The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Brief Title: A Study of MLN0264 in Patients With Pancreatic Cancer
Official Title: A Phase 2 Trial of MLN0264 in Previously Treated Patients With Advanced or Metastatic Pancreatic Adenocarcinoma Expressing Guanylyl Cyclase C (GCC)
Study ID: NCT02202785
Brief Summary: The purpose of this study is to assess the efficacy, safety and tolerability of MLN0264 in patients with advanced or metastatic guanylyl cyclase C (GCC)-positive adenocarcinoma of the pancreas.
Detailed Description: The drug being tested in this study is called MLN0264. MLN0264 is being tested to treat tumors in people who have metastatic adenocarcinoma of the pancreas expressing guanylyl cyclase C (GCC). This study will assess tumor size reduction in patients who are administered MLN0264. The study will enroll 42 to 81 patients. All participants will be administered MLN0264 at 1.8 mg/kg as a single, 30-minute, intravenous (IV) infusion on Day 1 of each 3-week treatment cycle, followed by a rest period of 20 days. Participants will continue to receive MLN0264 for up to 1 year or until disease progression or unacceptable toxicity occurs. This multi-centre trial will be conducted worldwide. The overall time to participate in this study is approximately 19 months. Participants will make 3 to 6 visits to the clinic per treatment cycle, an end-of-treatment visit will occur 30 days after the last dose of study medication, and follow-up assessments will occur every 12 weeks until death or 6 months after the last patient completes treatment - whichever occurs first.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
, Aurora, Colorado, United States
, St. Petersburg, Florida, United States
, Tampa, Florida, United States
, Boston, Massachusetts, United States
, Cincinnati, Ohio, United States
, Nashville, Tennessee, United States
, San Antonio, Texas, United States
, Brugge, , Belgium
, Leuven, , Belgium
, Barcelona, , Spain
, Madrid, , Spain
, Malaga, , Spain
, Sevilla, , Spain
, London, Greater London, United Kingdom
, Manchester, Greater Manchester, United Kingdom
, Sutton, Surrey, United Kingdom
Name: Medical Director Clinical Science
Affiliation: Millennium Pharmaceuticals, Inc.
Role: STUDY_DIRECTOR