Ignite Creation Date:
2024-05-05 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00486642
Status:
COMPLETED
Last Update Posted:
2017-05-24
First Post:
2007-06-13
Brief Title:
Pazopanib Hydrochloride With or Without Bicalutamide in Treating Patients With Prostate Cancer That Did Not Respond to Hormone Therapy
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase 2 Study of GW786034 Pazopanib With or Without Bicalutamide in Hormone Refractory Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2017-04
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:
This randomized phase II trial is studying how well giving pazopanib with or without bicalutamide works in treating patients with prostate cancer that did not respond to hormone therapy Pazopanib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor Androgens can cause the growth of prostate cancer cells Antihormone therapy such as bicalutamide may lessen the amount of androgens made by the body Giving pazopanib hydrochloride together with bicalutamide may be an effective treatment for prostate cancer
Detailed Description:
PRIMARY OBJECTIVES
I To determine the therapeutic activity of GW786034 pazopanib hydrochloride with and without bicalutamide in the treatment of hormone-refractory prostate cancer using prostate specific antigen PSA-response rate
SECONDARY OBJECTIVES
I To estimate objective tumor response in patients with measurable disease II To estimate the median time to progression III To investigate the safety and tolerability of GW786034 with and without bicalutamide
IV To estimate the median duration of PSA-response V To determine the steady state levels of GW786034 with and without bicalutamide
VI To investigate the correlation between prior exposure to bicalutamide and non-steroidal anti-androgens with response and survival outcomes
OUTLINE Patients are randomized to 1 of 2 treatment arms
ARM I Patients receive pazopanib hydrochloride orally PO once daily QD on days 1-28
ARM II Patients receive pazopanib hydrochloride PO QD on days 1-28 Patients also receive bicalutamide PO QD on days 8-28 of course 1 and on days 1-28 in all subsequent courses
Courses in both arms repeat every 28 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up every 4 weeks for 12 weeks
I To determine the therapeutic activity of GW786034 pazopanib hydrochloride with and without bicalutamide in the treatment of hormone-refractory prostate cancer using prostate specific antigen PSA-response rate
SECONDARY OBJECTIVES
I To estimate objective tumor response in patients with measurable disease II To estimate the median time to progression III To investigate the safety and tolerability of GW786034 with and without bicalutamide
IV To estimate the median duration of PSA-response V To determine the steady state levels of GW786034 with and without bicalutamide
VI To investigate the correlation between prior exposure to bicalutamide and non-steroidal anti-androgens with response and survival outcomes
OUTLINE Patients are randomized to 1 of 2 treatment arms
ARM I Patients receive pazopanib hydrochloride orally PO once daily QD on days 1-28
ARM II Patients receive pazopanib hydrochloride PO QD on days 1-28 Patients also receive bicalutamide PO QD on days 8-28 of course 1 and on days 1-28 in all subsequent courses
Courses in both arms repeat every 28 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up every 4 weeks for 12 weeks
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 |
|---|---|---|---|
| N01CM62203 | NIH | CTEP | httpsreporternihgovquickSearchN01CM62203 |
| NCI-2009-00200 | REGISTRY | None | None |
| PMH-PHL-058 | None | None | None |
| PMH-10036920 | None | None | None |
| CDR0000549528 | None | None | None |
| PHL-058 | OTHER | None | None |
| 7640 | OTHER | None | None |
| N01CM00032 | NIH | None | None |