Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00031187
Status:
COMPLETED
Last Update Posted:
2011-10-24
First Post:
2002-02-27
Brief Title:
Study of SGN-15 Antibody-Drug Conjugate to Treat Hormone Refractory Prostate Cancer
Sponsor:
Seagen Inc
Organization:
Seagen Inc
Study Overview
Official Title:
Phase II Study of SGN-15 cBR96 - Doxorubicin Immunoconjugate Combined With Taxotere in Patients With Hormone Refractory Prostate Carcinoma
Status:
COMPLETED
Status Verified Date:
2011-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
SGN-15 is being investigated for therapy of patients with prostate cancer in combination with the cytotoxic agent Taxotere The study is an open label randomized phase II study for patients with documented hormone refractory prostate cancer who have not had any prior therapy with Taxotere or Novantrone Both SGN-15 and Taxotere will be administered weekly over two 6 week courses separated by a 2 week rest period
Detailed Description:
The purpose of this study is to evaluate a new class of biologic agent the monoclonal antibody mAb drug conjugate SGN-15 cBR96 - Doxorubicin immunoconjugate used in combination with the taxane agent TAXOTERE docetaxel as a strategy for targeting advanced stage hormone refractory prostate carcinoma HRPC This is a randomized open label phase II study evaluating the immunoconjugate SGN-15 in combination with the taxane TAXOTERE in comparison to TAXOTERE alone in patients with HRPC Based on a previous phase I study of the SGN-15TAXOTERE combination the weekly dose of SGN-15 will be 200 mgm2 and the weekly dose of TAXOTERE will be 35 mgm2 The schedule of administration for both agents will be weekly with SGN-15 administered prior to the TAXOTERE in the patients treated with the combination A single course of therapy will be defined as 6 weekly doses followed by a 2 week rest period for a total of 8 weeks The study will perform an interim analysis of the data after 80 patients have completed two courses Patients should be treated for a minimum of 2 courses of therapy Additionally for patients who remain eligible and have experienced tolerable levels of drug toxicity repeat dosing with subsequent cycles is possible Patients will be removed from study if there is evidence of tumor progression or intolerable toxicity Follow-up assessments include adverse event reporting clinical laboratory studies and quality of life QOL assessment using a validated QOL instrument
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