Ignite Creation Date:
2024-05-06 @ 12:33 AM
Last Modification Date:
2024-10-26 @ 10:51 AM
Study NCT ID:
NCT01606345
Status:
COMPLETED
Last Update Posted:
2016-04-22
First Post:
2012-05-23
Brief Title:
Phase I Study of Percutaneous Valrubicin for Upper Tract Urothelial Carcinoma
Sponsor:
H Lee Moffitt Cancer Center and Research Institute
Organization:
H Lee Moffitt Cancer Center and Research Institute
Study Overview
Official Title:
Phase I Dose Escalation and Landmark Study of Percutaneous Valrubicin for Upper Tract Urothelial Carcinoma UTUC Following Endoscopic Resection
Status:
COMPLETED
Status Verified Date:
2016-04
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:
The purpose of this study is to learn more about how well the drug valrubicin VALSTAR works to help treat the patients cancer when administered through a nephrostomy tube inserted through their back into their kidney The study is also being done to determine how safe and easy it is to tolerate valrubicin at specific dose levels as well as the way in which the drug is eliminated from the human body Pharmacokinetics or PK
Detailed Description:
Eligible patients will receive percutaneous valrubicin beginning no sooner than 10 days following nephrostomy placement and within 6 weeks of tumor treatmentresection Therapy will be administered at one of three dose levels in a 3 3 design 200 mg75 ml diluent 400 mg75 ml diluent or 800 mg75 ml diluent It is anticipated that at least 3 patients will be accrued at both of the 200 and 400 mg dose levels Assuming acceptable toxicity the accrual target for the 800 mg dose level will be 9 patients If the maximum tolerated dose is determined to be 200 mg or 400 mg expansion to 9 patients will occur at the maximum tolerated dose MTD dose level Drug will be administered on a weekly basis for 8 total treatments
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