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A Phase 1 Study of IXAZOMIB in Adult Patients With Advanced Nonhematologic Malignancies

NCT00830869 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 116

Last updated 2019-09-09

Study results available
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Summary

This is an open-label, multicenter, phase 1, dose escalation study of IXAZOMIB. The primary purpose of this study is to determine the safety profile, establish the maximum tolerated dose, and inform the phase 2 dose of IXAZOMIB administered intravenously in participants with nonhematologic malignancies.

Conditions

  • Advanced Non-hematologic Malignancies

Interventions

DRUG

IXAZOMIB

All participants will receive IXAZOMIB IV injection on Days 1, 4, 8, and 11 of each treatment cycle followed by a rest period of 10 days. The first stage of the study will be initiated at a starting dose of 0.125 mg/m\^2. Subsequent doses will increase until a maximum tolerated dose (MTD) is established.

Sponsors & Collaborators

  • Millennium Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Medical Monitor · Millennium Pharmaceuticals, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-02
Primary Completion
2012-04-20
Completion
2012-04-20
FDA Drug
Yes

Countries

  • United States
  • Canada

Study Locations

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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 NCT00830869 on ClinicalTrials.gov