Carcinoma, Non-small Cell Lung
Conditions
Keywords
non-small cell lung cancer, thioredoxin reductase
Brief summary
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.
Detailed description
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.
Interventions
DRUGethaselen
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
Sponsors
Hunan Province Tumor Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* advanced non-small cell lung cancer, stage IIIB/IV who had received more than 2 standard treatment scheme * 18-75 years old, anticipate overall survival more than 3 months, ECOG 0-2 * within 4 weeks, not receive chemotherapy, radiotherapy or surgery * HB≥90g/L； ANC ≥1.5×109/L；PLT ≥80×109/L * EGFR/ALK mutation negative * immunohistochemistry test of cancer tissue showed ++ or +++ of thioredoxin reductase * brain metastasis without symptoms
Exclusion criteria
* according to NCCN non-small cell lung cancer guidelines (2014 v3), there were standard treatment scheme for the patients * pregnancy or breast-feeding women * any serious disease which could not be controled * urine protein≥++, or 24h urine protein\>1g * received any anti-cancer treatment within 4 weeks
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 6 week disease control rate | within 6 weeks after patients received ethaselen treatment | disease control rate will be measured within 6 weeks after patients received ethaselen treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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. |
| overall survival | 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. | 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. |
| safety of drug | safety of drug will be recorded during treatment, up to 6 weeks after treatment | 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. |
Countries
China
Outcome results
None listed