Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Label indication TRISENOX is an arsenical indicated: In combination with tretinoin for treatment of adults with newly-diagnosed low-risk acute promyelocytic leukemia (APL) whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression. FDA label
Also known as Trisenox, ATO
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 has been studied as a treatment for small cell lung cancer, a form of lung cancer. It was evaluated in a Phase 2 clinical trial in adults with this condition. The drug is a small molecule being developed by Teva Pharmaceutical Industries Limited for oncology indications.
Arsenic Trioxide is developed by Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA. The company sponsored the clinical research evaluating the drug in lung cancer.
Arsenic Trioxide is in Phase 2 development for lung cancer. The single Phase 2 trial in this indication has been completed. The drug is investigational for lung cancer and is not approved for this use based on the available development information.
Arsenic Trioxide was studied in the Phase 2 trial NCT01470248, titled Study of Arsenic Trioxide in Small Cell Lung Cancer. The trial enrolled 20 participants in the United States, was uncontrolled, and has been completed. It enrolled adults aged 18 years and older of all sexes.
The Phase 2 trial of Arsenic Trioxide in small cell lung cancer, NCT01470248, enrolled 20 participants. The study was uncontrolled, meaning it did not use a comparator arm, and it has been completed.