A Rollover Study for Patients Who Participated in Other Romidepsin Protocols
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01353664|
Recruitment Status : Completed
First Posted : May 16, 2011
Results First Posted : December 19, 2013
Last Update Posted : April 19, 2016
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma Cancer||Drug: Romidepsin||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||19 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open Label, Single-Arm Rollover Study for Subjects Who Participated In Other Romidepsin Protocols|
|Study Start Date :||May 2011|
|Actual Primary Completion Date :||September 2012|
|Actual Study Completion Date :||September 2012|
This study is an open-label, single-arm study. The study is divided into the Screening Period, Treatment Period, and Follow-up Period.
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 Name: Istodax®, ROMI
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01353664
|United States, Florida|
|Florida Cancer Specialists|
|Sarasota, Florida, United States, 34232|
|United States, Tennessee|
|Sarah Cannon Research Institute|
|Nashville, Tennessee, United States, 37203|
|Sarah Cannon Research UK|
|London, United Kingdom, W1G6AD|
|Study Director:||Ken Takeshita, MD||Celgene Corporation|