20070782 Darb alfa Ph3 Study in anaemic patients with NSCLC

• Research type

  Research Study

• Full title

  A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Long-term Safety and Efficacy of Darbepoetin Alfa Administered at 500 µg Once-Every-3- Weeks in Anemic Subjects With Advanced Stage Non-small Cell Lung Cancer Receiving Multi cycle Chemotherapy

• IRAS ID

  17475

• Contact name

  Yvonne Summers

• Eudract number

  2007-005792-34

• ISRCTN Number

  Unknown

• Research summary

  The 20070782 study is a large, multi-national study intended to provide safety and efficacy data that are applicable to all regions where a class of drugs known as erythropoiesis stimulating agents (ESAs) are approved for the treatment of chemotherapy-induced anaemia. Darbepoetin alfa is an ESA, which increases red blood cell production. The purpose of this study is to determine the safety of darbepoetin alfa, including effects on survival and cancer progression, as well as the need for blood transfusions in anaemic subjects with advanced non-small cell lung cancer receiving chemotherapy.Anaemia is a condition where the number of red blood cells in the body is abnormally low. Red blood cells are important because they contain haemoglobin that carries oxygen throughout the body to tissues and organs. Chemotherapy used to treat cancer patients often causes anaemia. Anaemia can result in physical weakness (fatigue), shortness of breath, pale skin, and rapid heartbeat. Treating anaemia by increasing the number of red blood cells in the patient??s body may reduce or eliminate some of these symptoms. If the subject decides to participate in this study they will have some tests to determine if they are eligible. If they are eligible, their participation will consist of 2 parts: the treatment period and the long term follow-up period. The treatment period includes a screening period of up to 14 days before enrolment and then treatment visits once-every-3-weeks. These visits (plus the 9-weekly imaging visits) will continue until their disease has progressed or within 3 weeks after the last dose of chemotherapy, whichever comes first. An end of treatment visit will follow after disease progression. At this point, their doctor will follow their progress with study visits every three months, until the conclusion of the study which will be when approximately 2700 deaths have occurred.

• REC name

  South West - Cornwall & Plymouth Research Ethics Committee

• REC reference

  09/H0206/23

• Date of REC Opinion

  9 Jul 2009

• REC opinion

  Further Information Favourable Opinion