Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Alisertib · 3 trials · 5 indications
Treatment emergent adverse events are those events reported on or after the first dose of investigational product and up to 28 days after the last dose.
Objective response rate is defined as the percentage of participants demonstrating a confirmed objective response during the study.
Duration of response is measured from the time at which measurement criteria are first met for Complete Response (CR) or Partial Response (PR) (whichever status is recorded first) until the first date of recurrence or progressive disease (PD) or death is objectively documented.
Disease control rate is the proportion of participants who achieve overall tumor response (confirmed CR or PR) or Stable Disease (SD) lasting for at least 24 weeks from randomization.
Progression Free Survival (PFS) is measured in months and based on the local tumor assessment. The time interval from the date of randomization until the first date on which recurrence, progression, or death due to any cause, is documented.
Overall survival (OS) is defined as the time from randomization to death due to any cause, censored at the last date known alive on or prior to the data cutoff employed for the analysis, whichever was earlier.
Treatment emergent adverse events are those events reported on or after the first dose of investigational product and up to 28 days after last dose.
Objective response rate is defined as the percentage of participants demonstrating a confirmed objective response during the study
Duration of response is measured from the time at which measurement criteria are first met for CR or PR (whichever status is recorded first) until the first date of recurrence or progressive disease (PD) or death is objectively documented.
Disease control rate is the proportion of patients who achieve overall tumor response (confirmed CR or PR) or SD lasting for at least 8 weeks from first dose of investigational product.
Progression Free Survival (PFS) is measured in months and based on the local tumor assessment. The time interval from the date of first dose until the first date on which recurrence, progression, or death due to any cause, is documented.
Overall survival (OS) is defined as the time from date of first dose to death due to any cause, censored at the last date known alive on or prior to the data cutoff employed for the analysis, whichever was earlier.
| Arm | Type | Description |
|---|---|---|
| Cohort 1: Alisertib 30 mg BID + Paclitaxel | EXPERIMENTAL | Approximately ten participants will be enrolled in the cohort. Alisertib dose may be increased by 10 mg BID in the next cohort if 3 or fewer participants experience an Event during Cycle 1. |
| Cohort 2: Alisertib 40 mg BID + Paclitaxel | EXPERIMENTAL | Approximately ten participants will be enrolled in the cohort. Alisertib dose may be increased by 10 mg BID in the next cohort if 3 or fewer participants experience an Event during Cycle 1. |
| Cohort 3: Alisertib 50 mg BID + Paclitaxel | EXPERIMENTAL | Approximately ten participants will be enrolled in the cohort. Alisertib dose may be increased by 10 mg BID in the next cohort if 3 or fewer participants experience an Event during Cycle 1. |
| Cohort 4: Alisertib 60 mg BID + Paclitaxel | EXPERIMENTAL | Approximately ten participants will be enrolled in the cohort. Alisertib dose may be increased by 10 mg BID in the next cohort if 3 or fewer participants experience an Event during Cycle 1. |
| Cohort 5: Alisertib 70 mg BID + Paclitaxel | EXPERIMENTAL | Approximately ten participants will be enrolled in the cohort. |
| Alisertib 50 mg | EXPERIMENTAL | Alisertib with selected endocrine therapy |
| Alisertib 40 mg | EXPERIMENTAL | Alisertib with selected endocrine therapy |
| Alisertib 30 mg | EXPERIMENTAL | Alisertib with selected endocrine therapy |
| Alisertib | EXPERIMENTAL | 50 mg (Prior to Amendment 2) or 60 mg (Amendment 2) or 70 mg (Amendment 3 or later) of alisertib PO BID on days 1-7 of each 21-day cycle |
| Name | Type | Description |
|---|---|---|
| Alisertib | DRUG | Alisertib enteric-coated tablets, 30 mg BID self-administered orally on Days 1-7 of every 21-day cycle |
| Paclitaxel | DRUG | 60 mg/m\^2 IV on Days 1 and 8 of every 21-day cycle |
| Endocrine therapy | DRUG | Investigator selected endocrine therapy will be taken in 28-day dosing cycles according to the approved prescribing information. 1 mg of anastrozole tablet by mouth once daily or 2.5 mg of letrozole tablet by mouth once daily or 25 mg of exemestane tablet by mouth once daily or 20 mg of tamoxifen tablet by mouth once daily or 500 mg of fulvestrant intramuscular injection on Study Day 1, 15, 29, and once every 28 days thereafter |
Inclusion Criteria: * Aged ≥18 years at signing of informed consent * Pathologically confirmed SCLC * Prior treatment with one platinum-based chemotherapy and an anti-PD-1/PD-L1 immunotherapy. Up to one additional systemic anti-cancer therapy for SCLC is allowed, for a total of up to 2 prior treatm...
Alisertib is an investigational small molecule being studied for the treatment of small cell lung cancer (SCLC) and hormone receptor positive, HER2 negative breast cancer. It is currently in Phase 2 clinical trials for these oncology indications.
Alisertib is being developed by Puma Biotechnology Inc (NASDAQ: PBYI). The company is conducting Phase 2 clinical trials to evaluate the drug in patients with small cell lung cancer and hormone receptor positive, HER2 negative breast cancer.
Alisertib is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA. There are three ongoing Phase 2 trials studying Alisertib in small cell lung cancer and breast cancer.
Alisertib is being studied in three Phase 2 trials: NCT06095505 in extensive stage small cell lung cancer, NCT06369285 in HR-positive, HER2-negative recurrent or metastatic breast cancer, and NCT07465757 in combination with paclitaxel for small cell lung cancer.
Yes, one trial (NCT07465757) is studying Alisertib in combination with paclitaxel in patients with small cell lung cancer. Another trial (NCT06369285) is evaluating Alisertib in combination with endocrine therapy for HR-positive, HER2-negative breast cancer.
Alisertib is also known by the research code MLN8237. It is an investigational Aurora kinase A inhibitor being developed by Puma Biotechnology Inc for the treatment of certain cancers, including small cell lung cancer and breast cancer.