Neoplasms

All Conditions

Blood and Lymph Conditions

Carcinoma

Thymoma

Thymus Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Thoracic Neoplasms

Lymphatic Diseases

Antineoplastic Agents

All Drugs and Chemicals

Amino Acids

Sunitinib

Angiogenesis Inhibitors

Growth Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

Sunitinib orally administered at 50 mg once daily for 4 consecutive weeks, followed by a 2-week rest period (schedule 4/2) to comprise a complete cycle of 6 weeks

small-molecule, multi-targeted receptor tyrosine kinase (RTK) inhibitor

Marina Chiara Garassino, MD

Rosaria Gallucci, MSc

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

Trial of Sunitinib in Patients With Type B3 Thymoma or Thymic Carcinoma in Second and Further Lines (Style Trial)

Phase II Trial of Sunitinib in Patients With Type B3 Thymoma or Thymic Carcinoma in Second and Further Lines (Style Trial)

Best tumour response (Complete Response + Partial Response)

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)

The OS is defined as the time from the date of randomization to the date of death

Complete Response + Partial Response + Stable Disease

will be utilized the CTCAE v 4.0 criteria for assessment of toxicity and serious adverse event reporting.

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.

Spots Global Cancer Trial Database for type b3 thymoma