Protocol IMGN0007 amendment 2

• Research type

  Research Study

• Full title

  A Phase 1/2 Study to Assess the Safety and Efficacy of Lorvotuzumab Mertansine (IMGN901) in Combination with Carboplatin/Etoposide in Patients with Advanced Solid Tumors including Extensive Stage Small Cell Lung Cancer

• IRAS ID

  91322

• Contact name

  Paul Lorigan

• Sponsor organisation

  ImmunoGen, Inc

• Eudract number

  2010-022950-17

• Clinicaltrials.gov Identifier

  NCT01237678

• Research summary

  This is an early phase study testing whether a new type of drug called Lorvotuzumab mertansine (IMGN901), a humanized monoclonal antibody linked to a cytotoxic agent, is safe and effective when added together with standard existing therapy of two drugs called carboplatin and etoposide. All patients who meet the eligibility criteria for entry into the study will receive the standard therapy of carboplatin and etoposide and have a two out of three chance of getting the new drug being tested. Patients will be followed closely throughout the study and will have a series of tests performed including regular scans, blood tests, assessment of their cancer and assessment of their overall health.

• REC name

  North West - Liverpool Central Research Ethics Committee

• REC reference

  11/NW/0864

• Date of REC Opinion

  23 Feb 2012

• REC opinion

  Further Information Favourable Opinion