Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003890
Status:
COMPLETED
Last Update Posted:
2020-04-06
First Post:
2000-06-02
Brief Title:
MG98 in Treating Patients With Advanced Solid Tumors
Sponsor:
NCIC Clinical Trials Group
Organization:
Canadian Cancer Trials Group
Study Overview
Official Title:
A Phase I Study of MG98 Given as a 2 Hour Twice Weekly IV Infusion in Patients With Advanced Cancer
Status:
COMPLETED
Status Verified Date:
2020-04
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:
RATIONALE Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die
PURPOSE Phase I trial to study the effectiveness of MG98 in treating patients who have advanced solid tumors
PURPOSE Phase I trial to study the effectiveness of MG98 in treating patients who have advanced solid tumors
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose of MG98 in patients with advanced solid tumors
Assess the safety toxicity and pharmacokinetics of this treatment regimen in this patient population
Evaluate the effectiveness of this treatment regimen in these patients
OUTLINE This is a dose escalation multicenter study
Patients receive MG98 IV over 2 hours twice weekly for 3 weeks Courses are repeated every 4 weeks Treatment continues in the absence of disease progression or unacceptable toxicity
The dose of MG98 is escalated in cohorts of 1-6 patients 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
Patients are followed at week 4 then at least every 3 months until relapse of disease
PROJECTED ACCRUAL Approximately 20 patients will be accrued for this study within 10-12 months
Determine the maximum tolerated dose of MG98 in patients with advanced solid tumors
Assess the safety toxicity and pharmacokinetics of this treatment regimen in this patient population
Evaluate the effectiveness of this treatment regimen in these patients
OUTLINE This is a dose escalation multicenter study
Patients receive MG98 IV over 2 hours twice weekly for 3 weeks Courses are repeated every 4 weeks Treatment continues in the absence of disease progression or unacceptable toxicity
The dose of MG98 is escalated in cohorts of 1-6 patients 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
Patients are followed at week 4 then at least every 3 months until relapse of disease
PROJECTED ACCRUAL Approximately 20 patients will be accrued for this study within 10-12 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000067059 | OTHER | PDQ | None |
| CAN-NCIC-IND125 | OTHER | None | None |
| METHYL-MG98-002 | OTHER | None | None |