Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003028
Status:
COMPLETED
Last Update Posted:
2012-07-02
First Post:
1999-11-01
Brief Title:
MEN-10755 in Treating Adults With Recurrent or Refractory 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 3 Weeks
Status:
COMPLETED
Status Verified Date:
2012-06
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 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 adults who have recurrent or refractory solid tumors
PURPOSE Phase I trial to study the effectiveness of MEN-10755 in treating adults who have recurrent or refractory solid tumors
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose MTD of MEN-10755 in patients with recurrent or refractory adult solid tumors II Determine the qualitative and quantitative toxic effects of MEN-10755 and study the predictability duration intensity onset reversibility and dose relationship of the toxic effects in these patients III Propose a safe dose for phase II study IV Assess the pharmacokinetics of MEN-10755 at different dose levels in these patients V Document any possible antitumor activity of MEN-10755
OUTLINE This is an open label nonrandomized study Patients receive MEN-10755 as a single 15 minute intravenous infusion every 3 weeks or upon recovery from toxicity Doses will be escalated in decreasing rates and depending on the clinical judgement of the investigator The MTD is the dose at which dose limiting toxicity is observed in at least 2 of 6 patients at a given dose level Patients will be removed from the study if cardiac toxicity disease progression or renal cardiac or pulmonary decline is present
PROJECTED ACCRUAL At least 5 evaluable patients will be enrolled
OUTLINE This is an open label nonrandomized study Patients receive MEN-10755 as a single 15 minute intravenous infusion every 3 weeks or upon recovery from toxicity Doses will be escalated in decreasing rates and depending on the clinical judgement of the investigator The MTD is the dose at which dose limiting toxicity is observed in at least 2 of 6 patients at a given dose level Patients will be removed from the study if cardiac toxicity disease progression or renal cardiac or pulmonary decline is present
PROJECTED ACCRUAL At least 5 evaluable patients will be enrolled
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-16969 | None | None | None |