Gemcitabine Hydrochloride With or Without WEE1 Inhibitor MK-1775 in Treating Patients With Recurrent Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
| Condition | Ovarian Brenner Tumor, Ovarian Clear Cell Cystadenocarcinoma, Ovarian Endometrioid Adenocarcinoma, Ovarian Malignant Mixed Mesodermal Tumor |
|---|---|
| Phase | Phase 2 |
| Sponsor | National Cancer Institute (NCI) |
| Status | Active, not recruiting |
| Enrollment | 124 participants |
| Interventions | Adavosertib, Gemcitabine Hydrochloride, Laboratory Biomarker Analysis, Pharmacological Study, Placebo Administration |
| Start date | Jul 21, 2014 |
| Completion date | Feb 3, 2022 |
| Results posted | Sep 8, 2023 |
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.
Progression Free Survival
| Arm I (WEE1 Inhibitor AZD1775, Gemcitabine Hydrochloride) | 4.6 months |
|---|---|
| Arm II (Placebo, Gemcitabine Hydrochloride) | 3.0 months |
| Arm III (Exploratory WEE1 Inhibitor AZD1775, Gemcitabine) | 5.3 months |
Open in BENITIONS View on ClinicalTrials.gov
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- Comparison of Standard of Care Treatment With a Triplet Combination of Targeted Immunother — National Cancer Institute (NCI)
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