Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Mobocertinib · 3 trials · 4 indications
Terminal elimination rate constant (λz) is a mathematical estimate calculated using log-linear regression of the terminal portions of a plasma concentration against time curve.
Terminal elimination rate constant (λz) is a mathematical estimate calculated using log-linear regression of the terminal portions of a plasma concentration against time curve.
The RP2D was the maximum tolerated dose (MTD) or less. The MTD was declared when at least 9 participants were evaluable in the study and 6 participants were evaluable at the current dose, and the current dose was recommended for the next cohort. The dose recommended for use in phase 2 part was analyzed on the basis of the safety and tolerability data obtained in phase 1 part of the study.
Confirmed ORR is defined as percentage of participants who were confirmed to had achieved complete response (CR) or partial response (PR) per IRC using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 after the initiation of study treatment. Confirmed responses were responses that persisted on repeat imaging \>=4 weeks after initial response. CR (target lesion response): disappearance of all extranodal target lesions, all pathological lymph nodes must have decreased to \<10 millimeter (mm) in short axis. CR (non-target lesion response): disappearance of all extranodal nontarget lesions, all lymph nodes must be nonpathological in size (\<10 mm short axis) and normalization of tumor marker level. PR (target lesions): at least 30% decrease in sum of the longest diameters (SLD) of target lesions, taking as reference baseline sum diameters. The SLD must also demonstrate an absolute increase of at least 5 mm.
| Arm | Type | Description |
|---|---|---|
| Moderate HI (Child-Pugh B): Mobocertinib 40 mg | EXPERIMENTAL | Mobocertinib 40 milligram (mg), capsule, orally, a single dose on Day 1. |
| Severe HI (Child-Pugh C): Mobocertinib 40 mg | EXPERIMENTAL | Mobocertinib 40 mg, capsule, orally, a single dose on Day 1. |
| Normal Hepatic Function: Mobocertinib 40 mg | EXPERIMENTAL | Mobocertinib 40 mg, capsule, orally, a single dose on Day 1. |
| Severe Renal Impairment: Mobocertinib 80 mg | EXPERIMENTAL | Participants with severe renal impairment received a single dose of mobocertinib 80 mg, capsule, orally, on Day 1. |
| Normal Renal Function: Mobocertinib 80 mg | EXPERIMENTAL | Participants with normal renal function received a single dose of mobocertinib 80 mg, capsule, orally, on Day 1. |
| Mobocertinib, Phase 1 Part | EXPERIMENTAL | Mobocertinib 40 milligrams (mg) (as the starting dose), capsules, orally, once daily on Days 1-28 of each 28-day treatment cycle for up to disease progression or intolerable toxicity, or another discontinuation criterion, and increasing until 160 mg, once daily (for up to approximately 10-12 cycles). |
| Mobocertinib, Phase 2 Part | EXPERIMENTAL | Mobocertinib 160 mg, once daily, for up to approximately 10-12 cycles. |
| Name | Type | Description |
|---|---|---|
| Mobocertinib | DRUG | Mobocertinib capsule. |
Inclusion Criteria: Inclusion Criteria for Healthy Participants 1. Continuous non-smoker or moderate smoker (less than or equal to (\<=) 10 cigarettes/day or the equivalent) before screening. Participant must agree to consume no more than 5 cigarettes or equivalent/day from the 7 days prior to mob...
Mobocertinib is being studied for use in non-small cell lung cancer, renal impairment, and hepatic impairment. It is an investigational small molecule being evaluated in clinical trials for these conditions. The drug is not approved and remains in clinical development.
Mobocertinib is a kinase inhibitor, belonging to the -tinib class of drugs. Kinase inhibitors work by blocking specific enzymes involved in cell signaling. The drug is being studied in patients with non-small cell lung cancer, where kinase pathways are often implicated in tumor growth.
Mobocertinib is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. Takeda is conducting clinical trials to evaluate the drug's safety and efficacy in various patient populations.
Mobocertinib is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The ongoing Phase 1 trials are assessing the drug in patients with non-small cell lung cancer, as well as in people with kidney or liver problems.
Mobocertinib has been studied in several Phase 1 trials. NCT03807778 is an active study in Japanese adults with non-small cell lung cancer. NCT04056455, a completed study, evaluated the drug in people with severe kidney problems and healthy volunteers. NCT04056468, also completed, assessed the drug in participants with moderate or severe hepatic impairment.
Mobocertinib is an investigational small molecule being developed by Takeda for non-small cell lung cancer. It is also being studied in people with renal and hepatic impairment to understand how the body processes the drug. The drug is currently in Phase 1 trials.