Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004026
Status:
TERMINATED
Last Update Posted:
2020-10-19
First Post:
1999-11-01
Brief Title:
CT-2584 in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Previous Therapy
Sponsor:
CTI BioPharma
Organization:
CTI BioPharma
Study Overview
Official Title:
A Phase II Study of CT-2584 Mesylate in Patients With Hormone Refractory Prostate Cancer
Status:
TERMINATED
Status Verified Date:
2020-10
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 CT-2584 may stop the growth of prostate cancer by stopping blood flow to the tumor
PURPOSE Randomized phase II trial to study the effectiveness of CT-2584 in treating patients who have metastatic prostate cancer that has not responded to previous therapy
PURPOSE Randomized phase II trial to study the effectiveness of CT-2584 in treating patients who have metastatic prostate cancer that has not responded to previous therapy
Detailed Description:
OBJECTIVES I Compare the efficacy safety and pharmacokinetics of 2 different treatment schedules of CT-2584 in patients with hormone refractory metastatic adenocarcinoma of the prostate
OUTLINE This is a randomized multicenter study Patients are randomized to 1 of 2 treatment arms Arm I Patients receive CT-2584 IV over 6 hours daily for 3 days every 3 weeks Arm II Patients receive CT-2584 IV over 6 hours once every 7 days for 3 weeks Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL Approximately 80 patients will be accrued for this study
OUTLINE This is a randomized multicenter study Patients are randomized to 1 of 2 treatment arms Arm I Patients receive CT-2584 IV over 6 hours daily for 3 days every 3 weeks Arm II Patients receive CT-2584 IV over 6 hours once every 7 days for 3 weeks Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL Approximately 80 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 |
|---|---|---|---|
| CPMC-IRB-8781 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000067257 | REGISTRY | None | None |