Non-Small Cell Lung Cancer Clinical Trial
Official title:
SORAVE-Sorafenib and Everolimus in Solid Tumors. A Phase I Clinical Trial to Evaluate the Safety of Combined Sorafenib and Everolimus Treatment in Patients With Relapsed Solid Tumors
Dose finding part: A phase I clinical trial to evaluate the safety of combined sorafenib and
everolimus treatment in patients with relapsed solid tumors (finished).
Extension part:Treatment of non-small cell lung cancer (NSCLC) with KRAS mutation after ≥
1st relapse (recruiting)
Dose finding part: Patients will be recruited to receive combination of defined sorafenib
dose (2x400mg) with increasing dose of everolimus (2.5mg, 5mg, 7.5mg, 10mg). There will be a
run-in phase of 14 days of everolimus followed by combination sorafenib+everolimus starting
from day 15. The combination will be continued as long as it is tolerated by the patient and
the patient benefits from the treatment according to RECIST criteria. The maximal tolerated
dose will be establish in 3+3 design. Patients will be recruited sequentially at least 14
days apart. The next dose level according to 3+3 design will be initiated if all patients on
the previous dose level reach day 29.
Extension part: Patients will be treated with a dose of 7,5 mg Everolimus for 14 days
(run-in phase) and sorafenib 2x 400 mg until progression
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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