Study to investigate response to sunitinib in patients with thymic epithelial tumours who had progressive disease after at least one previous regimen of platinum-based chemotherapy.
This trial will be conducted to assess the activity of Sunitinib in patients affected by advanced or recurrent B3 thymoma or thymic carcinoma progressing after at least one line of chemotherapy (including one platinum based regimen). Taking into account the different biology and historically discrepant responses and survival of thymoma and thymic carcinoma, patients will be enrolled with these tumour types in two separate cohorts. Sunitinib will be self orally administered at 50 mg once daily, is 50 mg taken orally once daily, for 4 consecutive weeks, followed by a 2-week rest period (schedule 4/2) to comprise a complete cycle of 6 weeks until tumour progression, unacceptable toxicity or other criteria for discontinuation is met. Sunitinib dose reductions are permitted as per the approved product label for safety reasons. Dose reductions should occur in 12.5 mg decrements. No more than 2 dose reductions are allowed. If more than 2 dose reductions are necessary (ie, reduction to less than 25 mg daily), the subject must be permanently discontinued (Section 7.2.2) Possible dose reductions: * Sunitinib at dose of 37,5 mg orally once daily for 4 weeks followed by 2 weeks rest-period in cycles of 6 weeks. * Sunitinib at dose of 25 mg orally once daily for 4 weeks followed by 2 weeks rest-period in cycles of 6 weeks
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
56
small-molecule, multi-targeted receptor tyrosine kinase (RTK) inhibitor
National Cancer Institute
Milan, Italy
RECRUITINGActivity of Sunitinib
Best tumour response (Complete Response + Partial Response)
Time frame: 4 years
Progression Free Survival (PFS)
The PFS is defined as the time from the date of randomization to the date of documented progressive disease, recurrence or Death (whichever occurs first)
Time frame: 4 years
Overall Survival (OS)
The OS is defined as the time from the date of randomization to the date of death
Time frame: 4 years
Duration of activity of sunitinib
Complete Response + Partial Response + Stable Disease
Time frame: 4 years
Safety and toxicity profile of sunitinib
will be utilized the CTCAE v 4.0 criteria for assessment of toxicity and serious adverse event reporting.
Time frame: 4 years
Incidence of adverse events (AEs)
Incidence of adverse events (AEs) will be graded according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 4.0, laboratory values, physical examinations, vital signs.
Time frame: 4 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.