A Study Comparing AZD-1775 (MK-1775) and Gemcitabine With Gemcitabine Alone in Ovarian, Peritoneal or Fallopian Tube Cancers

Official Title

A Randomized Placebo-Controlled Phase II Trial Comparing Gemcitabine Monotherapy to Gemcitabine in Combination With AZD1775 (MK1775) in Women With Recurrent, Platinum Resistant Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancers

Summary:

This is a phase 2 (the second phase in testing a new drug or drug combination, to see how useful the drug or combination is) of chemotherapy drug, gemcitabine, when given alone or in combination with investigational drug, AZD 1775 (also called MK-1775), in patients with recurrent (the cancer has returned), platinum-resistant (the cancer does not respond to platinum-based therapies) ovarian, peritoneal or fallopian tube cancers. Gemcitabine is a chemotherapy drug commonly used to treat patients with recurrent, platinumresistant ovarian, peritoneal or fallopian tube cancers. Gemcitabine works by preventing 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. AZD 1775 (MK-1775) is a new drug which may block Wee1 protein activity. When given in combination with gemcitabine, AZD 1775 (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 gemcitabine.

Trial Description

Primary Outcome:

• Progression free survival (in months) of gemcitabine and AZD 1775 (MK 1775) compared to gemcitabine alone

• Change in tumour size (in millimeters) of gemcitabine and AZD 1775 (MK 1775) compared to gemcitabine alone
• Change in levels of CA125 of gemcitabine and AZD 1775 (MK 1775) compared to gemcitabine alone
• Overall survival (in months) of gemcitabine and AZD 1775 (MK 1775) compared to gemcitabine alone
• Total incidence of adverse events by event and rate
• Number of TP53 mutations compared to response to treatment
• Levels of p53 protein compared to response to treatment

View this trial on ClinicalTrials.gov