B3 thimoma or thymic carcinoma MedDRA version: 20.0 Level: PT Classification code 10043670 Term: Thymoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: SUTENT - 50 MG CAPSULE 30 CAPSULE
Product Name: SUTENT
Product Code: [NA]
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: SUNITINIB MALEATO
CAS Number: 341031-54-7
Current Sponsor
Sponsors
FONDAZIONE IRCCS "ISTITUTO NAZIONALE DEI TUMORI"
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Signed and dated IRB/IEC-approved Informed Consent 2.Histological diagnosis of invasive recurrent or metastatic type B3 thymoma or thymic carcinoma. In case of presence of both histologies it will be classified based on the predominantly part. B2 thymoma with areas of B3 thymoma are eligible. 3.Patients must have had at least one prior platinum-containing chemotherapy regimen. There is no limit to the number of prior chemotherapy regimens or targeted agents received. Progressive disease should have been documented before entry into the study 4.Patients must have measurable disease, defined as at least one lesion that can be accurately measured according with RECIST 1.1 criteria 5.Availability of archival tissue (paraffine block or at least 10 unstained slides) 6.Patients must have recovered from toxicity related to prior therapy to at least grade 1 (defined by v.CTCAE 4.0) 7.Patients must not have had major surgery, radiation therapy, chemotherapy, biologic therapy (including any investigational agents), or hormonal therapy (other than replacement), within 4 weeks prior to entering the study 8.Age > 18 years 9.Life expectancy > 3 months 10.Performance status (ECOG) = 2 11.Negative pregnancy test (if female in reproductive years) 12.Patients must have adequate organ and marrow function (as defined below). Patients must have returned to baseline or grade 1 from any acute toxicity related to prior therapy: •Absolute neutrophil count = 1,500/mm •Hemoglobin = 9 g/dL •Platelets = 100,000/mm •Total bilirubin = 1.5 x institutional upper limit of normal (ULN) , except for patients affected by Gilbert’s syndrome •AST(SGOT)/ALT(SGPT) = 3 x institutional ULN (5x if LFT elevations due to liver metastases) •Creatinine = 1.5 x institutional ULN 13. Women of childbearing potential (WOCBP) must agree to follow instructions for method(s) of contraception before study entry, for all the duration of the study and for at least 8 weeks after the last dose of investigational drug (30 days for an ovarian cycle turnover plus the time required for the active metabolite of sunitinib to undergo five half-lives). 14. Males who are sexually active with WOCBP must agree to follow instructions for method(s) of before study entry, for all the duration of the study and for at least 16 weeks after the last dose of investigational drug (90 days for sperm turnover plus the time required for the active metabolite of sunitinib to undergo five half-lives) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 35 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 21
Exclusion criteria
Exclusion criteria: 1. Patients with symptomatic brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. However, patients who have had treatment for their brain metastases and whose brain metastatic disease status has remained stable for at least 3 months without steroids may be enrolled at the discretion of the investigator. 2. Major surgery, other than diagnostic surgery, within 4 weeks prior to treatment 3. Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy 4. Pregnant or breast feeding women 5. Previous (within the last 5 years) or current malignancies at other sites, except for adequately treated basal cell or squamous cell skin cancer or in situ carcinoma of the cervix uteri 6. Current enrollment in or participation in another therapeutic clinical trial within 4 weeks before treatment start. 7. Patients with uncontrolled or significant cardiovascular disease (AMI within 12 months, unstable angina within 6 months, NYHA Class III, IV Congestive heart failure or left ventricular ejection fraction below local institutional lower limit of normal or below 45%, 8. Ongoing symptomatic cardiac dysrhythmias, uncontrolled atrial fibrillation, or prolongation of the Fridericia corrected QT (QTcF) interval defined as > 450 msec for males and > 470 msec for females, where QTcF = QT / 3vRR 9. Poorly controlled hypertension 10. History of cerebrovascular accident including transient ischemic attack within the past 12 months. 11. History of deep vein thrombosis (DVT) unless adequately treated with low molecular weight heparin 12. History of pulmonary embolism within the past 6 months unless stable, asymptomatic, and treated with low molecular weight heparin for at least 6 weeks. 13. Evidence of active bleeding or bleeding susceptibility; or medically significant hemorrhage within prior 30 days. 14. Receiving concomitant CYP3A4 inducers or strong CYP3A4 inhibitors 15. Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of sunitinib 16. Known HIV infection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the activity of Sunitinib in subjects with advanced or recurrent type B3 thymoma or thymic carcinoma previously treated with platinum-based chemotherapy by the determination of best tumour response (CR + PR) at any point.;Secondary Objective: To assess the progression free survival and overall survival; To assess the duration of activity of sunitinib (CR+PR+SD); To assess the safety and toxicity profile of sunitinib in recurrent and/or metastatic B3 thymoma or thymic carcinoma; Incidence of adverse events (AEs).;Primary end point(s): To evaluate the activity of Sunitinib in subjects with advanced or recurrent type B3 thymoma or thymic carcinoma previously treated with platinum-based chemotherapy by the determination of best tumour response (CR + PR) at any point.;Timepoint(s) of evaluation of this end point: Four years | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): To assess the progression free survival (PFS); To assess the duration of activity of sunitinib (CR+PR+SD).; To assess the overall survival (OS); To assess the safety and toxicity profile of sunitinib in recurrent and/or metastatic B3 thymoma or thymic carcinoma.; To assess the incidence of adverse events (AEs);Timepoint(s) of evaluation of this end point: Four years; Four years; Four years; Four years | — |
Countries
Italy
Contacts
Public ContactClinical Trial Center
Fondazione IRCCS Istituto Nazionale Tumori
Outcome results
None listed