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NCT Number: NCT02160951

Dose Escalation Study of 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.

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Key information

Conditions

Multiple Myeloma Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novartis Investigative Site, Nagoya, Aichi-ken, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

LGH447

Drug

LGH447, QD

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

A Multi-center, Open-label, Dose Escalation, Phase 1 Study of Oral LGH447 in Japanese Patients With Relapsed and/or Refractory Hematologic Malignancies

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jun 11, 2014
Registry last updated
Dec 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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