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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
87
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
Cetuximab 400 mg/mg/m\^2 IV loading dose, followed by 250 mg/m\^2 weekly
Cisplatin at 100 mg/m\^2 IV infused over 1 hour, every three weeks up to a maximum of 6 cycles
Carboplatin IV over 30 to 60 minutes, every 3 weeks for a maximum of 6 cycles
Placebo to match patritumab
Institut Jules Bordet
Brussels, Belgium
Univeristair Ziekenhuis Antwerpen
Edegem, Belgium
UZ Leuven
Leuven, Belgium
Institut Curie
Paris, Cedex, France
Institut de Cancerologie de l'Ouest
Angers, France
Centre Hospitalier de Bordeaux - Hôpital Saint André
Progression Free Survival (PFS) in the Heregulin (HRG)-High Expression Population
PFS is defined as the time from the date of randomization to the date of the first radiographic disease progression or death due to any cause, whichever comes first. Median PFS is from Kaplan-Meier analysis. Confidence interval (CI) for median was computed using Brookmeyer-Crowley method.
Time frame: from Day 0 to end of active study (study termination) - within 12 months
Median Overall Survival
Overall survival (OS) is defined as the time from the date of randomization to death due to any cause
Time frame: at approximately 25 months
Percentage of Participants With Best Overall Response
Best overall response rate (ORR) is defined as the percentage of participants with Complete Response (CR) or Partial Response (PR)
Time frame: at approximately 22 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Bordeaux, France
Hopital Croix-Rousse
Lyon, France
Centre Leon Berard
Lyon, France
CHU Hopital de la Timone
Marseille, France
Hopital Saint Joseph
Marseille, France
...and 24 more locations