Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
LDK378 · 8 trials · 7 indications
ORR, defined as the percentage of participants with a best overall confirmed response of complete response (CR) or partial response (PR) in the whole body as assessed per RECIST 1.1 by the investigator. CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm; PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
ORR per RECIST 1.1 calculated as the percentage of participants with a best overall response (OR) defined as complete response (CR) or partial response (PR) as assessed by the investigator. CR:Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
ORR per RECIST 1.1 calculated as the percentage of patients with a best overall confirmed response defined as complete response or partial response (CR+PR) as assessed by investigator. CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm 1. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
AUClast: The area under the concentration-time curve from time zero to the last measurable concentration time. AUC0-24h: The area under the plasma concentration-time curve calculated from time zero to 24 hours. AUCinf: Area under the plasma (serum, or blood) concentration versus time curve from time zero to infinity
AUC0-24h: The area under the plasma concentration-time curve calculated from time zero to 24 hours.
Cmax is the maximum (peak) concentration of drug in plasma
Tmax is the time to reach maximum plasma concentration.
Safety and tolerability of LDK378 at 750 mg once daily dose in Chinese adult patients with ALK-rearranged locally advanced or metastatic NSCLC
Evaluate the pharmacokinetics of a single dose of LDK378 in subjects with impaired hepatic function as compared to healthy subjects
Evaluate the pharmacokinetics of a single dose of LDK378 in subjects with impaired hepatic function as compared to healthy subjects
Evaluate the pharmacokinetics of a single dose of LDK378 in subjects with impaired hepatic function as compared to healthy subjects
Evaluate the pharmacokinetics of a single dose of LDK378 in subjects with impaired hepatic function as compared to healthy subjects
Evaluate the pharmacokinetics of a single dose of LDK378 in subjects with impaired hepatic function as compared to healthy subjects
Evaluate the pharmacokinetics of a single dose of LDK378 in subjects with impaired hepatic function as compared to healthy subjects
Evaluate the pharmacokinetics of a single dose of LDK378 in subjects with impaired hepatic function as compared to healthy subjects
cycle = within the first 28 days of patient's first dose
As a single agent when administered orally to Japanese patients with tumors characterized by genetic alterations in ALK. The number of patients and category of Dose Limiting Toxicities (DLTs)
The maximum tolerated dose (MTD) was defined as the highest dose for a given schedule that was expected to cause DLTs in no more than 33% of patients during the first cycle of treatment. A patient with multiple occurrences of a DLT under one treatment is counted only once in the AE category for that treatment. MTD was determined at 750mg.
| Arm | Type | Description |
|---|---|---|
| LDK378 (Ceritinib) | EXPERIMENTAL | Participants who received LDK378 750mg once daily on a 28 day cycle. |
| LDK378 | EXPERIMENTAL | Patients treated with ceritinib/LDK378 750 mg once-daily, fasted |
| Normal Hepatic Function | EXPERIMENTAL | Subjects with normal hepatic function |
| Mild Hepatic Impairment | EXPERIMENTAL | Subjects with mild hepatic impairment |
| Moderate Hepatic Impairment | EXPERIMENTAL | Subjects with moderate hepatic impairment |
| Severe Hepatic Impairment | EXPERIMENTAL | Subjects with severe hepatic impairment |
| LDK378 and AUY922 | EXPERIMENTAL | - |
| Dose-escalation | EXPERIMENTAL | Open-label dose escalation study of LDK378, administered orally in Japanese patients with tumors characterized by genetic alterations in anaplastic lymphoma kinase (ALK) |
| Dose-expansion | EXPERIMENTAL | Open-label study of LDK378, administered orally in Japanese patients with tumors characterized by genetic alterations in ALK to see further safety, anti-tumor activity, and PK data in patients who has progressed since prior therapy with alectinib |
| LDK378 750 mg: Arm 1A and Arm 1B | EXPERIMENTAL | NSCLC patients previously treated with an ALK inhibitor |
| LDK378 750 mg: Arm 2 | EXPERIMENTAL | NSCLC patients not previously treated with an ALK inhibitor |
| LDK378 750 mg: Arm 3 | EXPERIMENTAL | Patients with other tumors that are ALK positive other than NSCLC |
| Name | Type | Description |
|---|---|---|
| LDK378 | DRUG | Oral LDK378 750mg once daily |
| AUY922 | DRUG | AUY922 is an intravenous infusion that will be administered by the investigative site to the patient on a weekly basis. |
Key Inclusion Criteria: * Histologically or cytologically confirmed diagnosis of Stage IIIb or IV NSCLC that carries an ALK rearrangement as determined locally by Vysis ALK Break Apart FISH Probe Kit (Abbott Molecular Inc.) test. * Patients must have NSCLC that has progressed at study enrollment. *...
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LDK378 is an investigational small molecule being studied for the treatment of tumors characterized by genetic alterations in anaplastic lymphoma kinase (ALK), including non-small-cell lung cancer (NSCLC). It is being developed by Novartis AG (NVS) and is currently in clinical trials, though it is not yet approved.
LDK378 targets the anaplastic lymphoma kinase (ALK) protein. It is designed to treat cancers, particularly non-small-cell lung cancer, that have genetic alterations or abnormalities in ALK. The drug is being studied in patients whose tumors harbor these specific genetic changes.
LDK378 is being developed by Novartis AG, a global pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. Novartis is conducting clinical trials to evaluate the safety and efficacy of LDK378 in patients with ALK-altered tumors.
LDK378 is in Phase 1 and Phase 2 clinical trials. The drug is investigational and has not been approved by regulatory authorities. It is being studied in early-stage trials to assess dosing, safety, and preliminary efficacy in patients with ALK-positive tumors.
LDK378 has been studied in several completed clinical trials, including NCT01283516, a Phase 1 dose escalation/expansion study in patients with ALK genetic abnormalities; NCT01772797, a Phase 1b study combining LDK378 with AUY922 in ALK-rearranged NSCLC; and NCT01950481, a pharmacokinetic study in hepatic impairment.
LDK378 is also known as ceritinib, an ALK inhibitor developed by Novartis. While the data provided does not explicitly state this alternative name, LDK378 is the investigational code for the drug that is commonly referred to as ceritinib in medical literature.