Back to resultsA Phase II Study of Palbociclib for Recurrent or Refractory Advanced Thymic Epithelial Tumor
Primary Purpose
Thymic Cancer
Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Palbociclib
Sponsored by
About this trial
This is an interventional treatment trial for Thymic Cancer
Eligibility Criteria
Inclusion Criteria:
- Histologically proven thymic epithelial tumor (TET) patients
- Be ≥18 years of age on day of signing informed consent.
- Documented progressive disease according to RECIST v1.1 following receipt of at least one cytotoxic chemotherapy regimen administered for inoperable or metastatic disease.
- Measurable disease as defined per RECIST v 1.1. Tumor lesions previously irradiated or subjected to other locoregional therapy will only be deemed measurable if disease progression at the treated sited after completion of therapy is clearly documented.
- Availability of a tumor tissue specimen (ie, archived formalin fixed paraffin embedded tissue [block preferred, or 10 unstained slides]), which will be used for retrospective biomarker analysis. If archived tumor tissue is not available, then a de novo biopsy will be required for patient participation.
- ECOG performance status of 0 to 2
Exclusion Criteria:
- Known active uncontrolled or symptomatic central nervous system (CNS) metastases, carcinomatous meningitis, or leptomeningeal disease as indicated by clinical symptoms, cerebral edema, and/or progressive growth. Patients with a history of CNS metastases or cord compression are eligible if they have been definitively treated with local therapy (eg, radiotherapy, stereotactic surgery) and are clinically stable off anticonvulsants and steroids for at least 4 weeks before randomization.
- Inability to swallow capsules.
- Prior treatment with any CDK4/6 inhibitor.
Sites / Locations
- Samsung Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
palbociclib
Arm Description
oral palbociclib 125mg daily for 21days followed by a 7-day break. Cycle will be repeated every 28 days.
Outcomes
Primary Outcome Measures
Progression-free survival ( PFS)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03219554
Brief Title
A Phase II Study of Palbociclib for Recurrent or Refractory Advanced Thymic Epithelial Tumor
Official Title
Samsung Medical Center
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Unknown status
Study Start Date
August 2017 (Anticipated)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thymic Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
33 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
palbociclib
Arm Type
Experimental
Arm Description
oral palbociclib 125mg daily for 21days followed by a 7-day break. Cycle will be repeated every 28 days.
Intervention Type
Drug
Intervention Name(s)
Palbociclib
Intervention Description
oral palbociclib 125mg daily for 21days followed by a 7-day break. Cycle will be repeated every 28 days.
Primary Outcome Measure Information:
Title
Progression-free survival ( PFS)
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically proven thymic epithelial tumor (TET) patients
Be ≥18 years of age on day of signing informed consent.
Documented progressive disease according to RECIST v1.1 following receipt of at least one cytotoxic chemotherapy regimen administered for inoperable or metastatic disease.
Measurable disease as defined per RECIST v 1.1. Tumor lesions previously irradiated or subjected to other locoregional therapy will only be deemed measurable if disease progression at the treated sited after completion of therapy is clearly documented.
Availability of a tumor tissue specimen (ie, archived formalin fixed paraffin embedded tissue [block preferred, or 10 unstained slides]), which will be used for retrospective biomarker analysis. If archived tumor tissue is not available, then a de novo biopsy will be required for patient participation.
ECOG performance status of 0 to 2
Exclusion Criteria:
Known active uncontrolled or symptomatic central nervous system (CNS) metastases, carcinomatous meningitis, or leptomeningeal disease as indicated by clinical symptoms, cerebral edema, and/or progressive growth. Patients with a history of CNS metastases or cord compression are eligible if they have been definitively treated with local therapy (eg, radiotherapy, stereotactic surgery) and are clinically stable off anticonvulsants and steroids for at least 4 weeks before randomization.
Inability to swallow capsules.
Prior treatment with any CDK4/6 inhibitor.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
myung-ju ahn, M.D. Ph.D
Phone
82-2-3410-3459
Email
silk.ahn@samsung.com
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
A Phase II Study of Palbociclib for Recurrent or Refractory Advanced Thymic Epithelial Tumor
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