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Pharmacokinetics Study of Oral IXAZOMIB in Participants With Advanced Nonhematologic Malignancies or Lymphoma | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

A Phase 1 Study of Oral IXAZOMIB (MLN9708) to Assess Relative Bioavailability, Food Effect, Drug-Drug Interaction With Ketoconazole, Clarithromycin or Rifampin; and Safety and Tolerability in Patients With Advanced Nonhematologic Malignancies or Lymphoma

NCT01454076•Millennium Pharmaceuticals, Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Male or female participants 18 years or older.
•Participants must have a diagnosis of histologically or cytologically confirmed metastatic and/or advanced solid tumor malignancy or lymphoma for which no effective standard treatment is available.
•Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
•Female participants who are postmenopausal at least 1 year, or surgically sterile, or if of childbearing potential, agree to practice 2 effective methods of contraception, at the same time from the time of signing the consent form through 90 days after the last dose of study drug, or agree to practice true abstinence.
•Male participants, even if surgically sterilized, agree to practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study drug or agree to practice true abstinence.
•Voluntary written informed consent.
•Clinical laboratory values as specified in protocol.
•Suitable venous access.
•Recovered (that is, less than \[\< \] Grade 1 toxicity or participant's baseline status) from the reversible effects of prior anticancer therapy.

Exclusion Criteria

•Peripheral neuropathy greater than (\>) Grade 2 on clinical examination.
•Systemic treatment with strong inhibitors of cytochrome P450 (CYP) 1A2, strong inhibitors of CYP3A, or strong CYP3A inducers or use of ginkgo biloba or St. John's wort within 14 days before the first dose of IXAZOMIB.
•Participant has symptomatic brain metastasis. Participants with brain metastases must: have stable neurologic status following surgery or radiation for at least 2 weeks after completion of the definitive therapy; and be without neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
•Female participants who are pregnant or lactating.
•Serious illness that could interfere with protocol completion.
•Autologous stem cell transplant within 6 months before Day 1 of Cycle 1, or prior allogeneic stem cell transplant at any time.
•Prior treatment with rituximab or other unconjugated any antibody treatment within 42 days (21 days if there is clear evidence of progressive disease or immediate treatment is mandated).
•Ongoing treatment with corticosteroids.
•Radiotherapy within 21 days before the first dose of study drug.
•Major surgery within 14 days before the first dose of study drug.
+11 more criteria

Locations (1)

Dallas, Texas, United States

Key Dates

Start Date

November 10, 2011

Primary Completion Date

April 1, 2015

Completion Date

June 16, 2016

Last Updated

November 1, 2017

Enrollment

112

ACTUAL participants

Conditions

Nonhematologic MalignanciesLymphoma

Interventions

Ixazomib 2.5 mg

DRUG

Ixazomib 4 mg Capsule A

DRUG

Ixazomib 4 mg Capsule B

DRUG

Ketoconazole

DRUG

Rifampin

DRUG

Clarithromycin

DRUG

Ixazomib 4 mg Capsule B

DRUG

Azacitidine and Abatacept in Relapsed or Refractory T-Cell Lymphoma

NCT07388563

Lymphoma, T Cell, PeripheralT-cell Lymphoma+4 more

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RECRUITINGPHASE2/PHASE3

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DLBCLDiffuse Large B-Cell Lymphoma

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 1, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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