Clinical Research Details

A Phase II study of AMG 655 in Combination with Modified Folfox6 and Bevacizumab for First-Line Treatment of Subjects with Metastatic Colorectal Cancer

The purpose of this study is to help us understand which dose of the investigational drug in combination with a standard of care chemotherapy called mFOLFOX6 (which includes a modified dose of 5-fluorouracil [5-FU], oxaliplatin, and leucovorin) and bevacizumab, can be safely given to humans and produce a desired result. This study will explore how effective the investigational drug is in treating colorectal cancer.

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Histologically or cytologically confirmed metastatic adenocarcinoma of the colon or rectum. • Measurable disease according to modified RECIST criteria or non-measurable disease assessed within 21 days before randomization. • Availability of paraffin-embedded and/or snap frozen tumor tissue samples (from primary tumor or metastasis) taken as part of routine clinical care available for central biomarker testing. • Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1. Men or women = 18 years of age
Before any study specific procedure is performed, the appropriate approved written informed consent must be obtained. The following labs
within 7 days before randomization, unless otherwise specified:
• Hematological function, as follows
- Hemoglobin = 9 g/dL
- Absolute neutrophil count = 1.5 x 109/L
- Platelet count = 100 x 109/L (without transfusion = 14 days before
randomization)
• Renal function, as follows:
- Serum creatinine = 1.5 x ULN
- Urinary protein < 2+ (unless total quantitative protein is = 1000mg
protein/day as determined by 24-hr urine collection)
• Hepatic function, as follows:
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT)
= 2.5 x ULN OR AST and ALT = 5.0 x ULN if clearly attributable to liver
metastasis
- Albumin = 2.5 g/dL
- Total bilirubin = 1.5 x ULN
• Partial thromboplastin time (PTT) = 1.0 x ULN and international normalized ratio
(INR) = 1.5 unless subject is on full dose anticoagulation therapy. Patients on full dose anticoagulation are eligible if the following criteria are met: - The patient has an in-range INR (usually between 2 and 3) on a stable dose of oral anticoagulant or be on a stable dose of low molecular weight heparin. The patient has no active bleeding or pathological condition that carries high risk of bleeding (eg, tumor involving major vessels or known varices)
• Amylase = 2 x ULN
• Lipase = 2 x ULN
• Negative pregnancy test within 3 days before randomization (females only)

You will receive five drugs by IV (through your vein). Everyone will receive bevacizumab, which may be infused before the administration of the other chemotherapy (mFOLFOX6) at the investigator’s discretion. The other drugs that are given will be 5-FU, leucovorin and oxaliplatin.

The fifth drug you will receive is either the investigational drug AMG 655 or a placebo. You will also receive this drug through the vein as the other drugs above. You will not know if you are receiving the actual AMG 655 or placebo; neither will the doctors or nurses.

Deepak Malhotra, M.D.

(708) 327-1240