This is a multi-center, open-label, dose escalation, Phase 1 study of oral LGH447 in Japanese patients with relapsed and/or refractory multiple myeloma for which no standard effective treatment options exist. The study consists of a dose escalation part to estimate the maximum tolerated dose and/or the recommended dose for expansion and a dose expansion part to further assess safety and preliminary anti-cancer activity of LGH447 at the maximum tolerated dose and/or the recommended dose for expansion.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
13
LGH447, QD
Novartis Investigative Site
Nagoya, Aichi-ken, Japan
Novartis Investigative Site
Kobe, Hyōgo, Japan
Novartis Investigative Site
Kyoto, Kyoto, Japan
Novartis Investigative Site
Okayama, Okayama-ken, Japan
Incidence rate of dose limiting toxicities
Estimate the maximum tolerated dose and/or recommended dose for expansion of LGH447 in Japanese patients
Time frame: 28 days
Number of patients with adverse events as a measure of safety and tolerability of LGH447
Adverse events, serious adverse events, changes in laboratory values, and electrocardiograms
Time frame: 28 days and till the end of the study, an average of 84 days
Pharmacokinetics profile of LGH447 and its metabolites if appropriate
PK parameters such as AUC, Cmax, Tmax, T1/2. Cycle = 28 days
Time frame: Baseline, 0.5, 1, 2, 3, 4, 5, 6, 8, 24 hours on Cycle1Day1, 14 and 28 and baseline on Cycle2Day14 and Cycle3Day1
Overall Response Rate
Describe any preliminary anti-cancer activity associated with LGH447 based on International Myeloma Working group Criteria with modification.
Time frame: Every 28 days till the end of the study, an average of 84 days
Disease control rate
Describe any preliminary anti-cancer activity associated with LGH447 based on International Myeloma Working group Criteria with modification.
Time frame: Every 28 days till the end of the study, an average of 84 days
Clinical benefit rate
Describe any preliminary anti-cancer activity associated with LGH447 based on International Myeloma Working group Criteria with modification.
Time frame: Every 28 days till the end of the study, an average of 84 days
Duration of Response
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Describe any preliminary anti-cancer activity associated with LGH447 based on International Myeloma Working group Criteria with modification.
Time frame: Every 28 days till the end of the study, an average of 84 days, from the first documented onset of confirmed PR or better response to the date of documented disease progression/relapse or death due to multiple myeloma
Progression Free Survival
Describe any preliminary anti-cancer activity associated with LGH447 based on International Myeloma Working group Criteria with modification.
Time frame: Every 28 days till the end of the study, an average of 84 days, from start of treatment to the date of event defined as the first documented disease progression/relapse, or death due to any cause
Time to response
Describe any preliminary anti-cancer activity associated with LGH447 based on International Myeloma Working group Criteria with modification.
Time frame: Every 28 days till the end of the study, an average of 84 days, from start of treatment until first documented best overall response