Ignite Creation Date:
2024-05-05 @ 12:06 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00248521
Status:
UNKNOWN
Last Update Posted:
2013-08-02
First Post:
2005-11-03
Brief Title:
17-Dimethylaminoethylamino-17-Demethoxygeldanamycin 17-DMAG in Treating Patients With Metastatic Solid Tumors or Tumors That Cannot Be Removed By Surgery
Sponsor:
Institute of Cancer Research United Kingdom
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Cancer Research UK Phase I Trial to Evaluate the Safety Tolerability and Pharmacokinetics of 17-Dimethylaminoethyl-amino-17-Demethoxygeldanamycin 17-DMAG Given as a Once Weekly Infusion in Patients With Advanced Solid Tumors
Status:
UNKNOWN
Status Verified Date:
2008-03
Last Known Status:
ACTIVE_NOT_RECRUITING
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 such as 17-dimethylaminoethylamino-17-demethoxygeldanamycin 17-DMAG work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing
PURPOSE This phase I trial is studying the side effects and best dose of 17-DMAG in treating patients with metastatic solid tumors or tumors that cannot be removed by surgery
PURPOSE This phase I trial is studying the side effects and best dose of 17-DMAG in treating patients with metastatic solid tumors or tumors that cannot be removed by surgery
Detailed Description:
OBJECTIVES
Primary
Determine the maximum tolerated dose dose-limiting toxicity and recommended phase II dose of 17-dimethylaminoethylamino-17-demethoxygeldanamycin 17-DMAG in patients with unresectable or metastatic solid tumors
Determine the feasibility safety and toxicity profile of this drug in these patients
Secondary
Determine the clinical pharmacokinetic profile of this drug in these patients
Determine tumor response in patients treated with this drug
Determine the biologically effective dose
OUTLINE This is an open-label non-randomized dose-escalation multicenter study
Patients receive 17-dimethylaminoethylamino-17-demethoxygeldanamycin 17-DMAG IV over 1 hour on days 1 8 15 and 22 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of 17-DMAG 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 An additional 10 patients are treated at the MTD
After completion of study treatment patients are followed for 28 days
PROJECTED ACCRUAL Approximately 25-35 patients will be accrued for this study within 12-18 months
Primary
Determine the maximum tolerated dose dose-limiting toxicity and recommended phase II dose of 17-dimethylaminoethylamino-17-demethoxygeldanamycin 17-DMAG in patients with unresectable or metastatic solid tumors
Determine the feasibility safety and toxicity profile of this drug in these patients
Secondary
Determine the clinical pharmacokinetic profile of this drug in these patients
Determine tumor response in patients treated with this drug
Determine the biologically effective dose
OUTLINE This is an open-label non-randomized dose-escalation multicenter study
Patients receive 17-dimethylaminoethylamino-17-demethoxygeldanamycin 17-DMAG IV over 1 hour on days 1 8 15 and 22 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of 17-DMAG 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 An additional 10 patients are treated at the MTD
After completion of study treatment patients are followed for 28 days
PROJECTED ACCRUAL Approximately 25-35 patients will be accrued for this study within 12-18 months
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-6547 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000442402 | REGISTRY | None | None |