MM-141-07-02-02 (CARRIE) Pancreatic Cancer Phase 2

• Research type

  Research Study

• Full title

  A Randomized, Double-blind, Placebo-controlled Phase 2 Study of MM-141 plus Nab-Paclitaxel and Gemcitabine versus Nab-Paclitaxel and Gemcitabine in Front-Line Metastatic Pancreatic Cancer (CARRIE)

• IRAS ID

  180129

• Contact name

  David Watkins

• Contact email

  david.watkins@rmh.nhs.uk

• Sponsor organisation

  Merrimack Pharmaceuticals

• Eudract number

  2014-004572-34

• Clinicaltrials.gov Identifier

  NCT02399137

• Clinicaltrials.gov Identifier

  114689, IND

• Duration of Study in the UK

  2 years, 2 months, 1 days

• Research summary

  This study is taking place to learn more about the investigational drug, MM-141 and how it works when given together with nab-paclitaxel and gemcitabine. The combination of nab-paclitaxel and gemcitabine is a standard treatment option that has shown benefit in the treatment of pancreatic cancer.

  The main purpose of Part 1 of this study is to find out how safe and tolerable MM-141 is when given as a fixed-dose (as compared to a dose determined by a patient’s weight) in combination with nab-paclitaxel and gemcitabine. Researchers are also trying to learn how long MM-141 remains in the body after a fixed-dose of MM-141 is given in combination with nab-paclitaxel and gemcitabine.
  The main purpose of part 2 of the study is to determine whether the combination of MM-141 plus nab-paclitaxel and gemcitabine is more effective than nab-paclitaxel and gemcitabine alone based on Progression Free Survival (PFS) in front-line metastatic pancreatic cancer patients

• REC name

  London - Riverside Research Ethics Committee

• REC reference

  15/LO/1246

• Date of REC Opinion

  14 Aug 2015

• REC opinion

  Favourable Opinion