A Study of Adavosertib as Treatment for Uterine Serous Carcinoma (NCT04590248) | Clinical Trial Compass
CompletedPhase 2
A Study of Adavosertib as Treatment for Uterine Serous Carcinoma
United States109 participantsStarted 2020-11-30
Plain-language summary
This Phase 2b study aims to evaluate the efficacy and safety of adavosertib, an inhibitor of the tyrosine kinase WEE1, in subjects with recurrent or persistent uterine serous carcinoma (USC) who have previously received at least 1 prior platinum-based chemotherapy regimen for the management of USC.
Who can participate
Age range18 Years – 130 Years
SexFEMALE
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Inclusion criteria
✓. Subjects must be aged ≥ 18 years of age inclusive, at the time of signing the informed consent.
✓. Histologically confirmed recurrent or persistent USC. Subjects with carcinosarcomas are not eligible.
✓. Evidence of measurable disease as per RECIST v1.1.
✓. At least 1 prior platinum-based chemotherapy regimen for the management of USC. Prior receipt of immune checkpoint inhibitors, vascular endothelial growth factor (VEGF) inhibitors and human epidermal growth factor receptor 2 (HER2) targeted therapy is allowed. There is no restriction on the number of prior lines of systemic therapy.
✓. Eastern Cooperative Oncology Group performance (ECOG) status 0-1.
✓. Life expectancy ≥ 12 weeks.
✓. Subjects must have normal organ and marrow function at baseline, within 7 days prior to study drug administration.
✓. Consent to submit and provide a mandatory Formalin-fixed paraffin-embedded tumor sample for central testing.
Exclusion criteria
✕. 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.
✕. 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.
✕. Spinal cord compression or metastases unless asymptomatic, stable, and not requiring steroids for at least 4 weeks prior to start of study intervention.
✕. Subjects with current signs or symptoms of bowel obstruction, including sub-occlusive disease, related to underlying disease.
✕. Any of the following cardiac diseases currently or within the last 6 months:
✕. History of Torsades de pointes unless all risk factors that contributed to Torsades have been corrected.
✕. a) Resting corrected QTc interval using the Fridericia formula (QTcF) \> 480 msec, or b) congenital long QT syndrome.