NCT02160951

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for phase_1 multiple-myeloma

Timeline
Completed

Started Sep 2014

Shorter than P25 for phase_1 multiple-myeloma

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 30, 2014

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 11, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

December 17, 2020

Status Verified

January 1, 2017

Enrollment Period

1.7 years

First QC Date

May 30, 2014

Last Update Submit

December 16, 2020

Conditions

Multiple Myeloma

Keywords

Multiple Myeloma,Phase I,PIM,Japanese patients,LGH447

Outcome Measures

Primary Outcomes (1)

  • Incidence rate of dose limiting toxicities

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

    28 days

Secondary Outcomes (8)

  • Number of patients with adverse events as a measure of safety and tolerability of LGH447

    28 days and till the end of the study, an average of 84 days

  • Pharmacokinetics profile of LGH447 and its metabolites if appropriate

    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

    Every 28 days till the end of the study, an average of 84 days

  • Disease control rate

    Every 28 days till the end of the study, an average of 84 days

  • Clinical benefit rate

    Every 28 days till the end of the study, an average of 84 days

  • +3 more secondary outcomes

Study Arms (1)

LGH447

EXPERIMENTAL

LGH447, QD

Drug: LGH447

Interventions

LGH447DRUG

LGH447, QD

LGH447

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Confirmed diagnosis of relapsed and/or refractory MM for which no standard effective treatment options exist.

You may not qualify if:

  • Uncontrolled cardiovascular condition, including ongoing cardiac arrhythmias, congestive heart failure, angina, or myocardial infarction within the past 6 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Novartis Investigative Site

Nagoya, Aichi-ken, 467-8602, Japan

Location

Novartis Investigative Site

Kobe, Hyōgo, 650-0017, Japan

Location

Novartis Investigative Site

Kyoto, Kyoto, 602-8566, Japan

Location

Novartis Investigative Site

Okayama, Okayama-ken, 701-1192, Japan

Location

Related Publications (1)

  • 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.

    PMID: 33638035DERIVED

Related Links

MeSH Terms

Conditions

Multiple Myeloma

Interventions

LGH-447

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 30, 2014

First Posted

June 11, 2014

Study Start

September 1, 2014

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

December 17, 2020

Record last verified: 2017-01

Locations

JP(4)