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
- 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.
- 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
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
Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment
Recommended phase II dose of 17-dimethylaminoethylamino-17-demethoxygeldanamycin (17-DMAG) at 28 days after treatment
Ian R. Judson, MA, MD, FRCP
Institute of Cancer Research, United Kingdom
United States: Federal Government