A Rollover Study for Patients Who Participated in Other Romidepsin Protocols

Phase 2

Completed

• Conditions: Lymphoma; Cancer
• Interventions: Drug: Romidepsin

• Registration Number: NCT01353664
• Lead Sponsor: Celgene

Brief Summary

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.

Detailed Description

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

Study Timeline

• Study Start: 2011-05-01
• Study First Submitted: 2011-05-12
• Study First Submitted QC: 2011-05-13
• Study First Posted: 2011-05-16
• Primary Completion: 2012-09-05
• Study Completion: 2012-09-05
• Results First Submitted: 2013-10-29
• Results First Submitted QC: 2013-10-29
• Results First Posted: 2013-12-19
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-14
• Last Update Posted: 2019-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Romidepsin	Romidepsin	This study is an open-label, single-arm study. The study is divided into the Screening Period, Treatment Period, and Follow-up Period.

Primary Outcome Measures

Name	Time	Method
Summary of Participants With Treatment Emergent Adverse Events (TEAEs)	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.

Trial Locations

Locations (3)

Sarah Cannon Research UK; 🇬🇧 London, United Kingdom

Florida Cancer Specialists; 🇺🇸 Sarasota, Florida, United States

Sarah Cannon Research Institute; 🇺🇸 Nashville, Tennessee, United States