Ignite Creation Date:
2024-05-05 @ 11:37 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00097851
Status:
COMPLETED
Last Update Posted:
2022-06-27
First Post:
2004-11-30
Brief Title:
Trial of PI-88 With Docetaxel in Advanced Non-Small-Cell Lung Cancer NSCLC
Sponsor:
Cellxpert Biotechnology Corp
Organization:
Cellxpert Biotechnology Corp
Study Overview
Official Title:
Phase II Trial of Docetaxel With PI-88 in Patients With Advanced Non-Small-Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2022-06
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:
PI-88 is a new experimental drug that inhibits tumour growth by reducing the formation of new blood vessels into tumours Docetaxel is a standard second-line treatment offered to patients with non-small-cell lung cancer who havent responded to first-line therapies platinum-based drugs or radiotherapy Of this group of patients only 20 remain progression-free 6 months after starting docetaxel treatment The PR88202 study has been designed to compare two different cancer treatments docetaxel only and docetaxel plus PI-88 and to work out which is more effective against the cancer It is hoped that the combination of PI-88 with docetaxel will allow patients to extend the time it takes for their disease to progress and also to improve their quality of life
Detailed Description:
PR88202 is an open-label randomized study In the initial phase of the study patients will be randomized to receive weekly docetaxel alone or PI-88 in combination with weekly docetaxel Both groups will receive docetaxel 30 mgm2 administered by intravenous infusion on days 1 8 and 15 of a 28-day cycle The second group only will receive PI-88 250 mgday in addition to docetaxel PI-88 will be administered by subcutaneous injection on days 1-4 8-11 and 15-18 of each cycle The primary efficacy endpoint is the non-progression rate at 6 months In the extension phase of the study patients in the combination arm who have stable disease or an objective response after up to six treatment cycles will remain on PI-88 alone as maintenance therapy Patients who initially receive docetaxel alone and who have disease progression or unacceptable toxicity before the completion of six cycles will be eligible to receive PI-88 alone as third-line therapy
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