Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03994796 | Genetic Testing in Guiding Treatment for Patients With Brain Metastases | PHASE2 | ACTIVE NOT_RECRUITING | 50 | — | — | Oct 17, 2019 | Jun 1, 2028 | Apr 13, 2026 | 435 | United States |
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 |
| Myriad Genetics, Inc. | MYGN | 1 | PHASE1 | Melphalan, BCNU, Vitamin B12B, Vitamin C |
| Adlai Nortye Ltd. Sponsored ADR | ANL | 1 | PHASE1 | AN9025 |
| Pasithea Therapeutics Corp. | KTTA | 1 | PHASE1 | PAS-004 |