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Investigational Cancer Drug · 1 trial · 2 indications
| Name | Type | Description |
|---|---|---|
| Investigational Cancer Drug | DRUG | - |
Inclusion Criteria: (The patient must meet the following criteria in order to be eligible for this study.) * Signed informed consent * No more than two prior regimens for metastatic breast cancer. Each regimen must have contained Herceptin. * Refractory Stage IIIb or IV breast cancer * HER2/neu tum...
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It is a small molecule oncology candidate that GSK plc (ticker GSK) is developing for metastatic breast cancer. It has been studied in a Phase 2 trial in women with refractory metastatic breast cancer after first-line or second-line Herceptin. It is investigational and has not been approved.
It is being studied for metastatic breast cancer, specifically in women whose disease is refractory after first-line or second-line Herceptin. The Phase 2 study enrolled patients with metastatic breast cancer and related breast neoplasms. The program is biomarker selected, meaning trial eligibility was tied to a biomarker.
GSK plc, which trades under the ticker GSK, is the developer of this small molecule oncology candidate. GSK sponsored the Phase 2 study of the drug in refractory metastatic breast cancer. No other developer or partner is identified for this asset.
It is in Phase 2 development. One Phase 2 trial has been completed, and no trials are currently active. The drug is investigational and is not approved for any indication. The completed study was conducted in the United States.
The drug was evaluated in NCT00051103, titled Oral Drug Study In Women With Refractory Metastatic Breast Cancer After First-line or Second-line Herceptin. That Phase 2 trial is completed. It was an uncontrolled study with no randomization or blinding, enrolled women aged 18 years and older, and did not include healthy volunteers.