Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BKM120 · 1 trial · 3 indications
CBR in the patients following WBRT or SRS or both will be the primary endpoint and is calculated as the total number of responders (CR or PR, assessed by RECIST 1.1) plus stable disease greater than or equal to 24 weeks (CR + PR + SD ≥ 24 weeks) divided by the total number of evaluable patients. 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 diameters of target lesions, taking as reference the baseline sum diameters.
| Arm | Type | Description |
|---|---|---|
| BKM120 plus Capecitabine | EXPERIMENTAL | BKM120 will be administered at a dose of 100 mg orally (PO) daily. Capecitabine will be administered at a dose of 1000 mg/m2 orally (PO) twice a day (rounded down to the nearest 500 mg pill) 14 days on and 7 days off. For patients with HER2+ MBC only, standard every 3-weekly trastuzumab (6 mg/kg IV) will be added to the capecitabine/BKM120. |
| Name | Type | Description |
|---|---|---|
| BKM120 | DRUG | - |
| capecitabine | DRUG | - |
| Trastuzumab | DRUG | - |
Inclusion Criteria: 1. Age ≥ 18 years 2. Female 3. Histologically and/or cytologically confirmed diagnosis of inoperable metastatic breast cancer 4. ER+/HER2- OR HER2+ OR triple-negative breast cancer, assessed as ER-, PgR-, and HER2-negative by local laboratory testing; HER2 negative status (based...
BKM120 is an investigational small molecule being studied for the treatment of brain metastases in patients with metastatic breast cancer. It is a Phase 2 oncology drug that was evaluated in a completed clinical trial in the United States.
BKM120 is being developed by McKesson Corporation, which trades under the ticker symbol MCK. The company conducted a Phase 2 clinical trial of the drug in patients with brain metastases from breast cancer.
BKM120 is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied for safety and efficacy in clinical trials.
BKM120 was studied in a single completed Phase 2 clinical trial with the identifier NCT02000882, titled 'STAR Cape+BKM120 MBC With Brain Met.' The trial enrolled 10 female patients aged 18 years and older with brain metastases and metastatic breast cancer in the United States.
No, BKM120 is not the same as STAR Cape. STAR Cape is the name of the clinical trial, not an alternative name for the drug. The trial combined BKM120 with capecitabine, a chemotherapy agent, to treat metastatic breast cancer with brain metastases.