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ACTIVE NOT RECRUITING
NCT02101775
PHASE2

Gemcitabine Hydrochloride With or Without WEE1 Inhibitor MK-1775 in Treating Patients With Recurrent Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

Sponsor: National Cancer Institute (NCI)

View on ClinicalTrials.gov

Summary

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.

Official title: A Randomized Placebo-Controlled Phase II Trial Comparing Gemcitabine Monotherapy to Gemcitabine in Combination With AZD 1775 (MK 1775) in Women With Recurrent, Platinum Resistant Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

124

Start Date

2014-07-21

Completion Date

2027-03-06

Last Updated

2026-04-09

Healthy Volunteers

No

Interventions

DRUG

Adavosertib

Given PO

DRUG

Gemcitabine Hydrochloride

Given IV

OTHER

Laboratory Biomarker Analysis

Correlative studies

OTHER

Pharmacological Study

Correlative studies

OTHER

Placebo Administration

Given PO

OTHER

Questionnaire Administration

Ancillary studies

Locations (16)

City of Hope Comprehensive Cancer Center

Duarte, California, United States

City of Hope South Pasadena

South Pasadena, California, United States

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, United States

Decatur Memorial Hospital

Decatur, Illinois, United States

Indiana University/Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, United States

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

University of Pittsburgh Cancer Institute (UPCI)

Pittsburgh, Pennsylvania, United States

BCCA-Cancer Centre for the Southern Interior

Kelowna, British Columbia, Canada

BCCA-Vancouver Cancer Centre

Vancouver, British Columbia, Canada

London Regional Cancer Program

London, Ontario, Canada

Ottawa Hospital and Cancer Center-General Campus

Ottawa, Ontario, Canada

University Health Network Princess Margaret Cancer Center P2C

Toronto, Ontario, Canada

University Health Network-Princess Margaret Hospital

Toronto, Ontario, Canada

CHUM - Centre Hospitalier de l'Universite de Montreal

Montreal, Quebec, Canada

National University Hospital Singapore

Singapore, Singapore