Trial Outcomes & Findings for Vorinostat and Bortezomib in Treating Patients With Advanced Soft Tissue Sarcoma (NCT NCT00937495)
NCT ID: NCT00937495
Last Updated: 2014-05-14
Results Overview
The number of confirmed tumor responses is defined as a complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) on two consecutive evaluations at least six weeks apart. Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the longest dimension (LD) of target lesions taking as reference the baseline sum LD.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
16 participants
Primary outcome timeframe
Up to 2 years
Results posted on
2014-05-14
Participant Flow
Sixteen patients were accrued to this study from June 2009 through July 2010.
One participant received commercial drug instead of study drug and was deemed a violation. Another participant did not have a post baseline measurement scan and by protocol is not evaluable for the primary endpoint. These patients were excluded from the primary endpoint analysis. Therefore, 14 participants were evaluated for each endpoint.
Participant milestones
| Measure |
Treatment (Vorinostat, Bortezomib)
Patients receive 400 mg vorinostat orally once daily on days 1-14. Patients also receive 1.3 mg/m\^2 bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
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|---|---|
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Overall Study
STARTED
|
16
|
|
Overall Study
COMPLETED
|
14
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Treatment (Vorinostat, Bortezomib)
Patients receive 400 mg vorinostat orally once daily on days 1-14. Patients also receive 1.3 mg/m\^2 bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
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|---|---|
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Overall Study
Protocol Violation
|
2
|
Baseline Characteristics
Vorinostat and Bortezomib in Treating Patients With Advanced Soft Tissue Sarcoma
Baseline characteristics by cohort
| Measure |
Treatment (Vorinostat, Bortezomib)
n=16 Participants
Patients receive 400 mg vorinostat orally once daily on days 1-14. Patients also receive 1.3 mg/m\^2 bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
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|---|---|
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Age, Continuous
|
62 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 2 yearsThe number of confirmed tumor responses is defined as a complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) on two consecutive evaluations at least six weeks apart. Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the longest dimension (LD) of target lesions taking as reference the baseline sum LD.
Outcome measures
| Measure |
Treatment (Vorinostat, Bortezomib)
n=14 Participants
Patients receive 400 mg vorinostat orally once daily on days 1-14. Patients also receive 1.3 mg/m\^2 bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
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|---|---|
|
Confirmed Tumor Responses
Complete Response (CR)
|
0 participants
|
|
Confirmed Tumor Responses
Partial Response (PR)
|
0 participants
|
SECONDARY outcome
Timeframe: Up to 2 yearsProgression-free survival is defined as the time from registration to the time of progression or death, whichever comes first. The distribution and median of progression-free survival times will be estimated using the method of Kaplan-Meier.
Outcome measures
| Measure |
Treatment (Vorinostat, Bortezomib)
n=14 Participants
Patients receive 400 mg vorinostat orally once daily on days 1-14. Patients also receive 1.3 mg/m\^2 bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
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|---|---|
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Progression Free Survival
|
1.5 months
Interval 1.3 to 2.9
|
SECONDARY outcome
Timeframe: Time from registration to death due to any cause, assessed up to 2 yearsThe distribution of survival time will be estimated using the method of Kaplan-Meier.
Outcome measures
| Measure |
Treatment (Vorinostat, Bortezomib)
n=14 Participants
Patients receive 400 mg vorinostat orally once daily on days 1-14. Patients also receive 1.3 mg/m\^2 bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Survival
|
16.4 months
Interval 9.4 to
The upper bound of the 95% confidence interval could not be estimated due to an insufficient number of events.
|
Adverse Events
Treatment (Vorinostat, Bortezomib)
Serious events: 6 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment (Vorinostat, Bortezomib)
n=16 participants at risk
Patients receive 400 mg vorinostat orally once daily on days 1-14. Patients also receive 1.3 mg/m\^2 bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
6.2%
1/16 • Number of events 2
|
|
Gastrointestinal disorders
Diarrhea
|
18.8%
3/16 • Number of events 3
|
|
Gastrointestinal disorders
Nausea
|
6.2%
1/16 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
12.5%
2/16 • Number of events 2
|
|
General disorders
Fatigue
|
6.2%
1/16 • Number of events 1
|
|
Investigations
INR increased
|
6.2%
1/16 • Number of events 1
|
|
Investigations
Platelet count decreased
|
18.8%
3/16 • Number of events 5
|
|
Metabolism and nutrition disorders
Anorexia
|
6.2%
1/16 • Number of events 1
|
|
Metabolism and nutrition disorders
Dehydration
|
6.2%
1/16 • Number of events 1
|
|
Nervous system disorders
Depressed level of consciousness
|
6.2%
1/16 • Number of events 1
|
|
Nervous system disorders
Syncope
|
6.2%
1/16 • Number of events 1
|
|
Psychiatric disorders
Confusion
|
6.2%
1/16 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
6.2%
1/16 • Number of events 1
|
|
Vascular disorders
Hypotension
|
6.2%
1/16 • Number of events 1
|
Other adverse events
| Measure |
Treatment (Vorinostat, Bortezomib)
n=16 participants at risk
Patients receive 400 mg vorinostat orally once daily on days 1-14. Patients also receive 1.3 mg/m\^2 bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
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Blood and lymphatic system disorders
Hemoglobin decreased
|
75.0%
12/16 • Number of events 35
|
|
Eye disorders
Optic nerve edema
|
6.2%
1/16 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
6.2%
1/16 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
75.0%
12/16 • Number of events 35
|
|
Gastrointestinal disorders
Dyspepsia
|
6.2%
1/16 • Number of events 1
|
|
Gastrointestinal disorders
Ear, nose and throat examination abnormal
|
6.2%
1/16 • Number of events 2
|
|
Gastrointestinal disorders
Flatulence
|
6.2%
1/16 • Number of events 2
|
|
Gastrointestinal disorders
Intra-abdominal hemorrhage
|
6.2%
1/16 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
87.5%
14/16 • Number of events 35
|
|
Gastrointestinal disorders
Oral hemorrhage
|
12.5%
2/16 • Number of events 2
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
6.2%
1/16 • Number of events 2
|
|
Gastrointestinal disorders
Vomiting
|
68.8%
11/16 • Number of events 18
|
|
General disorders
Chills
|
6.2%
1/16 • Number of events 1
|
|
General disorders
Edema limbs
|
12.5%
2/16 • Number of events 4
|
|
General disorders
Fatigue
|
93.8%
15/16 • Number of events 48
|
|
Infections and infestations
Mucosal infection
|
6.2%
1/16 • Number of events 1
|
|
Investigations
Alanine aminotransferase increased
|
6.2%
1/16 • Number of events 1
|
|
Investigations
Aspartate aminotransferase increased
|
31.2%
5/16 • Number of events 6
|
|
Investigations
Bilirubin increased
|
6.2%
1/16 • Number of events 1
|
|
Investigations
Creatinine increased
|
6.2%
1/16 • Number of events 1
|
|
Investigations
Leukocyte count decreased
|
56.2%
9/16 • Number of events 11
|
|
Investigations
Neutrophil count decreased
|
6.2%
1/16 • Number of events 1
|
|
Investigations
Platelet count decreased
|
81.2%
13/16 • Number of events 33
|
|
Metabolism and nutrition disorders
Anorexia
|
56.2%
9/16 • Number of events 29
|
|
Metabolism and nutrition disorders
Dehydration
|
12.5%
2/16 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
6.2%
1/16 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
6.2%
1/16 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
18.8%
3/16 • Number of events 9
|
|
Nervous system disorders
Peripheral motor neuropathy
|
18.8%
3/16 • Number of events 5
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
31.2%
5/16 • Number of events 18
|
|
Nervous system disorders
Syncope
|
6.2%
1/16 • Number of events 1
|
|
Psychiatric disorders
Insomnia
|
6.2%
1/16 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.2%
1/16 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
12.5%
2/16 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
6.2%
1/16 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
6.2%
1/16 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash desquamating
|
6.2%
1/16 • Number of events 2
|
|
Vascular disorders
Hypotension
|
6.2%
1/16 • Number of events 1
|
|
Vascular disorders
Thrombosis
|
6.2%
1/16 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60