A Study of MK-1775 in Combination With Cisplatin and Radiation in Cervical Cancer

Official Title

Phase I Study of the Wee 1 Kinase (Wee 1) Inhibitor MK-1775 in Combination With Cisplatin and Radiation in Cervical Cancer

Summary:

This is a phase 1 study to find the best dose of a new investigational drug MK-1775 as well as to see how safe the drug is in combination with cisplatin and radiation in patients with cervical cancer. MK-1775 is a new drug which may block Wee1 protein activity. When given in combination with cisplatin and radiation therapy, 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 and radiation therapy.

Trial Description

Primary Outcome:

• Number of patients who experience dose limiting toxicity

Secondary Outcome:

• Number of and severity of side effects
• Duration of progression free survival per patient

This study will be done in two parts. The first part, called the Dose Escalation Phase, will initially have two different groups or "cohorts":

• Cohort 1: MK-1775 will be given twice daily on the day of the cisplatin (chemotherapy) administration and the day after;

• Cohort 2: MK-1775 will be given twice daily at the end of each week of treatment, for 2 or 3 days.

These cohorts will help determine the safety of MK-1775 and the effects on the cancer cells when given at different schedules; with chemotherapy at the same time as radiation therapy (Cohort 1) or when given with radiation therapy (Cohort 2). 
 At the beginning of the study, 3 to 6 patients will be treated with a low dose of MK-1775 in each of the cohorts. If these doses do not cause bad side effects, the doses of drug will slowly be increased as new patients take part in the study. When the highest dose is reached, if it does not cause bad side effects, three patients will take part in a third cohort: 

Cohort 3: MK-1775 will be given twice daily for 5 days each week (from Monday to Friday) 

Once the highest dose of MK-1775 that can be given to patients without causing side effects that are too severe is found, another group of patients will be asked to take part in the study to further test the safety and effectiveness of this dose in the second phase called the Dose Expansion Phase.

View this trial on ClinicalTrials.gov