Ignite Creation Date:
2024-05-06 @ 1:06 PM
Last Modification Date:
2024-10-26 @ 1:08 PM
Study NCT ID:
NCT03930771
Status:
TERMINATED
Last Update Posted:
2022-08-09
First Post:
2019-04-25
Brief Title:
Capecitabine and Temozolomide for Treatment of Recurrent Pituitary Adenomas
Sponsor:
Weill Medical College of Cornell University
Organization:
Weill Medical College of Cornell University
Study Overview
Official Title:
Capecitabine and Temozolomide for Treatment of Recurrent Pituitary Adenomas
Status:
TERMINATED
Status Verified Date:
2022-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
the study had a low accrual rate
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TMZ-Cap
Brief Summary:
This is an open label study to assess the efficacy of capecitabine CAP and temozolomide TMZ in recurrent pituitary adenomas There will be a safety run-in of at least three patients to establish any dose limiting toxicities Enrolled patients will receive treatment in 28-day cycles capecitabine 1500mgm2 per day divided into two doses with maximum daily dose of 2500mg on days 1 through 14 and oral temozolomide 150 to 200 mgm2 on days 10 through 14 This will be followed by 14 days off treatment MRI imaging will be completed after every two cycles Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None