Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Poziotinib · 3 trials · 2 indications
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. |
| Part 1: Itraconazole/Poziotinib Drug-drug interaction (DDI) | EXPERIMENTAL | On Day 1 of Treatment period 1, a single oral dose of 8 milligrams (mg) poziotinib will be administered. On Day 1 of Treatment Period 2, 200 mg itraconazole oral solution will be administered twice a day (BID) followed by 200 mg itraconazole oral solution once daily (QD) for 7 consecutive days (Day 2 to Day 8) with a single oral dose of 8 mg poziotinib coadministered on Day 4. |
| Part 2: Phenytoin/Poziotinib DDI | EXPERIMENTAL | On Day 1 of Treatment period 1, a single oral dose of 16 mg poziotinib will be administered. In treatment period 2, an oral dose of 100 mg phenytoin will be administered three times daily (TID) for 17 consecutive days (Day 1 to Day 17) with a single oral dose of 16 mg poziotinib coadministered on Day 14. |
| Part 3: Paroxetine/Poziotinib DDI | EXPERIMENTAL | On Day 1 of Treatment Period 1, a single oral dose of 8 mg poziotinib will be administered. On Day 1 and Day 2 of Treatment Period 2, an oral dose of 20 mg paroxetine will be administered BID followed by 20 mg paroxetine QD for 9 consecutive days (Day 3 to Day 11) with a single oral dose of 8 mg poziotinib coadministered on Day 7. |
| Poziotinib | EXPERIMENTAL | A single oral dose of 8 mg poziotinib as a capsule formulation (as the hydrochloride salt) containing approximately 100 μCi of \[14C\]-poziotinib |
| Name | Type | Description |
|---|---|---|
| Poziotinib | DRUG | 8 mg oral tablets, administered QD. |
| Itraconazole | DRUG | Itraconazole Oral solution |
| Phenytoin | DRUG | Phenytoin Capsules |
| Paroxetine | DRUG | Paroxetine Tablets |
| [14C]-Poziotinib | DRUG | Single oral administration of 8 mg (as the hydrocholoride salt) of \[14C\]-poziotinib |
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 ...
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Poziotinib is an investigational small molecule being studied for the treatment of HER2-positive metastatic breast cancer. It is also being evaluated in healthy subjects for pharmacokinetic studies. The drug is currently in Phase 2 clinical development for breast cancer, with completed trials in this indication.
Poziotinib targets HER2, a protein that can promote cancer cell growth. It is being studied in patients with HER2-positive metastatic breast cancer, where this target is overexpressed. The drug is designed to inhibit HER2 signaling, potentially slowing tumor progression in this patient population.
Poziotinib is being developed by Assertio Holdings, Inc., a company traded on NASDAQ under the ticker symbol ASRT. The company is conducting clinical trials to evaluate the drug's safety and efficacy in oncology and healthy volunteer studies.
Poziotinib is in Phase 2 clinical development for HER2-positive metastatic breast cancer. It has completed two clinical trials, including a Phase 2 study in breast cancer and a Phase 1 study in healthy subjects. The drug is investigational and not yet approved by regulatory authorities.
Poziotinib has completed two clinical trials. NCT02659514 was a Phase 2 study in 67 patients with HER2-positive metastatic breast cancer in the United States. NCT04436562 was a Phase 1 study in 8 healthy male subjects to evaluate absorption, metabolism, and excretion of the drug.
Poziotinib is not known by any alternative names. It is being developed under this single name by Assertio Holdings, Inc. for the treatment of HER2-positive metastatic breast cancer and for pharmacokinetic studies in healthy volunteers.