Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Abemaciclib · 1 trial · 7 indications
Assessed per Response Assessment in Neuro-Oncology (RANO) criteria for brain metastases. The response rate is defined as the number of patients who have achieved complete response (CR) or partial response (PR) per RANO for brain metastases criteria during treatment with CDK, PI3K, NTRK/ROS, or KRAS G12C inhibitors divided by total number of evaluable patients. The response rate and associated exact confidence interval will be estimated within each cohort defined by the targeted agent and histology.
| Arm | Type | Description |
|---|---|---|
| Arm I (CDK gene mutation) | EXPERIMENTAL | Patients receive abemaciclib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. |
| Arm II (PI3K gene mutation) | EXPERIMENTAL | Patients receive PI3K inhibitor paxalisib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. |
| Arm III (NTRK/ROS1 gene mutation) | EXPERIMENTAL | Patients receive entrectinib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. |
| Arm IV (KRAS G12C mutation) | EXPERIMENTAL | Patients receive adagrasib (MRTX849) PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. |
| Name | Type | Description |
|---|---|---|
| Abemaciclib | DRUG | Given PO |
| PI3K Inhibitor paxalisib | DRUG | Given PO |
| Entrectinib | DRUG | Given PO |
| Adagrasib | DRUG | Given PO |
Inclusion Criteria: PRE-REGISTRATION ELIGIBILITY CRITERIA (ALL PATIENTS) • Tissue available for biomarker testing (any brain metastasis tissue and extracranial site from any prior resection or biopsy). REGISTRATION ELIGIBILITY CRITERIA (ALL PATIENTS) * Participants must have histologically confir...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Tango Therapeutics, Inc. | TNGX | 1 | PHASE1 | TNG462, RMC-9805, RMC-6236, mFOLFIRINOX, gemcitabine/nab-paclitaxel |
| Pasithea Therapeutics Corp. | KTTA | 1 | PHASE1 | PAS-004 |
| Adlai Nortye Ltd. Sponsored ADR | ANL | 1 | PHASE1 | AN9025 |
| Myriad Genetics, Inc. | MYGN | 1 | PHASE1 | Melphalan, BCNU, Vitamin B12B, Vitamin C |
Abemaciclib is an investigational small molecule being studied for use in patients with CDK gene mutations, including those with brain metastases and metastatic solid neoplasms. It is currently in Phase 2 clinical development for this oncology indication.
Abemaciclib targets CDK4 and CDK6, which are cyclin-dependent kinases involved in cell cycle regulation. As a CDK inhibitor, it is designed to interfere with the activity of these targets in cancer cells.
Abemaciclib is being developed by Kazia Therapeutics Limited, a biopharmaceutical company listed on the NASDAQ under the ticker symbol KZIA. The company is conducting clinical trials to evaluate the drug's potential in oncology.
Abemaciclib is currently in Phase 2 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. The ongoing Phase 2 trial is active but not recruiting participants.
Abemaciclib is being evaluated in the clinical trial NCT03994796, titled 'Genetic Testing in Guiding Treatment for Patients With Brain Metastases.' This Phase 2 study is enrolling approximately 50 patients in the United States with CDK gene mutations and other genetic alterations.
Abemaciclib is also known by the ChEMBL identifier CHEMBL3301610. This identifier is used in chemical and biological databases to track the compound. No other alternative names have been established for this drug.