Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Entrectinib
Entrectinib Test Formulation · 1 trial · 1 indication
The area under the concentration-time curve extrapolated to infinity is calculated using the formula: AUC0-inf = AUC0-t + (Ct/λz) where Ct is the last measurable concentration and λz is the apparent terminal elimination rate constant. The presented values in the table are based on all 14 participants receiving the F1 formulation in a 2-way crossover pattern.
The area under the concentration-time curve calculated from Hour 0 to the last measurable concentration, calculated using the linear trapezoidal rule for increasing concentrations and the logarithmic rule for decreasing concentrations. The presented values in the table are based on all 14 participants receiving the F1 formulation in a 2-way crossover pattern.
The presented values in the table are based on all 14 participants receiving the F1 formulation in a 2-way crossover pattern.
| Arm | Type | Description |
|---|---|---|
| F1 to F06 Crossover | EXPERIMENTAL | Participants first randomized to this arm will receive a single oral dose of entrectinib F1 (test formulation) on Day 1 of Period 1 after a standardized meal. This dose will be followed by a minimum 14-day washout period, after which participants will receive a single oral dose of entrectinib F06 (reference formulation) under fasted conditions on Day 1 of Period 2 (Periods 1 and 2 = 6 days). |
| F06 to F1 Crossover | EXPERIMENTAL | Participants first randomized to this arm will receive a single oral dose of entrectinib F06 (reference formulation) on Day 1 of Period 1 after a standardized meal. This dose will be followed by a minimum 14-day washout period, after which participants will receive a single oral dose of entrectinib F1 (test formulation) under fasted conditions on Day 1 of Period 2 (Periods 1 and 2 = 6 days). |
| Name | Type | Description |
|---|---|---|
| Entrectinib Test Formulation (F1) | DRUG | Participants will receive a single oral dose of entrectinib F1 after completion of a standardized meal. |
| Entrectinib Reference Formulation (F06) | DRUG | Participants will receive a single oral dose of entrectinib F06 after completion of a standardized meal. |
Inclusion Criteria: * Healthy in the opinion of the investigator. Healthy is defined by the absence of evidence of any active disease or clinically significant medical condition based on a detailed medical history and examination * Negative test results for Hepatitis B, Hepatitis C, and Human Immun...
Entrectinib is an investigational small molecule being studied for the treatment of various cancers, including locally advanced solid tumors, advanced unresectable or metastatic solid malignancies, solid tumors, carcinoma, and non-small-cell lung cancer. It is also being evaluated in pediatric patients with solid or primary CNS tumors who have no satisfactory treatment options.
Entrectinib is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company is conducting clinical trials to evaluate the drug's safety and efficacy in multiple oncology indications.
Entrectinib is in clinical development, with trials listed as Phase 1, Phase 2, and Phase 3. It is an investigational drug and has not been approved by the FDA. The ongoing studies include a Phase 1 trial in children and adolescents and a Phase 3 trial in non-small-cell lung cancer.
Entrectinib is being studied in several clinical trials, including NCT02650401, a Phase 1 study in children and adolescents with solid or CNS tumors; NCT03961100, a completed Phase 1 bioavailability study in healthy volunteers; NCT04589845, a Phase 2 platform study in solid tumors; and NCT04603807, a Phase 3 trial comparing Entrectinib to crizotinib in ROS1-positive NSCLC.
Entrectinib is a kinase inhibitor, belonging to the -tinib class of drugs. It works by targeting and inhibiting specific kinases involved in tumor growth. The drug is being evaluated for its ability to block these molecular targets in various solid tumors and non-small-cell lung cancer.
Yes, Entrectinib is also known as RXDX-101. The Phase 1 clinical trial NCT02650401, which studies the drug in children and adolescents with locally advanced or metastatic solid or primary CNS tumors, refers to Entrectinib as RXDX-101 in its title.