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

NCT03219554 | Unknown Phase 2

• 1 other identifier: 2016-12-006
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Thymic Cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free survival ( PFS)

  6 months

Study Arms (1)

palbociclib

EXPERIMENTAL

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

Drug: Palbociclib

Interventions

Palbociclib DRUG

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

palbociclib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

Location

MeSH Terms

Conditions

Thymus Neoplasms

Interventions

palbociclib

Condition Hierarchy (Ancestors)

Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lymphatic Diseases; Hemic and Lymphatic Diseases

Central Study Contacts

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

CONTACT

82-2-3410-3459; silk.ahn@samsung.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD,PhD,Professor

Study Record Dates

• First Submitted: July 13, 2017
• First Posted: July 17, 2017
• Study Start: August 1, 2017
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2020
• Last Updated: August 2, 2017

Record last verified: 2017-08

Locations

KR (1)