20060534, AMG479 and AMG102 in extensive SCLC

• Research type

  Research Study

• Full title

  A Phase 1b/ 2 Trial of AMG 479 or AMG 102 in Combination with Platinum-based Chemotherapy as First-Line Treatment for Extensive Stage Small Cell Lung Cancer

• IRAS ID

  7333

• Sponsor organisation

  Amgen

• Eudract number

  2008-003292-42

• ISRCTN Number

  n/a

• Research summary

  The purpose of this study is to test the effectiveness and safety of the study drug (AMG102 or AMG479) when given with chemotherapy in subjects with extensive stage small cell lung cancer (SCLC). Both these study drugs may play a role in the stopping the growth of cancer cells. The study aims to identify a safe and tolerable dose of AMG102 and AMG479 for use in combination with etoposide plus either carboplatin or cisplatin (chemotherapy) (Part 1). The second part of the study is to estimate the relative treatment effect of AMG479 OR AMG102 in combination with chemotherapy when compared to a placebo arm (therefore Chemotherapy only arm). The phase 2 component of the study is assessing if patients with extensive stage SCLC benefit from either AMG 102 or AMG 479 when one of these study drugs are administered to patients in conjunction with etoposide combined with either carboplatin or cisplatin. The chemotherapy only arm is the control group.

• REC name

  South West - Cornwall & Plymouth Research Ethics Committee

• REC reference

  09/H0206/3

• Date of REC Opinion

  13 Feb 2009

• REC opinion

  Further Information Favourable Opinion