Initial Results of a Multicenter, Single-Arm Phase 2 Study of AMG 706, an Oral Multikinase Inhibitor, for the Treatment of Advanced Imatinib-Resistant Gastrointestinal Stromal Tumors (GIST).
Initial Results of a Multicenter, Single-Arm Phase 2 Study of AMG 706, an Oral Multikinase Inhibitor, for the Treatment of Advanced Imatinib-Resistant Gastrointestinal Stromal Tumors (GIST)
Robert Benjamin, Patrick Schöffski, Jörg Thomas Hartmann, Binh Nguyen Bui, Justus Duyster, Scott Schuetze, Jean-Yves Blay, Peter Reichardt, Lee Rosen, Keith Skubitz, Michael Eschenberg, Daniel Stepan, and Laurence Baker
On behalf of the study investigators
4 November 2006
Herbst R et al. Eur J Cancer. 2005;3(Suppl):1455.
Rosen L et al. Proc ASCO. 2005. Abstract 3013.
aStem cell factor
Evaluate the effect of treatment with AMG 706 on the objective response rate (by RECIST) in patients with advanced GIST who developed progressive disease or relapsed while receiving imatinib
aScreened one or more patients
aIncludes all subjects who received at least one administration of AMG 706 and who were classified as
having pre-study disease progression (per RECIST) per independent review.
aDefined as > 25% decrease in average standardized uptake value (SUVmax) in all RECIST target lesions compared with the average SUVmax in all RECIST target lesions at baseline as measured by the independent reviewer.
bAll patients with a baseline and week 8 18FDG-PET scan. Does not include patients who discontinue study prior to week 8, even if discontinuation is due to clinical progression.
Screening: 21 June 05
Week 8: 24 August 05
aDefined as ≥ 10% decrease in the sum of the longest diameter of the target lesions (identified by RECIST) and/or ≥ 15% decrease in the average target tumor density (in Hounsfield units, HU) using the RECIST target lesions compared with the average baseline density based on CT scans.
bAll patients with both baseline and week 8 measures of the sum of the longest diameters (SLD) or tumor density (in HU).
HU = 141.4
HU = 89.8
Data are n (%)
aReversible posterior leukoencephalopathy syndrome
Data are n (%)
aTwo patients experienced both a thromboembolic event and a cardiac disorder
bPatients were not monitored with serial TSH levels during the study
To the global network of investigators, research nurses, study coordinators, and operations staff
Participating Investigators (Number of Patients Enrolled)
B Benjamin (14), S Schuetze and L Baker (10), L Rosen (7), K Skubitz (6), D Mahadevan (5), M Fanucchi (5), R Tozer (4), EG Chiorean (3), E Borden (3), A Staddon (2),A Evens (2), R Taub (2), M von Mehran (2), K Mulder (2), B Brockstein (1), A Elias (1), S Chawla (1)
JT Hartmann (12),P Schöffski and AT van Oosterom (10), BN Bui (10), J Duyster (10), JY Blay (7), P Reichardt (7), M Flasshove and T Ebeling (5), A Le Cesne (3), I Judson (2), P Casali (1), M Marangolo (1)
Amgen, Inc. (Sponsor)
D Stepan, D Reese, M Eschenberg, Y-N Sun, A Koutsoukos, M MacDonald, W Lovelace, K Aitchison, C Puzo, S Creamer, J Wright, T Juan