Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00027781
Status:
COMPLETED
Last Update Posted:
2012-07-24
First Post:
2001-12-07
Brief Title:
MEN-10755 in Treating Patients With Progressive Prostate Cancer That Has Not Responded to Hormone Therapy
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
Open Label Phase II Study of MEN-10755 Administered Every 3 Weeks in Patients With Progressive Hormone Refractory Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2012-07
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:
RATIONALE Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die
PURPOSE Phase II trial to study the effectiveness of MEN-10755 in treating patients who have progressive prostate cancer that has not responded to hormone therapy
PURPOSE Phase II trial to study the effectiveness of MEN-10755 in treating patients who have progressive prostate cancer that has not responded to hormone therapy
Detailed Description:
OBJECTIVES
Assess the activity of MEN-10755 in patients with progressive hormone-refractory adenocarcinoma of the prostate
Determine the rate and duration of objective PSA response in patients treated with this drug
Determine the clinical response rate in patients with measurable disease treated with this drug
Determine the acute side effects of this drug in these patients
OUTLINE This is a multicenter study
Beginning within 2 weeks after the last PSA measurement patients receive MEN-10755 IV over 30 minutes on day 1 Treatment repeats every 3 weeks for at least 4 courses in the absence of disease progression or unacceptable toxicity Patients who achieve a complete or partial response continue to receive additional courses Patients who achieve stable disease may receive more than 4 courses at the discretion of the investigator
Patients are followed every 6 weeks until disease progression or initiation of a new therapy
PROJECTED ACCRUAL A total of 18-32 patients will be accrued for this study
Assess the activity of MEN-10755 in patients with progressive hormone-refractory adenocarcinoma of the prostate
Determine the rate and duration of objective PSA response in patients treated with this drug
Determine the clinical response rate in patients with measurable disease treated with this drug
Determine the acute side effects of this drug in these patients
OUTLINE This is a multicenter study
Beginning within 2 weeks after the last PSA measurement patients receive MEN-10755 IV over 30 minutes on day 1 Treatment repeats every 3 weeks for at least 4 courses in the absence of disease progression or unacceptable toxicity Patients who achieve a complete or partial response continue to receive additional courses Patients who achieve stable disease may receive more than 4 courses at the discretion of the investigator
Patients are followed every 6 weeks until disease progression or initiation of a new therapy
PROJECTED ACCRUAL A total of 18-32 patients will be accrued for this 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 |
|---|---|---|---|
| EORTC-16006-30005 | None | None | None |
| MAC-07 | None | None | None |