Tasisulam vs Paclitaxel as 2nd Line Treatment in Metastatic Melanoma

• Research type

  Research Study

• Full title

  Protocol H8K-MC-JZAO. A Randomised Phase 3 Study of Tasisulam Administered as an Intravenous Infusion on Day 1 of a 28-Day Cycle vs. Paclitaxel as Second-Line treatment in Patients with Metastatic Melanoma.

• IRAS ID

  43669

• Contact name

  Paul Lorigan

• Sponsor organisation

  Eli Lilly

• Eudract number

  2009-014591-21

• ISRCTN Number

  n.a

• Clinicaltrials.gov Identifier

  n.a

• Research summary

  This is a study in approximately 800 patients (>18 years of age) with metastatic melanoma who have previously received, but not responded to, 1 treatment regimen for the disease. The previous treatment can contain either dacarbazine or temozolomide or could have been an immunotherapy-based treatment. There is currently no drug approved for use as second-line therapy for metastatic melanoma, although many treatments have been tested. Tasisulam (the trial drug) has been tested in other studies and has shown some promising results with regards to response rate. There are 2 arms to the study which patients will be randomised to equally. Arm 1: Tasisulam (the trial drug) administered as a 2 hour intravenous (IV) infusion on day 1 of a 28 day cycle. Arm 2: Paclitaxel (the comparator drug) administered as a 1 hour IV infusion on days 1, 8 and 15 of a 28 day cycle. Due to the drug being delivered intravenously, the trial sites participating will all be hospitals in the UK. Subjects will continue to be treated in cycles until their disease progresses or there are unacceptable side effects. Various safety and research measures will be performed throughout the study, including taking of blood samples and radiographic assessments (CT scans, MRIs or x-rays)

• REC name

  East of England - Cambridge East Research Ethics Committee

• REC reference

  10/H0304/8

• Date of REC Opinion

  31 Mar 2010

• REC opinion

  Further Information Favourable Opinion