Dose Escalation Study of LGH447 in Japanese Patients With Relapsed and/or Refractory Hematologic Malignancies
Conditions
Multiple Myeloma
Conditions: official terms
Multiple Myeloma - Neoplasms, Plasma Cell
Conditions: Keywords
Multiple Myeloma,, Phase I,, PIM,, Japanese patients,, LGH447
Study Type
Interventional
Study Phase
Phase 1
Study Design
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: LGH447
Type: Drug
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: 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.
Locations
Novartis Investigative Site
Nagoya-city, Aichi, Japan
Status: Recruiting
Novartis Investigative Site
Okayama-city, Okayama, Japan
Status: Recruiting
Novartis Investigative Site
Koto, Tokyo, Japan
Status: Recruiting
Novartis Investigative Site
Kyoto, Japan
Status: Recruiting
Start Date
September 2014
Completion Date
February 2018
Sponsors
Novartis Pharmaceuticals
Source
Novartis
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page