A study of Adavosertib as Treatment for Uterine Serous Carcinoma - ADAGIO

Exclusion Criteria

• 1) Any underlying medical condition and uncontrolled intercurrent illness that would impair the ability of the subject to receive study treatment, as judged by the investigator.
• 2) With the exception of alopecia, any unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 at the time of starting study treatment.
• 3) Unable to swallow oral medications.
• 4) Spinal cord compression or metastases unless asymptomatic, stable, and not requiring steroids for at least 4 weeks prior to start of study intervention.
• 5) Subjects with current signs or symptoms of bowel obstruction, including sub-occlusive disease, related to underlying disease.
• 6) Any of the following cardiac diseases currently or within the last 6 months:
• • Unstable angina pectoris
• • Acute myocardial infarction
• • Congestive heart failure
• • Conduction abnormality not controlled with pacemaker or medication
• • Significant ventricular or supraventricular arrhythmias
• 7) History of Torsades de pointes unless all risk factors that contributed to Torsades have been corrected.
• 8) a) Resting corrected QTc interval using the Fridericia formula (QTcF) > 480 msec, or b) congenital long QT syndrome.
• 9) Immunocompromised subjects.
• 10) Subjects with known active hepatitis (ie, hepatitis B or C).
• 11) Prior treatment with any of the following:
• • Cell cycle checkpoint inhibitor.
• • Anticancer treatment drug ≤ 21 days (≤ 6 weeks for nitrosoureas or mitomycin C) or use of an investigational product within 5 half-lives prior to the first dose of adavosertib. For Programmed cell death-1 receptor (PD-1) /Programmed death-ligand 1 (PD-L1) inhibitors, a minimum of 28 days since last dose is required.
• • Prescription or non-prescription drugs known as moderate to strong inhibitors / inducers of CYP3A4 within 2 weeks prior to the first dose of study treatment.
• • Herbal medications 7 days prior to first dose of study treatment.
• 12) Palliative radiotherapy with a limited field of radiation within 2 weeks or with wide field of radiation within 4 weeks prior to the first dose of study intervention.
• 13) Major surgical procedures ≤ 28 days, or minor surgical procedures ≤ 7 days, prior to beginning study.
• 14) Subjects with a known hypersensitivity or contraindication to adavosertib or any of the excipients of the product.
• 15) Currently pregnant or breast-feeding.