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Trial record 4 of 57 for:    Romidepsin | Phase 2

A Trial of Romidepsin for Progressive or Relapsed Peripheral T-cell Lymphoma

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ClinicalTrials.gov Identifier: NCT00426764
Recruitment Status : Completed
First Posted : January 25, 2007
Results First Posted : August 13, 2012
Last Update Posted : May 30, 2019
Sponsor:
Information provided by (Responsible Party):
Celgene

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Peripheral T-cell Lymphoma
Intervention Drug: Romidepsin
Enrollment 131
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Romidepsin
Hide Arm/Group Description Participants received romidepsin 14 mg/m^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.
Period Title: Overall Study
Started 131 [1]
Discontinued Prior to or During Cycle 6 98
Discontinued at End of or After Cycle 6 33
Completed 0
Not Completed 131
Reason Not Completed
Protocol Violation             1
Withdrawal by Subject             4
Physician Decision             6
Compassionate Use             1
Progressive Disease             83
Adverse Event             24
Not Specified             1
Death             1
Other Reasons (Miscellaneous)             10
[1]
Represents the number of patients who received any amount of study drug.
Arm/Group Title Romidepsin
Hide Arm/Group Description Participants received romidepsin 14 mg/m^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Participants who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.
Overall Number of Baseline Participants 131
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 131 participants
59.4  (12.83)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 131 participants
Female
42
  32.1%
Male
89
  67.9%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
White Number Analyzed 131 participants
116
  88.5%
Black Number Analyzed 131 participants
7
   5.3%
Asian Number Analyzed 131 participants
3
   2.3%
Other Number Analyzed 131 participants
4
   3.1%
Unknown Number Analyzed 131 participants
1
   0.8%
Body Surface Area (BSA)   [1] 
Mean (Standard Deviation)
Unit of measure:  M^2
Number Analyzed 128 participants
1.84  (0.2348)
[1]
Measure Analysis Population Description: participants with a Baseline measurement
Eastern Cooperative Oncology Group Performance Status   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
0 Number Analyzed 131 participants
46
  35.1%
1 Number Analyzed 131 participants
66
  50.4%
2 Number Analyzed 131 participants
17
  13.0%
Missing Number Analyzed 131 participants
1
   0.8%
Unknown Number Analyzed 131 participants
1
   0.8%
[1]
Measure Description: The ECOG scale is as follows: Grade 0: Fully active, able to carry on all pre-disease activities without restriction; Grade 1: Restricted in physically strenuous activity, ambulatory and able to carry out work of a light nature; Grade 2: Ambulatory and capable of all self-care but unable to work. Up and about more than 50% of waking hours; Grade 3: Capable of only limited self-care, confined to bed or chair > 50% of waking hours; Grade 4: Completely disabled. Cannot carry on any self-care. Confined to bed or Chair.
Duration of peripheral T-cell lymphoma (PTCL)  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 131 participants
2.268  (2.6654)
PTCL Subtype Based on Central Diagnosis   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
PTCL Unspecified (NOS) Number Analyzed 131 participants
69
  52.7%
Angioimmunoblastic T-cell lymphoma (AITL) Number Analyzed 131 participants
27
  20.6%
ALK-1 negative ALCL Number Analyzed 131 participants
21
  16.0%
Enteropathy-type T-cell lymphoma Number Analyzed 131 participants
6
   4.6%
Subcutaneous panniculitis-like T-cell lymphoma Number Analyzed 131 participants
3
   2.3%
ALK-1 positive ALCL Number Analyzed 131 participants
1
   0.8%
Cutaneous γδ T-cell lymphoma Number Analyzed 131 participants
1
   0.8%
Extranodal NK/T cell lymphoma nasal type Number Analyzed 131 participants
1
   0.8%
Transformed mycosis fungoides Number Analyzed 131 participants
1
   0.8%
Unknown Number Analyzed 131 participants
1
   0.8%
[1]
Measure Description: ALK-1=anaplastic lymphoma kinase; ALCL=anaplastic large cell lymphoma
1.Primary Outcome
Title Percentage of Participants With a Complete Response According to the International Workshop Response Criteria (IWC) for Non-Hodgkin's Lymphomas (NHL) Assessed by an Independent Review Committee
Hide Description Complete Response (CR): >75% decrease in size aggregate of nodal index lesions (large and small), complete disappearance of extranodal and non-index lesions; total disappearance of clinical disease including skin involvement; disease-related signs and symptoms, normalization of biochemical abnormalities and reduction in size of spleen or liver so no longer palpable. Unconfirmed CR: all above criteria except all nodal index lesions must have regressed >75% in the sum of the product diameters (SPD) from baseline. Individual nodes previously confluent must have regressed by >75% in their SPD.
Time Frame Response was assessed after every 2 cycles of treatment and at completion of therapy, up until 30 September 2012 (data cutoff for analysis). Maximum duration on study was 1931 days.
Hide Outcome Measure Data
Hide Analysis Population Description
Histologically Confirmed Population, comprised all enrolled patients who received at least 1 dose of study treatment and who had histopathologically confirmed peripheral T-cell lymphoma(s). Patients who discontinued prior to any response evaluation or who had no post-baseline assessment of response were classified as non-responders.
Arm/Group Title Romidepsin
Hide Arm/Group Description:
Participants received romidepsin 14 mg/m^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.
Overall Number of Participants Analyzed 130
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
15.4
(9.7 to 22.8)
2.Secondary Outcome
Title Percentage of Participants With Objective Disease Response
Hide Description Objective disease response was defined as patients with a Complete Response, Unconfirmed Complete Response or a Partial Response (PR) according to the IWC 1999 assessed by an independent review committee: CR, Cru defined above, PR defined as ≥50% decrease in size of 6 largest dominant nodes and/or nodal masses & extranodal index lesions and no increase of non-index lesions, liver, or spleen; no new sites of disease evident; skin lesions decreased by ≥50%.
Time Frame Response was assessed after every 2 cycles of treatment and at completion of therapy, up until 30 September 2012 (data cutoff for analysis). Maximum duration on study was 1931 days.
Hide Outcome Measure Data
Hide Analysis Population Description
Histologically Confirmed Population. Patients who discontinued prior to any response evaluation or who had no post-baseline assessment of response were classified as non-responders.
Arm/Group Title Romidepsin
Hide Arm/Group Description:
Participants received romidepsin 14 mg/m^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.
Overall Number of Participants Analyzed 130
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
26.2
(18.8 to 34.6)
3.Secondary Outcome
Title Duration of Objective Disease Response
Hide Description Duration of response was defined as the number of days from the date of the first disease response (Complete, Unconfirmed Complete or Partial Response) until the date of progression and was determined using Kaplan-Meier product-limit estimates. Progression was defined as: a ≥50% increase from the nadir in the individual sum of the products of the diameters of any index lesion; the reappearance of pathology, enlargement of liver/spleen, or unequivocal progression of non-measurable disease or appearance of any new lesions.
Time Frame Response was assessed after every 2 cycles of treatment and at completion of therapy, up until 30 September 2012 (data cutoff for analysis). Maximum duration on study was 1931 days.
Hide Outcome Measure Data
Hide Analysis Population Description
Histopathologically-Confirmed Population with an objective response. Censoring for patients who did not have a date of progression was conducted based on last assessment reported for the patient.
Arm/Group Title Romidepsin
Hide Arm/Group Description:
Participants received romidepsin 14 mg/m^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.
Overall Number of Participants Analyzed 34
Median (95% Confidence Interval)
Unit of Measure: days
NA [1] 
(353 to NA)
[1]
The median and the upper limit of the 95% confidence interval were not estimable due to the low number of events.
4.Secondary Outcome
Title Duration of Complete Disease Response
Hide Description Duration of response was defined as the number of days from the date of the first disease response (Complete or Unconfirmed Complete) until the date of progression and was determined using Kaplan-Meier product-limit estimates. Progression was defined as: a ≥50% increase from the nadir in the individual sum of the products of the diameters of any index lesion; the reappearance of pathology, enlargement of liver/spleen, or unequivocal progression of non-measurable disease or appearance of any new lesions.
Time Frame Response was assessed after every 2 cycles of treatment and at completion of therapy, up until 30 September 2012 (data cutoff for analysis). Maximum duration on study was 1931 days.
Hide Outcome Measure Data
Hide Analysis Population Description
Histopathologically-Confirmed Population with a complete response. Censoring for patients who did not have a date of progression was conducted based on last assessment reported for the patient.
Arm/Group Title Romidepsin
Hide Arm/Group Description:
Participants received romidepsin 14 mg/m^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.
Overall Number of Participants Analyzed 20
Median (95% Confidence Interval)
Unit of Measure: days
NA [1] 
(500 to NA)
[1]
Median and upper limit of the 95% confidence interval was not estimable due to the low number of events.
5.Secondary Outcome
Title Time to Disease Progression
Hide Description Time to progression (≥50% increase from the nadir in the individual sum of the products of the diameters of any index lesion; the reappearance of pathology, enlargement of liver/spleen, or unequivocal progression of non-measurable disease or appearance of any new lesions) was defined as the duration from the date of the first study drug dose to the date of relapse or progression as reported by the independent review committee and was determined using Kaplan-Meier product-limit estimates.
Time Frame Response was assessed after every 2 cycles of treatment and at completion of therapy, up until 30 September 2012 (data cutoff for analysis). Maximum duration on study was 1931 days.
Hide Outcome Measure Data
Hide Analysis Population Description
Histopathologically-Confirmed Population. Censoring for patients who did not have a date of progression was conducted based on last assessment reported for the patient.
Arm/Group Title Romidepsin
Hide Arm/Group Description:
Participants received romidepsin 14 mg/m^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.
Overall Number of Participants Analyzed 130
Median (95% Confidence Interval)
Unit of Measure: days
182
(106 to 290)
6.Secondary Outcome
Title Change in Eastern Cooperative Oncology Group (ECOG) Performance Status
Hide Description The ECOG scale is as follows: Grade 0: Fully active, able to perform all pre-disease activities without restriction; Grade 1: Restricted in physically strenuous activity, ambulatory, able to carry out light work; Grade 2: Ambulatory and capable of all self-care but unable to work. Up and about more than 50% of waking hours; Grade 3: Capable of only limited self-care, confined to bed or chair > 50% of waking hours; Grade 4: Completely disabled. Cannot carry on any self-care. Confined to bed or chair. Data reported is the shift from Baseline ECOG score to best on-study assessment score.
Time Frame From Baseline up until 30 September 2012 (data cutoff for analysis). Maximum duration on study was 1931 days.
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population: all participants who received at least 1 dose of romidepsin.
Arm/Group Title Missing Best ECOG = 0 Best ECOG = 1 Best ECOG = 2 Best ECOG = 3 Best ECOG = 4
Hide Arm/Group Description:
Participants with a missing best on study ECOG performance score, who received romidepsin 14 mg/m^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.
Participants with a best on study ECOG performance score of 0, who received romidepsin 14 mg/m^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.
Participants with a best on study ECOG performance score of 1, who received romidepsin 14 mg/m^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.
Participants with a best on study ECOG performance score of 2, who received romidepsin 14 mg/m^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.
Participants with a best on study ECOG performance score of 3, who received romidepsin 14 mg/m^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.
Participants with a best on study ECOG performance score of 4, who received romidepsin 14 mg/m^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.
Overall Number of Participants Analyzed 5 40 57 19 6 4
Measure Type: Number
Unit of Measure: participants
Missing Baseline ECOG Score 1 0 0 0 0 0
Baseline ECOG Score = 0 2 26 16 1 0 1
Baseline ECOG Score = 1 1 13 35 12 4 2
Baseline ECOG Score = 2 1 1 6 6 2 1
Baseline ECOG Score = 3 0 0 0 0 0 0
Baseline ECOG Score = 4 0 0 0 0 0 0
7.Secondary Outcome
Title Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Hide Description An adverse event or experience (AE) is defined as any untoward medical occurrence, which does not necessarily have to have a causal relationship with this treatment. A serious AE is any untoward medical occurrence that at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event or condition. Related AEs are defined as those considered by the Investigator to have a possible, probable, or very likely/certain relationship to the study drug. AEs were graded as mild (1), moderate (2), severe (3), lifethreatening (4), or death (5). TEAEs occurred from the first dose of study medication through the end of the study (30 days post last dose) or any event that was present at baseline but worsened in intensity or was subsequently considered drug-related by the Investigator through end of study.
Time Frame From first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. Mean duration of treatment up until 30 September 2012 (data cutoff for analysis) was 169 days.
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population: all participants who received at least 1 dose of romidepsin.
Arm/Group Title Romidepsin
Hide Arm/Group Description:
Participants received romidepsin 14 mg/m^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.
Overall Number of Participants Analyzed 131
Measure Type: Count of Participants
Unit of Measure: Participants
TEAE
128
  97.7%
≥ Grade 3 TEAE
89
  67.9%
≥ Grade 4 TEAE
27
  20.6%
Serious TEAE
61
  46.6%
TEAE Leading to Discontinuation
25
  19.1%
Deaths within 30 days of Last Dose
8
   6.1%
Time Frame Adverse events were reported and documented throughout the study from first dose of study treatment until the final study visit, which occurred 30 days after receiving the last dose. The mean duration of treatment was 210 days.
Adverse Event Reporting Description NOTE: events shown include data from 6 participants who were ongoing in study treatment at the time of the last data cut-off (30-Sep-2012), which updated the mean duration of treatment from 196 to 210 days.
 
Arm/Group Title Romidepsin
Hide Arm/Group Description Participants received romidepsin 14 mg/m^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.
All-Cause Mortality
Romidepsin
Affected / at Risk (%)
Total   9/131 (6.87%) 
Show Serious Adverse Events Hide Serious Adverse Events
Romidepsin
Affected / at Risk (%)
Total   62/131 (47.33%) 
Blood and lymphatic system disorders   
Anaemia  1  3/131 (2.29%) 
Anaemia haemolytic autoimmune  1  2/131 (1.53%) 
Febrile neutropenia  1  4/131 (3.05%) 
Leukopenia  1  3/131 (2.29%) 
Neutropenia  1  3/131 (2.29%) 
Pancytopenia  1  1/131 (0.76%) 
Thrombocytopenia  1  2/131 (1.53%) 
Cardiac disorders   
Cardiogenic shock  1  1/131 (0.76%) 
Subendocardial ischaemia  1  1/131 (0.76%) 
Supraventricular tachycardia  1  1/131 (0.76%) 
Eye disorders   
Angle closure glaucoma  1  1/131 (0.76%) 
Gastrointestinal disorders   
Abdominal pain  1  4/131 (3.05%) 
Colitis  1  2/131 (1.53%) 
Diarrhoea  1  1/131 (0.76%) 
Gastric ulcer  1  1/131 (0.76%) 
Gastrointestinal haemorrhage  1  1/131 (0.76%) 
Intussusception  1  1/131 (0.76%) 
Lower gastrointestinal haemorrhage  1  1/131 (0.76%) 
Nausea  1  1/131 (0.76%) 
Pancreatitis  1  1/131 (0.76%) 
Peritonitis  1  1/131 (0.76%) 
Small intestinal obstruction  1  1/131 (0.76%) 
Vomiting  1  6/131 (4.58%) 
General disorders   
Asthenia  1  1/131 (0.76%) 
Chest pain  1  3/131 (2.29%) 
Chills  1  1/131 (0.76%) 
Fatigue  1  1/131 (0.76%) 
Multi-organ failure  1  1/131 (0.76%) 
Oedema peripheral  1  1/131 (0.76%) 
Pain  1  1/131 (0.76%) 
Pyrexia  1  11/131 (8.40%) 
Immune system disorders   
Cytokine release syndrome  1  1/131 (0.76%) 
Hypersensitivity  1  1/131 (0.76%) 
Infections and infestations   
Candida sepsis  1  1/131 (0.76%) 
Catheter related infection  1  1/131 (0.76%) 
Cellulitis  1  5/131 (3.82%) 
Erysipelas  1  1/131 (0.76%) 
Herpes zoster  1  1/131 (0.76%) 
Infection  1  1/131 (0.76%) 
Oral candidiasis  1  1/131 (0.76%) 
Pneumocystis jiroveci pneumonia  1  1/131 (0.76%) 
Pneumonia  1  7/131 (5.34%) 
Respiratory tract infection  1  1/131 (0.76%) 
Sepsis  1  6/131 (4.58%) 
Septic shock  1  1/131 (0.76%) 
Sinusitis  1  1/131 (0.76%) 
Staphylococcal infection  1  2/131 (1.53%) 
Urinary tract infection  1  2/131 (1.53%) 
Viral upper respiratory tract infection  1  1/131 (0.76%) 
Investigations   
Aspartate aminotransferase increased  1  1/131 (0.76%) 
Aspiration tracheal  1  1/131 (0.76%) 
C-reactive protein increased  1  1/131 (0.76%) 
Ejection fraction decreased  1  1/131 (0.76%) 
Electrocardiogram QT prolonged  1  1/131 (0.76%) 
Electrocardiogram T wave inversion  1  1/131 (0.76%) 
Electrocardiogram repolarisation abnormality  1  1/131 (0.76%) 
Hepatic enzyme increased  1  1/131 (0.76%) 
Liver function test abnormal  1  1/131 (0.76%) 
Metabolism and nutrition disorders   
Dehydration  1  3/131 (2.29%) 
Failure to thrive  1  1/131 (0.76%) 
Hypercalcaemia  1  1/131 (0.76%) 
Hyponatraemia  1  2/131 (1.53%) 
Magnesium deficiency  1  1/131 (0.76%) 
Tumour lysis syndrome  1  2/131 (1.53%) 
Musculoskeletal and connective tissue disorders   
Arthralgia  1  1/131 (0.76%) 
Muscular weakness  1  1/131 (0.76%) 
Periarthritis  1  1/131 (0.76%) 
Tendon disorder  1  1/131 (0.76%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Malignant melanoma  1  1/131 (0.76%) 
Myelodysplastic syndrome  1  1/131 (0.76%) 
Neoplasm malignant  1  1/131 (0.76%) 
Tumour flare  1  1/131 (0.76%) 
Tumour pain  1  1/131 (0.76%) 
Nervous system disorders   
Cerebrovascular accident  1  1/131 (0.76%) 
Dizziness  1  1/131 (0.76%) 
Lethargy  1  1/131 (0.76%) 
Polyneuropathy  1  1/131 (0.76%) 
Somnolence  1  1/131 (0.76%) 
Syncope  1  1/131 (0.76%) 
Psychiatric disorders   
Mental status changes  1  2/131 (1.53%) 
Renal and urinary disorders   
Hydronephrosis  1  1/131 (0.76%) 
Nephrolithiasis  1  1/131 (0.76%) 
Pelvi-ureteric obstruction  1  1/131 (0.76%) 
Proteinuria  1  1/131 (0.76%) 
Renal failure  1  2/131 (1.53%) 
Renal failure acute  1  2/131 (1.53%) 
Urinary retention  1  1/131 (0.76%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnoea  1  3/131 (2.29%) 
Hypoxia  1  2/131 (1.53%) 
Pleural effusion  1  1/131 (0.76%) 
Pulmonary embolism  1  3/131 (2.29%) 
Vascular disorders   
Deep vein thrombosis  1  5/131 (3.82%) 
Hypotension  1  1/131 (0.76%) 
Thrombosis  1  1/131 (0.76%) 
1
Term from vocabulary, MedDRA 17.0
Indicates events were collected by systematic assessment
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   124/131 (94.66%) 
Blood and lymphatic system disorders   
Anaemia  1  32/131 (24.43%) 
Leukopenia  1  15/131 (11.45%) 
Neutropenia  1  37/131 (28.24%) 
Thrombocytopenia  1  53/131 (40.46%) 
Cardiac disorders   
Tachycardia  1  13/131 (9.92%) 
Gastrointestinal disorders   
Abdominal pain  1  15/131 (11.45%) 
Abdominal pain upper  1  9/131 (6.87%) 
Constipation  1  39/131 (29.77%) 
Diarrhoea  1  46/131 (35.11%) 
Dyspepsia  1  12/131 (9.16%) 
Nausea  1  76/131 (58.02%) 
Stomatitis  1  14/131 (10.69%) 
Vomiting  1  48/131 (36.64%) 
General disorders   
Asthenia  1  22/131 (16.79%) 
Chest pain  1  8/131 (6.11%) 
Chills  1  14/131 (10.69%) 
Fatigue  1  53/131 (40.46%) 
Oedema  1  7/131 (5.34%) 
Oedema peripheral  1  13/131 (9.92%) 
Pain  1  10/131 (7.63%) 
Pyrexia  1  44/131 (33.59%) 
Infections and infestations   
Nasopharyngitis  1  7/131 (5.34%) 
Oral candidiasis  1  7/131 (5.34%) 
Upper respiratory tract infection  1  12/131 (9.16%) 
Urinary tract infection  1  7/131 (5.34%) 
Investigations   
Weight decreased  1  14/131 (10.69%) 
Metabolism and nutrition disorders   
Anorexia  1  38/131 (29.01%) 
Decreased appetite  1  12/131 (9.16%) 
Hypokalaemia  1  14/131 (10.69%) 
Hypomagnesaemia  1  9/131 (6.87%) 
Musculoskeletal and connective tissue disorders   
Arthralgia  1  7/131 (5.34%) 
Back pain  1  9/131 (6.87%) 
Muscle spasms  1  12/131 (9.16%) 
Myalgia  1  8/131 (6.11%) 
Pain in extremity  1  7/131 (5.34%) 
Nervous system disorders   
Dizziness  1  10/131 (7.63%) 
Dysgeusia  1  27/131 (20.61%) 
Headache  1  19/131 (14.50%) 
Lethargy  1  8/131 (6.11%) 
Psychiatric disorders   
Anxiety  1  9/131 (6.87%) 
Insomnia  1  9/131 (6.87%) 
Respiratory, thoracic and mediastinal disorders   
Cough  1  24/131 (18.32%) 
Dyspnoea  1  16/131 (12.21%) 
Oropharyngeal pain  1  8/131 (6.11%) 
Rhinorrhoea  1  8/131 (6.11%) 
Skin and subcutaneous tissue disorders   
Dry skin  1  8/131 (6.11%) 
Night sweats  1  9/131 (6.87%) 
Pruritus  1  12/131 (9.16%) 
Rash  1  11/131 (8.40%) 
Skin lesion  1  11/131 (8.40%) 
Vascular disorders   
Hypotension  1  10/131 (7.63%) 
1
Term from vocabulary, MedDRA 17.0
Indicates events were collected by systematic assessment
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.
Upon investigator submission of a publication or presentation to Celgene, Celgene shall complete its review within 60 days after receipt of the proposed publication or presentation. Upon Celgene's request, proposed publication or presentation will be delayed up to 60 additional days to enable Celgene to secure adequate intellectual property protection of property of Celgene that would be affected by such proposed publication or presentation.
Results Point of Contact
Name/Title: Associate Director, Clinical Trials Disclosure
Organization: Celgene Corporation
Phone: 1-888-260-1599
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT00426764     History of Changes
Obsolete Identifiers: NCT00924378
Other Study ID Numbers: GPI-06-0002
2006-006228-21 ( EudraCT Number )
First Submitted: January 23, 2007
First Posted: January 25, 2007
Results First Submitted: July 5, 2012
Results First Posted: August 13, 2012
Last Update Posted: May 30, 2019