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NCT Number: NCT02166242

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

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.

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Key information

Conditions

Carcinoma, Non-small Cell Lung Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Hunan province tumor hospital

Changsha, Hunan, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ethaselen

Drug

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

Other names: BBSKE

Primary outcomes

  1. 6 week disease control rate

    Time frame: within 6 weeks after patients received ethaselen treatment

    disease control rate will be measured within 6 weeks after patients received ethaselen treatment

Secondary outcomes

  1. 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.

    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.

  2. 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.

    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.

  3. safety of drug

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Hunan Province Tumor Hospital

Other

Registry information

Official study 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.

Important dates

Study start
2014
Primary completion
2020
Study completion
2021
First posted
Jun 18, 2014
Registry last updated
Mar 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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