Trials / Active Not Recruiting

Active Not RecruitingNCT02659241

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

A Pilot Study of Wee1 Inhibition Induction Prior to Tumor Reductive Surgery in Ovarian Cancer

Status: Active Not Recruiting
Phase: EARLY_Phase 1
Study type: Interventional
Enrollment: 38 (actual)

Sponsor: M.D. Anderson Cancer Center · Academic / Other
Sex: Female
Age: 18 Years
Healthy volunteers: Not accepted

Summary

This pilot early phase I trial studies how adavosertib affects the tumor deoxyribonucleic acid (DNA) of patients undergoing surgery for high grade (fast growing or aggressive) ovarian, fallopian tube, or primary peritoneal cancer that has spread to other places in the body (advanced). Certain characteristics in the DNA of these patients may affect how well they respond to treatment. Learning how adavosertib affects DNA in tumor cells may help doctors plan effective treatment.

Detailed description

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.

Conditions

Interventions

Type	Name	Description
DRUG	Adavosertib	Given PO
OTHER	Laboratory Biomarker Analysis	Correlative studies

Timeline

Start date: 2016-02-04
Primary completion: 2026-12-31
Completion: 2026-12-31
First posted: 2016-01-20
Last updated: 2026-04-15

Locations

8 sites across 1 country: United States

Regulatory

FDA-regulated drug study

Source: ClinicalTrials.gov record NCT02659241. Inclusion in this directory is not an endorsement.