Clinical Trials /

Ethaselen for the Treatment of Thioredoxin Reductase High Expression Advanced Non-small Cell Lung Cancers

NCT02166242

Description:

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.

Related Conditions:
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1

URL:

https://clinicaltrials.gov/show/NCT02166242

Trial Eligibility

Document

Title

  • Brief Title: Ethaselen for the Treatment of Thioredoxin Reductase High Expression Advanced Non-small Cell Lung Cancers
  • Official Title: Phase 1c Single Arm Study of Thioredoxin Reductase Inhibitor Ethaselen, for the Treatment of Thioredoxin Reductase High Expressed Advanced Non-small Cell Lung Cancers Who Have Received More Than Two Lines Standard Treatment.

Clinical Trial IDs

  • ORG STUDY ID: BBSKE001
  • NCT ID: NCT02166242

Conditions

  • Carcinoma, Non-small Cell Lung

Interventions

DrugSynonymsArms
ethaselenBBSKEexperimental

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
experimentalExperimentalpatients 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, patients may quit the study whenever they would like or investigator evaluate that progression disease has developed, or any grade of SAE developed during the study.
  • ethaselen

Eligibility Criteria

        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
Maximum Eligible Age:75 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:6 week disease control rate
Time Frame:within 6 weeks after patients received ethaselen treatment
Safety Issue:
Description:disease control rate will be measured within 6 weeks after patients received ethaselen treatment

Secondary Outcome Measures

Measure:progression free survival
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.
Safety Issue:
Description: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.
Measure:overall survival
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 Issue:
Description: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.
Measure:safety of drug
Time Frame:safety of drug will be recorded during treatment, up to 6 weeks after treatment
Safety Issue:
Description: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.

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Hunan Province Tumor Hospital

Trial Keywords

  • non-small cell lung cancer
  • thioredoxin reductase

Last Updated

March 26, 2020