- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02160951
Dose Escalation Study of LGH447 in Japanese Patients With Relapsed and/or Refractory Hematologic Malignancies
A Multi-center, Open-label, Dose Escalation, Phase 1 Study of Oral LGH447 in Japanese Patients With Relapsed and/or Refractory Hematologic Malignancies
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 Overview
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Aichi
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Nagoya-city, Aichi, Japan, 467-8602
- Novartis Investigative Site
-
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Hyogo
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Kobe-city, Hyogo, Japan, 650-0017
- Novartis Investigative Site
-
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Kyoto
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Kyoto-city, Kyoto, Japan, 602-8566
- Novartis Investigative Site
-
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Okayama
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Okayama-city, Okayama, Japan, 701-1192
- Novartis Investigative Site
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: LGH447
LGH447, QD
|
LGH447, QD
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
28 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of patients with adverse events as a measure of safety and tolerability of LGH447
Time Frame: 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
|
28 days and till the end of the study, an average of 84 days
|
Pharmacokinetics profile of LGH447 and its metabolites if appropriate
Time Frame: 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
|
Baseline, 0.5, 1, 2, 3, 4, 5, 6, 8, 24 hours on Cycle1Day1, 14 and 28 and baseline on Cycle2Day14 and Cycle3Day1
|
Overall Response Rate
Time Frame: 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.
|
Every 28 days till the end of the study, an average of 84 days
|
Disease control rate
Time Frame: 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.
|
Every 28 days till the end of the study, an average of 84 days
|
Clinical benefit rate
Time Frame: 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.
|
Every 28 days till the end of the study, an average of 84 days
|
Duration of Response
Time Frame: 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.
|
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
|
Progression Free Survival
Time Frame: 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.
|
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
Time Frame: 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.
|
Every 28 days till the end of the study, an average of 84 days, from start of treatment until first documented best overall response
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Immunoproliferative Disorders
- Neoplasms by Site
- Hematologic Diseases
- Hemorrhagic Disorders
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Neoplasms, Plasma Cell
- Hematologic Neoplasms
- Multiple Myeloma
Other Study ID Numbers
- CLGH447X1101
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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