Trial of Sunitinib in Patients With Type B3 Thymoma or Thymic Carcinoma in Second and Further Lines (Style Trial) (Style)
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|ClinicalTrials.gov Identifier: NCT03449173|
Recruitment Status : Recruiting
First Posted : February 28, 2018
Last Update Posted : March 27, 2018
|Condition or disease||Intervention/treatment||Phase|
|Type B3 Thymoma Thymic Carcinoma||Drug: Sunitinib||Phase 2|
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 (Clinical Trial)|
|Estimated Enrollment :||56 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of Sunitinib in Patients With Type B3 Thymoma or Thymic Carcinoma in Second and Further Lines (Style Trial)|
|Actual Study Start Date :||March 2, 2017|
|Estimated Primary Completion Date :||March 2, 2021|
|Estimated Study Completion Date :||March 2, 2021|
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
Other Name: Sutent
- Activity of Sunitinib [ Time Frame: 4 years ]Best tumour response (Complete Response + Partial Response)
- Progression Free Survival (PFS) [ Time Frame: 4 years ]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)
- Overall Survival (OS) [ Time Frame: 4 years ]The OS is defined as the time from the date of randomization to the date of death
- Duration of activity of sunitinib [ Time Frame: 4 years ]Complete Response + Partial Response + Stable Disease
- Safety and toxicity profile of sunitinib [ Time Frame: 4 years ]will be utilized the CTCAE v 4.0 criteria for assessment of toxicity and serious adverse event reporting.
- Incidence of adverse events (AEs) [ Time Frame: 4 years ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03449173
|Contact: Marina Chiara Garassino, MDfirstname.lastname@example.org|
|Contact: Rosaria Gallucci, MScemail@example.com|
|National Cancer Institute||Recruiting|
|Milan, Italy, 20133|
|Principal Investigator:||Marina Chiara Garassino, MD||National Cancer Institute (NCI)|