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Trial record 2 of 57 for:    Romidepsin | Phase 2

A Rollover Study for Patients Who Participated in Other Romidepsin Protocols

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ClinicalTrials.gov Identifier: NCT01353664
Recruitment Status : Completed
First Posted : May 16, 2011
Results First Posted : December 19, 2013
Last Update Posted : April 19, 2016
Sponsor:
Information provided by (Responsible Party):
Celgene Corporation

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Lymphoma
Cancer
Intervention Drug: Romidepsin
Enrollment 19
Recruitment Details This rollover study was designed to give access to Romidepsin (Romi) for participants in and then discontinued from Romi studies ROMI-ADVM-001 (NCT01324310) and ROMI-ADVM-002 (NCT01324323) who in the opinion of the investigator could have benefited from ongoing therapy with Romi; those from GPI-06-0002 did not rollover as the study did not close.
Pre-assignment Details Participants started at any point during a cycle which corresponded to their previous Romi study, but continued cycle numbering where it left off from their previous participation in a Romi study
Arm/Group Title ROMI 4
Hide Arm/Group Description Participants received the same dose and frequency used for the last dose of romidepsin given in the preceding romidepsin study (either 8 mg/m^2 or 14 mg/m^2 on Days 1, 8 and 15 of a 28-day cycle), adjusted for any dose-limiting toxicities. For participants treated with the 4-hour infusion in their preceding romidepsin study, a change in the infusion time to 1-hour, at the dose/schedule of 10 mg/m^2 on Days 1, 8, and 15 every 28 days, was permitted upon consultation and agreement with the medical monitor.
Period Title: Overall Study
Started 19 [1]
Completed 0 [2]
Not Completed 19
Reason Not Completed
Other             3
Disease Progression             16
[1]
Participants who received at least 1 dose of study drug.
[2]
Completed = Number of participants who continued on Romidepsin treatment
Arm/Group Title ROMI 4
Hide Arm/Group Description Participants received the same dose and frequency used for the last dose of romidepsin given in the preceding romidepsin study (either 8 mg/m^2 or 14 mg/m^2 on Days 1, 8 and 15 of a 28-day cycle), adjusted for any dose-limiting toxicities. For participants treated with the 4-hour infusion in their preceding romidepsin study, a change in the infusion time to 1-hour, at the dose/schedule of 10 mg/m^2 on Days 1, 8, and 15 every 28 days, was permitted upon consultation and agreement with the medical monitor.
Overall Number of Baseline Participants 19
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 19 participants
62.3  (12.69)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 19 participants
≤ 65 10
> 65 9
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants
Female
9
  47.4%
Male
10
  52.6%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 19 participants
Hispanic or Latino 0
Not Hispanic or Latino 19
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 19 participants
Asian 2
Black or African American 1
White 15
Other (unspecified) 1
ECOG-Eastern Cooperative Oncology Group (ECOG) Performance Status   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 19 participants
0 = Fully Active (Most Favorable Activity) 9
1 = Restricted activity but ambulatory 10
2 = Ambulatory; unable to carry out activities 0
3 = Limited Self-Care 0
4 = Completely Disabled 0
[1]
Measure Description: Eastern Cooperative Oncology Group (ECOG) Performance Status is used by doctors and researchers to assess how a particpant's disease is progressing, assess how the disease affects the daily living activities of the participant and determine appropriate treatment and prognosis.
Height   [1] 
Mean (Standard Deviation)
Unit of measure:  Centimeters
Number Analyzed 19 participants
170.4  (11.02)
[1]
Measure Description: The total number for this baseline characteristic was 18; 1 participants' height was missing.
Weight   [1] 
Mean (Standard Deviation)
Unit of measure:  Kilograms
Number Analyzed 19 participants
75.1  (20.06)
[1]
Measure Description: The number of participants with weight measured was 15; 3 were missing.
1.Primary Outcome
Title Summary of Participants With Treatment Emergent Adverse Events (TEAEs)
Hide Description 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.
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
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population = Participants who received at least one dose of study drug.
Arm/Group Title ROMI 4
Hide Arm/Group Description:
Participants received the same dose and frequency used for the last dose of romidepsin given in the preceding romidepsin study (either 8 mg/m^2 or 14 mg/m^2 on Days 1, 8 and 15 of a 28-day cycle), adjusted for any dose-limiting toxicities. For participants treated with the 4-hour infusion in their preceding romidepsin study, a change in the infusion time to 1-hour, at the dose/schedule of 10 mg/m^2 on Days 1, 8, and 15 every 28 days, was permitted upon consultation and agreement with the medical monitor.
Overall Number of Participants Analyzed 19
Measure Type: Number
Unit of Measure: Participants
≥ 1 Adverse Event (AE) 18
≥ 1 AE related to study drug 14
≥ 1 NCI CTCAE Grade 3 AE 11
≥ 1 NCI CTCAE Grade 4-5 AE 0
≥ 1 NCI CTCAE Grade 3 AE related to study drug 6
≥ 1 NCI CTCAE Grade 4-5 AE related to study drug 0
≥ 1 Serious Adverse Event (SAE) 6
≥ 1 SAE related to study drug 1
≥ 1 AE leading to discontinuation 1
≥ 1 AE leading to stopping the study drug 0
≥ 1 AE leading to dose reduction/interruption 7
≥1 AE dose reduction related to study drug 4
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 time on study drug was 231 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title ROMI 4
Hide Arm/Group Description Participants received the same dose and frequency used for the last dose of romidepsin given in the preceding romidepsin study (either 8 mg/m^2 or 14 mg/m^2 on Days 1, 8 and 15 of a 28-day cycle), adjusted for any dose-limiting toxicities. For participants treated with the 4-hour infusion in their preceding romidepsin study, a change in the infusion time to 1-hour, at the dose/schedule of 10 mg/m^2 on Days 1, 8, and 15 every 28 days, was permitted upon consultation and agreement with the medical monitor.
All-Cause Mortality
ROMI 4
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
ROMI 4
Affected / at Risk (%)
Total   6/19 (31.58%) 
Blood and lymphatic system disorders   
Anaemia  1  1/19 (5.26%) 
Gastrointestinal disorders   
Constipation  1  1/19 (5.26%) 
Diarrhoea  1  1/19 (5.26%) 
Nausea  1  1/19 (5.26%) 
Vomiting  1  1/19 (5.26%) 
General disorders   
Fatigue  1  1/19 (5.26%) 
Infections and infestations   
Pneumonia  1  1/19 (5.26%) 
Sepsis  1  1/19 (5.26%) 
Metabolism and nutrition disorders   
Dehydration  1  1/19 (5.26%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Metastatic Carcinoma of the Bladder  1  1/19 (5.26%) 
Psychiatric disorders   
Mental Status Changes  1  1/19 (5.26%) 
Respiratory, thoracic and mediastinal disorders   
Chronic Obstructive Pulmonary Disease  1  1/19 (5.26%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA V 15.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
ROMI 4
Affected / at Risk (%)
Total   18/19 (94.74%) 
Blood and lymphatic system disorders   
Anaemia  1  3/19 (15.79%) 
Leukocytosis  1  1/19 (5.26%) 
Thrombocytopenia  1  1/19 (5.26%) 
Cardiac disorders   
Sinus Tachycardia  1  1/19 (5.26%) 
Endocrine disorders   
Hypothyroidism  1  1/19 (5.26%) 
Eye disorders   
Eye Swelling  1  1/19 (5.26%) 
Lacrimation Increased  1  1/19 (5.26%) 
Gastrointestinal disorders   
Constipation  1  5/19 (26.32%) 
Nausea  1  5/19 (26.32%) 
Abdominal Pain  1  3/19 (15.79%) 
Diarrhoea  1  3/19 (15.79%) 
Vomiting  1  3/19 (15.79%) 
Dysphagia  1  1/19 (5.26%) 
Gastrooesophageal Reflux Disease  1  1/19 (5.26%) 
Intestinal Obstruction  1  1/19 (5.26%) 
General disorders   
Fatigue  1  11/19 (57.89%) 
Asthenia  1  4/19 (21.05%) 
Pyrexia  1  4/19 (21.05%) 
Chills  1  1/19 (5.26%) 
Non-Cardiac Chest Pain  1  1/19 (5.26%) 
Infections and infestations   
Urinary Tract Infection  1  2/19 (10.53%) 
Bronchitis  1  1/19 (5.26%) 
Candidiasis  1  1/19 (5.26%) 
Cellulitis  1  1/19 (5.26%) 
Infection  1  1/19 (5.26%) 
Oral Candidiasis  1  1/19 (5.26%) 
Upper Respiratory Tract Infection  1  1/19 (5.26%) 
Injury, poisoning and procedural complications   
Concussion  1  1/19 (5.26%) 
Investigations   
Weight Decreased  1  2/19 (10.53%) 
Electrocardiogram T Wave Inversion  1  1/19 (5.26%) 
Metabolism and nutrition disorders   
Decreased Appetite  1  5/19 (26.32%) 
Dehydration  1  3/19 (15.79%) 
Hyperglycemia  1  1/19 (5.26%) 
Hyperlipidiaemia  1  1/19 (5.26%) 
Musculoskeletal and connective tissue disorders   
Back Pain  1  2/19 (10.53%) 
Bursitis  1  1/19 (5.26%) 
Muscle Spasms  1  1/19 (5.26%) 
Musculoskeletal Chest Pain  1  1/19 (5.26%) 
Musculoskeletal Pain  1  1/19 (5.26%) 
Neck Pain  1  1/19 (5.26%) 
Nervous system disorders   
Dizziness  1  4/19 (21.05%) 
Headache  1  3/19 (15.79%) 
Dysgeusia  1  2/19 (10.53%) 
Ageusia  1  1/19 (5.26%) 
Encephalopthy  1  1/19 (5.26%) 
Tremor  1  1/19 (5.26%) 
Psychiatric disorders   
Anxiety  1  3/19 (15.79%) 
Insomnia  1  2/19 (10.53%) 
Renal and urinary disorders   
Haematuria  1  1/19 (5.26%) 
Pollakiuria  1  1/19 (5.26%) 
Urinary Incontinence  1  1/19 (5.26%) 
Respiratory, thoracic and mediastinal disorders   
Cough  1  4/19 (21.05%) 
Dyspnoea  1  4/19 (21.05%) 
Oropharyngeal Pain  1  2/19 (10.53%) 
Pleural Effusion  1  2/19 (10.53%) 
Dysphonia  1  1/19 (5.26%) 
Nasal Congestion  1  1/19 (5.26%) 
Paranasal Sinus Hypersecretion  1  1/19 (5.26%) 
Rales  1  1/19 (5.26%) 
Respiratory Tract Congestion  1  1/19 (5.26%) 
Rhinorrhoea  1  1/19 (5.26%) 
Sinus Congestion  1  1/19 (5.26%) 
Tachypnoea  1  1/19 (5.26%) 
Wheezing  1  1/19 (5.26%) 
Skin and subcutaneous tissue disorders   
Decubitus Ulcer  1  1/19 (5.26%) 
Hyperhidrosis  1  1/19 (5.26%) 
Vascular disorders   
Deep Vein Thrombosis  1  1/19 (5.26%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA V 15.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
There is an agreement between the Principal Investigator and the Sponsor that restricts the PIs rights to publish trial results after the trial is completed. Upon investigator submission of a publication to Celgene, Celgene will complete its review within 60 days after receipt of the publication. Upon Celgene's request, the publication shall be delayed up to 90 additional days to enable Celgene to secure intellectual property protection that would be affected by such proposed publication.
Results Point of Contact
Name/Title: Anne McClain
Organization: Celgene Corporation
Phone: 1-888-260-1599
Responsible Party: Celgene Corporation
ClinicalTrials.gov Identifier: NCT01353664     History of Changes
Other Study ID Numbers: ROMI-ADVM-004
2010-023040-32 ( EudraCT Number )
First Submitted: May 12, 2011
First Posted: May 16, 2011
Results First Submitted: October 29, 2013
Results First Posted: December 19, 2013
Last Update Posted: April 19, 2016