AMG 319 in HPV Positive and Negative HNSCC
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|ClinicalTrials.gov Identifier: NCT02540928|
Recruitment Status : Recruiting
First Posted : September 4, 2015
Last Update Posted : January 8, 2018
|Condition or disease||Intervention/treatment||Phase|
|Human Papillomavirus (HPV) Positive or Negative Head and Neck Squamous Cell Carcinoma (HNSCC) of the Hypopharynx, Oropharynx, Oral Cavity, Supraglottis or Larynx||Drug: AMG 319 hydrate Drug: Placebo||Phase 2|
Cancers use 'defence mechanisms' to hide from the immune system and teach the immune system not to destroy cancer cells. AMG 319 works by blocking these defence mechanisms in the tumour. It targets and blocks an important protein called PI3K delta.
In the laboratory this leads to removal of a group of inhibitory immune cells. Releasing the immune brakes leads to immune attack and destruction of cancer cells.
AMG 319 looks promising in laboratory studies and in a very early study in a small number of patients with leukaemia and we now wish to find out if it will be useful in treating patients with head and neck cancer.
This study is a randomised, doubleblind, placebo controlled Phase II trial looking at the effects of giving AMG 319 to patients with either human papilloma virus (HPV) positive or negative head and neck cancer squamous cell carcinoma (HNSCC). We propose to treat patients prior to resection surgery so that we can study the effect of AMG 319 on the cancer in fine detail.
Approximately 54 patients with HPV positive or negative HNSCC of the hypopharynx, oropharynx, oral cavity, supraglottis or larynx will be entered into the study. Patients will be randomly assigned to one of two treatment groups and will receive between 20 and 29 days of oral dosing with AMG 319 or placebo immediately before resection surgery.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||54 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Cancer Research UK Randomised, Double Blind, Placebo Controlled Phase IIa Trial of AMG 319 Given Orally as a Neoadjuvant Therapy in Patients With Human Papillomavirus (HPV) Positive and Negative Head and Neck Squamous Cell Carcinoma (HNSCC)|
|Study Start Date :||October 2015|
|Estimated Primary Completion Date :||October 2020|
|Estimated Study Completion Date :||October 2020|
Experimental: AMG 319 Hydrate
Up to 36 patients will be randomised into the Active Treatment arm to receive AMG 319 400 mg once daily administered orally for a minimum of 20 days and a maximum of 29 days prior to resection surgery
|Drug: AMG 319 hydrate|
Placebo Comparator: Placebo
Up to 18 patients will be randomised into the Placebo arm to receive Placebo once daily administered orally for a minimum of 20 days and a maximum of 29 days prior to resection surgery
- Changes in CD8+ effector T cell numbers in tumour tissue [ Time Frame: Screening and Surgery ]
- Treatment emergent adverse events [ Time Frame: Assessed until 60 days after a patients last dose ]
- Steady State AMG 319 concentration in blood [ Time Frame: Days 8, 15 pre dose & Day 22 ]
- Changes in tumour size [ Time Frame: Screening and Pre-surgery ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02540928
|Contact: Louisa Essame||Louisa.Essame@cancer.org.uk|
|Aintree University Hospital - Clatterbridge Cancer Centre||Recruiting|
|Liverpool, United Kingdom, CH63 4JY|
|Principal Investigator: Terry Jones, Prof|
|Churchill Hospital, Blenheim H&N Unit||Recruiting|
|Oxford, United Kingdom, OX3 7LE|
|Principal Investigator: Stuart Winter, Dr|
|Poole, United Kingdom, BH15 2JB|
|Contact: Contact Person|
|Principal Investigator: Emma King, Dr|
|Queen Alexandra Hospital, Department of Oral and Maxillofacial Surgery||Recruiting|
|Portsmouth, United Kingdom, PO6 3LY|
|Principal Investigator: Peter Brennan, Dr|
|Southampton General Hospital||Recruiting|
|Southampton, United Kingdom, SO16 6YD|
|Principal Investigator: Christian Ottensmeier, Prof|