Ignite Creation Date:
2024-05-05 @ 12:10 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00268593
Status:
COMPLETED
Last Update Posted:
2011-06-15
First Post:
2005-12-20
Brief Title:
Pilot Efficacy Study of PI-88 With Docetaxel to Treat Prostate Cancer
Sponsor:
Progen Pharmaceuticals
Organization:
Progen Pharmaceuticals
Study Overview
Official Title:
A Randomised Phase II Study of Two Dose Schedules of PI-88 in Combination With Docetaxel in Patients With Androgen-independent Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2011-06
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:
Docetaxel Taxotere is an approved chemotherapeutic drug for the treatment of androgen-independent prostate cancer The aim of the study is to investigate whether addition of the investigational drug PI-88 will increase the efficacy of docetaxel in this disease PI-88 inhibits cancer growth by inhibiting the development of new blood vessels and starving the tumour of oxygen and nutrients anti-angiogenic Because PI-88 and docetaxel have different mechanisms of action they are expected to have increased synergistic activity when combined
Detailed Description:
The trial is a multi-centre open-label randomised phase II study in patients with androgen-independent prostate cancer AIPC with a lead-in combination tolerance study The aim of the lead-in phase is to establish the maximum tolerated dose MTD of PI-88 administered either 4 daysweek or 7 daysweek in combination with fixed doses of docetaxel 75 mgm2 every 21 days and prednisone 5 mg twice daily In the randomized phase II component patients will receive PI-88 at the MTD either 4 daysweek or 7 daysweek in combination with docetaxel and prednisone The patients will receive up to 10 treatment cycles of the combination therapy Response to treatment will be assessed by measuring serum levels of prostate specific antigen PSA Other efficacy measures will include radiological assessment progression-free survival overall survival and quality of life
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 |
|---|---|---|---|
| XRP6976J6216 | None | None | None |
| PROPIT | None | None | None |