Dose Escalation Study of LGH447 in Japanese Patients With Relapsed and/or Refractory Hematologic Malignancies
- Registration Number
- NCT02160951
- Lead Sponsor
- Novartis Pharmaceuticals
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 13
-Confirmed diagnosis of relapsed and/or refractory MM for which no standard effective treatment options exist.
-Uncontrolled cardiovascular condition, including ongoing cardiac arrhythmias, congestive heart failure, angina, or myocardial infarction within the past 6 months.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description LGH447 LGH447 LGH447, QD
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
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.
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.
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.
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.
Trial Locations
- Locations (1)
Novartis Investigative Site
🇯🇵Okayama-city, Okayama, Japan