A Rollover Study for Patients Who Participated in Other Romidepsin Protocols

This study is intended to provide access to Romidepsin for participants who received Romidepsin in other trials sponsored by Gloucester Pharmaceuticals or Celgene Corporation and for participants whom the investigator feels may benefit from continuing treatment with Romidepsin.

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Key information

Conditions

Lymphoma Cancer Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Sarah Cannon Research UK, London, United Kingdom

About this study

Participants must have previously participated in a Romidepsin study sponsored by Gloucester Pharmaceuticals or Celgene Corporation.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Previously participated in and fulfilled the inclusion and exclusion criteria in one of the romidepsin clinical trials: ROMI-ADVM-001 (NCT01324310), ROMI-ADVM-002 (NCT01324323). Additional studies added at the discretion of the medical monitor of the study
Physician believes continued romidepsin treatment is of benefit to participant.
Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures are conducted.
Able to adhere to the study visit schedule and other protocol requirements.
Negative urine or serum pregnancy test for females of child bearing potential; and
All females of child bearing potential must use an effective method of contraception (an intrauterine contraceptive device [IUCD] or double contraceptive method using condoms and a diaphragm plus spermicide) during the treatment period and for at least 1 month thereafter. Male participants should use contraception during the treatment period and for at least 3 months thereafter. Female participants 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.

Exclusion criteria

Concomitant use of drugs that may cause a significant prolongation of the corrected measurement of the time between the start of cardiac Q wave and the end of the T wave (QTc) .
Concomitant use of Cytochrome P 450 3A4 (CYP3A4) strong inhibitors within 1 week of trial medications.
Concomitant use of therapeutic warfarin due to a potential drug interaction. Use of a low dose of warfarin or another anticoagulant to maintain patency of venous access port and cannulas is permitted.
Prior chemotherapy or radiotherapy or any investigational agent after the last dose of romidepsin from the preceding romidepsin study.
Participants who are pregnant or breast-feeding.

Treatment and study plan

Romidepsin

Drug

The participants will generally continue at the same dose, infusion time and frequency used for the last dose of romidepsin given in the preceding romidepsin study. If the participant entered this rollover study in the middle of a cycle, then the cycle number and cycle day will be carried over from the preceding romidepsin study.

Other names: Istodax®, ROMI

Primary outcomes

Summary of Participants With Treatment Emergent Adverse Events (TEAEs)

Time frame: All AEs were recorded by the Investigator from the time the participant signed the informed consent to 28 days after the last dose of study drug; maximum drug exposure was 231 days

An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. Adverse events were assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4: On the following is the scale: Grade 1 = Mild AE, Grade 2 = Moderate AE, Grade 3 = Severe and Undesirable AE, Grade 4 = Life-threatening or Disabling AE, and Grade 5 = Death. Serious AEs (SAEs) are those that resulted in death, were life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly, or resulted in an important medical event that may have jeopardized the patient or required medical or surgical intervention. A TEAE is defined as any AE occurring or worsening on or after the first dose of study drug and within 28 days after the last dose of study drug.

Sponsors and collaborators

Lead sponsor

Celgene

Industry

Collaborators

Celgene Corporation

Registry information

Official study title

An Open Label, Single-Arm Rollover Study for Subjects Who Participated In Other Romidepsin Protocols

Important dates

Study start: 2011
Primary completion: 2012
Study completion: 2012
First posted: May 16, 2011
Registry last updated: Nov 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed