Phase I/II of Oral Vorinostat Combination With Erlotinib in NSCLC Patients With EGFR Mutations With DP After Erlotinib.
Status:
Terminated
Trial end date:
2011-12-01
Target enrollment:
Participant gender:
Summary
This is an open label, non-randomized, sequential, phase I/II trial in patients with stage
IIIB or IV non-small cell lung cancer (NSCLC) with EGFR mutations after progression to
Erlotinib. The study will have two parts. The first part (phase I) will be a dose finding
(MTD) study to be implemented at three hospitals. The second part of the study (phase II)
will asses the safety and efficacy of the combination. In this second part (phase II)
patients will be treated with oral Erlotinib 150 mg P.O daily plus oral Vorinostat
administered according to the results of the phase I. The study endpoints to be evaluated
will include safety and response rate (RR) as primary endpoints and clinical benefit rate
(CBR), time to progression, time to response, response duration and progression free survival
as secondary endpoints. All the patients (phase I and II) will be treated until progression
disease, unacceptable toxicity or withdrawal of the consent, and will be treated at the
discretion of the principal investigator.