Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02047344 | Efficacy, Safety and Pharmacokinetics Study of Antroquinonol to Treat NSCLC | PHASE2 | COMPLETED | 31 | — | — | Oct 1, 2013 | Dec 7, 2018 | Dec 26, 2019 | 10 | United States, Taiwan |
Tumor response will be assessed at 6 week intervals during the first treatment cycle using the RECIST criteria, version 1.1. Each patient will be assigned one of the following categories: 1) complete response (CR), 2) partial response (PR), 3) stable disease (SD), or 4) progressive disease (PD). Patients who died from any cause or discontinued the study for any reason without a post screening or Week 12 tumor assessment will be considered as failing to respond to treatment.
| Arm | Type | Description |
|---|---|---|
| Antroquinonol (Hocena) | EXPERIMENTAL | patients will receive one 12 week cycle of antroquinonol 200 mg t.i.d. or until disease progression, unacceptable toxicity, non compliance or withdrawal of consent by the patient, or the investigator decides to discontinue treatment, whichever comes first. |
| Name | Type | Description |
|---|---|---|
| Antroquinonol | DRUG | patients will receive one 12 week cycle of antroquinonol 200 mg t.i.d. or until disease progression, unacceptable toxicity, non compliance or withdrawal of consent by the patient, or the investigator decides to discontinue treatment, whichever comes first. |
Inclusion Criteria: * Cytologically or histologically confirmed non squamous NSCLC Stage IV (including pleural effusion). * Radiologically confirmed disease progression following two previous lines of anti-cancer therapy, one of which should be a platinum based regimen, OR the patient has refused t...