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

NCT ID: NCT02160951

Last Updated: 2020-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2016-05-31

Brief Summary

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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

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Conditions

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Multiple Myeloma

Keywords

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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LGH447

LGH447, QD

Group Type EXPERIMENTAL

LGH447

Intervention Type DRUG

LGH447, QD

Interventions

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LGH447

LGH447, QD

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Nagoya, Aichi-ken, Japan

Site Status

Novartis Investigative Site

Kobe, Hyōgo, Japan

Site Status

Novartis Investigative Site

Kyoto, Kyoto, Japan

Site Status

Novartis Investigative Site

Okayama, Okayama-ken, Japan

Site Status

Countries

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Japan

References

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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.

Reference Type DERIVED
PMID: 33638035 (View on PubMed)

Related Links

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https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=15748

Results for CLGH447X1101 can be found on the Novartis Clinical Trial Results Website

Other Identifiers

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CLGH447X1101

Identifier Type: -

Identifier Source: org_study_id