Trial Outcomes & Findings for Paricalcitol in Treating Patients With Advanced Prostate Cancer and Bone Metastases (NCT NCT00634582)
NCT ID: NCT00634582
Last Updated: 2018-07-06
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
2 participants
Primary outcome timeframe
16 weeks
Results posted on
2018-07-06
Participant Flow
Participant milestones
| Measure |
Paricalcitol
Paricalcitol capsules (Zemplar, Abbott) will be given on day 1 at 1 micrograms by mouth and continue daily for 16 weeks if all conditions for continuation are met
|
|---|---|
|
Overall Study
STARTED
|
2
|
|
Overall Study
COMPLETED
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Paricalcitol in Treating Patients With Advanced Prostate Cancer and Bone Metastases
Baseline characteristics by cohort
| Measure |
Paricalcitol
n=2 Participants
Paricalcitol capsules (Zemplar, Abbott) will be given on day 1 at 1 micrograms by mouth and continue daily for 16 weeks if all conditions for continuation are met
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
|
Age, Continuous
|
81.8 years
STANDARD_DEVIATION 2.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 16 weeksPopulation: This trial was closed for slow accrual. For cost reasons, analysis was to be done in a batch size never reached, so the analysis was not done.
Outcome measures
Outcome data not reported
Adverse Events
Paricalcitol
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Paricalcitol
n=2 participants at risk
Paricalcitol capsules (Zemplar, Abbott) will be given on day 1 at 1 micrograms by mouth and continue daily for 16 weeks if all conditions for continuation are met
|
|---|---|
|
General disorders
Pain
|
50.0%
1/2 • Number of events 1 • 16 weeks
|
|
Investigations
hyponatremia
|
50.0%
1/2 • Number of events 1 • 16 weeks
|
|
Vascular disorders
Edema: limb
|
50.0%
1/2 • Number of events 1 • 16 weeks
|
|
Infections and infestations
Lung infection
|
50.0%
1/2 • Number of events 1 • 16 weeks
|
|
General disorders
Syncope (fainting)
|
50.0%
1/2 • Number of events 1 • 16 weeks
|
Other adverse events
| Measure |
Paricalcitol
n=2 participants at risk
Paricalcitol capsules (Zemplar, Abbott) will be given on day 1 at 1 micrograms by mouth and continue daily for 16 weeks if all conditions for continuation are met
|
|---|---|
|
Investigations
low Platelets
|
50.0%
1/2 • Number of events 1 • 16 weeks
|
|
Investigations
Low Hemoglobin
|
100.0%
2/2 • Number of events 2 • 16 weeks
|
|
General disorders
Anorexia
|
50.0%
1/2 • Number of events 1 • 16 weeks
|
|
Investigations
Alkaline phosphatase
|
50.0%
1/2 • Number of events 1 • 16 weeks
|
|
Nervous system disorders
Neuropathy: motor
|
50.0%
1/2 • Number of events 1 • 16 weeks
|
|
General disorders
Dizziness
|
50.0%
1/2 • Number of events 1 • 16 weeks
|
|
Nervous system disorders
Neurology
|
50.0%
1/2 • Number of events 2 • 16 weeks
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin
|
50.0%
1/2 • Number of events 1 • 16 weeks
|
|
General disorders
Fatigue
|
50.0%
1/2 • Number of events 1 • 16 weeks
|
|
Investigations
hyperglycemia
|
100.0%
2/2 • Number of events 2 • 16 weeks
|
|
Investigations
hypocalcemia
|
50.0%
1/2 • Number of events 1 • 16 weeks
|
|
Investigations
hypoalbuminemia
|
50.0%
1/2 • Number of events 1 • 16 weeks
|
|
Investigations
serum glutamic pyruvic transaminase
|
50.0%
1/2 • Number of events 1 • 16 weeks
|
|
Gastrointestinal disorders
Constipation
|
50.0%
1/2 • Number of events 1 • 16 weeks
|
|
Investigations
serum glutamic oxaloacetic transaminase
|
100.0%
2/2 • Number of events 2 • 16 weeks
|
|
General disorders
Fever without neutropenia
|
50.0%
1/2 • Number of events 1 • 16 weeks
|
|
Cardiac disorders
Cardiac Arrhythmia - Other
|
50.0%
1/2 • Number of events 1 • 16 weeks
|
|
Vascular disorders
Edema: limb
|
50.0%
1/2 • Number of events 1 • 16 weeks
|
|
General disorders
Confusion
|
50.0%
1/2 • Number of events 1 • 16 weeks
|
|
General disorders
Ataxia
|
50.0%
1/2 • Number of events 1 • 16 weeks
|
|
General disorders
Pain: Back
|
50.0%
1/2 • Number of events 1 • 16 weeks
|
|
General disorders
Pain: Bone
|
50.0%
1/2 • Number of events 1 • 16 weeks
|
|
General disorders
Flushing
|
50.0%
1/2 • Number of events 1 • 16 weeks
|
|
General disorders
Voice changes
|
50.0%
1/2 • Number of events 1 • 16 weeks
|
|
Investigations
Lymphopenia
|
50.0%
1/2 • Number of events 1 • 16 weeks
|
|
General disorders
Muscle weakness
|
50.0%
1/2 • Number of events 1 • 16 weeks
|
Additional Information
Gary Schwartz, PhD
Comprehensive Cancer Center of Wake Forest Univeresity
Phone: 336-716-7446
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place