An open label study of NKTR-102 on participants with Breast Cancer

• Research type

  Research Study

• Full title

  A Multicenter, Open-Label, Phase 2 Study to Evaluate the Safety and Efficacy of NKTR-102 (PEG-Irinotecan) When Given on a Q14 Day or a Q21 Day Schedule in Patients with Metastatic Breast Cancer Whose Disease has Failed prior Taxane-Based Treatment

• IRAS ID

  9895

• Sponsor organisation

  Nektar Therapeutics

• Eudract number

  2008-005577-36

• Research summary

  This is a multicenter, open label, two-arm, phase 2 study of experimental drug called NKTR-102 in patients with metastatic or locally advanced Breast Cancer who??s Disease has Failed Prior Taxane-Based Treatment.NKTR-102 is a form of irinotecan (or Camptosar©). Irinotecan is approved in the U.S., Japan, Australia, Canada and other countries in Europe and around the world for treatment of colorectal cancer, and has been used for many years.This study is being done to see if NKTR-102 is safe and effective in treating patients with breast cancer. This study will also look at how your cancer responds to the study drug. It will look at the side effects of the study drug, and it will examine how long the study drug stays in your blood.Up to 70 patients will take part in this multinational study. The study will take place at about 20 study centres. During the study the participants will be assigned to one of two treatment arms randomly (like the flip of a coin). In either treatment arm, they will receive the same dose of study drug (170 mg/m2). The difference in the two treatment arms is how often they will receive the study drug.In Treatment Arm A, the participant will receive the study drug once every 14 days.In Treatment Arm B, the participant will receive the study drug once every 21 days.The study is planned to last for about 2 years. How long the participant remains in this study depends on any possible side effects they may have to the study drug. It also depends on how well their cancer responds to the study drug.

• REC name

  Scotland A REC

• REC reference

  08/MRE00/107

• Date of REC Opinion

  2 Mar 2009

• REC opinion

  Further Information Favourable Opinion