Trial Outcomes & Findings for Depsipeptide (Romidepsin) in Treating Patients With Metastatic or Unresectable Soft Tissue Sarcoma (NCT NCT00112463)
NCT ID: NCT00112463
Last Updated: 2017-06-14
Results Overview
Objective tumor response was evaluated using the criteria proposed by the Response Evaluation Criteria In Solid Tumors (RECIST) Committee (JNCI 92(3):205-216,2000). Changes in only the largest diameter (unidimensional measurement) of the target lesions are used. A sum of the longest diameter (LD) for all target lesions was calculated and reported as the baseline sum LD. The baseline sum LD was used as reference by which to characterize the objective tumor response. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum LD; Overall Response (OR) = CR + PR
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
40 participants
Primary outcome timeframe
While on treatment - max of 16 months
Results posted on
2017-06-14
Participant Flow
Participant milestones
| Measure |
Treatment (Single-agent Depsipeptide)
Patients receive depsipeptide (romidepsin) intravenously (IV) over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 6 additional courses beyond documentation of CR.
|
|---|---|
|
Overall Study
STARTED
|
40
|
|
Overall Study
COMPLETED
|
1
|
|
Overall Study
NOT COMPLETED
|
39
|
Reasons for withdrawal
| Measure |
Treatment (Single-agent Depsipeptide)
Patients receive depsipeptide (romidepsin) intravenously (IV) over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 6 additional courses beyond documentation of CR.
|
|---|---|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
Progression
|
30
|
|
Overall Study
Second Primary
|
1
|
|
Overall Study
Toxicity
|
3
|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Never started treatment
|
2
|
Baseline Characteristics
Depsipeptide (Romidepsin) in Treating Patients With Metastatic or Unresectable Soft Tissue Sarcoma
Baseline characteristics by cohort
| Measure |
Treatment (Single-agent Depsipeptide)
n=40 Participants
Patients receive depsipeptide (romidepsin) intravenously (IV) over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 6 additional courses beyond documentation of CR.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
24 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
16 Participants
n=5 Participants
|
|
Age, Continuous
|
59 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
40 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
32 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
40 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: While on treatment - max of 16 monthsPopulation: Participants who were evaluable for response
Objective tumor response was evaluated using the criteria proposed by the Response Evaluation Criteria In Solid Tumors (RECIST) Committee (JNCI 92(3):205-216,2000). Changes in only the largest diameter (unidimensional measurement) of the target lesions are used. A sum of the longest diameter (LD) for all target lesions was calculated and reported as the baseline sum LD. The baseline sum LD was used as reference by which to characterize the objective tumor response. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum LD; Overall Response (OR) = CR + PR
Outcome measures
| Measure |
Treatment (Single-agent Depsipeptide)
n=35 Participants
Patients receive depsipeptide (romidepsin) intravenously (IV) over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 6 additional courses beyond documentation of CR.
|
|---|---|
|
Objective Tumor Response (Complete and Partial)
|
2 Participants
|
PRIMARY outcome
Timeframe: Until disease progression - max of 48 monthsPopulation: All treated participants
Progressive disease is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameters (LD) of target lesions, taking as reference the smallest sum LD recorded since treatment started, or a measurable increase in a non-target lesion, or the appearance of new lesions. Time to progression is the number of months from first treatment until the date of progression.
Outcome measures
| Measure |
Treatment (Single-agent Depsipeptide)
n=38 Participants
Patients receive depsipeptide (romidepsin) intravenously (IV) over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 6 additional courses beyond documentation of CR.
|
|---|---|
|
Time to Progression
|
1.9 months
Interval 1.7 to 2.5
|
PRIMARY outcome
Timeframe: During treatment (max of 16 months) and for 1 month following treatmentPopulation: All treated participants
The outcome reported here is the number (%) of participants who experienced grade 3 or greater toxicity while on study. A summary of the individual toxicities can be found in the AE/SAE results.
Outcome measures
| Measure |
Treatment (Single-agent Depsipeptide)
n=38 Participants
Patients receive depsipeptide (romidepsin) intravenously (IV) over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 6 additional courses beyond documentation of CR.
|
|---|---|
|
Toxicity as Assessed Using the Expanded Common Toxicity Criteria Version 3
|
13 Participants
|
SECONDARY outcome
Timeframe: Max of 98 monthsPopulation: All treated participants
Months from first treatment until death or the last date of contact
Outcome measures
| Measure |
Treatment (Single-agent Depsipeptide)
n=38 Participants
Patients receive depsipeptide (romidepsin) intravenously (IV) over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 6 additional courses beyond documentation of CR.
|
|---|---|
|
Survival
|
12.2 months
Interval 7.6 to 19.3
|
Adverse Events
Treatment (Single-agent Depsipeptide)
Serious events: 13 serious events
Other events: 38 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment (Single-agent Depsipeptide)
n=38 participants at risk
Patients receive depsipeptide (romidepsin) intravenously (IV) over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 6 additional courses beyond documentation of CR.
|
|---|---|
|
Metabolism and nutrition disorders
Anorexia
|
5.3%
2/38 • Number of events 2 • During treatment (max of 16 months) and for 1 month following treatment
Toxicities were evaluated weekly while the participant was on treatment
|
|
Cardiac disorders
Cardiac Arrhythmia - Other
|
7.9%
3/38 • Number of events 4 • During treatment (max of 16 months) and for 1 month following treatment
Toxicities were evaluated weekly while the participant was on treatment
|
|
Cardiac disorders
Cardiac Dysrhythmia
|
2.6%
1/38 • Number of events 1 • During treatment (max of 16 months) and for 1 month following treatment
Toxicities were evaluated weekly while the participant was on treatment
|
|
Cardiac disorders
Cardiac General - Other
|
5.3%
2/38 • Number of events 2 • During treatment (max of 16 months) and for 1 month following treatment
Toxicities were evaluated weekly while the participant was on treatment
|
|
Blood and lymphatic system disorders
Coagulation - Other
|
2.6%
1/38 • Number of events 1 • During treatment (max of 16 months) and for 1 month following treatment
Toxicities were evaluated weekly while the participant was on treatment
|
|
Gastrointestinal disorders
Constipation
|
5.3%
2/38 • Number of events 2 • During treatment (max of 16 months) and for 1 month following treatment
Toxicities were evaluated weekly while the participant was on treatment
|
|
Metabolism and nutrition disorders
Dehydration
|
7.9%
3/38 • Number of events 4 • During treatment (max of 16 months) and for 1 month following treatment
Toxicities were evaluated weekly while the participant was on treatment
|
|
Gastrointestinal disorders
GI - Other
|
2.6%
1/38 • Number of events 1 • During treatment (max of 16 months) and for 1 month following treatment
Toxicities were evaluated weekly while the participant was on treatment
|
|
Endocrine disorders
Hyperglycemia
|
5.3%
2/38 • Number of events 3 • During treatment (max of 16 months) and for 1 month following treatment
Toxicities were evaluated weekly while the participant was on treatment
|
|
Infections and infestations
Infection - Other
|
2.6%
1/38 • Number of events 1 • During treatment (max of 16 months) and for 1 month following treatment
Toxicities were evaluated weekly while the participant was on treatment
|
|
Metabolism and nutrition disorders
Malise/Fatigue
|
2.6%
1/38 • Number of events 1 • During treatment (max of 16 months) and for 1 month following treatment
Toxicities were evaluated weekly while the participant was on treatment
|
|
Metabolism and nutrition disorders
Metabolic - Other
|
7.9%
3/38 • Number of events 4 • During treatment (max of 16 months) and for 1 month following treatment
Toxicities were evaluated weekly while the participant was on treatment
|
|
Gastrointestinal disorders
Nausea
|
7.9%
3/38 • Number of events 5 • During treatment (max of 16 months) and for 1 month following treatment
Toxicities were evaluated weekly while the participant was on treatment
|
|
Nervous system disorders
Pain - Other
|
2.6%
1/38 • Number of events 2 • During treatment (max of 16 months) and for 1 month following treatment
Toxicities were evaluated weekly while the participant was on treatment
|
|
Gastrointestinal disorders
Vomiting
|
10.5%
4/38 • Number of events 5 • During treatment (max of 16 months) and for 1 month following treatment
Toxicities were evaluated weekly while the participant was on treatment
|
|
Metabolism and nutrition disorders
Weight Loss
|
2.6%
1/38 • Number of events 1 • During treatment (max of 16 months) and for 1 month following treatment
Toxicities were evaluated weekly while the participant was on treatment
|
Other adverse events
| Measure |
Treatment (Single-agent Depsipeptide)
n=38 participants at risk
Patients receive depsipeptide (romidepsin) intravenously (IV) over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 6 additional courses beyond documentation of CR.
|
|---|---|
|
Immune system disorders
AGC/ANC
|
7.9%
3/38 • Number of events 5 • During treatment (max of 16 months) and for 1 month following treatment
Toxicities were evaluated weekly while the participant was on treatment
|
|
Metabolism and nutrition disorders
Anorexia
|
23.7%
9/38 • Number of events 55 • During treatment (max of 16 months) and for 1 month following treatment
Toxicities were evaluated weekly while the participant was on treatment
|
|
Cardiac disorders
Cardiac Arrhythmia
|
13.2%
5/38 • Number of events 9 • During treatment (max of 16 months) and for 1 month following treatment
Toxicities were evaluated weekly while the participant was on treatment
|
|
Cardiac disorders
Caridac General - Other
|
10.5%
4/38 • Number of events 4 • During treatment (max of 16 months) and for 1 month following treatment
Toxicities were evaluated weekly while the participant was on treatment
|
|
Blood and lymphatic system disorders
Coagulation - Other
|
7.9%
3/38 • Number of events 5 • During treatment (max of 16 months) and for 1 month following treatment
Toxicities were evaluated weekly while the participant was on treatment
|
|
Gastrointestinal disorders
Constipation
|
50.0%
19/38 • Number of events 82 • During treatment (max of 16 months) and for 1 month following treatment
Toxicities were evaluated weekly while the participant was on treatment
|
|
Gastrointestinal disorders
Constitutional Symptioms - Other
|
34.2%
13/38 • Number of events 51 • During treatment (max of 16 months) and for 1 month following treatment
Toxicities were evaluated weekly while the participant was on treatment
|
|
Renal and urinary disorders
Creatinine
|
7.9%
3/38 • Number of events 3 • During treatment (max of 16 months) and for 1 month following treatment
Toxicities were evaluated weekly while the participant was on treatment
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin
|
15.8%
6/38 • Number of events 11 • During treatment (max of 16 months) and for 1 month following treatment
Toxicities were evaluated weekly while the participant was on treatment
|
|
Gastrointestinal disorders
Diarrhea
|
21.1%
8/38 • Number of events 9 • During treatment (max of 16 months) and for 1 month following treatment
Toxicities were evaluated weekly while the participant was on treatment
|
|
Nervous system disorders
Dizziness
|
7.9%
3/38 • Number of events 16 • During treatment (max of 16 months) and for 1 month following treatment
Toxicities were evaluated weekly while the participant was on treatment
|
|
Gastrointestinal disorders
Dyspepsia/Heartburn
|
10.5%
4/38 • Number of events 20 • During treatment (max of 16 months) and for 1 month following treatment
Toxicities were evaluated weekly while the participant was on treatment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea/SOB
|
36.8%
14/38 • Number of events 26 • During treatment (max of 16 months) and for 1 month following treatment
Toxicities were evaluated weekly while the participant was on treatment
|
|
Infections and infestations
Fever in the absence of neutropenia
|
7.9%
3/38 • Number of events 4 • During treatment (max of 16 months) and for 1 month following treatment
Toxicities were evaluated weekly while the participant was on treatment
|
|
Gastrointestinal disorders
GI - Other
|
65.8%
25/38 • Number of events 65 • During treatment (max of 16 months) and for 1 month following treatment
Toxicities were evaluated weekly while the participant was on treatment
|
|
Blood and lymphatic system disorders
Hemoglobin
|
28.9%
11/38 • Number of events 84 • During treatment (max of 16 months) and for 1 month following treatment
Toxicities were evaluated weekly while the participant was on treatment
|
|
Endocrine disorders
Hot flashes/flushes
|
7.9%
3/38 • Number of events 19 • During treatment (max of 16 months) and for 1 month following treatment
Toxicities were evaluated weekly while the participant was on treatment
|
|
Endocrine disorders
Hyperglycemia
|
13.2%
5/38 • Number of events 14 • During treatment (max of 16 months) and for 1 month following treatment
Toxicities were evaluated weekly while the participant was on treatment
|
|
Infections and infestations
Infection - Other
|
15.8%
6/38 • Number of events 10 • During treatment (max of 16 months) and for 1 month following treatment
Toxicities were evaluated weekly while the participant was on treatment
|
|
Metabolism and nutrition disorders
Malise/Fatigue
|
84.2%
32/38 • Number of events 198 • During treatment (max of 16 months) and for 1 month following treatment
Toxicities were evaluated weekly while the participant was on treatment
|
|
Metabolism and nutrition disorders
Metabolic - Other
|
23.7%
9/38 • Number of events 21 • During treatment (max of 16 months) and for 1 month following treatment
Toxicities were evaluated weekly while the participant was on treatment
|
|
Infections and infestations
Mucositis/stomatitis
|
10.5%
4/38 • Number of events 6 • During treatment (max of 16 months) and for 1 month following treatment
Toxicities were evaluated weekly while the participant was on treatment
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
13.2%
5/38 • Number of events 8 • During treatment (max of 16 months) and for 1 month following treatment
Toxicities were evaluated weekly while the participant was on treatment
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/Soft Tissue - Other
|
28.9%
11/38 • Number of events 23 • During treatment (max of 16 months) and for 1 month following treatment
Toxicities were evaluated weekly while the participant was on treatment
|
|
Gastrointestinal disorders
Nausea
|
68.4%
26/38 • Number of events 150 • During treatment (max of 16 months) and for 1 month following treatment
Toxicities were evaluated weekly while the participant was on treatment
|
|
Nervous system disorders
Neurologic - Other
|
36.8%
14/38 • Number of events 59 • During treatment (max of 16 months) and for 1 month following treatment
Toxicities were evaluated weekly while the participant was on treatment
|
|
Nervous system disorders
Pain - Other
|
57.9%
22/38 • Number of events 123 • During treatment (max of 16 months) and for 1 month following treatment
Toxicities were evaluated weekly while the participant was on treatment
|
|
Nervous system disorders
Pain: Abdomen NOS
|
7.9%
3/38 • Number of events 8 • During treatment (max of 16 months) and for 1 month following treatment
Toxicities were evaluated weekly while the participant was on treatment
|
|
Nervous system disorders
Pain: Back
|
10.5%
4/38 • Number of events 5 • During treatment (max of 16 months) and for 1 month following treatment
Toxicities were evaluated weekly while the participant was on treatment
|
|
Nervous system disorders
Pain: Extremity-limb
|
10.5%
4/38 • Number of events 15 • During treatment (max of 16 months) and for 1 month following treatment
Toxicities were evaluated weekly while the participant was on treatment
|
|
Nervous system disorders
Pain: Head/Headache
|
10.5%
4/38 • Number of events 5 • During treatment (max of 16 months) and for 1 month following treatment
Toxicities were evaluated weekly while the participant was on treatment
|
|
Nervous system disorders
Pain: NOS
|
18.4%
7/38 • Number of events 22 • During treatment (max of 16 months) and for 1 month following treatment
Toxicities were evaluated weekly while the participant was on treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Other
|
18.4%
7/38 • Number of events 18 • During treatment (max of 16 months) and for 1 month following treatment
Toxicities were evaluated weekly while the participant was on treatment
|
|
Renal and urinary disorders
Renal/Genitourinary - Other
|
13.2%
5/38 • Number of events 7 • During treatment (max of 16 months) and for 1 month following treatment
Toxicities were evaluated weekly while the participant was on treatment
|
|
Nervous system disorders
Taste Alteration
|
18.4%
7/38 • Number of events 49 • During treatment (max of 16 months) and for 1 month following treatment
Toxicities were evaluated weekly while the participant was on treatment
|
|
Gastrointestinal disorders
Vomiting
|
39.5%
15/38 • Number of events 42 • During treatment (max of 16 months) and for 1 month following treatment
Toxicities were evaluated weekly while the participant was on treatment
|
|
Infections and infestations
WBC
|
10.5%
4/38 • Number of events 11 • During treatment (max of 16 months) and for 1 month following treatment
Toxicities were evaluated weekly while the participant was on treatment
|
|
Metabolism and nutrition disorders
Weight Gain
|
7.9%
3/38 • Number of events 3 • During treatment (max of 16 months) and for 1 month following treatment
Toxicities were evaluated weekly while the participant was on treatment
|
|
Metabolism and nutrition disorders
Weight Loss
|
28.9%
11/38 • Number of events 18 • During treatment (max of 16 months) and for 1 month following treatment
Toxicities were evaluated weekly while the participant was on treatment
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60