Ignite Creation Date:
2025-12-24 @ 11:59 AM
Ignite Modification Date:
2026-01-02 @ 2:24 AM
Study NCT ID:
NCT00796861
Status:
TERMINATED
Last Update Posted:
2017-12-20
First Post:
2008-11-21
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Trial of Sunitinib for Refractory Malignant Ascites
Sponsor:
Milton S. Hershey Medical Center
Organization:
Study Overview
Official Title:
Phase II Pilot Efficacy Trial of Sunitinib for Refractory Malignant Ascites
Status:
TERMINATED
Status Verified Date:
2017-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Phycisican decided to terminate study due to slow patient accrual.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study is to see whether treatment with Sunitinib decreases the accumulation of ascites in patients with refractory malignant ascites.
Detailed Description:
This is a single arm, non-randomized, phase II pilot study in patients who have stopped cytotoxic and biologic therapy for their neoplasms and are suffering from malignant ascites that requires drainage for comfort. The study will employ a Simon 2-stage optimal design. Initially up to 17 patients would be enrolled. If there are no responses among the first 12 patients, the study would be terminated. Otherwise the trial would be expanded by 23 to a total of 37 patients. If there are 3 or fewer responses by the end of the trial, then no further investigation would be warranted.
Study Oversight
Has Oversight DMC:
True
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?: