KCT0003820
Recruiting
未知
A phase II study of palbociclib for recurrent or refractory advanced thymic epithelial tumor
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Samsung Medical Center
- Enrollment
- 33
- Status
- Recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
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
- •7\.Adequate organ function as evidence by the following;
- •Absolute neutrophil count \= 1\.5 x 109/L
- •Platelets \> 75 x 109/L
- •Hemoglobin (Hb) \= 9g/dL
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.
- •4\.Patients treated within the last 7 days prior to administration of palbociclib with:
- •Food or drugs that are known to be strong CYP (cytochrome P\-450\) 3A4 inhibitors (ie, amprenavir, atazanavir, boceprevir, clarithromycin, conivaptan, delavirdine, diltiazem, erythromycin, fosamprenavir, indinavir, itraconazole, ketoconazole, lopinavir, mibefradil, miconazole, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, verapamil, voriconazole, and grapefruit or grapefruit juice)
- •Drugs that are known to be strong CYP3A4 inducers (ie, carbamazepine, felbamate, nevirapine, phenobarbital, phenytoin, primidone, rifabutin, rifampin, rifapentin, and St. John’s wort)
- •Drugs that are known to prolong the QT interval
- •5\.Major surgery, chemotherapy, radiotherapy, any investigational agents, or other anti\-cancer therapy within 2 week before administration of palbociclib.
- •6\.Diagnosis of any other malignancy within 3 years prior to administration of palbociclib, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix.
- •7\.QTc \> 480msec (based on the mean value of the triplicate electrocardiograms (ECGs), family or personal history of long or short QT syndrome, Brugada syndrome or known history of QTc prolongation, or Torsade de Pointes.
Outcomes
Primary Outcomes
Not specified
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