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Study of Oral Ixazomib in Adult Participants With Relapsed or Refractory Light Chain Amyloidosis

NCT01318902 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2020-04-01

Study results available
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Summary

This study will include participants with previously treated systemic relapsed or refractory light-chain (AL) amyloidosis who require further therapy and will be aimed at determining the safety profile and the maximum tolerated dose/recommended phase 2 dose of MLN9078 (Ixazomib) administered orally.

Conditions

  • Light-Chain Amyloidosis

Interventions

DRUG

Ixazomib

Ixazomib capsules.

DRUG

Dexamethasone

Dexamethasone tablets.

Sponsors & Collaborators

  • Millennium Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Medical Monitor · Millennium Pharmaceuticals, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-04-27
Primary Completion
2018-11-13
Completion
2018-11-13

Countries

  • United States
  • Canada
  • France
  • Germany
  • Italy

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01318902 on ClinicalTrials.gov