AMGEN launches phase ll clinical-No placebo

After meeting by teleconference to discuss the new phase ll clinical trial for AMG706 we asked AMGEN pharmaceuticals to summarize their presentation. The following was submitted by AMGEN:

“AMG 706 is a potent, oral, multikinase inhibitor with anti-angiogenic and anti-tumor activity achieved by selectively targeting all known VEGF, PDGF, Kit and Ret receptors.

The safety profile observed in the ongoing Phase I study supports continuous uninterrupted once daily dosing. Continuous suppression of the mutant KIT kinase appears to be important in control of GIST tumors, as the Gleevec® experience has demonstrated.

There are currently two open enrolling clinical studies of AMG 706 in advanced cancers; the ongoing Phase I study and the new Phase II Gleevec resistant GIST study. The Phase I experience with AMG 706 has shown sufficient evidence of clinical benefit to warrant a Phase II GIST study.

The Phase II GIST study is a single arm, open-label trial. All patients will receive AMG 706 at a single initial dose level that has been demonstrated in the Phase I study to be safe and well tolerated.

The phase II study is accepting adult patients with advanced GIST who have had progressive disease despite at least 2 months of Gleevec at doses of at least 600 mg daily. Patients must have adequate organ function and radiographic evidence of disease progression by the RECIST definition. No previous exposure to AMG 706 or other tyrosine kinase inhibitors of c-kit (except Gleevec) or VEGF (vascular endothelial growth factor) type (e.g., SU11248, PTK787) or anti-VEGF antibody (Avastin®) is allowed.

The ongoing Phase I study has recently been amended to include patients with GIST who have also progressed on SU11248. If this amendment is approved at the 2 sites, these patients who otherwise meet eligibility criteria will be permitted.

A brief synopsis of the study appears on the www.amgentrials.com site and on www.clinicaltrials.gov site

The best way for patients to find out if there is a site open near their location is to call the Amgen Call Center (866- 57AMGEN or 866-572-6436)…”

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Comments: As the LRG has previously reported AMGEN is extending its phase l trial to permit SU11248 trial patients who will be excluded from the phase ll trial to receive AMG706. They are also planning a second arm of the phase ll study in the near future to compare patients on Gleevec to patients on AMG706, with Gleevec patients switching to AMG706 at the first sign of progression. Our understanding is that this cross-over will be based upon clinical observation rather than RECIST criteria. Most importantly there will be no placebo in either study arm

Finally, AMGEN will make a list of clinical trial sites available to the LRG very shortly. Watch our website at www.liferaftgroup.org.

Norman Scherzer and Jerry Call