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Spots Global Cancer Trial Database for A Study of MLN0264 in Patients With Pancreatic Cancer

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Trial Identification

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

Interventions

MLN0264

Study Description

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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

, 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

Contact Details

Name: Medical Director Clinical Science

Affiliation: Millennium Pharmaceuticals, Inc.

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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