Gemcitabine +/− MK-1775 for Ovarian Cancer

Recruiting in Palo Alto (17 mi)

+17 other locations

Overseen ByAmit Oza, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Prior Safety Data

Approved in 4 jurisdictions

Trial Summary

What is the purpose of this trial?This randomized phase II clinical trial studies how well gemcitabine hydrochloride and WEE1 inhibitor MK-1775 work compared to gemcitabine hydrochloride alone in treating patients with ovarian, primary peritoneal, or fallopian tube cancer that has come back after a period of time. Gemcitabine hydrochloride may prevent tumor cells from multiplying by damaging their deoxyribonucleic acid (DNA, molecules that contain instructions for the proper development and functioning of cells), which in turn stops the tumor from growing. The protein WEE1 may help to repair the damaged tumor cells, so the tumor continues to grow. WEE1 inhibitor MK-1775 may block the WEE1 protein activity and may increase the effectiveness of gemcitabine hydrochloride by preventing the WEE1 protein from repairing damaged tumor cells without causing harm to normal cells. It is not yet known whether gemcitabine hydrochloride with or without WEE1 inhibitor MK-1775 may be an effective treatment for recurrent ovarian, primary peritoneal, or fallopian tube cancer.

Eligibility Criteria

This trial is for patients with recurrent ovarian, primary peritoneal, or fallopian tube cancer who are platinum-resistant or have platinum-refractory disease. They must have a life expectancy over 3 months, acceptable blood counts and organ function, and be able to tolerate oral medication without an active bowel obstruction. Women of childbearing potential must use contraception.

Inclusion Criteria

Patients must be able to tolerate oral medication and not have evidence of active bowel obstruction

Patients must have disease amenable to biopsy and must be willing to undergo a paired biopsy for correlative analyses (the first biopsy within 28 days prior to start of treatment and the second biopsy while on treatment)

You should be able to perform everyday activities without help.

Exclusion Criteria

You have received gemcitabine before for treating the same disease.

You are currently taking any other experimental medications.

If you have HIV and are taking multiple medications to treat it, you cannot participate.

Participant Groups

The study compares the effectiveness of gemcitabine hydrochloride alone versus combined with WEE1 inhibitor MK-1775 in treating certain cancers that have returned after treatment. The aim is to see if blocking WEE1 protein activity with MK-1775 enhances the impact of gemcitabine by preventing tumor cell repair.

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm I (WEE1 inhibitor MK-1775, gemcitabine hydrochloride)Experimental Treatment5 Interventions

Patients receive WEE1 inhibitor MK-1775 PO on days 1, 2, 8, 9, 15, and 16 and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Group II: Arm II (placebo, gemcitabine hydrochloride)Active Control5 Interventions

Patients receive placebo PO on days 1, 2, 8, 9, 15, and 16 and gemcitabine hydrochloride as patients in Arm I. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Gemcitabine Hydrochloride is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺 Approved in European Union as Gemzar for: