A phase II study of palbociclib for recurrent or refractory advanced thymic epithelial tumor(TET)
- Conditions
- Neoplasms
- Registration Number
- KCT0003820
- Lead Sponsor
- Samsung Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 33
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
• Estimated creatinine clearance = 40mL/min as calculated using the method standard for the institution
• Total serum bilirubin =1.5 X UNL
• AST and/or ALT < 5 X UNL
8.Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
9.Patients who are willing and able to comply with scheduled visit, treatment plan, laboratory test, and other study procedure.
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.
8.Uncontrolled electrolyte disorders that can compound the effects of a QTc-prolonging drug (eg, hypocalcemia, hypokalemia, hypomagnesemia).
9.Any of the following within 6 months of administration of palbociclib: myocardial infarction, severe/unstable angina, ongoing cardiac dysrhythmias of NCI CTCAE version 4.03 Grade >2, atrial fibrillation of any grade, symptomatic congestive heart failure, cerebrovascular accident, or symptomatic pulmonary embolism.
10.Active inflammatory bowel disease or chronic diarrhea, short bowel syndrome, or any upper gastrointestinal surgery including gastric resection that could impair drug absorption.
11.Known human immunodeficiency virus infection.
12.Other severe acute or chronic medical or psychiatric condition, including recent (within the past year) or active suicidal ideation or behavior, or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
13.Pregnant or nursing women. Male and female subjects of childbearing potential who are unwilling or unable to use two highly effective methods of contraception as outlined in this protocol for the duration of the study and for 6 months after the last dose of palbociclib.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression-free survival (PFS)
- Secondary Outcome Measures
Name Time Method Overall survival;Overall response rate