Thioredoxin reductase plays an critical role in lung cancer patients, in vitro study showed that, ethaselen, specific inhibitor of thioredoxin reductase, could inhibit lung cancer cell growth and induce apoptosis. In China, phase 1 clinical trials of ethaselen showed that 1200 mg dose ethaselen could be well tolerated, in pre-clinical study we found that, approximately 50% non-small cell lung cancers harbored high thioredoxin reductase expression(IHC result ++ or +++), phase 1a/b of ethaselen had finished in 2008, the result showed that 1200mg ethaselen per day was safety and tolerated by Chinese malignant tumor patients.In pre-clinical research, our group found that, elevated of thioredoxin reductase activity was associated with the expression of thioredoxin reductase tested by immunohistochemistry, which means high expression of this enzyme may be a favourite predicted factor of ethaselen, the specific inhibitor of thioredoxin reductase.
This phase 1c study will include patients pathologic diagnosis advanced non-small cell lung cancer who had received more than two lines standard treatment, according to NCCN Non-small cell lung cancer guideline, there were no standard treatment scheme for these patients. Approximately 40 patients will be included in the study, patients will received oral ethaselen dispersible tablet, 600 mg bid dose, primary endpoint of this study is 6 week disease control rate(DCR, CR+PR+SD), secondary endpoints include progression free survival(PFS), overall survival(OS), quality of life(QOL) and drug safety.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
ethaselen is a specific thioredoxin reductase inhibitor, which has finished phase 1a study in China, phase 1 study of ethaselen showed that 600 mg ethaselen bid could be well tolerated
Hunan province tumor hospital
Changsha, Hunan, China
6 week disease control rate
disease control rate will be measured within 6 weeks after patients received ethaselen treatment
Time frame: within 6 weeks after patients received ethaselen treatment
progression free survival
the first time investigator evaluate PFS will be at the sixth week since the study begin, the second time investigator evaluate PFS will be at the 12th week, the next time will be at the 18th week. Up to 30 weeks after the study was finished.
Time frame: the first time investigator evaluate PFS will be at the sixth week since the study begin, the second time investigator evaluate PFS will be at the 12th week, the next time will be at the 18th week.
overall survival
the first time investigator evaluate OS will be at the sixth week since the study begin, the second time investigator evaluate OS will be at the 12th week, the next time will be at the 18th week. Up to 30 weeks after the study was finished.
Time frame: the first time investigator evaluate OS will be at the sixth week since the study begin, the second time investigator evaluate PFS will be at the 12th week, the next time will be at the 18th week. Up to 30 weeks after the study was finished.
safety of drug
any SAE should be recorded and reported to SFDA within 1 day during ethaselen treatment, after treatment drug associated safety will be in 6 weeks.
Time frame: safety of drug will be recorded during treatment, up to 6 weeks after treatment
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