Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00073892
Status:
COMPLETED
Last Update Posted:
2022-06-27
First Post:
2003-12-10
Brief Title:
PI-88 in Treating Patients With an Advanced Malignancy Cancer or Stage IV Melanoma
Sponsor:
Cellxpert Biotechnology Corp
Organization:
Cellxpert Biotechnology Corp
Study Overview
Official Title:
A Phase III Study Of PI-88 In Advanced Malignancies Phase I And In Advanced MelanomaPhase II
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:
RATIONALE PI-88 may stop the growth of cancer by stopping blood flow to the tumor
PURPOSE Phase III trial to study the effectiveness of PI-88 in treating patients who have an advanced malignancy cancer or stage IV melanoma
PURPOSE Phase III trial to study the effectiveness of PI-88 in treating patients who have an advanced malignancy cancer or stage IV melanoma
Detailed Description:
OBJECTIVES
Phase I
Determine the maximum tolerated dose of PI-88 in patients with an advanced malignancy
Determine the safety and tolerability of this drug in these patients
Phase II
Determine the progression-free survival and time to progression in patients with stage IV melanoma treated with this drug
Determine the biological activity of this drug in these patients
OUTLINE This is an open-label dose-escalation study
Phase I parts 1 and 2
Part 1 Patients receive PI-88 subcutaneously SC once daily on days 1-4 and 15-18
Cohorts of 3-6 patients receive escalating doses of PI-88 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity Once the MTD has been determined in part I the effect of dose frequency is determined in patients in part II
Part 2 Patients receive PI-88 SC once daily on days 1-4 8-11 15-18 and 22-25 at a dose based on the MTD determined in part 1
Cohorts of 3 patients receive escalating doses of PI-88 until the MTD at this frequency is determined
Phase II patients with metastatic melanoma Patients receive PI-88 as in phase I part 2 at the MTD
Treatment in both phases repeats every 28 days in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 18-69 patients 18-30 for phase I part 1 6-9 for phase I part 2 and 25-30 for phase II will be accrued for this study
Phase I
Determine the maximum tolerated dose of PI-88 in patients with an advanced malignancy
Determine the safety and tolerability of this drug in these patients
Phase II
Determine the progression-free survival and time to progression in patients with stage IV melanoma treated with this drug
Determine the biological activity of this drug in these patients
OUTLINE This is an open-label dose-escalation study
Phase I parts 1 and 2
Part 1 Patients receive PI-88 subcutaneously SC once daily on days 1-4 and 15-18
Cohorts of 3-6 patients receive escalating doses of PI-88 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity Once the MTD has been determined in part I the effect of dose frequency is determined in patients in part II
Part 2 Patients receive PI-88 SC once daily on days 1-4 8-11 15-18 and 22-25 at a dose based on the MTD determined in part 1
Cohorts of 3 patients receive escalating doses of PI-88 until the MTD at this frequency is determined
Phase II patients with metastatic melanoma Patients receive PI-88 as in phase I part 2 at the MTD
Treatment in both phases repeats every 28 days in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 18-69 patients 18-30 for phase I part 1 6-9 for phase I part 2 and 25-30 for phase II 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 |
|---|---|---|---|
| CDR0000335412 | REGISTRY | None | None |
| COMIRB-01-207 | Registry Identifier | PDQ Physician Data Query | None |