Trial Outcomes & Findings for Cediranib Maleate With or Without Dasatinib in Patients With HRPC-Resistant to Treatment With Docetaxel (NCT NCT01260688)
NCT ID: NCT01260688
Last Updated: 2018-08-08
Results Overview
Progression is defined using the Prostate Cancer Clinical Trials Working Group (PCWG2) criteria, which includes a compilation of prostate-specific antigen (PSA), bone scan, and CT-scan assessments (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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
22 participants
Primary outcome timeframe
3 months
Results posted on
2018-08-08
Participant Flow
Study was open to recruitment on October 25, 2010 and closed to accrual on July 31, 2012. Study participants were identified in clinic. The target enrolment was 50 study participants; however only 22 participants enrolled as the study was terminated due to discontinuation of cediranib drug supply due to clinical development discontinuation.
Participant milestones
| Measure |
Arm I - Cediranib Plus Dasatinib
Patients receive oral cediranib maleate once daily and oral dasatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm II - Cediranib Alone
Patients receive cediranib maleate as in arm I. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
11
|
|
Overall Study
COMPLETED
|
11
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cediranib Maleate With or Without Dasatinib in Patients With HRPC-Resistant to Treatment With Docetaxel
Baseline characteristics by cohort
| Measure |
Arm I - Cediranib Plus Dasatinib
n=11 Participants
Patients receive oral cediranib maleate once daily and oral dasatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm II - Cediranib Alone
n=11 Participants
Patients receive cediranib maleate as in arm I. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Total
n=22 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Age, Continuous
|
65.4 years
STANDARD_DEVIATION 7.1 • n=5 Participants
|
72.7 years
STANDARD_DEVIATION 6.5 • n=7 Participants
|
69 years
STANDARD_DEVIATION 7.6 • 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
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
9 participants
n=5 Participants
|
8 participants
n=7 Participants
|
17 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
5 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: All patients were included in the analysis for 12-week PFS.
Progression is defined using the Prostate Cancer Clinical Trials Working Group (PCWG2) criteria, which includes a compilation of prostate-specific antigen (PSA), bone scan, and CT-scan assessments (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 I - Cediranib Plus Dasatinib
n=11 Participants
Patients receive oral cediranib maleate once daily and oral dasatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm II - Cediranib Alone
n=11 Participants
Patients receive oral cediranib maleate once daily for 28 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
12-week Progression-free Survival as Per the Prostate Cancer Clinical Trials Working Group (PCWG2)
|
2 participants
|
8 participants
|
SECONDARY outcome
Timeframe: Up to 30 days after last dose of study drugsIncidence of toxicities graded according to the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) v4.0
Outcome measures
| Measure |
Arm I - Cediranib Plus Dasatinib
n=11 Participants
Patients receive oral cediranib maleate once daily and oral dasatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm II - Cediranib Alone
n=11 Participants
Patients receive oral cediranib maleate once daily for 28 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Number of Participants With Toxicities
|
11 participants
|
11 participants
|
SECONDARY outcome
Timeframe: After every cycle (median duration on study = 4 cycles)Population: Analysis was performed patients receiving single agent cediranib or combination of cediranib plus dasatinib.
Present Pain Intensity (PPI) scale. Scale is measured 0-5, where 0=no pain, 1=mild pain, 2=discomforting pain, 3=distressing pain, 4=horrible pain and 5=excruciating pain Participants who were up to completing the assessment (did not decline) and who reported a score \>=2 at the end of any cycle are reported.
Outcome measures
| Measure |
Arm I - Cediranib Plus Dasatinib
n=11 Participants
Patients receive oral cediranib maleate once daily and oral dasatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm II - Cediranib Alone
n=11 Participants
Patients receive oral cediranib maleate once daily for 28 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Qualtiy of Life Assessment Number of Participants With a Score ≥2 on the Present Pain Intensity (PPI) Scale
|
4 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Cycle 1 (an average of 28 days)Number of patients who experienced study medication dose of over 80% during Cycle 1 was assessed.
Outcome measures
| Measure |
Arm I - Cediranib Plus Dasatinib
n=11 Participants
Patients receive oral cediranib maleate once daily and oral dasatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm II - Cediranib Alone
n=11 Participants
Patients receive oral cediranib maleate once daily for 28 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Number Who Experienced Study Medication Dose Intensity
|
6 participant
|
9 participant
|
SECONDARY outcome
Timeframe: Cycle 1 (average of 28 days)Population: Analysis was performed on study participants enrolled on the trial assessing number of patients who discontinued treatment in cycle 1.
Discontinuation of treatment in cycle 1 (average of 28 days)
Outcome measures
| Measure |
Arm I - Cediranib Plus Dasatinib
n=11 Participants
Patients receive oral cediranib maleate once daily and oral dasatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm II - Cediranib Alone
n=11 Participants
Patients receive oral cediranib maleate once daily for 28 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Treatment Discontinuation
|
7 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Through study completion (median duration on study = 4 cycles)Treatment discontinuation due to Adverse Events
Outcome measures
| Measure |
Arm I - Cediranib Plus Dasatinib
n=11 Participants
Patients receive oral cediranib maleate once daily and oral dasatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm II - Cediranib Alone
n=11 Participants
Patients receive oral cediranib maleate once daily for 28 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Treatment Discontinuation Due to Adverse Events (AEs)
|
2 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Through study completion (median duration on study = 4 cycles)Non-Adverse Event related Treatment Discontinuation
Outcome measures
| Measure |
Arm I - Cediranib Plus Dasatinib
n=11 Participants
Patients receive oral cediranib maleate once daily and oral dasatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm II - Cediranib Alone
n=11 Participants
Patients receive oral cediranib maleate once daily for 28 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Non-AE Related Treatment Discontinuation
Progressive Disease
|
4 participants
|
4 participants
|
|
Non-AE Related Treatment Discontinuation
Death
|
0 participants
|
2 participants
|
|
Non-AE Related Treatment Discontinuation
Other
|
5 participants
|
4 participants
|
SECONDARY outcome
Timeframe: Duration of Study (median duration on study = 4 cycles)Best overall response rate of each evaluable patient
Outcome measures
| Measure |
Arm I - Cediranib Plus Dasatinib
n=11 Participants
Patients receive oral cediranib maleate once daily and oral dasatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm II - Cediranib Alone
n=11 Participants
Patients receive oral cediranib maleate once daily for 28 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Overall Response Rate
|
2.6 months
Interval 1.4 to
confidence interval not reached.
|
6.4 months
Interval 1.9 to
confidence interval not reached.
|
SECONDARY outcome
Timeframe: Through study completion (median duration on study = 4 cycles)Population: In Arm II (Cediranib alone), 1 patient presented retroperitoneal hemorrhage (Grade 5).
Number of treatment related deaths
Outcome measures
| Measure |
Arm I - Cediranib Plus Dasatinib
n=11 Participants
Patients receive oral cediranib maleate once daily and oral dasatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm II - Cediranib Alone
n=11 Participants
Patients receive oral cediranib maleate once daily for 28 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Treatment Related Deaths
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Through study completion (median duration on study = 4 cycles)Population: Analysis was done on study participatns for which beta-C telopeptide was reduced.
Participants for which beta-C telopeptide was reduced
Outcome measures
| Measure |
Arm I - Cediranib Plus Dasatinib
n=11 Participants
Patients receive oral cediranib maleate once daily and oral dasatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm II - Cediranib Alone
n=9 Participants
Patients receive oral cediranib maleate once daily for 28 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Participants for Which Bone Biomarkers for Beta-C Telopeptide Was Reduced
|
7 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Through study completion (median duration on study = 4 cycles)Number of participants with increased alkaline phosphatase BAP
Outcome measures
| Measure |
Arm I - Cediranib Plus Dasatinib
n=9 Participants
Patients receive oral cediranib maleate once daily and oral dasatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm II - Cediranib Alone
n=11 Participants
Patients receive oral cediranib maleate once daily for 28 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Number of Participants With Increased Alkaline Phosphatase BAP
|
5 participants
|
10 participants
|
SECONDARY outcome
Timeframe: Through study completion (median duration on study = 4 cycles)Population: Analysis was performed on study participants assessing the number of participants with dose-interruptions due to adverse events.
The number of participants with dose-interruptions in each arm due to adverse events
Outcome measures
| Measure |
Arm I - Cediranib Plus Dasatinib
n=11 Participants
Patients receive oral cediranib maleate once daily and oral dasatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm II - Cediranib Alone
n=11 Participants
Patients receive oral cediranib maleate once daily for 28 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Dose Interruption Due to AEs
|
8 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Duration of Study (median duration on study = 4 cycles)Population: Analysis conducted on the number of participants with dose reductions in each arm of the study.
The number of participants with dose reductions in each arm
Outcome measures
| Measure |
Arm I - Cediranib Plus Dasatinib
n=11 Participants
Patients receive oral cediranib maleate once daily and oral dasatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm II - Cediranib Alone
n=11 Participants
Patients receive oral cediranib maleate once daily for 28 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Dose Reductions
|
5 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Duration of Study (median duration on study = 4 cycles)Population: Analysis of number of participants who experienced response rates of SD and PD.
Response Rate of Stable Disease and Progressive Disease
Outcome measures
| Measure |
Arm I - Cediranib Plus Dasatinib
n=11 Participants
Patients receive oral cediranib maleate once daily and oral dasatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm II - Cediranib Alone
n=11 Participants
Patients receive oral cediranib maleate once daily for 28 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Overall Response Rate
Stable Disease
|
22 percentage of participants
|
77 percentage of participants
|
|
Overall Response Rate
Progressive Disease
|
45 percentage of participants
|
18 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 16 weeksPopulation: Some participants (overall and post-baseline) did not complete the questionnaire or failed to answer more than 7 questions and could not be included in the analysis (a summary score could not be calculated).
Scale is measured on a range from 0 (worst quality of life) to 156 (best quality of life).
Outcome measures
| Measure |
Arm I - Cediranib Plus Dasatinib
n=10 Participants
Patients receive oral cediranib maleate once daily and oral dasatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm II - Cediranib Alone
n=10 Participants
Patients receive oral cediranib maleate once daily for 28 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Quality of Life Assessment Using Functional Assessment of Cancer Therapy - Prostate (FACT-P) Questionnaire
Cycle 3 (12 weeks)
|
109.1 units on a scale
Interval 70.2 to 132.0
|
105.8 units on a scale
Interval 91.0 to 119.0
|
|
Quality of Life Assessment Using Functional Assessment of Cancer Therapy - Prostate (FACT-P) Questionnaire
Baseline
|
117.5 units on a scale
Interval 78.3 to 129.5
|
108.5 units on a scale
Interval 83.0 to 124.0
|
|
Quality of Life Assessment Using Functional Assessment of Cancer Therapy - Prostate (FACT-P) Questionnaire
Cycle 2 (8 weeks)
|
120.6 units on a scale
Interval 74.0 to 131.5
|
107 units on a scale
Interval 67.0 to 131.0
|
|
Quality of Life Assessment Using Functional Assessment of Cancer Therapy - Prostate (FACT-P) Questionnaire
Cycle 4 (16 weeks)
|
114.5 units on a scale
Interval 67.5 to 119.0
|
93.8 units on a scale
Interval 93.7 to 94.0
|
Adverse Events
Arm I - Cediranib Plus Dasatinib
Serious events: 5 serious events
Other events: 11 other events
Deaths: 0 deaths
Arm II - Cediranib Alone
Serious events: 7 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm I - Cediranib Plus Dasatinib
n=11 participants at risk
Patients receive oral cediranib maleate (20mg) once daily and oral dasatinib (100mg) once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
|
Arm II - Cediranib Alone
n=11 participants at risk
Patients receive oral cediranib maleate (20mg) once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
|
|---|---|---|
|
Infections and infestations
Lung infection
|
0.00%
0/11
|
9.1%
1/11 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
9.1%
1/11 • Number of events 1
|
0.00%
0/11
|
|
Blood and lymphatic system disorders
Anemia
|
9.1%
1/11 • Number of events 1
|
18.2%
2/11 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
0.00%
0/11
|
9.1%
1/11 • Number of events 1
|
|
Hepatobiliary disorders
Bile obstruction
|
0.00%
0/11
|
9.1%
1/11 • Number of events 1
|
|
General disorders
Fatigue
|
0.00%
0/11
|
18.2%
2/11 • Number of events 2
|
|
Nervous system disorders
Pending Spinal Cord compression
|
9.1%
1/11 • Number of events 1
|
0.00%
0/11
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/11
|
9.1%
1/11 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Disease progression
|
0.00%
0/11
|
18.2%
2/11 • Number of events 2
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/11
|
9.1%
1/11 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
9.1%
1/11 • Number of events 1
|
0.00%
0/11
|
|
Gastrointestinal disorders
Abdominal pain
|
9.1%
1/11 • Number of events 1
|
0.00%
0/11
|
|
Gastrointestinal disorders
Upper Gastrointestinal hemorrhage
|
9.1%
1/11 • Number of events 1
|
0.00%
0/11
|
|
Gastrointestinal disorders
Lower Gastrointestinal hemorrhage
|
9.1%
1/11 • Number of events 1
|
0.00%
0/11
|
|
Gastrointestinal disorders
Retroperitoneal hemorrhage
|
0.00%
0/11
|
9.1%
1/11 • Number of events 1
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/11
|
9.1%
1/11 • Number of events 1
|
Other adverse events
| Measure |
Arm I - Cediranib Plus Dasatinib
n=11 participants at risk
Patients receive oral cediranib maleate (20mg) once daily and oral dasatinib (100mg) once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
|
Arm II - Cediranib Alone
n=11 participants at risk
Patients receive oral cediranib maleate (20mg) once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
|
|---|---|---|
|
Vascular disorders
Hypertension
|
81.8%
9/11
|
100.0%
11/11
|
|
Blood and lymphatic system disorders
Anemia
|
100.0%
11/11
|
100.0%
11/11
|
|
Gastrointestinal disorders
Diarrhea
|
72.7%
8/11
|
63.6%
7/11
|
|
General disorders
Fatigue
|
100.0%
11/11
|
81.8%
9/11
|
|
Investigations
Alkaline Phosphatase Increased
|
72.7%
8/11
|
90.9%
10/11
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
27.3%
3/11
|
45.5%
5/11
|
|
Investigations
Lymphocyte Count decreased
|
72.7%
8/11
|
81.8%
9/11
|
|
Gastrointestinal disorders
Nausea
|
54.5%
6/11
|
36.4%
4/11
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
54.5%
6/11
|
36.4%
4/11
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
18.2%
2/11
|
27.3%
3/11
|
|
Renal and urinary disorders
Hematuria
|
18.2%
2/11
|
45.5%
5/11
|
|
Metabolism and nutrition disorders
Obesity
|
9.1%
1/11
|
18.2%
2/11
|
|
Metabolism and nutrition disorders
Anorexia
|
45.5%
5/11
|
54.5%
6/11
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/11
|
27.3%
3/11
|
|
Gastrointestinal disorders
Constipation
|
45.5%
5/11
|
63.6%
7/11
|
|
Investigations
Weight loss
|
81.8%
9/11
|
36.4%
4/11
|
|
Gastrointestinal disorders
Gastroesophageal Reflux Disease
|
0.00%
0/11
|
27.3%
3/11
|
|
Investigations
Platelet Count Decreased
|
45.5%
5/11
|
45.5%
5/11
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
54.5%
6/11
|
45.5%
5/11
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
27.3%
3/11
|
27.3%
3/11
|
|
Investigations
Electrocardiogram QT Corrected Interval Prolonged
|
18.2%
2/11
|
36.4%
4/11
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
0.00%
0/11
|
18.2%
2/11
|
|
Vascular disorders
Hot Flashes
|
36.4%
4/11
|
18.2%
2/11
|
|
Psychiatric disorders
Depression
|
27.3%
3/11
|
18.2%
2/11
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
45.5%
5/11
|
72.7%
8/11
|
|
Cardiac disorders
Sinus tachycardia
|
9.1%
1/11
|
27.3%
3/11
|
|
Renal and urinary disorders
Urinary incontinence
|
9.1%
1/11
|
36.4%
4/11
|
|
Metabolism and nutrition disorders
Hyponatremia
|
45.5%
5/11
|
54.5%
6/11
|
|
General disorders
Edema limbs
|
18.2%
2/11
|
45.5%
5/11
|
|
Gastrointestinal disorders
Stomach pain
|
9.1%
1/11
|
9.1%
1/11
|
|
Investigations
Aspartate aminotransferase Increase
|
72.7%
8/11
|
36.4%
4/11
|
|
Psychiatric disorders
Insomnia
|
9.1%
1/11
|
36.4%
4/11
|
|
Renal and urinary disorders
Proteinuria
|
36.4%
4/11
|
54.5%
6/11
|
|
Nervous system disorders
Dysgeusia
|
18.2%
2/11
|
18.2%
2/11
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
27.3%
3/11
|
63.6%
7/11
|
|
Investigations
Creatinine increased
|
9.1%
1/11
|
27.3%
3/11
|
|
Gastrointestinal disorders
Dyspepsia
|
9.1%
1/11
|
27.3%
3/11
|
|
Investigations
Alanine Aminotransferase Increased
|
18.2%
2/11
|
18.2%
2/11
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
36.4%
4/11
|
36.4%
4/11
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/11
|
18.2%
2/11
|
|
Renal and urinary disorders
Urinary frequency
|
36.4%
4/11
|
18.2%
2/11
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
45.5%
5/11
|
27.3%
3/11
|
|
Gastrointestinal disorders
Oral dysesthesia
|
0.00%
0/11
|
9.1%
1/11
|
|
Gastrointestinal disorders
Abdominal pain
|
27.3%
3/11
|
27.3%
3/11
|
|
Investigations
Erythrocytes decreased
|
0.00%
0/11
|
9.1%
1/11
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
27.3%
3/11
|
9.1%
1/11
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/11
|
9.1%
1/11
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/11
|
18.2%
2/11
|
|
Skin and subcutaneous tissue disorders
Scalp dermatitis
|
0.00%
0/11
|
9.1%
1/11
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/11
|
9.1%
1/11
|
|
Injury, poisoning and procedural complications
Bruising
|
9.1%
1/11
|
18.2%
2/11
|
|
Gastrointestinal disorders
Flatulence
|
9.1%
1/11
|
9.1%
1/11
|
|
Endocrine disorders
Hypothyroidism
|
27.3%
3/11
|
18.2%
2/11
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
18.2%
2/11
|
9.1%
1/11
|
|
Nervous system disorders
Seizure
|
0.00%
0/11
|
9.1%
1/11
|
|
Gastrointestinal disorders
Bloating
|
0.00%
0/11
|
9.1%
1/11
|
|
Metabolism and nutrition disorders
Hypokalemia
|
36.4%
4/11
|
18.2%
2/11
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
9.1%
1/11
|
9.1%
1/11
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
0.00%
0/11
|
9.1%
1/11
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
9.1%
1/11
|
9.1%
1/11
|
|
Investigations
White blood cell decreased
|
9.1%
1/11
|
18.2%
2/11
|
|
Investigations
Cholesterol high
|
0.00%
0/11
|
9.1%
1/11
|
|
Respiratory, thoracic and mediastinal disorders
Diminished breath sounds
|
0.00%
0/11
|
9.1%
1/11
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/11
|
9.1%
1/11
|
|
Gastrointestinal disorders
Fecal incontinence
|
0.00%
0/11
|
9.1%
1/11
|
|
Reproductive system and breast disorders
Genital edema
|
0.00%
0/11
|
9.1%
1/11
|
|
Nervous system disorders
Headache
|
36.4%
4/11
|
18.2%
2/11
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
9.1%
1/11
|
18.2%
2/11
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
0.00%
0/11
|
18.2%
2/11
|
|
Musculoskeletal and connective tissue disorders
Restless legs
|
0.00%
0/11
|
9.1%
1/11
|
|
Respiratory, thoracic and mediastinal disorders
Bilateral rales
|
0.00%
0/11
|
9.1%
1/11
|
|
General disorders
Chills
|
18.2%
2/11
|
9.1%
1/11
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/11
|
9.1%
1/11
|
|
Nervous system disorders
Dizziness
|
27.3%
3/11
|
18.2%
2/11
|
|
General disorders
Fever
|
18.2%
2/11
|
18.2%
2/11
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/11
|
9.1%
1/11
|
|
Cardiac disorders
Irregular heart rate and rhythm
|
0.00%
0/11
|
9.1%
1/11
|
|
Investigations
Lymphocyte count increased
|
0.00%
0/11
|
9.1%
1/11
|
|
Renal and urinary disorders
Nocturia
|
9.1%
1/11
|
9.1%
1/11
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
0.00%
0/11
|
18.2%
2/11
|
|
Gastrointestinal disorders
rectal hemorrhage
|
9.1%
1/11
|
9.1%
1/11
|
|
Nervous system disorders
Spasticity
|
0.00%
0/11
|
9.1%
1/11
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/11
|
9.1%
1/11
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.1%
1/11
|
9.1%
1/11
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.00%
0/11
|
9.1%
1/11
|
|
Musculoskeletal and connective tissue disorders
Blood bilirubin increased
|
0.00%
0/11
|
9.1%
1/11
|
|
Psychiatric disorders
Confusion
|
0.00%
0/11
|
9.1%
1/11
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Disease Progression
|
0.00%
0/11
|
9.1%
1/11
|
|
Vascular disorders
Flushing
|
0.00%
0/11
|
9.1%
1/11
|
|
Metabolism and nutrition disorders
Glucose Intolerance
|
18.2%
2/11
|
9.1%
1/11
|
|
Gastrointestinal disorders
hemorrhoidal hemorhage
|
0.00%
0/11
|
9.1%
1/11
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/11
|
9.1%
1/11
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
0.00%
0/11
|
9.1%
1/11
|
|
Metabolism and nutrition disorders
Hypernatremia
|
0.00%
0/11
|
9.1%
1/11
|
|
Infections and infestations
Lung infection
|
9.1%
1/11
|
9.1%
1/11
|
|
Gastrointestinal disorders
Mucositis oral
|
36.4%
4/11
|
9.1%
1/11
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/11
|
9.1%
1/11
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/11
|
9.1%
1/11
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
9.1%
1/11
|
9.1%
1/11
|
|
Investigations
Neutrophil Count decreased
|
9.1%
1/11
|
9.1%
1/11
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/11
|
9.1%
1/11
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/11
|
9.1%
1/11
|
|
Skin and subcutaneous tissue disorders
Retroperitoneal hemorrhage
|
0.00%
0/11
|
9.1%
1/11
|
|
Investigations
Serum amylase increased
|
0.00%
0/11
|
9.1%
1/11
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/11
|
9.1%
1/11
|
|
Gastrointestinal disorders
Vomiting
|
54.5%
6/11
|
9.1%
1/11
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
18.2%
2/11
|
0.00%
0/11
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
18.2%
2/11
|
0.00%
0/11
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
18.2%
2/11
|
0.00%
0/11
|
|
Gastrointestinal disorders
Dry mouth
|
18.2%
2/11
|
0.00%
0/11
|
|
Ear and labyrinth disorders
Hearing impaired
|
18.2%
2/11
|
0.00%
0/11
|
|
Cardiac disorders
Ventricular Diastolic disorder
|
9.1%
1/11
|
0.00%
0/11
|
|
Gastrointestinal disorders
Dry throat
|
9.1%
1/11
|
0.00%
0/11
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
9.1%
1/11
|
0.00%
0/11
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
18.2%
2/11
|
0.00%
0/11
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis of Jaw
|
9.1%
1/11
|
0.00%
0/11
|
|
Cardiac disorders
Ventricular arrhythmia
|
9.1%
1/11
|
0.00%
0/11
|
|
Gastrointestinal disorders
Anal fissure
|
9.1%
1/11
|
0.00%
0/11
|
|
Gastrointestinal disorders
Blood in stool
|
9.1%
1/11
|
0.00%
0/11
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
9.1%
1/11
|
0.00%
0/11
|
|
Gastrointestinal disorders
Lip sore
|
9.1%
1/11
|
0.00%
0/11
|
|
Investigations
Low T3
|
9.1%
1/11
|
0.00%
0/11
|
|
Musculoskeletal and connective tissue disorders
Movements involuntary
|
9.1%
1/11
|
0.00%
0/11
|
|
Musculoskeletal and connective tissue disorders
Rib pain
|
9.1%
1/11
|
0.00%
0/11
|
|
Musculoskeletal and connective tissue disorders
Shoulder pain
|
9.1%
1/11
|
0.00%
0/11
|
|
Gastrointestinal disorders
Sore throat
|
9.1%
1/11
|
0.00%
0/11
|
|
Ear and labyrinth disorders
Tinnitus
|
9.1%
1/11
|
0.00%
0/11
|
|
Gastrointestinal disorders
Abdominal distension
|
9.1%
1/11
|
0.00%
0/11
|
|
Ear and labyrinth disorders
Ear pain
|
9.1%
1/11
|
0.00%
0/11
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
9.1%
1/11
|
0.00%
0/11
|
|
Gastrointestinal disorders
Gastroparesis
|
9.1%
1/11
|
0.00%
0/11
|
|
Investigations
Low T4
|
9.1%
1/11
|
0.00%
0/11
|
|
Gastrointestinal disorders
Lower Gastrointestinal hemorrhage
|
9.1%
1/11
|
0.00%
0/11
|
|
General disorders
Malaise
|
9.1%
1/11
|
0.00%
0/11
|
|
Infections and infestations
Mucosal infection
|
9.1%
1/11
|
0.00%
0/11
|
|
Skin and subcutaneous tissue disorders
Palmar-Plantar Erythrodysesthesia
|
9.1%
1/11
|
0.00%
0/11
|
|
Respiratory, thoracic and mediastinal disorders
Runny nose
|
9.1%
1/11
|
0.00%
0/11
|
|
Gastrointestinal disorders
Upper Gastrointestinal hemorrhage
|
9.1%
1/11
|
0.00%
0/11
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60