Pilot Phase I/II Study of Megestrol + Formoterol in Cancer Cachexia

• Research type

  Research Study

• Full title

  Open-Label, Pilot Phase I/II Study of the Efficacy and Safety of Concomitant Megestrol + Formoterol in Patients with Cachexia and Advanced Malignancy.

• IRAS ID

  14468

• Sponsor organisation

  Acacia Pharma Ltd

• Eudract number

  2008-008857-53

• Research summary

  Cancer cachexia is a debilitating condition with no approved drug treatment. New therapies are urgently needed. There is a good scientific reason to use APD209, a combination of two well-known drugs, a ×ý2-agonist and a progestin, to treat cachexia; and results when animals were treated were encouraging. Both drugs are mild in terms of side effects, confirmed over many years of use in patients. This open-label study will look at the effect of the two agents on muscle mass and function, using highly sensitive measurement techniques, and confirm that the drugs can be safe when given together in patients with advanced cancer and cachexia. Information will also be collected on patients' quality of life and activity levels.

• REC name

  West of Scotland REC 1

• REC reference

  09/S0703/28

• Date of REC Opinion

  9 Feb 2009

• REC opinion

  Favourable Opinion