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Trial record 13 of 57 for:    Romidepsin | Phase 2

A Single Agent Phase II Study of Romidepsin (Depsipeptide, FK228) in the Treatment of Cutaneous T-cell Lymphoma (CTCL)

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ClinicalTrials.gov Identifier: NCT00106431
Recruitment Status : Completed
First Posted : March 25, 2005
Results First Posted : April 23, 2010
Last Update Posted : March 16, 2011
Sponsor:
Information provided by:
Celgene

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Cutaneous T-cell Lymphoma
Intervention Drug: romidepsin (depsipeptide, FK228)
Enrollment 102
Recruitment Details Patients were enrolled between January 2005 and July 2007. Patients were enrolled at academic centers in the US and Europe that had experience in treating CTCL patients
Pre-assignment Details Eligible patients were required to have failed at least 1 prior systemic therapy, e.g., interferon, chemotherapy, Ontak® (denileukin diftitox), or Targretin® (bexarotene).
Arm/Group Title Romidepsin
Hide Arm/Group Description Regimen was 14 mg/m2 IV over a 4-hour period on Days 1, 8, and 15 of a 28-day cycle. The protocol included 6 cycles of treatment; responding patients and patients who achieved at least Stable Disease (SD) had the option of continuing treatment beyond 6 cycles at the discretion of the Investigator and based on local regulations.
Period Title: Overall Study
Started 102
Completed 37 [1]
Not Completed 65
[1]
37 represents the number of patients who reached at least 6 months treatment
Arm/Group Title Romidepsin
Hide Arm/Group Description Regimen was 14 mg/m2 IV over a 4-hour period on Days 1, 8, and 15 of a 28-day cycle. The protocol included 6 cycles of treatment; responding patients and patients who achieved at least Stable Disease (SD) had the option of continuing treatment beyond 6 cycles at the discretion of the Investigator and based on local regulations.
Overall Number of Baseline Participants 102
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 102 participants
<=18 years
0
   0.0%
Between 18 and 65 years
79
  77.5%
>=65 years
23
  22.5%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 102 participants
57.0  (11.93)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 102 participants
Female
40
  39.2%
Male
62
  60.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 102 participants
France 5
United States 20
Poland 24
Russian Federation 17
Germany 6
United Kingdom 20
Georgia 3
Ukraine 7
Eastern Cooperative Oncology Group (ECOG) Performance status  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 102 participants
0, Fully active, able to carry on all pre-disease 53
1, Restricted in physically strenuous activity but 49
2, Ambulatory and capable of all selfcare but unab 0
1.Primary Outcome
Title The Percent of Patients (Pts) With Objective Disease Response
Hide Description The percent of pts with confirmed Objective Disease Response (confirmed best responses of complete response [CR], clinical complete response [CCR], or partial response [PR]). Responses were evaluated according to a composite assessment (Objective Primary Disease Response Evaluation Criteria - OPDREC).
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analysis based on interim analysis of data for as treated population
Arm/Group Title Romidepsin
Hide Arm/Group Description:
Regimen was 14 mg/m2 IV over a 4-hour period on Days 1, 8, and 15 of a 28-day cycle. The protocol included 6 cycles of treatment; responding patients and patients who achieved at least Stable Disease (SD) had the option of continuing treatment beyond 6 cycles at the discretion of the Investigator and based on local regulations.
Overall Number of Participants Analyzed 96
Measure Type: Number
Unit of Measure: Percent of participants
34
2.Secondary Outcome
Title Duration of Objective Disease Response
Hide Description Duration of Objective Response was defined as the number of months from the date of the first disease response (clinical complete response [CCR], or partial response [PR]) (later confirmed) until the date of progression and was determined using Kaplan-Meier product-limit estimates. In this analysis, pts who did not progress were censored as of their last evaluation with an OPDREC assessment.
Time Frame Up to 10 months; median duration of follow up was 5.1 months
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analysis based on interim analysis of data for as treated population
Arm/Group Title Romidepsin
Hide Arm/Group Description:
Regimen was 14 mg/m2 IV over a 4-hour period on Days 1, 8, and 15 of a 28-day cycle. The protocol included 6 cycles of treatment; responding patients and patients who achieved at least Stable Disease (SD) had the option of continuing treatment beyond 6 cycles at the discretion of the Investigator and based on local regulations.
Overall Number of Participants Analyzed 96
Median (Full Range)
Unit of Measure: Months
14.91
(0.03 to 19.81)
3.Secondary Outcome
Title Time to Objective Disease Response
Hide Description Time to Objective Response was defined as the time in months from first dose date to the first date of objective disease response (later confirmed) and time to CCR was defined as the time in months from first dose date to the first date of CCR (later confirmed).
Time Frame Up to 10 months
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analysis based on interim analysis of data for as treated population
Arm/Group Title Romidepsin
Hide Arm/Group Description:
Regimen was 14 mg/m2 IV over a 4-hour period on Days 1, 8, and 15 of a 28-day cycle. The protocol included 6 cycles of treatment; responding patients and patients who achieved at least Stable Disease (SD) had the option of continuing treatment beyond 6 cycles at the discretion of the Investigator and based on local regulations.
Overall Number of Participants Analyzed 96
Median (Full Range)
Unit of Measure: Months
1.87
(0.89 to 4.76)
4.Secondary Outcome
Title Time to Disease Progression
Hide Description Time To Progression was defined as the duration from the date of the first study drug dose to the date of progression (PD). In this analysis, pts who did not progress were censored at their last evaluation with an OPDREC assessment.
Time Frame Up to 10 months; median duration of follow up was 6.1 months
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analysis based on interim analysis of data for as treated population
Arm/Group Title Romidepsin
Hide Arm/Group Description:
Regimen was 14 mg/m2 IV over a 4-hour period on Days 1, 8, and 15 of a 28-day cycle. The protocol included 6 cycles of treatment; responding patients and patients who achieved at least Stable Disease (SD) had the option of continuing treatment beyond 6 cycles at the discretion of the Investigator and based on local regulations.
Overall Number of Participants Analyzed 96
Median (Full Range)
Unit of Measure: Months
8.28
(0 to 21.65)
5.Secondary Outcome
Title Decrease in Pruritus Visual Analogue Scale (VAS) Score of ≥30 mm or a Score of 0 for at Least 2 Consecutive Cycles.
Hide Description Pruritus was reported monthly by pts using a 0 (no itching) to 100 (unbearable itching) mm visual analog scale (VAS). Pts were considered to have significant pruritus if the baseline VAS score was ≥ 30 mm. Clinically meaningful reduction in pruritus was defined as a decrease in VAS score of ≥ 30 mm or a score of 0 for at least 2 consecutive cycles.
Time Frame Up to 10 months
Hide Outcome Measure Data
Hide Analysis Population Description
Patients meeting definition of moderate to severe pruritus on VAS (i.e., had a VAS of >=30 mm)
Arm/Group Title Romidepsin
Hide Arm/Group Description:
Regimen was 14 mg/m2 IV over a 4-hour period on Days 1, 8, and 15 of a 28-day cycle. The protocol included 6 cycles of treatment; responding patients and patients who achieved at least Stable Disease (SD) had the option of continuing treatment beyond 6 cycles at the discretion of the Investigator and based on local regulations.
Overall Number of Participants Analyzed 52
Measure Type: Number
Unit of Measure: participants
25
6.Secondary Outcome
Title Duration of Objective Disease Control (ODC)
Hide Description For pts with confirmed ODC (pts with CR, CCR, PR, SD90 [stable disease for 90 days]) based on OPDREC, duration of ODC was summarized with descriptive statistics, including number of censored observations, and 25th, 50th, 75th percentiles of distribution, based on Kaplan-Meier product limit estimates. For pts with confirmed progressive disease (PD), duration of ODC was calculated from first date of study drug to first date of diagnosis of confirmed PD. For pts without confirmed PD, duration of ODC was calculated from first date of study drug to date of the last visit with any OPDREC data.
Time Frame Up to 10 months; median duration of follow up was 6.0 months
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analysis based on interim analysis of data for as treated population
Arm/Group Title Romidepsin
Hide Arm/Group Description:
Regimen was 14 mg/m2 IV over a 4-hour period on Days 1, 8, and 15 of a 28-day cycle. The protocol included 6 cycles of treatment; responding patients and patients who achieved at least Stable Disease (SD) had the option of continuing treatment beyond 6 cycles at the discretion of the Investigator and based on local regulations.
Overall Number of Participants Analyzed 96
Median (Full Range)
Unit of Measure: Months
17.67
(0.03 to 19.81)
7.Secondary Outcome
Title Percent of Pts With Objective Disease Control
Hide Description The percent of pts with confirmed ODC (CR, CCR, PR and SD90) based on OPDREC was summarized.
Time Frame Up to 10 months
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analysis based on interim analysis of data for as treated population
Arm/Group Title Romidepsin
Hide Arm/Group Description:
Regimen was 14 mg/m2 IV over a 4-hour period on Days 1, 8, and 15 of a 28-day cycle. The protocol included 6 cycles of treatment; responding patients and patients who achieved at least Stable Disease (SD) had the option of continuing treatment beyond 6 cycles at the discretion of the Investigator and based on local regulations.
Overall Number of Participants Analyzed 96
Measure Type: Number
Unit of Measure: Percent of participants
64
Time Frame Treatment emergent events were collected from first dose to last visit which occurred approximately 1 month after the last dose. Patients were to be treated for 6 cycles (approximately 6 months) or until progression.
Adverse Event Reporting Description Patients could remain on treatment after 6 months if they experienced a response to treatment.
 
Arm/Group Title Romidepsin
Hide Arm/Group Description Regimen was 14 mg/m2 IV over a 4-hour period on Days 1, 8, and 15 of a 28-day cycle. The protocol included 6 cycles of treatment; responding patients and patients who achieved at least Stable Disease (SD) had the option of continuing treatment beyond 6 cycles at the discretion of the Investigator and based on local regulations.
All-Cause Mortality
Romidepsin
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Romidepsin
Affected / at Risk (%)
Total   23/102 (22.55%) 
Blood and lymphatic system disorders   
Anaemia NOS  1  1/102 (0.98%) 
Leukocytosis  1  1/102 (0.98%) 
Neutropenia  1  2/102 (1.96%) 
Cardiac disorders   
Atrioventricular Block First Degree  1  1/102 (0.98%) 
Atrioventricular Block Second Degree  1  1/102 (0.98%) 
Cardiac Failure NOS  1  1/102 (0.98%) 
Cardiopulmonary Failure  1  1/102 (0.98%) 
Cardiac Tamponade  1  1/102 (0.98%) 
Bradyarrhythmia  1  1/102 (0.98%) 
Supraventricular Tachycardia  1  1/102 (0.98%) 
Ventricular Tachycardia  1  1/102 (0.98%) 
Gastrointestinal disorders   
Constipation  1  1/102 (0.98%) 
Colonic Perforation  1  1/102 (0.98%) 
General disorders   
Fatigue  1  1/102 (0.98%) 
Malaise  1  1/102 (0.98%) 
Rigors  1  1/102 (0.98%) 
Pyrexia  1  3/102 (2.94%) 
Disease Progression NOS  1  2/102 (1.96%) 
Pain Exacerbated  1  1/102 (0.98%) 
Infections and infestations   
Oral Candidiasis  1  1/102 (0.98%) 
Oropharyngeal Candidiasis  1  1/102 (0.98%) 
Perineal Abscess  1  1/102 (0.98%) 
Sepsis NOS  1  3/102 (2.94%) 
Skin Bacterial Infection  1  1/102 (0.98%) 
Staphylococcal Bacteraemia  1  1/102 (0.98%) 
Pharnygitis  1  1/102 (0.98%) 
Tonsillitis  1  1/102 (0.98%) 
Urinary Tract Infection  1  1/102 (0.98%) 
Investigations   
Electrocardiogram St Segment Depression  1  1/102 (0.98%) 
Troponin I Increased  1  1/102 (0.98%) 
Urine Output Decreased  1  1/102 (0.98%) 
Metabolism and nutrition disorders   
Anorexia  1  1/102 (0.98%) 
Hyperglycaemia NOS  1  1/102 (0.98%) 
Acidosis NOS  1  1/102 (0.98%) 
Hypoalbuminaemia  1  1/102 (0.98%) 
Musculoskeletal and connective tissue disorders   
Myositis  1  1/102 (0.98%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Neoplasm Progression NOS  1  4/102 (3.92%) 
Tumor Lysis Syndrome  1  2/102 (1.96%) 
Nervous system disorders   
Syncope  1  1/102 (0.98%) 
Psychiatric disorders   
Depression  1  1/102 (0.98%) 
Renal and urinary disorders   
Renal Failure Acute  1  1/102 (0.98%) 
Respiratory, thoracic and mediastinal disorders   
Laryngeal Stenosis  1  1/102 (0.98%) 
Pleural Effusion  1  1/102 (0.98%) 
Pulmonary Embolism  1  1/102 (0.98%) 
Skin and subcutaneous tissue disorders   
Dermatitis Medicamentosa  1  1/102 (0.98%) 
Vascular disorders   
Haematoma NOS  1  1/102 (0.98%) 
Thrombosis  1  1/102 (0.98%) 
Hypotension NOS  1  2/102 (1.96%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 6.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Romidepsin
Affected / at Risk (%)
Total   99/102 (97.06%) 
Blood and lymphatic system disorders   
Thrombocytopenia  1  15/102 (14.71%) 
Anaemia NOS  1  12/102 (11.76%) 
Neutropenia  1  8/102 (7.84%) 
Gastrointestinal disorders   
Nausea  1  57/102 (55.88%) 
Vomiting NOS  1  35/102 (34.31%) 
Diarrhoea NOS  1  20/102 (19.61%) 
Constipation  1  12/102 (11.76%) 
Dry Mouth  1  7/102 (6.86%) 
Abdominal Pain NOS  1  6/102 (5.88%) 
General disorders   
Fatigue  1  34/102 (33.33%) 
Pyrexia  1  20/102 (19.61%) 
Asthenia  1  14/102 (13.73%) 
Oedema Peripheral  1  8/102 (7.84%) 
Lethargy  1  6/102 (5.88%) 
Rigors  1  5/102 (4.90%) 
Infections and infestations   
Skin Infection  1  8/102 (7.84%) 
Upper Respiratory Tract Infection NOS  1  6/102 (5.88%) 
Investigations   
Blood Magnesium Decreased  1  13/102 (12.75%) 
Haemoglobin Decreased  1  7/102 (6.86%) 
Weight Decreased  1  5/102 (4.90%) 
Metabolism and nutrition disorders   
Anorexia  1  23/102 (22.55%) 
Hypomagnesaemia  1  10/102 (9.80%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Neoplasm Progression NOS  1  8/102 (7.84%) 
Nervous system disorders   
Headache  1  17/102 (16.67%) 
Dysgeusia  1  15/102 (14.71%) 
Ageusia  1  12/102 (11.76%) 
Skin and subcutaneous tissue disorders   
Pruritus  1  7/102 (6.86%) 
Vascular disorders   
Hypotension NOS  1  7/102 (6.86%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 6.0
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.
Sponsor can review results at least 60 days prior to the date of submission for publication or public disclosure; sponsor will complete review within review period and will have authority to require institution/PI to delete confidential information other than the results.
Results Point of Contact
Name/Title: Elizabeth Faust, PhD, Vice President, Clinical Research Services
Organization: Celgene Corporation
Phone: 617/583-1300
Responsible Party: Jean Nichols, Ph.D., Gloucester Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00106431     History of Changes
Obsolete Identifiers: NCT00337025
Other Study ID Numbers: GPI-04-0001
First Submitted: March 24, 2005
First Posted: March 25, 2005
Results First Submitted: March 2, 2010
Results First Posted: April 23, 2010
Last Update Posted: March 16, 2011