Ignite Creation Date:
2025-12-18 @ 8:13 AM
Ignite Modification Date:
2025-12-23 @ 10:36 PM
Study NCT ID:
NCT00690924
Status:
None
Last Update Posted:
2018-06-04 00:00:00
First Post:
2008-06-04 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Calcitriol in Preventing Lung Cancer in Smokers and Former Smokers at High Risk of Lung Cancer
Sponsor:
None
Organization:
Study Overview
Official Title:
A Pilot Study of Oral Calcitriol in Patients at High Risk for Lung Cancer
Status:
None
Status Verified Date:
2018-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
OBJECTIVES:
Primary
* To establish the safety of calcitriol in patients at high risk of lung cancer.
* To determine the dose-limiting toxicities of calcitriol in these patients.
OUTLINE: Patients receive oral calcitriol on day 1. Courses repeat every 2 weeks for 3 months in absence of unacceptable toxicity.
Patients undergo blood collection periodically for pharmacokinetic and molecular analysis.
After completion of study therapy, patients are followed periodically.
Primary
* To establish the safety of calcitriol in patients at high risk of lung cancer.
* To determine the dose-limiting toxicities of calcitriol in these patients.
OUTLINE: Patients receive oral calcitriol on day 1. Courses repeat every 2 weeks for 3 months in absence of unacceptable toxicity.
Patients undergo blood collection periodically for pharmacokinetic and molecular analysis.
After completion of study therapy, patients are followed periodically.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: