Trial Outcomes & Findings for A Single Agent Phase II Study of Romidepsin (Depsipeptide, FK228) in the Treatment of Cutaneous T-cell Lymphoma (CTCL) (NCT NCT00106431)
NCT ID: NCT00106431
Last Updated: 2019-10-30
Results Overview
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).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
102 participants
Primary outcome timeframe
6 months
Results posted on
2019-10-30
Participant Flow
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
Eligible patients were required to have failed at least 1 prior systemic therapy, e.g., interferon, chemotherapy, Ontak® (denileukin diftitox), or Targretin® (bexarotene).
Participant milestones
| Measure |
Romidepsin
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.
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|---|---|
|
Overall Study
STARTED
|
102
|
|
Overall Study
COMPLETED
|
37
|
|
Overall Study
NOT COMPLETED
|
65
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Single Agent Phase II Study of Romidepsin (Depsipeptide, FK228) in the Treatment of Cutaneous T-cell Lymphoma (CTCL)
Baseline characteristics by cohort
| Measure |
Romidepsin
n=102 Participants
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.
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|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
79 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
23 Participants
n=5 Participants
|
|
Age, Continuous
|
57.0 years
STANDARD_DEVIATION 11.93 • n=5 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
62 Participants
n=5 Participants
|
|
Region of Enrollment
France
|
5 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
24 participants
n=5 Participants
|
|
Region of Enrollment
Russian Federation
|
17 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
6 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
20 participants
n=5 Participants
|
|
Region of Enrollment
Georgia
|
3 participants
n=5 Participants
|
|
Region of Enrollment
Ukraine
|
7 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance status
0, Fully active, able to carry on all pre-disease
|
53 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance status
1, Restricted in physically strenuous activity but
|
49 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance status
2, Ambulatory and capable of all selfcare but unab
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Efficacy analysis based on interim analysis of data for as treated population
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).
Outcome measures
| Measure |
Romidepsin
n=96 Participants
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.
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|---|---|
|
The Percent of Patients (Pts) With Objective Disease Response
|
34 Percent of participants
|
SECONDARY outcome
Timeframe: Up to 10 months; median duration of follow up was 5.1 monthsPopulation: Efficacy analysis based on interim analysis of data for as treated population
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.
Outcome measures
| Measure |
Romidepsin
n=96 Participants
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.
|
|---|---|
|
Duration of Objective Disease Response
|
14.91 Months
Interval 0.03 to 19.81
|
SECONDARY outcome
Timeframe: Up to 10 monthsPopulation: Efficacy analysis based on interim analysis of data for as treated population
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).
Outcome measures
| Measure |
Romidepsin
n=96 Participants
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.
|
|---|---|
|
Time to Objective Disease Response
|
1.87 Months
Interval 0.89 to 4.76
|
SECONDARY outcome
Timeframe: Up to 10 months; median duration of follow up was 6.1 monthsPopulation: Efficacy analysis based on interim analysis of data for as treated population
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.
Outcome measures
| Measure |
Romidepsin
n=96 Participants
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.
|
|---|---|
|
Time to Disease Progression
|
8.28 Months
Interval 0.0 to 21.65
|
SECONDARY outcome
Timeframe: Up to 10 monthsPopulation: Patients meeting definition of moderate to severe pruritus on VAS (i.e., had a VAS of \>=30 mm)
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.
Outcome measures
| Measure |
Romidepsin
n=52 Participants
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.
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|---|---|
|
Decrease in Pruritus Visual Analogue Scale (VAS) Score of ≥30 mm or a Score of 0 for at Least 2 Consecutive Cycles.
|
25 participants
|
SECONDARY outcome
Timeframe: Up to 10 months; median duration of follow up was 6.0 monthsPopulation: Efficacy analysis based on interim analysis of data for as treated population
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.
Outcome measures
| Measure |
Romidepsin
n=96 Participants
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.
|
|---|---|
|
Duration of Objective Disease Control (ODC)
|
17.67 Months
Interval 0.03 to 19.81
|
SECONDARY outcome
Timeframe: Up to 10 monthsPopulation: Efficacy analysis based on interim analysis of data for as treated population
The percent of pts with confirmed ODC (CR, CCR, PR and SD90) based on OPDREC was summarized.
Outcome measures
| Measure |
Romidepsin
n=96 Participants
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.
|
|---|---|
|
Percent of Pts With Objective Disease Control
|
64 Percent of participants
|
Adverse Events
Romidepsin
Serious events: 23 serious events
Other events: 99 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Romidepsin
n=102 participants at risk
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.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia NOS
|
0.98%
1/102 • 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.
Patients could remain on treatment after 6 months if they experienced a response to treatment.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.98%
1/102 • 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.
Patients could remain on treatment after 6 months if they experienced a response to treatment.
|
|
Blood and lymphatic system disorders
Neutropenia
|
2.0%
2/102 • 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.
Patients could remain on treatment after 6 months if they experienced a response to treatment.
|
|
Cardiac disorders
Atrioventricular Block First Degree
|
0.98%
1/102 • 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.
Patients could remain on treatment after 6 months if they experienced a response to treatment.
|
|
Cardiac disorders
Atrioventricular Block Second Degree
|
0.98%
1/102 • 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.
Patients could remain on treatment after 6 months if they experienced a response to treatment.
|
|
Cardiac disorders
Cardiac Failure NOS
|
0.98%
1/102 • 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.
Patients could remain on treatment after 6 months if they experienced a response to treatment.
|
|
Cardiac disorders
Cardiopulmonary Failure
|
0.98%
1/102 • 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.
Patients could remain on treatment after 6 months if they experienced a response to treatment.
|
|
Cardiac disorders
Cardiac Tamponade
|
0.98%
1/102 • 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.
Patients could remain on treatment after 6 months if they experienced a response to treatment.
|
|
Cardiac disorders
Bradyarrhythmia
|
0.98%
1/102 • 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.
Patients could remain on treatment after 6 months if they experienced a response to treatment.
|
|
Cardiac disorders
Supraventricular Tachycardia
|
0.98%
1/102 • 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.
Patients could remain on treatment after 6 months if they experienced a response to treatment.
|
|
Cardiac disorders
Ventricular Tachycardia
|
0.98%
1/102 • 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.
Patients could remain on treatment after 6 months if they experienced a response to treatment.
|
|
Gastrointestinal disorders
Constipation
|
0.98%
1/102 • 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.
Patients could remain on treatment after 6 months if they experienced a response to treatment.
|
|
Gastrointestinal disorders
Colonic Perforation
|
0.98%
1/102 • 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.
Patients could remain on treatment after 6 months if they experienced a response to treatment.
|
|
General disorders
Fatigue
|
0.98%
1/102 • 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.
Patients could remain on treatment after 6 months if they experienced a response to treatment.
|
|
General disorders
Malaise
|
0.98%
1/102 • 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.
Patients could remain on treatment after 6 months if they experienced a response to treatment.
|
|
General disorders
Rigors
|
0.98%
1/102 • 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.
Patients could remain on treatment after 6 months if they experienced a response to treatment.
|
|
General disorders
Pyrexia
|
2.9%
3/102 • 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.
Patients could remain on treatment after 6 months if they experienced a response to treatment.
|
|
General disorders
Disease Progression NOS
|
2.0%
2/102 • 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.
Patients could remain on treatment after 6 months if they experienced a response to treatment.
|
|
General disorders
Pain Exacerbated
|
0.98%
1/102 • 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.
Patients could remain on treatment after 6 months if they experienced a response to treatment.
|
|
Infections and infestations
Oral Candidiasis
|
0.98%
1/102 • 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.
Patients could remain on treatment after 6 months if they experienced a response to treatment.
|
|
Infections and infestations
Oropharyngeal Candidiasis
|
0.98%
1/102 • 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.
Patients could remain on treatment after 6 months if they experienced a response to treatment.
|
|
Infections and infestations
Perineal Abscess
|
0.98%
1/102 • 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.
Patients could remain on treatment after 6 months if they experienced a response to treatment.
|
|
Infections and infestations
Sepsis NOS
|
2.9%
3/102 • 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.
Patients could remain on treatment after 6 months if they experienced a response to treatment.
|
|
Infections and infestations
Skin Bacterial Infection
|
0.98%
1/102 • 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.
Patients could remain on treatment after 6 months if they experienced a response to treatment.
|
|
Infections and infestations
Staphylococcal Bacteraemia
|
0.98%
1/102 • 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.
Patients could remain on treatment after 6 months if they experienced a response to treatment.
|
|
Infections and infestations
Pharnygitis
|
0.98%
1/102 • 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.
Patients could remain on treatment after 6 months if they experienced a response to treatment.
|
|
Infections and infestations
Tonsillitis
|
0.98%
1/102 • 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.
Patients could remain on treatment after 6 months if they experienced a response to treatment.
|
|
Infections and infestations
Urinary Tract Infection
|
0.98%
1/102 • 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.
Patients could remain on treatment after 6 months if they experienced a response to treatment.
|
|
Investigations
Electrocardiogram St Segment Depression
|
0.98%
1/102 • 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.
Patients could remain on treatment after 6 months if they experienced a response to treatment.
|
|
Investigations
Troponin I Increased
|
0.98%
1/102 • 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.
Patients could remain on treatment after 6 months if they experienced a response to treatment.
|
|
Investigations
Urine Output Decreased
|
0.98%
1/102 • 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.
Patients could remain on treatment after 6 months if they experienced a response to treatment.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.98%
1/102 • 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.
Patients could remain on treatment after 6 months if they experienced a response to treatment.
|
|
Metabolism and nutrition disorders
Hyperglycaemia NOS
|
0.98%
1/102 • 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.
Patients could remain on treatment after 6 months if they experienced a response to treatment.
|
|
Metabolism and nutrition disorders
Acidosis NOS
|
0.98%
1/102 • 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.
Patients could remain on treatment after 6 months if they experienced a response to treatment.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.98%
1/102 • 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.
Patients could remain on treatment after 6 months if they experienced a response to treatment.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.98%
1/102 • 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.
Patients could remain on treatment after 6 months if they experienced a response to treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm Progression NOS
|
3.9%
4/102 • 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.
Patients could remain on treatment after 6 months if they experienced a response to treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor Lysis Syndrome
|
2.0%
2/102 • 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.
Patients could remain on treatment after 6 months if they experienced a response to treatment.
|
|
Nervous system disorders
Syncope
|
0.98%
1/102 • 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.
Patients could remain on treatment after 6 months if they experienced a response to treatment.
|
|
Psychiatric disorders
Depression
|
0.98%
1/102 • 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.
Patients could remain on treatment after 6 months if they experienced a response to treatment.
|
|
Renal and urinary disorders
Renal Failure Acute
|
0.98%
1/102 • 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.
Patients could remain on treatment after 6 months if they experienced a response to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal Stenosis
|
0.98%
1/102 • 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.
Patients could remain on treatment after 6 months if they experienced a response to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.98%
1/102 • 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.
Patients could remain on treatment after 6 months if they experienced a response to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.98%
1/102 • 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.
Patients could remain on treatment after 6 months if they experienced a response to treatment.
|
|
Skin and subcutaneous tissue disorders
Dermatitis Medicamentosa
|
0.98%
1/102 • 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.
Patients could remain on treatment after 6 months if they experienced a response to treatment.
|
|
Vascular disorders
Haematoma NOS
|
0.98%
1/102 • 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.
Patients could remain on treatment after 6 months if they experienced a response to treatment.
|
|
Vascular disorders
Thrombosis
|
0.98%
1/102 • 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.
Patients could remain on treatment after 6 months if they experienced a response to treatment.
|
|
Vascular disorders
Hypotension NOS
|
2.0%
2/102 • 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.
Patients could remain on treatment after 6 months if they experienced a response to treatment.
|
Other adverse events
| Measure |
Romidepsin
n=102 participants at risk
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.
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
55.9%
57/102 • 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.
Patients could remain on treatment after 6 months if they experienced a response to treatment.
|
|
Gastrointestinal disorders
Vomiting NOS
|
34.3%
35/102 • 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.
Patients could remain on treatment after 6 months if they experienced a response to treatment.
|
|
Gastrointestinal disorders
Diarrhoea NOS
|
19.6%
20/102 • 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.
Patients could remain on treatment after 6 months if they experienced a response to treatment.
|
|
Gastrointestinal disorders
Constipation
|
11.8%
12/102 • 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.
Patients could remain on treatment after 6 months if they experienced a response to treatment.
|
|
Gastrointestinal disorders
Dry Mouth
|
6.9%
7/102 • 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.
Patients could remain on treatment after 6 months if they experienced a response to treatment.
|
|
Gastrointestinal disorders
Abdominal Pain NOS
|
5.9%
6/102 • 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.
Patients could remain on treatment after 6 months if they experienced a response to treatment.
|
|
General disorders
Fatigue
|
33.3%
34/102 • 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.
Patients could remain on treatment after 6 months if they experienced a response to treatment.
|
|
General disorders
Pyrexia
|
19.6%
20/102 • 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.
Patients could remain on treatment after 6 months if they experienced a response to treatment.
|
|
General disorders
Asthenia
|
13.7%
14/102 • 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.
Patients could remain on treatment after 6 months if they experienced a response to treatment.
|
|
General disorders
Oedema Peripheral
|
7.8%
8/102 • 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.
Patients could remain on treatment after 6 months if they experienced a response to treatment.
|
|
General disorders
Lethargy
|
5.9%
6/102 • 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.
Patients could remain on treatment after 6 months if they experienced a response to treatment.
|
|
General disorders
Rigors
|
4.9%
5/102 • 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.
Patients could remain on treatment after 6 months if they experienced a response to treatment.
|
|
Infections and infestations
Skin Infection
|
7.8%
8/102 • 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.
Patients could remain on treatment after 6 months if they experienced a response to treatment.
|
|
Infections and infestations
Upper Respiratory Tract Infection NOS
|
5.9%
6/102 • 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.
Patients could remain on treatment after 6 months if they experienced a response to treatment.
|
|
Investigations
Blood Magnesium Decreased
|
12.7%
13/102 • 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.
Patients could remain on treatment after 6 months if they experienced a response to treatment.
|
|
Investigations
Haemoglobin Decreased
|
6.9%
7/102 • 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.
Patients could remain on treatment after 6 months if they experienced a response to treatment.
|
|
Investigations
Weight Decreased
|
4.9%
5/102 • 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.
Patients could remain on treatment after 6 months if they experienced a response to treatment.
|
|
Metabolism and nutrition disorders
Anorexia
|
22.5%
23/102 • 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.
Patients could remain on treatment after 6 months if they experienced a response to treatment.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
9.8%
10/102 • 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.
Patients could remain on treatment after 6 months if they experienced a response to treatment.
|
|
Nervous system disorders
Headache
|
16.7%
17/102 • 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.
Patients could remain on treatment after 6 months if they experienced a response to treatment.
|
|
Nervous system disorders
Dysgeusia
|
14.7%
15/102 • 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.
Patients could remain on treatment after 6 months if they experienced a response to treatment.
|
|
Nervous system disorders
Ageusia
|
11.8%
12/102 • 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.
Patients could remain on treatment after 6 months if they experienced a response to treatment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
14.7%
15/102 • 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.
Patients could remain on treatment after 6 months if they experienced a response to treatment.
|
|
Blood and lymphatic system disorders
Anaemia NOS
|
11.8%
12/102 • 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.
Patients could remain on treatment after 6 months if they experienced a response to treatment.
|
|
Blood and lymphatic system disorders
Neutropenia
|
7.8%
8/102 • 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.
Patients could remain on treatment after 6 months if they experienced a response to treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.9%
7/102 • 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.
Patients could remain on treatment after 6 months if they experienced a response to treatment.
|
|
Vascular disorders
Hypotension NOS
|
6.9%
7/102 • 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.
Patients could remain on treatment after 6 months if they experienced a response to treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm Progression NOS
|
7.8%
8/102 • 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.
Patients could remain on treatment after 6 months if they experienced a response to treatment.
|
Additional Information
Elizabeth Faust, PhD, Vice President, Clinical Research Services
Celgene Corporation
Phone: 617/583-1300
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER