Thymic Cancer Clinical Trial
Official title:
Samsung Medical Center
This is a phase II single center, open-label, single arm study of palbociclib treatment in patients with recurrent or metastatic advanced TETs after failure of one or more cytotoxic chemotherapy regimens. Patients will receive oral palbociclib 125mg daily for 21days followed by a 7-day break. Cycle will be repeated every 28 days.
Patients will continue to receive Palbociclib until objective disease progression,
symptomatic deterioration, unacceptable toxicity, death, or withdrawn of consent, whichever
occurs first.
Disease assessments will be performed every 8 weeks (±7 days) from the date of initiation of
treatment. Each assessment will be performed as scheduled according to the calendar
regardless of any dosing delay to prevent the introduction of bias into the assessment of
efficacy. Tumor assessments will be performed until radiographically and/or clinically (ie,
for photographed or palpable lesions) documented progressive disease (PD) as per RECIST
v.1.1, initiation of new anticancer therapy, or discontinuation of patient from overall study
participation (eg, death, patient's request, lost to follow-up), whichever occurs first.
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