NCT00003969

Geldanamycin Analogue in Treating Patients With Advanced Cancer

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: —
• Sponsor: Cancer Research UK · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
DRUG	tanespimycin

Timeline

• Start date: 1998-08-01
• Completion: 2007-01-01
• First posted: 2003-01-27
• Last updated: 2013-06-26

Locations

1 site across 1 country: United Kingdom