Samsung Medical Center

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



Sponsors


Source

Samsung Medical Center

Oversight Info

Has Dmc

No

Is Fda Regulated Drug

No

Is Fda Regulated Device

No


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symptomatic deterioration, unacceptable toxicity, death, or withdrawn of consent, whichever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.

Overall Status

Not yet recruiting

Start Date

2017-08-01

Completion Date

2020-12-01

Primary Completion Date

2019-12-01

Phase

Phase 2

Study Type

Interventional

Primary Outcome

Measure

Time Frame

Progression-free survival ( PFS)
6 months

Enrollment

33

Condition


Intervention

Intervention Type

Drug

Intervention Name


Description

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

Arm Group Label

palbociclib


Eligibility

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.

Gender

All

Minimum Age

18 Years

Maximum Age

N/A

Healthy Volunteers

No


Overall Contact

Last Name

myung-ju ahn, M.D. Ph.D

Phone

82-2-3410-3459

Email

[email protected]


Location

Facility

Samsung Medical Center
Seoul 135-710 Korea, Republic of

Location Countries

Country

Korea, Republic of


Verification Date

2017-07-01

Lastchanged Date

2017-07-14

Firstreceived Date

2017-07-13

Responsible Party

Responsible Party Type

Principal Investigator

Investigator Affiliation

Samsung Medical Center

Investigator Full Name

Myung-Ju Ahn

Investigator Title

MD,PhD


Has Expanded Access

No

Condition Browse


Number Of Arms

1

Intervention Browse

Mesh Term

Palbociclib


Arm Group

Arm Group Label

palbociclib

Arm Group Type

Experimental

Description

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


Firstreceived Results Date

N/A

Firstreceived Results Disposition Date

N/A

Study Design Info

Intervention Model

Single Group Assignment

Primary Purpose

Treatment

Masking

No masking



ClinicalTrials.gov processed this data on July 17, 2017

Conditions

Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov, conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions

Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase

Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions that study is seeking to answer:

In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.



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