NCT02160951
Completed
Phase 1
A Multi-center, Open-label, Dose Escalation, Phase 1 Study of Oral LGH447 in Japanese Patients With Relapsed and/or Refractory Hematologic Malignancies
Overview
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Novartis Pharmaceuticals
- Enrollment
- 13
- Locations
- 1
- Primary Endpoint
- Incidence rate of dose limiting toxicities
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
LGH447
Experimental
LGH447, QD
Intervention: LGH447 (Drug)
Outcomes
Primary Outcomes
Incidence rate of dose limiting toxicities
Time Frame: 28 days
Estimate the maximum tolerated dose and/or recommended dose for expansion of LGH447 in Japanese patients
Secondary Outcomes
- 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)
- 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)
- 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)
- Overall Response Rate(Every 28 days till the end of the study, an average of 84 days)
- Disease control rate(Every 28 days till the end of the study, an average of 84 days)
- Clinical benefit rate(Every 28 days till the end of the study, an average of 84 days)
- 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)
- 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)
Investigators
Study Sites (1)
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