Multiple Myeloma
Conditions
Keywords
Multiple Myeloma,, Phase I,, PIM,, Japanese patients,, LGH447
Brief summary
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.
Interventions
DRUGLGH447
LGH447, QD
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
-Confirmed diagnosis of relapsed and/or refractory MM for which no standard effective treatment options exist.
Exclusion criteria
-Uncontrolled cardiovascular condition, including ongoing cardiac arrhythmias, congestive heart failure, angina, or myocardial infarction within the past 6 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence rate of dose limiting toxicities | 28 days | Estimate the maximum tolerated dose and/or recommended dose for expansion of LGH447 in Japanese patients |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics profile of LGH447 and its metabolites if appropriate | Baseline, 0.5, 1, 2, 3, 4, 5, 6, 8, 24 hours on Cycle1Day1, 14 and 28 and baseline on Cycle2Day14 and Cycle3Day1 | PK parameters such as AUC, Cmax, Tmax, T1/2. Cycle = 28 days |
| Overall Response Rate | Every 28 days till the end of the study, an average of 84 days | Describe any preliminary anti-cancer activity associated with LGH447 based on International Myeloma Working group Criteria with modification. |
| Disease control rate | Every 28 days till the end of the study, an average of 84 days | Describe any preliminary anti-cancer activity associated with LGH447 based on International Myeloma Working group Criteria with modification. |
| Number of patients with adverse events as a measure of safety and tolerability of LGH447 | 28 days and till the end of the study, an average of 84 days | Adverse events, serious adverse events, changes in laboratory values, and electrocardiograms |
| Duration of Response | 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 | Describe any preliminary anti-cancer activity associated with LGH447 based on International Myeloma Working group Criteria with modification. |
| Progression Free Survival | 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 | Describe any preliminary anti-cancer activity associated with LGH447 based on International Myeloma Working group Criteria with modification. |
| Time to response | Every 28 days till the end of the study, an average of 84 days, from start of treatment until first documented best overall response | Describe any preliminary anti-cancer activity associated with LGH447 based on International Myeloma Working group Criteria with modification. |
| Clinical benefit rate | Every 28 days till the end of the study, an average of 84 days | Describe any preliminary anti-cancer activity associated with LGH447 based on International Myeloma Working group Criteria with modification. |
Countries
Japan
Outcome results
None listed