Last updated: June 8, 2021
Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Overall Status: Active - Recruiting
Phase
2
Condition
Head And Neck Cancer
Carcinoma
Thymomas
Treatment
N/AClinical Study ID
NCT03449173
INT 165-16
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Signed and dated IRB (Independent Review Board)/IEC (Independent EthicsCommittee)-approved Informed Consent
- Histological diagnosis of invasive recurrent or metastatic type B3 thymoma or thymiccarcinoma. In case of presence of both histologies it will be classified based on thepredominantly part. B2 thymoma with areas of B3 thymoma are eligible.
- 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 agentsreceived. Progressive disease should have been documented before entry into the study
- Patients must have measurable disease, defined as at least one lesion that can beaccurately measured according with RECIST 1.1 criteria
- Availability of archival tissue (paraffine block or at least 10 unstained slides)
- Patients must have recovered from toxicity related to prior therapy to at least grade 1 (defined by v.CTCAE 4.0)
- Patients must not have had major surgery, radiation therapy, chemotherapy, biologictherapy (including any investigational agents), or hormonal therapy (other thanreplacement), within 4 weeks prior to entering the study
- Age > 18 years
- Life expectancy > 3 months
- Performance status (ECOG) ≤ 2
- Negative pregnancy test (if female in reproductive years)
- Patients must have adequate organ and marrow function (as defined below). Patientsmust have returned to baseline or grade 1 from any acute toxicity related to priortherapy:
- 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 forpatients affected by Gilbert's syndrome
- AST(SGOT) (aspartate aminotransferase) /ALT(SGPT) (alanine transaminase) ≤ 3 xinstitutional ULN (5x if LFT (liver function test) elevations due to livermetastases)
- Creatinine ≤ 1.5 x institutional ULN
- Women of childbearing potential (WOCBP) must agree to follow instructions formethod(s) of contraception before study entry, for all the duration of the study andfor at least 8 weeks after the last dose of investigational drug (30 days for anovarian cycle turnover plus the time required for the active metabolite of sunitinibto undergo five half-lives).
- Males who are sexually active with WOCBP must agree to follow instructions formethod(s) of before study entry, for all the duration of the study and for at least 16weeks after the last dose of investigational drug (90 days for sperm turnover plus thetime required for the active metabolite of sunitinib to undergo five half-lives).
Exclusion
Exclusion Criteria:
- untreated CNS metastases. Patients with treated brain metastases are eligible if theyare clinically stable with regard to neurologic function, off steroids after cranialirradiation (whole brain radiation therapy, focal radiation therapy, and stereotacticradiosurgery) ending at least 2 weeks prior to start of treatment, or after surgicalresection performed at least 28 days prior to start of treatment. The patient may haveno evidence of Grade ≥1 CNS haemorrhage based on pre-treatment Magnetic ResonanceImaging (MRI) or IV contrast CT scan (performed within 28 days before start oftreatment)
- Major surgery, other than diagnostic surgery, within 4 weeks prior to treatment
- Active, uncontrolled bacterial, viral, or fungal infections, requiring systemictherapy
- Pregnant or breast feeding women
- Previous (within the last 5 years) or current malignancies at other sites, except foradequately treated basal cell or squamous cell skin cancer or in situ carcinoma of thecervix uteri
- Current enrollment in or participation in another therapeutic clinical trial within 4weeks before treatment start.
- Patients with uncontrolled or significant cardiovascular disease (AMI within 12months, unstable angina within 6 months, NYHA (New York Heart Association) Class III,IV Congestive heart failure or left ventricular ejection fraction below localinstitutional lower limit of normal or below 45%,
- Ongoing symptomatic cardiac dysrhythmias, uncontrolled atrial fibrillation, orprolongation of the Fridericia corrected QT (QTcF) interval defined as > 450 msec formales and > 470 msec for females, where QTcF = QT / 3√RR
- Poorly controlled hypertension
- History of cerebrovascular accident including transient ischemic attack within thepast 12 months.
- History of deep vein thrombosis (DVT) unless adequately treated with low molecularweight heparin
- History of pulmonary embolism within the past 6 months unless stable, asymptomatic,and treated with low molecular weight heparin for at least 6 weeks.
- Evidence of active bleeding or bleeding susceptibility; or medically significanthemorrhage within prior 30 days.
- Receiving concomitant CYP3A4 inducers or strong CYP3A4 inhibitors
- Impairment of gastrointestinal function or gastrointestinal disease that maysignificantly alter the absorption of sunitinib
- Known HIV infection
Study Design
Total Participants: 56
Study Start date:
March 02, 2017
Estimated Completion Date:
May 31, 2022
Study Description
Connect with a study center
National Cancer Institute
Milan, 20133
ItalyActive - Recruiting


Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.