Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003982
Status:
COMPLETED
Last Update Posted:
2012-07-11
First Post:
1999-11-01
Brief Title:
MEN-10755 in Treating Patients With Solid Tumors
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
Phase I Study to Determine the Safety of MEN-10755 BMS-195615 in Patients With a Solid Tumor on a Short IV Infusion Given Once Every Week for 3 Consecutive Weeks Followed by One Weeks Rest
Status:
COMPLETED
Status Verified Date:
2012-07
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 MEN-10755 in treating patients who have solid tumors
PURPOSE Phase I trial to study the effectiveness of MEN-10755 in treating patients who have solid tumors
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose of MEN-10755 in patients with solid tumors II Determine the qualitative and quantitative toxic effects of this drug and study the predictability duration intensity onset reversibility and dose relationship of the toxic effects in this patient population III Propose a safe dose for phase II study IV Study the pharmacokinetics of this drug at different dose levels in this patient population V Document any possible antitumor activity of this drug in this patient population
OUTLINE This is a dose escalation study Patients receive MEN-10755 IV over 15 minutes on days 1 8 and 15 Treatment continues every 4 weeks or upon recovery of toxicity whichever comes later Treatment continues for at least 2 courses in the absence of unacceptable toxicity or disease progression Cohorts of 3-6 patients receive escalating doses of MEN-10755 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity Patients are followed for at least 3 weeks
PROJECTED ACCRUAL A total of 30 patients will be accrued for this study over 12 months
OUTLINE This is a dose escalation study Patients receive MEN-10755 IV over 15 minutes on days 1 8 and 15 Treatment continues every 4 weeks or upon recovery of toxicity whichever comes later Treatment continues for at least 2 courses in the absence of unacceptable toxicity or disease progression Cohorts of 3-6 patients receive escalating doses of MEN-10755 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity Patients are followed for at least 3 weeks
PROJECTED ACCRUAL A total of 30 patients will be accrued for this study over 12 months
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 |
|---|---|---|---|
| EORTC-16970 | None | None | None |