Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Alisertib · 1 trial · 4 indications
Measurement of tumors (sum of longest diameters) every 8 weeks for CT/MRI and photographs, and every 12 weeks for bone scan, if applicable. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions (plus an absolute increase of at least 5 mm), or a measurable increase in a non-target lesion, or the appearance of new lesions
| Arm | Type | Description |
|---|---|---|
| ER+/HER2- Paclitaxel Alone | ACTIVE_COMPARATOR | Paclitaxel 90 mg/m2 IV on days 1, 8 and 15 of a 28-day cycle |
| ER+/HER2- Paclitaxel plus Alisertib | EXPERIMENTAL | Paclitaxel 60 mg/m2 intravenously (IV) on days 1, 8 and 15 of a 28-day cycle; Alisertib 40 mg twice a day (BID) on days 1-3, 8-10, and 15-17 of a 28-day cycle |
| Triple Negative Paclitaxel Alone | ACTIVE_COMPARATOR | Paclitaxel 90 mg/m2 IV on days 1, 8 and 15 of a 28-day cycle |
| Triple Negative Paclitaxel plus Alisertib | EXPERIMENTAL | Paclitaxel 60 mg/m2 intravenously (IV) on days 1, 8 and 15 of a 28-day cycle; Alisertib 40 mg BID on days 1-3, 8-10, and 15-17 of a 28-day cycle |
| Name | Type | Description |
|---|---|---|
| Paclitaxel | DRUG | either 60 mg/m2 intravenously (IV) on days 1, 8 and 15 of a 28-day cycle (on Paclitaxel plus Alisertib arm) or 90 mg/m2 IV on days 1, 8 and 15 of a 28-day cycle (on Paclitaxel Alone arm) |
| Alisertib | DRUG | 40 mg BID (twice a day) on days 1-3, 8-10, and 15-17 of a 28-day cycle |
Inclusion Criteria: * Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care, and signed Health Insurance Portabili...
Top 20 of 92 competitors
Alisertib is an investigational small molecule being studied for the treatment of breast cancer, specifically in patients with metastatic or locally recurrent breast cancer. It is currently in Phase 2 clinical development and has not been approved by the FDA.
Alisertib is a small molecule that targets Aurora kinase A, a protein involved in cell division. By inhibiting this target, it aims to disrupt cancer cell proliferation. This mechanism is being evaluated in the context of breast cancer treatment.
Alisertib is being developed by McKesson Corporation, a company publicly traded under the ticker symbol MCK. The drug is currently in Phase 2 clinical trials for breast cancer.
Alisertib is in Phase 2 clinical development for breast cancer. It is an investigational drug, meaning it has not yet been approved by regulatory authorities and is still undergoing clinical trials to assess its safety and efficacy.
Alisertib has one completed Phase 2 clinical trial, identified as NCT02187991. This study compared Alisertib combined with paclitaxel versus paclitaxel alone in patients with metastatic or locally recurrent breast cancer. The trial enrolled 169 female participants in the United States.
No, Alisertib is not the same as paclitaxel. Alisertib is an Aurora kinase A inhibitor, while paclitaxel is a chemotherapy drug that stabilizes microtubules. In the clinical trial NCT02187991, Alisertib was studied in combination with paclitaxel to compare its effects against paclitaxel alone.