Adavosertib Before Surgery in Treating Patients With Advanced High Grade Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Adavosertib Before Surgery in Treating Patients With Advanced High Grade Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

PRIMARY OBJECTIVE:
I. To explore baseline levels and effects of adavosertib (AZD1775) on DNA copy number, mutation, and level of ribonucleic acid (RNA) and protein expression (together described as “molecular results”) in tumor protein p53 (p53)-related pathways before and after treatment in women with primary advanced high grade serous ovarian, fallopian tube, or primary peritoneal cancer.
SECONDARY OBJECTIVES:
I. To correlate molecular results to clinical endpoints including response and survival.
II. To correlate molecular results to pathologic endpoints including tumor volume and apoptosis.
III. To compare DNA copy number and level of RNA and protein expression in p53-related pathways in tissue from patients treated with AZD1775 to those untreated with AZD1775 in the preoperative period.
IV. To determine the toxicity of AZD1775 given preoperatively, with a focus on postoperative wound healing.
V. To determine the feasibility of treating preoperatively with AZD1775.
OUTLINE:
Patients receive adavosertib orally (PO) once daily (QD) on days 1-5. Patients then undergo standard of care laparoscopy. Patients may also receive adavosertib PO QD on days 8-12, 15-19, and 22-26 for up to 28 days based on surgery schedule.
After completion of study treatment, patients are followed up at 30 days and then every 3 months thereafter.

Source: View full study details on ClinicalTrials.gov

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January 5, 2023Comments OffClinicalTrials.gov | Endocrinology Clinical Trials | Endocrinology Studies | US National Library of Medicine
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