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Brief Title: Patritumab With Cetuximab and a Platinum Containing Therapy for Patients With Head and Neck Cancer
Official Title: An Open Label, Phase 1B Safety Evaluation of Patritumab (U31287) in Combination With Cetuximab Plus Platinum Containing Therapy In Subjects With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
Study ID: NCT02350712
Brief Summary: The purpose of this study is to test a study drug called patritumab. Patritumab may work when combined with other medications that are approved in the UK for treating Squamous Cell Carcinoma of the Head and Neck (SCCHN), called cetuximab, cisplatin or carboplatin. It is hoped that patritumab may have some benefit in treating patients with cancer. This study will help identify how much patritumab can be given in combination with cetuximab, and cisplatin or carboplatin. This study will show how safe and how well tolerated patritumab is when these medications are given together.
Detailed Description: The trial will be performed in two "phases" (Periods): Period 1: Initial phase in which the recommended phase 2 dose (RP2D) is determined Period 2: Extension phase in which participants who are deriving benefit (stable disease or better) will have the opportunity to continue treatment at the discretion of the Investigator
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
The Royal Marsden Hospital, Sutton, Surrey, United Kingdom
University College London Hospital, London, , United Kingdom
The Royal Marsden Hospital, London, , United Kingdom
Name: Global Team Leader
Affiliation: Daiichi Sankyo
Role: STUDY_DIRECTOR