NCT03219554

A Phase II Study of Palbociclib for Recurrent or Refractory Advanced Thymic Epithelial Tumor

Samsung Medical Center

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 33 (estimated)
• Sponsor: Samsung Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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to receive Palbociclib until objective disease progression, symptomatic deterioration, unacceptable toxicity, death, or withdrawn of consent, whichever occurs first.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.

Conditions

• Thymic Cancer

Interventions

Type	Name	Description
DRUG	Palbociclib	oral palbociclib 125mg daily for 21days followed by a 7-day break. Cycle will be repeated every 28 days.

Timeline

• Start date: 2017-08-01
• Primary completion: 2019-12-01
• Completion: 2020-12-01
• First posted: 2017-07-17
• Last updated: 2017-08-02

Locations

1 site across 1 country: South Korea