NCT02633800

Patritumab With Cetuximab and a Platinum Agent for Squamous Cell Carcinoma (Cancer) of the Head and Neck (SCCHN )

Randomized, Placebo-controlled, Double-blind Phase 2 Study of Patritumab (U3-1287) in Combination With Cetuximab Plus Platinum-based Therapy in First Line Setting in Subjects With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 87 (actual)
• Sponsor: Daiichi Sankyo · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will test an investigational study drug called patritumab. It is a 'randomized study' which means participants have an equal chance of being assigned to receive the experimental medication (patritumab) or a substance that looks like the experimental product, but is not (placebo). Patritumab may work when combined with other medications that are approved for the treatment of head and neck cancer. They are called cetuximab, cisplatin or carboplatin. All participants will receive the other medications approved for treatment of head and neck cancer, even if they do not receive the experimental product.

Detailed description

Main objective of the trial: The main objective of the trial is to evaluate progression-free survival (PFS) in the heregulin (HRG) high expression population from subjects treated with patritumab + cetuximab + platinum-based therapy compared to placebo + cetuximab + platinum-based therapy.

Conditions

• Head and Neck Neoplasms

Interventions

Type	Name	Description
DRUG	Patritumab	Patritumab initial loading dose is 18 mg/kg IV over 60 minutes followed by a maintenance dose of 9 mg/kg IV over 60 minutes (± 10 minutes) every three weeks
DRUG	Cetuximab	Cetuximab 400 mg/mg/m\^2 IV loading dose, followed by 250 mg/m\^2 weekly
DRUG	Cisplatin	Cisplatin at 100 mg/m\^2 IV infused over 1 hour, every three weeks up to a maximum of 6 cycles
DRUG	Carboplatin	Carboplatin IV over 30 to 60 minutes, every 3 weeks for a maximum of 6 cycles
DRUG	Placebo	Placebo to match patritumab

Timeline

• Start date: 2015-12-22
• Primary completion: 2018-01-11
• Completion: 2018-02-21
• First posted: 2015-12-17
• Last updated: 2019-01-07
• Results posted: 2019-01-07

Locations

34 sites across 7 countries: Belgium, France, Germany, Hungary, Poland, Romania, United Kingdom

Regulatory

• FDA-regulated drug study