A Study of Cisplatin With or Without MK-1775 in Squamous Cell Cancer of the Head and Neck

Official Title

A Randomized Phase II Trial of Cisplatin With or Without Wee1 Kinase Inhibitor MK-1775 for First-line Treatment of Recurrent or Metastatic Squamous Cell Cancer of the Head and Neck (RM-SCCHN

Summary:

This is a phase 2 study to see how useful investigational drug MK-1775 in combination with cisplatin is compared to cisplatin alone in patients with recurrent or metastatic squamous cell carcinoma of the head and neck. Chemotherapy is toxic to tumour cells. It prevents the tumour cells from multiplying by damaging their DNA, which in turn stops the tumour from growing. However, a protein, called Wee1, may play a role in helping to repair damaged tumour cells, so that the tumour continues to grow. MK-1775 is a new drug which may block Wee1 protein activity. When given in combination with chemotherapy drug cisplatin, MK-1775 may help prevent the Wee1 protein from repairing damaged tumour cells without causing harm to normal cells. This is believed to increase the effectiveness of cisplatin.

Trial Description

Primary Outcome:

• Number of patients with a complete or partial response to treatment with cisplatin and MK-1775 compared to number of patients with a complete or partial response to treatment with cisplatin and MK-1775 placebo

Secondary Outcome:

• Number of patients without worsening of disease
• Number of adverse events occurring per adverse event
• Number of adverse events per severity grade (1-5)

Participants will be randomized (assigned by chance, like flipping a coin) into 2 groups: Arm 1

• Cisplatin and MK-1775 or Arm 2
• Cisplatin and MK-1775 placebo (inactive substance that looks the same as MK-1775). Participants will have a 50% chance of being assigned to either arm.

View this trial on ClinicalTrials.gov