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Influence of Rifampin on the Pharmacokinetics of Romidepsin in Patients With Advanced Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Influence of Rifampin on the Pharmacokinetics of Romidepsin in Patients With Advanced Cancer

A Phase I Open-label, 2-period Study to Evaluate the Influence of Multiple Oral Doses of Rifampin on the Single Dose Pharmacokinetics of Romidepsin in Subjects With Advanced Cancer

NCT01324323•Celgene

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the effect and safety of multiple doses of rifampin on the pharmacokinetics of romidepsin after a single intravenous (IV) infusion.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Males and females 18 years of age or older at the time of signing the informed consent document.
•2. Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures are conducted.
•3. Able to adhere to the study visit schedule and other protocol requirements.
•4. Must have diagnosis of advanced malignancy and must have failed other available therapies considered standard of care for their disease.
•5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
•6. Negative urine or serum pregnancy test on females of childbearing potential; and
•7. All females of childbearing potential must use an effective barrier method of contraception (either an intrauterine contraceptive device \[IUCD\] or double barrier method using condoms or a diaphragm plus spermicide) during the treatment period and for at least 1 month thereafter. Male subjects should use a barrier method of contraception during the treatment period and for at least 3 months thereafter. Female subjects should avoid the use of estrogen-containing contraceptives, since romidepsin may reduce the effectiveness of estrogen-containing contraceptives. An in vitro binding assay determined that romidepsin competes with β-estradiol for binding to estrogen receptors.
•5. Concomitant use of drugs that may cause a significant prolongation of the corrected measurement of the time between the start of the cardiac Q wave and the end of the T wave (QTc).
•6. Concomitant use of Cytochrome P 450 3A4 (CYP3A4) strong inhibitors within 1 week of trial medications.
•7. Concomitant use of CYP3A4 strong inducers within 2 weeks of trial medications.
+28 more criteria

Exclusion Criteria

•1. Any significant medical condition or psychiatric illness that would prevent the subject from participating in the study.
•2. Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study.
•3. Subjects with significant gastrointestinal disease that may impair drug absorption, such as subjects with a history of Cohn's disease, colectomy, gastrectomy, celiac disease, or other diseases with known malabsorption.

Locations (3)

Florida Cancer Specialists

Sarasota, Florida, United States

Sarah Canon Research Institute

Nashville, Tennessee, United States

Sarah Cannon Research UK

London, United Kingdom

Key Dates

Start Date

April 1, 2011

Primary Completion Date

February 1, 2012

Completion Date

March 1, 2012

Last Updated

November 25, 2019

Enrollment

ACTUAL participants

Conditions

Hematologic MalignancyMalignant Lymphoma

Interventions

Romidepsin

DRUG

Rifampin

DRUG

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RECRUITINGPHASE1

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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 25, 2019Data 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.

View ClinicalTrials.gov Terms and Conditions

Influence of Rifampin on the Pharmacokinetics of Romidepsin in Patients With Advanced Cancer

Inclusion Criteria

Exclusion Criteria

Phase II Study of Pirtobrutinib With Venetoclax In Relapsed-Refractory MCL (Mantle Cell Lymphoma) Patients

CD45RA-depleted CD19-CAR T Cell Consolidation After TCRαβ+/CD19 B Cell-depleted Haploidentical Hematopoietic Cell Transplantation for Relapsed/Refractory CD19+ ALL and Lymphoma

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Study Evaluating the Safety and the Efficacy of Human T Lymphoid Progenitor (HTLP) Injection to Accelerate Immune Reconstitution After Umbilical Cord Blood (UCB) Transplantation in Adult Patients With Hematologic Malignancies (HTLP-ONCO)

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