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

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ClinicalTrials.gov Identifier: NCT03219554
Recruitment Status : Not yet recruiting
First Posted : July 17, 2017
Last Update Posted : August 2, 2017
Sponsor:
Information provided by (Responsible Party):
Myung-Ju Ahn, Samsung Medical Center

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.

Condition or disease Intervention/treatment Phase
Thymic Cancer Drug: Palbociclib Phase 2

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receive Palbociclib until objective disease progression, symptomatic deterioration, unacceptable toxicity, death, or withdrawn of consent, whichever occurs first.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


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 33 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Samsung Medical Center
Estimated Study Start Date : August 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Palbociclib

Arm Intervention/treatment
Experimental: palbociclib
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.




Primary Outcome Measures :
  1. Progression-free survival ( PFS) [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Histologically proven thymic epithelial tumor (TET) patients
  2. Be ≥18 years of age on day of signing informed consent.
  3. Documented progressive disease according to RECIST v1.1 following receipt of at least one cytotoxic chemotherapy regimen administered for inoperable or metastatic disease.
  4. 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.
  5. 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.
  6. ECOG performance status of 0 to 2

Exclusion Criteria:

  1. 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.
  2. Inability to swallow capsules.
  3. Prior treatment with any CDK4/6 inhibitor.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03219554


Contacts
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Contact: myung-ju ahn, M.D. Ph.D 82-2-3410-3459 silk.ahn@samsung.com

Locations
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Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Sponsors and Collaborators
Samsung Medical Center

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Responsible Party: Myung-Ju Ahn, MD,PhD,Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT03219554     History of Changes
Other Study ID Numbers: 2016-12-006
First Posted: July 17, 2017    Key Record Dates
Last Update Posted: August 2, 2017
Last Verified: August 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Thymus Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lymphatic Diseases
Palbociclib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action