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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02659514 | Study of Poziotinib in Participants With HER2-Positive Metastatic Breast Cancer | PHASE2 | COMPLETED | 67 | — | — | Feb 22, 2016 | Mar 11, 2020 | Mar 11, 2022 | 35 | United States |
ORR was defined as the percentage of participants whose best overall response (BOR) was complete response (CR) or partial response (PR) among participants in the Evaluable Population assessed per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). ORR was based on investigator assessed BOR. Per RECIST v1.1 for target lesions, CR was disappearance of all target tumor lesions (TLs) and all target lymph nodes (LNs) with short axis \<10mm. PR was ≥30% decrease in sum of diameters (SOD) from Baseline, and not progressive disease (PD) (≥20% increase in SOD from previous smallest SOD on study, and an absolute increase of ≥5mm).
| Arm | Type | Description |
|---|---|---|
| Cohort 1: Poziotinib 24 mg | EXPERIMENTAL | Participants received poziotinib 24 milligrams (mg), administered as three 8 mg tablets, orally, once daily (QD) on an intermittent dosing schedule of 14 days on treatment followed by 7 days off treatment, in a 21-day cycle until disease progression, death, intolerable adverse events (AEs) or for up to a maximum of 24 months, whichever occurs first. |
| Cohort 2: Poziotinib 16 mg | EXPERIMENTAL | Participants received poziotinib 16 mg, administered as two 8 mg tablets, orally, QD, on a continuous dosing schedule in a 21-day cycle until disease progression, death, intolerable AEs or for up to a maximum of 24 months, whichever occurs first. |
| Name | Type | Description |
|---|---|---|
| Poziotinib | DRUG | 8 mg oral tablets, administered QD. |
Inclusion Criteria: 1. Histopathologically confirmed primary breast cancer with metastatic lesions. 2. Confirmed HER2 overexpression or gene-amplified tumor 3. At least two prior HER2-directed therapy regimens for breast cancer, including trastuzumab and trastuzumab emtansine 4. Measurable disease ...