A Multi-center, Open-label, Dose Escalation, Phase 1 Study of Oral LGH447 in Japanese Patients With Relapsed and/or Refractory Hematologic Malignancies

简要总结

主要结局

次要结局

• 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)