Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Arsenic Trioxide · 1 trial · 5 indications
Response rate (complete response \[CR\]+ partial response \[PR\]) was evaluated using the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1). * Complete response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. * Partial response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. * Progressive disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. * Stable disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Sum of complete response (CR), partial response (PR) and stable disease (SD) in patients eligible for efficacy analysis.
| Arm | Type | Description |
|---|---|---|
| Arsenic Trioxide Treatment | EXPERIMENTAL | This is a single arm study. All patients will be treated with the investigational agent, Arsenic Trioxide, according to the dose and schedule indicated in the protocol. |
| Name | Type | Description |
|---|---|---|
| Arsenic Trioxide | DRUG | Drug will be given as a loading dose of 0.32mg/kg/day for 4 days in Week 1, followed by 0.25mg/kg/day twice per week for 5 weeks, followed by 2 weeks of rest, at which time response assessment will be performed. Patients will be restaged prior to the beginning of a new cycle, every 2 months on average. Maximum of 6 cycles of therapy will be administered in the absence of tumor progression or excessive side effects |
Inclusion Criteria: * Patients must have histologically or cytologically confirmed small cell lung cancer * Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and shor...
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Arsenic Trioxide is being studied for the treatment of lung cancer, specifically small cell lung cancer. It is an investigational small molecule in Phase 2 clinical development for this indication. The drug has been evaluated in a completed clinical trial in the United States.
Arsenic Trioxide is a small molecule therapeutic being investigated for lung cancer. Its specific molecular target has not been disclosed in the available information. The drug is being studied for its potential anti-cancer effects in small cell lung cancer.
Arsenic Trioxide is being developed by Teva Pharmaceutical Industries Limited, a company traded on the stock exchange under the ticker symbol TEVA. The company is conducting clinical research on this drug for the treatment of lung cancer.
Arsenic Trioxide is in Phase 2 clinical development for lung cancer. It is an investigational drug and has not been approved by regulatory authorities for this indication. The drug is still undergoing clinical trials to evaluate its safety and efficacy.
Arsenic Trioxide has one completed clinical trial, identified as NCT01470248, titled 'Study of Arsenic Trioxide in Small Cell Lung Cancer'. This Phase 2 trial enrolled 20 participants in the United States and was not randomized or double-blinded.
Arsenic Trioxide is not known by any alternative names in the available information. It is a distinct chemical compound being investigated for its potential use in treating lung cancer, specifically small cell lung cancer.