Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00022113
Status:
COMPLETED
Last Update Posted:
2013-01-25
First Post:
2001-08-10
Brief Title:
EMD 121974 in Treating Patients With Advanced Solid Tumors
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Study of EMD 121974 in Patients With Advanced Solid Tumors
Status:
COMPLETED
Status Verified Date:
2013-01
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:
Phase I trial to study the effectiveness of EMD 121974 in treating patients who have advanced solid tumors EMD 121974 may slow the growth of solid tumors by stopping blood flow to the tumor
Detailed Description:
OBJECTIVES
I Determine the toxic effects and maximum tolerated dose of EMD 121974 in patients with advanced solid tumors
II Determine the biologic activity of this drug in these patients III Determine the pharmacokinetic profile and plasma biological effects of this drug and identify any relationship with its biologic activity or observed toxicity in these patients
IV Determine preliminarily the antitumor efficacy of this drug in these patients
OUTLINE This is a dose-escalation study
Patients receive EMD 121974 IV over 1 hour twice weekly Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity
Cohorts of 3-10 patients receive escalating doses of EMD 121974 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
I Determine the toxic effects and maximum tolerated dose of EMD 121974 in patients with advanced solid tumors
II Determine the biologic activity of this drug in these patients III Determine the pharmacokinetic profile and plasma biological effects of this drug and identify any relationship with its biologic activity or observed toxicity in these patients
IV Determine preliminarily the antitumor efficacy of this drug in these patients
OUTLINE This is a dose-escalation study
Patients receive EMD 121974 IV over 1 hour twice weekly Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity
Cohorts of 3-10 patients receive escalating doses of EMD 121974 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
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 |
|---|---|---|---|
| CDR0000068786 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchU01CA099176 |
| 00-1096 | None | None | None |
| U01CA099176 | NIH | None | None |