Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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to receive Palbociclib until objective disease progression, symptomatic deterioration, unacceptable toxicity, death, or withdrawn of consent, whichever occurs first.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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| palbociclib | Experimental | oral palbociclib 125mg daily for 21days followed by a 7-day break. Cycle will be repeated every 28 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Palbociclib | Drug | oral palbociclib 125mg daily for 21days followed by a 7-day break. Cycle will be repeated every 28 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival ( PFS) | 6 months |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| myung-ju ahn, M.D. Ph.D | Contact | 82-2-3410-3459 | silk.ahn@samsung.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Seoul | 135-710 | South Korea |
Not provided
| ID | Term |
|---|---|
| D013953 | Thymus Neoplasms |
| ID | Term |
|---|---|
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008206 | Lymphatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C500026 | palbociclib |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| D006425 |
| Hemic and Lymphatic Diseases |