A Phase 1 First-in-Human Study Evaluating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 172 in Subjects With Relapsed / Refractory Renal Cell Carcinoma
This First in- human study of AMG 172 will be conducted in two parts: Part 1 (dose
exploration) and Part 2 (dose expansion). Part 1 of the study is aimed at evaluating the
safety, tolerability and PK of AMG 172 in subjects with in subjects with relapsed /
refractory cc RCC, and Part 2 is aimed at evaluating safety, tolerability, PK and response
rate. Up to 40 subjects may be enrolled in Part 1, and up to 20 subjects may be enrolled in
Part 2. The dose of AMG 172 utilized in Part 2 will be dependent upon data obtained in Part
1 of the study.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Clinically significant or ≥ Grade 3 CTCAE changes in safety laboratory tests, physical examinations, ECGs, or vital signs
28 days after the last subject enrolled of each cohort in Part 1 and every 10 subjects enrolled in Part 2 (if available)
Yes
MD
Study Director
Amgen
United States: Food and Drug Administration
20090515
NCT01497821
December 2011
May 2014
Name | Location |
---|---|
Phoenix, Arizona 85012 | |
Research Site | Mesa, Arizona |
Research Site | Branson, Missouri |