A Phase 2 interventional study of Palbociclib in Thymic Cancer, sponsored by Samsung Medical Center. Status unknown at 1 site in South Korea. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-08-02.
Sponsored by Samsung Medical Center · Phase 2, Interventional, and Treatment
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to receive Palbociclib until objective disease progression, symptomatic deterioration, unacceptable toxicity, death, or withdrawn of consent, whichever occurs first.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.
91 studies on the registry are indexed under Thymus Neoplasms; 22 are open to participants now.
This study's planned enrollment of 33 is below the median of 40 across 67 interventional studies indexed under Thymus Neoplasms.
Browse Thymus Neoplasms studies →Samsung Medical Center is the lead sponsor of 1,005 studies on the registry; 148 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.
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Exclusion Criteria:
oral palbociclib 125mg daily for 21days followed by a 7-day break. Cycle will be repeated every 28 days.
Drug: Palbociclib
oral palbociclib 125mg daily for 21days followed by a 7-day break. Cycle will be repeated every 28 days.
Progression-free survival ( PFS)
Time frame: 6 months
This study is status unknown, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Palbociclib