Ignite Creation Date:
2024-05-06 @ 12:53 AM
Last Modification Date:
2024-10-26 @ 10:56 AM
Study NCT ID:
NCT01683552
Status:
COMPLETED
Last Update Posted:
2012-09-12
First Post:
2012-09-05
Brief Title:
Aprepitant in the Management of Biological Therapies-related Severe Pruritus
Sponsor:
Campus Bio-Medico University
Organization:
Campus Bio-Medico University
Study Overview
Official Title:
Aprepitant in the Management of Biological Therapies-related Severe Pruritus a Pilot Study in 45 Cancer Patients
Status:
COMPLETED
Status Verified Date:
2012-09
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:
AprepIt
Brief Summary:
Itch is a common side effect of anti-epidermal growth factor receptor antibodies and tyrosine kinase inhibitors Investigators designed a pilot single-center phase II study evaluating the effects of Aprepitant a neurokinin receptor inhibitor in managing biological therapy-induced pruritus
Detailed Description:
Investigators enroll patients affected by solid tumors which present itch refractory to standard treatment refractory group and patients who did not receive any treatment for pruritus naïve group The intensity of itch will be evaluated with Visual Analogue Scale VAS score In the refractory group Aprepitant 125 mg on day 1 80 mg on day 3 80 mg on day 5 will be administered after at least 1 week of standard systemic treatment In the naïve group Aprepitant will be administered after the first onset of severe pruritus The primary end point is to evaluate the effect of aprepitant in managing pruritus both in naive and refractory group
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?:
None