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

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ClinicalTrials.gov Identifier: NCT02160951
Recruitment Status : Completed
First Posted : June 11, 2014
Last Update Posted : February 2, 2017
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Tracking Information
First Submitted Date  ICMJE May 30, 2014
First Posted Date  ICMJE June 11, 2014
Last Update Posted Date February 2, 2017
Study Start Date  ICMJE September 2014
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 9, 2014)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02160951 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 9, 2014)
  • 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
  • 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
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dose Escalation Study of LGH447 in Japanese Patients With Relapsed and/or Refractory Hematologic Malignancies
Official Title  ICMJE A Multi-center, Open-label, Dose Escalation, Phase 1 Study of Oral LGH447 in Japanese Patients With Relapsed and/or Refractory Hematologic Malignancies
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Multiple Myeloma
Intervention  ICMJE Drug: LGH447
LGH447, QD
Study Arms  ICMJE Experimental: LGH447
LGH447, QD
Intervention: Drug: LGH447
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 1, 2016)
13
Original Estimated Enrollment  ICMJE
 (submitted: June 9, 2014)
27
Actual Study Completion Date  ICMJE May 2016
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02160951
Other Study ID Numbers  ICMJE CLGH447X1101
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Novartis ( Novartis Pharmaceuticals )
Study Sponsor  ICMJE Novartis Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
PRS Account Novartis
Verification Date January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP