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Pharmacokinetics Study of Oral IXAZOMIB in Participants With Advanced Nonhematologic Malignancies or Lymphoma

NCT01454076 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 112

Last updated 2017-11-01

Study results available
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Summary

This is an open-label, multicenter, sequential, 5-arm, phase 1 study of oral IXAZOMIB designed to assess drug-drug interaction with ketoconazole (Arm 1), the relative bioavailability of 2 capsule formulations of IXAZOMIB (Arm 2), food effect (Arm 3), drug-drug interaction with rifampin (Arm 4), and drug-drug interaction with clarithromycin (Arm 5) in participants with advanced nonhematologic malignancies or lymphoma.

Conditions

Interventions

DRUG

Ixazomib 2.5 mg

Ixazomib 2.5 mg Capsule B (Cycle 1 only)

DRUG

Ixazomib 4 mg Capsule A

Ixazomib 4 mg Capsule A (Cycle 1 only)

DRUG

Ixazomib 4 mg Capsule B

Ixazomib 4 mg Capsule B (Cycle 2 and beyond )

DRUG

Ketoconazole

Ketoconazole 400 mg tablets (Cycle 1 only)

DRUG

Rifampin

Rifampin 600 mg capsule (Cycle 1 only)

DRUG

Clarithromycin

Clarithromycin 500 mg tablets (Cycle 1 only)

DRUG

Ixazomib 4 mg Capsule B

Ixazomib 4 mg Capsule B (Cycle 1 and beyond)

Sponsors & Collaborators

  • Millennium Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Medical Monitor · Millennium Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-10
Primary Completion
2015-04-01
Completion
2016-06-16
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

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 NCT01454076 on ClinicalTrials.gov