Trial Outcomes & Findings for Calcitriol in Preventing Lung Cancer in Smokers and Former Smokers at High Risk of Lung Cancer (NCT NCT00690924)
NCT ID: NCT00690924
Last Updated: 2018-06-04
Results Overview
Number of participants with Adverse Events, Grade II lasting more than two weeks or Grade III or higher, graded according to CTEP Version 4 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
16 participants
Primary outcome timeframe
3 months
Results posted on
2018-06-04
Participant Flow
Participant milestones
| Measure |
Calcitriol
calcitriol: Oral
laboratory biomarker analysis: Correlative Study
pharmacological study: Correlative Study
|
|---|---|
|
Overall Study
STARTED
|
16
|
|
Overall Study
COMPLETED
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Calcitriol in Preventing Lung Cancer in Smokers and Former Smokers at High Risk of Lung Cancer
Baseline characteristics by cohort
| Measure |
Calcitriol
n=16 Participants
calcitriol: Oral
laboratory biomarker analysis: Correlative Study
pharmacological study: Correlative Study
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
|
Age, Continuous
|
60.1 years
STANDARD_DEVIATION 8.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: All treated and eligible patients
Number of participants with Adverse Events, Grade II lasting more than two weeks or Grade III or higher, graded according to CTEP Version 4 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm.
Outcome measures
| Measure |
Calcitriol
n=16 Participants
calcitriol: Oral
laboratory biomarker analysis: Correlative Study
pharmacological study: Correlative Study
|
|---|---|
|
Grade III-IV Toxicities or Any Grade II Toxicities Lasting More Than 2 Weeks
II
|
1 participants
|
|
Grade III-IV Toxicities or Any Grade II Toxicities Lasting More Than 2 Weeks
III
|
0 participants
|
|
Grade III-IV Toxicities or Any Grade II Toxicities Lasting More Than 2 Weeks
IV
|
0 participants
|
|
Grade III-IV Toxicities or Any Grade II Toxicities Lasting More Than 2 Weeks
V
|
0 participants
|
Adverse Events
Calcitriol
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Calcitriol
n=16 participants at risk
calcitriol: Oral
laboratory biomarker analysis: Correlative Study
pharmacological study: Correlative Study
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
6.2%
1/16 • Number of events 1 • 4 months
|
|
Cardiac disorders
Arrhythmia
|
6.2%
1/16 • Number of events 1 • 4 months
|
|
Cardiac disorders
Palpitations
|
6.2%
1/16 • Number of events 1 • 4 months
|
|
Eye disorders
Eyelid irritation
|
6.2%
1/16 • Number of events 1 • 4 months
|
|
Gastrointestinal disorders
Abdominal pain
|
6.2%
1/16 • Number of events 5 • 4 months
|
|
Gastrointestinal disorders
Constipation
|
12.5%
2/16 • Number of events 2 • 4 months
|
|
Gastrointestinal disorders
Dry mouth
|
6.2%
1/16 • Number of events 1 • 4 months
|
|
Gastrointestinal disorders
Nausea
|
6.2%
1/16 • Number of events 1 • 4 months
|
|
Gastrointestinal disorders
Vomiting
|
6.2%
1/16 • Number of events 1 • 4 months
|
|
General disorders
Chills
|
6.2%
1/16 • Number of events 1 • 4 months
|
|
General disorders
Facial pain
|
6.2%
1/16 • Number of events 1 • 4 months
|
|
General disorders
Fatigue
|
12.5%
2/16 • Number of events 2 • 4 months
|
|
General disorders
Malaise
|
6.2%
1/16 • Number of events 1 • 4 months
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
6.2%
1/16 • Number of events 1 • 4 months
|
|
Investigations
Aspartate aminotransferase increased
|
25.0%
4/16 • Number of events 5 • 4 months
|
|
Investigations
Blood alkaline phosphatase increased
|
12.5%
2/16 • Number of events 2 • 4 months
|
|
Investigations
Calcium ionised increased
|
12.5%
2/16 • Number of events 2 • 4 months
|
|
Metabolism and nutrition disorders
Dehydration
|
6.2%
1/16 • Number of events 1 • 4 months
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
43.8%
7/16 • Number of events 13 • 4 months
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
25.0%
4/16 • Number of events 7 • 4 months
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
12.5%
2/16 • Number of events 3 • 4 months
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
12.5%
2/16 • Number of events 2 • 4 months
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
25.0%
4/16 • Number of events 6 • 4 months
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
25.0%
4/16 • Number of events 4 • 4 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
6.2%
1/16 • Number of events 1 • 4 months
|
|
Nervous system disorders
Dizziness
|
6.2%
1/16 • Number of events 5 • 4 months
|
|
Nervous system disorders
Headache
|
12.5%
2/16 • Number of events 3 • 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.2%
1/16 • Number of events 1 • 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
6.2%
1/16 • Number of events 1 • 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
12.5%
2/16 • Number of events 2 • 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
6.2%
1/16 • Number of events 1 • 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
6.2%
1/16 • Number of events 1 • 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
6.2%
1/16 • Number of events 1 • 4 months
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
6.2%
1/16 • Number of events 1 • 4 months
|
|
Vascular disorders
Hot flush
|
6.2%
1/16 • Number of events 1 • 4 months
|
|
Vascular disorders
Hypotension
|
6.2%
1/16 • Number of events 1 • 4 months
|
Additional Information
Senior Administrator, Compliance - Clinical Research Services
Roswell Park Cancer Institute
Phone: 716-845-2300
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place