studies
Pazopanib Hydrochloride: Given PO
Pharmacological Study: Correlative studies
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
12 Participants
n=35 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=39 Participants
|
9 Participants
n=41 Participants
|
11 Participants
n=35 Participants
|
|
Age, Continuous
|
71 years
n=39 Participants
|
70 years
n=41 Participants
|
71 years
n=35 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=39 Participants
|
13 Participants
n=41 Participants
|
23 Participants
n=35 Participants
|
|
Region of Enrollment
Canada
|
10 participants
n=39 Participants
|
13 participants
n=41 Participants
|
23 participants
n=35 Participants
|
PRIMARY outcome
Timeframe: Up to 12 weeksPopulation: 9 evaluable in Arm A + 12 evaluable in Arm B
Prostate-specific antigen (PSA) response rate (defined as a confirmed \> / = 50% decline (minimum 5ng/ml) in PSA from baseline maintained for \>4 weeks, and without other evidence of disease progression documented at time of confirmatory values).
Outcome measures
| Measure |
Arm A - Pazopanib
n=9 Participants
Patients receive pazopanib hydrochloride PO QD on days 1-28.
Laboratory Biomarker Analysis: Correlative studies
Pazopanib Hydrochloride: Given PO
Pharmacological Study: Correlative studies
|
Arm B - Pazopanib + Bicalutamide
n=12 Participants
Patients receive pazopanib hydrochloride PO QD on days 1-28. Patients also receive bicalutamide PO QD on days 8-28 of course 1 and on days 1-28 in all subsequent courses.
Laboratory Biomarker Analysis: Correlative studies
Pazopanib Hydrochloride: Given PO
Pharmacological Study: Correlative studies
|
|---|---|---|
|
PSA Response Rate
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Time from start of treatment to time criteria are met for disease progression or death from any cause, whichever came first, assessed up to 5 yearsPopulation: 5 evaluable patients in Arm A + 9 evaluable patients in Arm B
RECIST PR defined as - At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Outcome measures
| Measure |
Arm A - Pazopanib
n=5 Participants
Patients receive pazopanib hydrochloride PO QD on days 1-28.
Laboratory Biomarker Analysis: Correlative studies
Pazopanib Hydrochloride: Given PO
Pharmacological Study: Correlative studies
|
Arm B - Pazopanib + Bicalutamide
n=9 Participants
Patients receive pazopanib hydrochloride PO QD on days 1-28. Patients also receive bicalutamide PO QD on days 8-28 of course 1 and on days 1-28 in all subsequent courses.
Laboratory Biomarker Analysis: Correlative studies
Pazopanib Hydrochloride: Given PO
Pharmacological Study: Correlative studies
|
|---|---|---|
|
Objective Tumor Response Rate as Assessed by RECIST Criteria
|
0 patient
|
1 patient
|
SECONDARY outcome
Timeframe: From time of treatment initiation to disease progression or death from any cause, whichever came first, assessed up to 5 yearsPFS is defined as the time from treatment initiation to disease progression or death from any cause, whichever came first. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Outcome measures
| Measure |
Arm A - Pazopanib
n=10 Participants
Patients receive pazopanib hydrochloride PO QD on days 1-28.
Laboratory Biomarker Analysis: Correlative studies
Pazopanib Hydrochloride: Given PO
Pharmacological Study: Correlative studies
|
Arm B - Pazopanib + Bicalutamide
n=13 Participants
Patients receive pazopanib hydrochloride PO QD on days 1-28. Patients also receive bicalutamide PO QD on days 8-28 of course 1 and on days 1-28 in all subsequent courses.
Laboratory Biomarker Analysis: Correlative studies
Pazopanib Hydrochloride: Given PO
Pharmacological Study: Correlative studies
|
|---|---|---|
|
Progression-free Survival
|
7.3 months
Interval 1.2 to
Not reached
|
11.3 months
Interval 4.84 to
Not reached
|
SECONDARY outcome
Timeframe: From time PSA response criteria are met until time PSA progression criteria are met or death from any cause, whichever came first, up to 5 yearsPopulation: 1 patient in Arm A and 2 patients in Arm B had a PSA response.
Definition of PSA response: \>= 50% fall (minimum 5 ng/ml) in PSA from baseline maintained for \>4 weeks, and without other evidence of disease progression documented at time of confirmatory values. PSA response duration will commence on the date of the first \>=50% decline in PSA. The response duration ends when PSA progression criteria are met with the second increasing PSA value. PSA progression in PSA responders: rise in PSA of 50% (minimum 5ng/ml) above nadir value and confirmed by a second increasing value at least 1 week later.
Outcome measures
| Measure |
Arm A - Pazopanib
n=1 Participants
Patients receive pazopanib hydrochloride PO QD on days 1-28.
Laboratory Biomarker Analysis: Correlative studies
Pazopanib Hydrochloride: Given PO
Pharmacological Study: Correlative studies
|
Arm B - Pazopanib + Bicalutamide
n=2 Participants
Patients receive pazopanib hydrochloride PO QD on days 1-28. Patients also receive bicalutamide PO QD on days 8-28 of course 1 and on days 1-28 in all subsequent courses.
Laboratory Biomarker Analysis: Correlative studies
Pazopanib Hydrochloride: Given PO
Pharmacological Study: Correlative studies
|
|---|---|---|
|
Median Duration of PSA-Response
|
8.3 months
Interval 8.3 to 8.3
|
13.1 months
Interval 2.3 to 23.9
|
SECONDARY outcome
Timeframe: Measured from the start of the treatment until the criteria for progression are met or death from any cause, whichever came first, assessed up to 5 yearsPopulation: 5 evaluable patients in Arm A + 9 evaluable patients in Arm B
RECIST Stable defined as - Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Outcome measures
| Measure |
Arm A - Pazopanib
n=5 Participants
Patients receive pazopanib hydrochloride PO QD on days 1-28.
Laboratory Biomarker Analysis: Correlative studies
Pazopanib Hydrochloride: Given PO
Pharmacological Study: Correlative studies
|
Arm B - Pazopanib + Bicalutamide
n=9 Participants
Patients receive pazopanib hydrochloride PO QD on days 1-28. Patients also receive bicalutamide PO QD on days 8-28 of course 1 and on days 1-28 in all subsequent courses.
Laboratory Biomarker Analysis: Correlative studies
Pazopanib Hydrochloride: Given PO
Pharmacological Study: Correlative studies
|
|---|---|---|
|
Stable Disease Rate as Assessed by RECIST Criteria
|
2 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Time from start of treatment to time criteria are met for disease progression or death from any cause, whichever came first, assessed up to 5 yearsEarliest date on which disease progression was determined by any of the methods listed: PSA progression, objective disease progression (Response Evaluation Criteria in Solid Tumors \[RECIST\] criteria) or cancer-related symptomatic progression.
Outcome measures
| Measure |
Arm A - Pazopanib
n=10 Participants
Patients receive pazopanib hydrochloride PO QD on days 1-28.
Laboratory Biomarker Analysis: Correlative studies
Pazopanib Hydrochloride: Given PO
Pharmacological Study: Correlative studies
|
Arm B - Pazopanib + Bicalutamide
n=13 Participants
Patients receive pazopanib hydrochloride PO QD on days 1-28. Patients also receive bicalutamide PO QD on days 8-28 of course 1 and on days 1-28 in all subsequent courses.
Laboratory Biomarker Analysis: Correlative studies
Pazopanib Hydrochloride: Given PO
Pharmacological Study: Correlative studies
|
|---|---|---|
|
Time to Disease Progression
|
7.3 months
Interval 1.2 to
Not reached
|
11.3 months
Interval 4.84 to
Not reached
|
SECONDARY outcome
Timeframe: Assessed up to 5 yearsPatients who came off treatment due to toxicity.
Outcome measures
| Measure |
Arm A - Pazopanib
n=10 Participants
Patients receive pazopanib hydrochloride PO QD on days 1-28.
Laboratory Biomarker Analysis: Correlative studies
Pazopanib Hydrochloride: Given PO
Pharmacological Study: Correlative studies
|
Arm B - Pazopanib + Bicalutamide
n=13 Participants
Patients receive pazopanib hydrochloride PO QD on days 1-28. Patients also receive bicalutamide PO QD on days 8-28 of course 1 and on days 1-28 in all subsequent courses.
Laboratory Biomarker Analysis: Correlative studies
Pazopanib Hydrochloride: Given PO
Pharmacological Study: Correlative studies
|
|---|---|---|
|
Toxicity
|
3 participants
|
6 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 1 year after completion of treatmentPopulation: Very little death information is captured for this study so OS analysis was not done.
Calculated by Kaplan and Meier
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: At 1 yearPopulation: Very little death information is captured for this study so OS analysis was not done.
Calculated by Kaplan and Meier.
Outcome measures
Outcome data not reported
Adverse Events
Arm A - Pazopanib
Serious events: 2 serious events
Other events: 10 other events
Deaths: 1 deaths
Arm B - Pazopanib + Bicalutamide
Serious events: 3 serious events
Other events: 13 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Arm A - Pazopanib
n=10 participants at risk
Patients receive pazopanib hydrochloride PO QD on days 1-28.
Laboratory Biomarker Analysis: Correlative studies
Pazopanib Hydrochloride: Given PO
Pharmacological Study: Correlative studies
|
Arm B - Pazopanib + Bicalutamide
n=13 participants at risk
Patients receive pazopanib hydrochloride PO QD on days 1-28. Patients also receive bicalutamide PO QD on days 8-28 of course 1 and on days 1-28 in all subsequent courses.
Laboratory Biomarker Analysis: Correlative studies
Pazopanib Hydrochloride: Given PO
Pharmacological Study: Correlative studies
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.0%
1/10 • Number of events 1
|
0.00%
0/13
|
|
General disorders
Fatigue
|
10.0%
1/10 • Number of events 1
|
7.7%
1/13 • Number of events 1
|
|
General disorders
Fever
|
10.0%
1/10 • Number of events 1
|
0.00%
0/13
|
|
Renal and urinary disorders
Hematuria
|
10.0%
1/10 • Number of events 2
|
0.00%
0/13
|
|
Renal and urinary disorders
Urinary incontinence
|
10.0%
1/10 • Number of events 1
|
0.00%
0/13
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
10.0%
1/10 • Number of events 1
|
0.00%
0/13
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/10
|
7.7%
1/13 • Number of events 1
|
|
Vascular disorders
Hypertension
|
0.00%
0/10
|
7.7%
1/13 • Number of events 1
|
|
Metabolism and nutrition disorders
Glucose intolerance
|
0.00%
0/10
|
7.7%
1/13 • Number of events 2
|
|
Renal and urinary disorders
Urinary frequency
|
0.00%
0/10
|
7.7%
1/13 • Number of events 1
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/10
|
7.7%
1/13 • Number of events 1
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/10
|
7.7%
1/13 • Number of events 1
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/10
|
7.7%
1/13 • Number of events 1
|
Other adverse events
| Measure |
Arm A - Pazopanib
n=10 participants at risk
Patients receive pazopanib hydrochloride PO QD on days 1-28.
Laboratory Biomarker Analysis: Correlative studies
Pazopanib Hydrochloride: Given PO
Pharmacological Study: Correlative studies
|
Arm B - Pazopanib + Bicalutamide
n=13 participants at risk
Patients receive pazopanib hydrochloride PO QD on days 1-28. Patients also receive bicalutamide PO QD on days 8-28 of course 1 and on days 1-28 in all subsequent courses.
Laboratory Biomarker Analysis: Correlative studies
Pazopanib Hydrochloride: Given PO
Pharmacological Study: Correlative studies
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
10.0%
1/10
|
15.4%
2/13
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/10
|
15.4%
2/13
|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/10
|
15.4%
2/13
|
|
Nervous system disorders
Acoustic nerve disorder NOS
|
0.00%
0/10
|
7.7%
1/13
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/10
|
7.7%
1/13
|
|
Psychiatric disorders
Agitation
|
0.00%
0/10
|
7.7%
1/13
|
|
Investigations
Alanine aminotransferase increased
|
60.0%
6/10
|
38.5%
5/13
|
|
Investigations
Alkaline phosphatase increased
|
70.0%
7/10
|
38.5%
5/13
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
0.00%
0/10
|
7.7%
1/13
|
|
Gastrointestinal disorders
Anal mucositis
|
0.00%
0/10
|
7.7%
1/13
|
|
Blood and lymphatic system disorders
Anemia
|
70.0%
7/10
|
92.3%
12/13
|
|
Metabolism and nutrition disorders
Anorexia
|
70.0%
7/10
|
69.2%
9/13
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/10
|
7.7%
1/13
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
50.0%
5/10
|
30.8%
4/13
|
|
Investigations
Aspartate aminotransferase increased
|
50.0%
5/10
|
53.8%
7/13
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/10
|
15.4%
2/13
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
40.0%
4/10
|
38.5%
5/13
|
|
Infections and infestations
Bladder infection
|
10.0%
1/10
|
0.00%
0/13
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other
|
0.00%
0/10
|
7.7%
1/13
|
|
Investigations
Blood bilirubin increased
|
40.0%
4/10
|
30.8%
4/13
|
|
Eye disorders
Blurred vision
|
0.00%
0/10
|
7.7%
1/13
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/10
|
15.4%
2/13
|
|
Cardiac disorders
Chest pain - cardiac
|
0.00%
0/10
|
7.7%
1/13
|
|
General disorders
Chills
|
20.0%
2/10
|
7.7%
1/13
|
|
Psychiatric disorders
Confusion
|
0.00%
0/10
|
15.4%
2/13
|
|
Gastrointestinal disorders
Constipation
|
20.0%
2/10
|
38.5%
5/13
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
30.0%
3/10
|
38.5%
5/13
|
|
Investigations
Creatinine increased
|
10.0%
1/10
|
38.5%
5/13
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/10
|
7.7%
1/13
|
|
Psychiatric disorders
Depression
|
10.0%
1/10
|
7.7%
1/13
|
|
Gastrointestinal disorders
Diarrhea
|
50.0%
5/10
|
69.2%
9/13
|
|
Nervous system disorders
Dizziness
|
0.00%
0/10
|
53.8%
7/13
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/10
|
7.7%
1/13
|
|
Nervous system disorders
Dysgeusia
|
20.0%
2/10
|
7.7%
1/13
|
|
Gastrointestinal disorders
Dyspepsia
|
40.0%
4/10
|
23.1%
3/13
|
|
Nervous system disorders
Dysphasia
|
0.00%
0/10
|
7.7%
1/13
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
20.0%
2/10
|
30.8%
4/13
|
|
General disorders
Edema limbs
|
0.00%
0/10
|
15.4%
2/13
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/10
|
7.7%
1/13
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
10.0%
1/10
|
7.7%
1/13
|
|
General disorders
Fatigue
|
90.0%
9/10
|
84.6%
11/13
|
|
General disorders
Fever
|
10.0%
1/10
|
7.7%
1/13
|
|
Gastrointestinal disorders
Flatulence
|
20.0%
2/10
|
0.00%
0/13
|
|
General disorders
Flu like symptoms
|
0.00%
0/10
|
7.7%
1/13
|
|
Vascular disorders
Flushing
|
20.0%
2/10
|
7.7%
1/13
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/10
|
7.7%
1/13
|
|
General disorders
Gait disturbance
|
0.00%
0/10
|
7.7%
1/13
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/10
|
7.7%
1/13
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other
|
10.0%
1/10
|
15.4%
2/13
|
|
General disorders
General disorders and administration site conditions - Other
|
0.00%
0/10
|
7.7%
1/13
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/10
|
7.7%
1/13
|
|
Investigations
GGT increased
|
0.00%
0/10
|
7.7%
1/13
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/10
|
7.7%
1/13
|
|
Metabolism and nutrition disorders
Glucose intolerance
|
0.00%
0/10
|
7.7%
1/13
|
|
Nervous system disorders
Headache
|
10.0%
1/10
|
23.1%
3/13
|
|
Vascular disorders
Hematoma
|
10.0%
1/10
|
7.7%
1/13
|
|
Renal and urinary disorders
Hematuria
|
30.0%
3/10
|
15.4%
2/13
|
|
Renal and urinary disorders
Hemoglobinuria
|
40.0%
4/10
|
23.1%
3/13
|
|
Gastrointestinal disorders
Hemorrhoids
|
10.0%
1/10
|
7.7%
1/13
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
0.00%
0/10
|
7.7%
1/13
|
|
Vascular disorders
Hot flashes
|
40.0%
4/10
|
30.8%
4/13
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/10
|
15.4%
2/13
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
40.0%
4/10
|
23.1%
3/13
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
10.0%
1/10
|
0.00%
0/13
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/10
|
15.4%
2/13
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
0.00%
0/10
|
7.7%
1/13
|
|
Vascular disorders
Hypertension
|
80.0%
8/10
|
76.9%
10/13
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
50.0%
5/10
|
46.2%
6/13
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
20.0%
2/10
|
7.7%
1/13
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
10.0%
1/10
|
7.7%
1/13
|
|
Metabolism and nutrition disorders
Hypokalemia
|
10.0%
1/10
|
23.1%
3/13
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
30.0%
3/10
|
30.8%
4/13
|
|
Metabolism and nutrition disorders
Hyponatremia
|
30.0%
3/10
|
46.2%
6/13
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
10.0%
1/10
|
15.4%
2/13
|
|
Vascular disorders
Hypotension
|
0.00%
0/10
|
7.7%
1/13
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/10
|
7.7%
1/13
|
|
Infections and infestations
Infections and infestations - Other
|
0.00%
0/10
|
7.7%
1/13
|
|
Psychiatric disorders
Insomnia
|
10.0%
1/10
|
15.4%
2/13
|
|
Nervous system disorders
Ischemia cerebrovascular
|
0.00%
0/10
|
7.7%
1/13
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
0.00%
0/10
|
7.7%
1/13
|
|
Investigations
Lymphocyte count decreased
|
70.0%
7/10
|
69.2%
9/13
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/10
|
7.7%
1/13
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other
|
0.00%
0/10
|
7.7%
1/13
|
|
Gastrointestinal disorders
Mucositis oral
|
20.0%
2/10
|
23.1%
3/13
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
0.00%
0/10
|
7.7%
1/13
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other
|
20.0%
2/10
|
0.00%
0/13
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
10.0%
1/10
|
15.4%
2/13
|
|
Gastrointestinal disorders
Nausea
|
10.0%
1/10
|
53.8%
7/13
|
|
Nervous system disorders
Nervous system disorders - Other
|
0.00%
0/10
|
7.7%
1/13
|
|
Investigations
Neutrophil count decreased
|
40.0%
4/10
|
30.8%
4/13
|
|
General disorders
Non-cardiac chest pain
|
10.0%
1/10
|
0.00%
0/13
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/10
|
7.7%
1/13
|
|
General disorders
Pain
|
30.0%
3/10
|
38.5%
5/13
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
20.0%
2/10
|
30.8%
4/13
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/10
|
7.7%
1/13
|
|
Infections and infestations
Penile infection
|
0.00%
0/10
|
7.7%
1/13
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
10.0%
1/10
|
7.7%
1/13
|
|
Investigations
Platelet count decreased
|
40.0%
4/10
|
46.2%
6/13
|
|
Renal and urinary disorders
Proteinuria
|
40.0%
4/10
|
69.2%
9/13
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/10
|
7.7%
1/13
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.00%
0/10
|
7.7%
1/13
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
0.00%
0/10
|
7.7%
1/13
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/10
|
30.8%
4/13
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
20.0%
2/10
|
15.4%
2/13
|
|
Gastrointestinal disorders
Rectal pain
|
0.00%
0/10
|
7.7%
1/13
|
|
Renal and urinary disorders
Renal and urinary disorders - Other
|
0.00%
0/10
|
23.1%
3/13
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other
|
0.00%
0/10
|
7.7%
1/13
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/10
|
7.7%
1/13
|
|
Nervous system disorders
Sinus pain
|
0.00%
0/10
|
7.7%
1/13
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other
|
10.0%
1/10
|
7.7%
1/13
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
10.0%
1/10
|
0.00%
0/13
|
|
Gastrointestinal disorders
Stomach pain
|
0.00%
0/10
|
7.7%
1/13
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/10
|
7.7%
1/13
|
|
Infections and infestations
Tooth infection
|
0.00%
0/10
|
23.1%
3/13
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/10
|
7.7%
1/13
|
|
Nervous system disorders
Tremor
|
0.00%
0/10
|
7.7%
1/13
|
|
Infections and infestations
Upper respiratory infection
|
30.0%
3/10
|
7.7%
1/13
|
|
Renal and urinary disorders
Urinary frequency
|
20.0%
2/10
|
46.2%
6/13
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/10
|
15.4%
2/13
|
|
Renal and urinary disorders
Urinary retention
|
10.0%
1/10
|
7.7%
1/13
|
|
Renal and urinary disorders
Urinary tract pain
|
0.00%
0/10
|
7.7%
1/13
|
|
Vascular disorders
Vascular disorders - Other
|
0.00%
0/10
|
7.7%
1/13
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
30.0%
3/10
|
0.00%
0/13
|
|
Gastrointestinal disorders
Vomiting
|
10.0%
1/10
|
46.2%
6/13
|
|
Eye disorders
Watering eyes
|
10.0%
1/10
|
0.00%
0/13
|
|
Investigations
Weight loss
|
10.0%
1/10
|
46.2%
6/13
|
|
Investigations
White blood cell decreased
|
40.0%
4/10
|
23.1%
3/13
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60