A Phase Ib, Open-Label, Sequential, Dose-Finding, Study of AMG 706 in Combination With Gemcitabine to Treat Subjects With Solid Tumors
- Determine the maximum tolerated dose and safety of AMG 706 when given in combination
with gemcitabine hydrochloride in patients with advanced solid tumors or lymphoma.
- Determine the pharmacokinetic profiles of this regimen in these patients.
OUTLINE: This is a multicenter, open-label, dose-escalation study of AMG 706.
Patients receive oral AMG 706 once daily on days 2-56 and gemcitabine hydrochloride IV over
30 minutes on days 1, 8, 15, 22, 29, 36, and 43 of course 1. For all subsequent courses,
patients receive oral AMG 706 on days 1-28 and gemcitabine hydrochloride IV over 30 minutes
on days 1, 8, and 15. Treatment repeats every 4 weeks for up to 10 courses in the absence of
disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of AMG 706 until the maximum tolerated dose
(MTD) is determined. The MTD is defined as the dose preceding that at which 3 of 6 patients
experience dose-limiting toxicity.
During the first course of study treatment, patients undergo blood collection periodically
for pharmacokinetic analysis.
After completion of study treatment, patients are followed periodically for up to 5 years.
PROJECTED ACCRUAL: Approximately 18 patients will be accrued for this study.
Masking: Open Label, Primary Purpose: Treatment
Incidence of dose-limiting toxicity as assessed by NCI CTCAE v3.0
Carolyn Britten, MD
Jonsson Comprehensive Cancer Center
United States: Food and Drug Administration
|Jonsson Comprehensive Cancer Center at UCLA||Los Angeles, California 90095-1781|