Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00072670
Status:
COMPLETED
Last Update Posted:
2014-04-08
First Post:
2003-11-07
Brief Title:
A Phase 2 Study of Trabectedin Yondelis in Adult Male Participants With Advanced Prostate Cancer
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
Official Title:
Phase 2 Study of Yondelis in Men With Advanced Prostate Carcinoma
Status:
COMPLETED
Status Verified Date:
2014-04
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 evaluate safety and efficacy of trabectedin ET-743 in adult male participants with advanced metastatic spread of cancer cells from one part of the body to another prostate cancer
Detailed Description:
This is an open-label all people know the identity of the intervention non-randomized multi-center and Phase 2 study in adult male participants with advanced metastatic prostate cancer The study consists of 3 parts Screening consists of 14 days before study commences on Day -1 Treatment consists of 4-week dosing cycles wherein trabectedin will be administered as intravenously at a dose of either 058 milligram per square meter mgm2 weekly 3-hour infusion or 15 mgm2 or 12 mgm2 every three weeks 24-hour infusion and Follow-up until survival after the first dose of trabectedin Participants will discontinue study treatment at disease progression or unacceptable toxicity unless in the Investigators opinion it is deemed that the participants will continue to derive benefit from trabectedin Efficacy will be evaluated primarily through decline in prostate-specific antigen substance in blood that is measured to check for prostate cancer after 72 hours of therapy on Day 1 Participants safety will be monitored throughout the study
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ET-B-025-02 | None | None | None |