Metastatic Colorectal Cancer Clinical Trial
Official title:
Open Label Phase II Study Evaluating the Combination of Bevacizumab and AMG386 Without Chemotherapy as First Line Treatment of Advanced Colorectal Cancer
This is a clinical trial investigating the effectiveness and safety of the combination of
the study drugs bevacizumab and AMG386 in patients with advanced (metastatic)
chemotherapy-naive bowel (colorectal) cancer. Chemotherapy has a significant impact in
metastatic bowel cancer in terms of maintenance of quality of life and extension of
survival. However, ultimately tumours will develop resistance to these agents and further
treatment options are urgently required.
Angiogenesis is a process that results in the formation of new blood vessels. Similar to
normal tissues, solid tumours require new blood vessels for growth and survival. Hence,
drugs targeting angiogenesis may be useful treatment options for patients with bowel cancer.
AMG386 and bevacizumab act on 2 different pathways relevant to angiogenesis. There is
evidence from laboratory and animal studies to suggest that such a combination could be
useful as a cancer treatment. Previous studies in humans have shown that AMG386 and
bevacizumab can be combined safely.. This study aims to evaluate the effectiveness and
safety of the combination of AMG386 and bevacizumab in patients with advanced bowel cancer.
40 patients from approximately four hospitals in Australia will participate in this trial,
with approximately 20 patients being enrolled at Austin Health. All participants will
receive the same treatment.
n/a
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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