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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 : December 17, 2020
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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.


Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: LGH447 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : September 2014
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arm Intervention/treatment
Experimental: LGH447
LGH447, QD
Drug: LGH447
LGH447, QD




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02160951


Locations
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Japan
Novartis Investigative Site
Nagoya-city, Aichi, Japan, 467-8602
Novartis Investigative Site
Kobe-city, Hyogo, Japan, 650-0017
Novartis Investigative Site
Kyoto-city, Kyoto, Japan, 602-8566
Novartis Investigative Site
Okayama-city, Okayama, Japan, 701-1192
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02160951    
Other Study ID Numbers: CLGH447X1101
First Posted: June 11, 2014    Key Record Dates
Last Update Posted: December 17, 2020
Last Verified: January 2017
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Multiple Myeloma,
Phase I,
PIM,
Japanese patients,
LGH447
Additional relevant MeSH terms:
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Multiple Myeloma
Hematologic Neoplasms
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Neoplasms by Site