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Dose Escalation Study of LGH447 in Japanese Patients With Relapsed and/or Refractory Hematologic Malignancies

Primary Purpose

Multiple Myeloma

Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
LGH447
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring Multiple Myeloma,, Phase I,, PIM,, Japanese patients,, LGH447

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

LGH447

Arm Description

LGH447, QD

Outcomes

Primary Outcome Measures

Incidence rate of dose limiting toxicities
Estimate the maximum tolerated dose and/or recommended dose for expansion of LGH447 in Japanese patients

Secondary Outcome Measures

Number of patients with adverse events as a measure of safety and tolerability of LGH447
Adverse events, serious adverse events, changes in laboratory values, and electrocardiograms
Pharmacokinetics profile of LGH447 and its metabolites if appropriate
PK parameters such as AUC, Cmax, Tmax, T1/2. Cycle = 28 days
Overall Response Rate
Describe any preliminary anti-cancer activity associated with LGH447 based on International Myeloma Working group Criteria with modification.
Disease control rate
Describe any preliminary anti-cancer activity associated with LGH447 based on International Myeloma Working group Criteria with modification.
Clinical benefit rate
Describe any preliminary anti-cancer activity associated with LGH447 based on International Myeloma Working group Criteria with modification.
Duration of Response
Describe any preliminary anti-cancer activity associated with LGH447 based on International Myeloma Working group Criteria with modification.
Progression Free Survival
Describe any preliminary anti-cancer activity associated with LGH447 based on International Myeloma Working group Criteria with modification.
Time to response
Describe any preliminary anti-cancer activity associated with LGH447 based on International Myeloma Working group Criteria with modification.

Full Information

First Posted
May 30, 2014
Last Updated
December 16, 2020
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT02160951
Brief Title
Dose Escalation Study of LGH447 in Japanese Patients With Relapsed and/or Refractory Hematologic Malignancies
Official Title
A Multi-center, Open-label, Dose Escalation, Phase 1 Study of Oral LGH447 in Japanese Patients With Relapsed and/or Refractory Hematologic Malignancies
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
Multiple Myeloma,, Phase I,, PIM,, Japanese patients,, LGH447

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LGH447
Arm Type
Experimental
Arm Description
LGH447, QD
Intervention Type
Drug
Intervention Name(s)
LGH447
Intervention Description
LGH447, QD
Primary Outcome Measure Information:
Title
Incidence rate of dose limiting toxicities
Description
Estimate the maximum tolerated dose and/or recommended dose for expansion of LGH447 in Japanese patients
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Number of patients with adverse events as a measure of safety and tolerability of LGH447
Description
Adverse events, serious adverse events, changes in laboratory values, and electrocardiograms
Time Frame
28 days and till the end of the study, an average of 84 days
Title
Pharmacokinetics profile of LGH447 and its metabolites if appropriate
Description
PK parameters such as AUC, Cmax, Tmax, T1/2. Cycle = 28 days
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
Title
Overall Response Rate
Description
Describe any preliminary anti-cancer activity associated with LGH447 based on International Myeloma Working group Criteria with modification.
Time Frame
Every 28 days till the end of the study, an average of 84 days
Title
Disease control rate
Description
Describe any preliminary anti-cancer activity associated with LGH447 based on International Myeloma Working group Criteria with modification.
Time Frame
Every 28 days till the end of the study, an average of 84 days
Title
Clinical benefit rate
Description
Describe any preliminary anti-cancer activity associated with LGH447 based on International Myeloma Working group Criteria with modification.
Time Frame
Every 28 days till the end of the study, an average of 84 days
Title
Duration of Response
Description
Describe any preliminary anti-cancer activity associated with LGH447 based on International Myeloma Working group Criteria with modification.
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
Title
Progression Free Survival
Description
Describe any preliminary anti-cancer activity associated with LGH447 based on International Myeloma Working group Criteria with modification.
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
Title
Time to response
Description
Describe any preliminary anti-cancer activity associated with LGH447 based on International Myeloma Working group Criteria with modification.
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Nagoya-city
State/Province
Aichi
ZIP/Postal Code
467-8602
Country
Japan
Facility Name
Novartis Investigative Site
City
Kobe-city
State/Province
Hyogo
ZIP/Postal Code
650-0017
Country
Japan
Facility Name
Novartis Investigative Site
City
Kyoto-city
State/Province
Kyoto
ZIP/Postal Code
602-8566
Country
Japan
Facility Name
Novartis Investigative Site
City
Okayama-city
State/Province
Okayama
ZIP/Postal Code
701-1192
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
33638035
Citation
Iida S, Sunami K, Minami H, Hatake K, Sekiguchi R, Natsume K, Ishikawa N, Rinne M, Taniwaki M. A phase I, dose-escalation study of oral PIM447 in Japanese patients with relapsed and/or refractory multiple myeloma. Int J Hematol. 2021 Jun;113(6):797-806. doi: 10.1007/s12185-021-03096-9. Epub 2021 Feb 27.
Results Reference
derived
Links:
URL
https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=15748
Description
Results for CLGH447X1101 can be found on the Novartis Clinical Trial Results Website

Learn more about this trial

Dose Escalation Study of LGH447 in Japanese Patients With Relapsed and/or Refractory Hematologic Malignancies

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