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BYM338: HuCAL Antibody for the<br />
Unintentional Weight Loss in Cancer Patients<br />
Efficacy, Safety and Tolerability of BYM338 in Patients With<br />
Sporadic Inclusion Body Myositis<br />
Status Phase 2 (recruiting)<br />
Study Design<br />
Study Start Date August 2011<br />
Completion Date December 2011<br />
Enrollment 12<br />
Primary<br />
Outcome<br />
Measures<br />
Secondary<br />
Outcome<br />
Measures<br />
Randomized, double-blind, placebo-controlled<br />
study<br />
Assessment of the affect of BYM338 on thigh<br />
muscle volume by MRI (time frame: 8 weeks)<br />
Assessment of the effect of BYM338 on muscle<br />
function by 'Timed Get Up and Go' test<br />
(Time frame: 8 weeks)<br />
Patients Patients with sporadic Inclusion Body Myositis<br />
Clinical Study of BYM338 for the Treatment of Unintentional<br />
Weight Loss in Patients With Cancer of the Lung or the<br />
Pancreas<br />
Status Phase 2 (recruiting)<br />
Study Design<br />
Study Start Date August 2011<br />
Completion Date September 2012<br />
Enrollment 50<br />
Primary<br />
Outcome<br />
Measures<br />
Secondary<br />
Outcome<br />
Measures<br />
Patients<br />
Randomized, double-blind, placebo-controlled<br />
study<br />
Increase in thigh muscle volume as measured by<br />
MRI (Time Frame: 8 Weeks)<br />
� 6 minute walk test (Time frame: 8 weeks)<br />
� Efficacy in treating unintentional weight loss<br />
(Time frame: 8 weeks)<br />
� Obtain pharmacokinetic data in this population<br />
(Time frame: 8 weeks)<br />
� Efficacy in improving total lean body mass<br />
(LBM) and total bone mineral content<br />
(Time frame: 8 weeks)<br />
� Improving physical activity and function<br />
(Time frame: 8 weeks)<br />
Patients With Stage IV Non-small Cell Lung<br />
Cancer or Stage III/IV Adenocarcinoma of the<br />
Pancreas<br />
© <strong>MorphoSys</strong> AG<br />
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