I4J-MC-HHBE - A global, multi-center Phase 1b/2 study.

• Research type

  Research Study

• Full title

  A Phase 1b/2 double-blind randomized trial of the Hedgehog/SMO Antagonist LY2940680 in combination with Carboplatin and Etoposide followed by LY2940680 versus Carboplatin and Etoposide plus placebo followed by placebo in Patients with Extensive-Stage Small Cell Lung Cancer.

• IRAS ID

  116261

• Contact name

  Martin Forster

• Sponsor organisation

  Lilly UK

• Eudract number

  2012-003174-83

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  I4J-MC-HHBE is a global, multi-center Phase 1b/2 study which will be conducted in 2 parts in patients with extensive SCLC who have not received anti-cancer therapy. The Phase 1b dose-escalation portion is open label and will evaluate the safety, Pharmacokinetics (what the body does to the drug), and Pharmacodynamics (what the drug does to the body) of LY2940680 in combination with Carboplatin and Etoposide for 6 cycles, followed by LY2940680 as a single agent until disease progression. The Phase 2 portion is double-blind (patient, Investigator'sponsor), placebo-controlled and randomized and compares Carboplatin and Etoposide in addition to LY2940680 for 6 cycles, followed by maintenance LY2940680 vs. Carboplatin and Etoposide in addition to a placebo for 6 cycles, followed by placebo only.

• REC name

  South Central - Berkshire Research Ethics Committee

• REC reference

  12/SC/0656

• Date of REC Opinion

  11 Jan 2013

• REC opinion

  Further Information Favourable Opinion