Ignite Creation Date:
2024-05-05 @ 9:36 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003969
Status:
COMPLETED
Last Update Posted:
2013-06-26
First Post:
1999-11-01
Brief Title:
Geldanamycin Analogue in Treating Patients With Advanced Cancer
Sponsor:
Cancer Research UK
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Pharmacokinetic and Pharmacodynamic Study of 17-Allylamino-17-Demethoxygeldanamycin 17-AAG NSC 330507 Via Intravenous Administration in Patients With Advanced Malignancies
Status:
COMPLETED
Status Verified Date:
2000-12
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 This phase I trial is studying the side effects and best dose of a geldanamycin analogue in treating patients with advanced cancer
PURPOSE This phase I trial is studying the side effects and best dose of a geldanamycin analogue in treating patients with advanced cancer
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose for a geldanamycin analogue 17-allylamino-17-demethoxygeldanamycin AAG in patients with advanced malignancies
Determine the toxic effects and dose-limiting toxicity of AAG in this patient population
Determine the safe dose of AAG for a Phase II study
Measure the pharmacokinetic and pharmacodynamic profiles of AAG in these patients
Assess time to tumor progression and any antitumor activity in patients treated with AAG
OUTLINE This is a dose-escalation study
Patients receive a geldanamycin analogue 17-allylamino-17-demethoxygeldanamycin AAG IV over 15-30 minutes every week Treatment continues in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of AAG until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity
Patients are followed at 4 weeks
PROJECTED ACCRUAL Approximately 20-40 patients will be accrued for this study
Determine the maximum tolerated dose for a geldanamycin analogue 17-allylamino-17-demethoxygeldanamycin AAG in patients with advanced malignancies
Determine the toxic effects and dose-limiting toxicity of AAG in this patient population
Determine the safe dose of AAG for a Phase II study
Measure the pharmacokinetic and pharmacodynamic profiles of AAG in these patients
Assess time to tumor progression and any antitumor activity in patients treated with AAG
OUTLINE This is a dose-escalation study
Patients receive a geldanamycin analogue 17-allylamino-17-demethoxygeldanamycin AAG IV over 15-30 minutes every week Treatment continues in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of AAG until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity
Patients are followed at 4 weeks
PROJECTED ACCRUAL Approximately 20-40 patients will be accrued for this study
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 |
|---|---|---|---|
| EU-99055 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000067170 | REGISTRY | None | None |
| NCI-T99-0013 | None | None | None |