Trial Outcomes & Findings for Suberoylanilide Hydroxamic Acid in Treating Patients With Progressive Stage IV Breast Cancer (NCT NCT00132002)
NCT ID: NCT00132002
Last Updated: 2015-03-19
Results Overview
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
14 participants
Primary outcome timeframe
Up to 8 weeks
Results posted on
2015-03-19
Participant Flow
Participant milestones
| Measure |
Arm 1
Vorinostat, 200 mg orally twice daily, was administered for the first 14 days of each 21 day cycle. Treatment was continued unless either disease progression was determined, the patient requested to be withdrawn from the study, or excessive toxicity was noted.
|
|---|---|
|
Overall Study
STARTED
|
14
|
|
Overall Study
COMPLETED
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Suberoylanilide Hydroxamic Acid in Treating Patients With Progressive Stage IV Breast Cancer
Baseline characteristics by cohort
| Measure |
Arm 1
n=14 Participants
Vorinostat, 200 mg orally twice daily, was administered for the first 14 days of each 21 day cycle. Treatment was continued unless either disease progression was determined, the patient requested to be withdrawn from the study, or excessive toxicity was noted.
|
|---|---|
|
Age, Continuous
|
60 years
n=39 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=39 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=39 Participants
|
PRIMARY outcome
Timeframe: Up to 8 weeksPer Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Outcome measures
| Measure |
Arm 1
n=14 Participants
Vorinostat, 200 mg orally twice daily, was administered for the first 14 days of each 21 day cycle. Treatment was continued unless either disease progression was determined, the patient requested to be withdrawn from the study, or excessive toxicity was noted.
|
|---|---|
|
Objective Tumor Response Rate
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: From the initial date of treatment to time of death, up to 5 years.Estimated using the product-limit method of Kaplan and Meier.
Outcome measures
| Measure |
Arm 1
n=14 Participants
Vorinostat, 200 mg orally twice daily, was administered for the first 14 days of each 21 day cycle. Treatment was continued unless either disease progression was determined, the patient requested to be withdrawn from the study, or excessive toxicity was noted.
|
|---|---|
|
Overall Survival
|
24 Months
Interval 17.4 to
The upper limit of the 95% confidence interval was not calculable because an insufficient number of participants reached the event at the final time point for assessment.
|
SECONDARY outcome
Timeframe: From start of treatment to the time of documented progression, assessed up to 5 yearsEstimated using the product-limit method of Kaplan and Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Outcome measures
| Measure |
Arm 1
n=14 Participants
Vorinostat, 200 mg orally twice daily, was administered for the first 14 days of each 21 day cycle. Treatment was continued unless either disease progression was determined, the patient requested to be withdrawn from the study, or excessive toxicity was noted.
|
|---|---|
|
Progression-free Survival
|
2.6 Months
Interval 1.4 to
The upper limit of the 95% confidence interval was not calculable because an insufficient number of participants reached the event at the final time point for assessment.
|
Adverse Events
Arm 1
Serious events: 3 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm 1
n=14 participants at risk
Vorinostat, 200 mg orally twice daily, was administered for the first 14 days of each 21 day cycle. Treatment was continued unless either disease progression was determined, the patient requested to be withdrawn from the study, or excessive toxicity was noted.
|
|---|---|
|
General disorders
Disease progression
|
14.3%
2/14 • Number of events 2 • Adverse events occured over a period of 1 year and 7 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.1%
1/14 • Number of events 1 • Adverse events occured over a period of 1 year and 7 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
Other adverse events
| Measure |
Arm 1
n=14 participants at risk
Vorinostat, 200 mg orally twice daily, was administered for the first 14 days of each 21 day cycle. Treatment was continued unless either disease progression was determined, the patient requested to be withdrawn from the study, or excessive toxicity was noted.
|
|---|---|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
64.3%
9/14 • Number of events 20 • Adverse events occured over a period of 1 year and 7 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Constipation
|
28.6%
4/14 • Number of events 9 • Adverse events occured over a period of 1 year and 7 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Diarrhea
|
42.9%
6/14 • Number of events 12 • Adverse events occured over a period of 1 year and 7 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Dry mouth
|
14.3%
2/14 • Number of events 2 • Adverse events occured over a period of 1 year and 7 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Ear, nose and throat examination abnormal
|
14.3%
2/14 • Number of events 3 • Adverse events occured over a period of 1 year and 7 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Mucositis oral
|
21.4%
3/14 • Number of events 5 • Adverse events occured over a period of 1 year and 7 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Nausea
|
85.7%
12/14 • Number of events 32 • Adverse events occured over a period of 1 year and 7 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Vomiting
|
50.0%
7/14 • Number of events 7 • Adverse events occured over a period of 1 year and 7 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Edema limbs
|
14.3%
2/14 • Number of events 2 • Adverse events occured over a period of 1 year and 7 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Fatigue
|
78.6%
11/14 • Number of events 29 • Adverse events occured over a period of 1 year and 7 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Pain
|
21.4%
3/14 • Number of events 3 • Adverse events occured over a period of 1 year and 7 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Alanine aminotransferase increased
|
28.6%
4/14 • Number of events 6 • Adverse events occured over a period of 1 year and 7 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Alkaline phosphatase increased
|
42.9%
6/14 • Number of events 10 • Adverse events occured over a period of 1 year and 7 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
85.7%
12/14 • Number of events 38 • Adverse events occured over a period of 1 year and 7 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Creatinine increased
|
21.4%
3/14 • Number of events 5 • Adverse events occured over a period of 1 year and 7 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Hyperbilirubinemia
|
14.3%
2/14 • Number of events 2 • Adverse events occured over a period of 1 year and 7 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Leukopenia
|
42.9%
6/14 • Number of events 15 • Adverse events occured over a period of 1 year and 7 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Lymphopenia
|
71.4%
10/14 • Number of events 26 • Adverse events occured over a period of 1 year and 7 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Platelet count decreased
|
42.9%
6/14 • Number of events 11 • Adverse events occured over a period of 1 year and 7 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Weight loss
|
14.3%
2/14 • Number of events 2 • Adverse events occured over a period of 1 year and 7 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Anorexia
|
21.4%
3/14 • Number of events 3 • Adverse events occured over a period of 1 year and 7 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
14.3%
2/14 • Number of events 2 • Adverse events occured over a period of 1 year and 7 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
57.1%
8/14 • Number of events 13 • Adverse events occured over a period of 1 year and 7 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
14.3%
2/14 • Number of events 2 • Adverse events occured over a period of 1 year and 7 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
7.1%
1/14 • Number of events 1 • Adverse events occured over a period of 1 year and 7 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
7.1%
1/14 • Number of events 1 • Adverse events occured over a period of 1 year and 7 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
64.3%
9/14 • Number of events 22 • Adverse events occured over a period of 1 year and 7 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
14.3%
2/14 • Number of events 2 • Adverse events occured over a period of 1 year and 7 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
21.4%
3/14 • Number of events 8 • Adverse events occured over a period of 1 year and 7 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
28.6%
4/14 • Number of events 5 • Adverse events occured over a period of 1 year and 7 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
28.6%
4/14 • Number of events 6 • Adverse events occured over a period of 1 year and 7 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
21.4%
3/14 • Number of events 3 • Adverse events occured over a period of 1 year and 7 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Serum phosphate decreased
|
7.1%
1/14 • Number of events 1 • Adverse events occured over a period of 1 year and 7 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Serum potassium decreased
|
7.1%
1/14 • Number of events 1 • Adverse events occured over a period of 1 year and 7 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
7.1%
1/14 • Number of events 1 • Adverse events occured over a period of 1 year and 7 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.1%
1/14 • Number of events 1 • Adverse events occured over a period of 1 year and 7 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
21.4%
3/14 • Number of events 8 • Adverse events occured over a period of 1 year and 7 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Joint pain
|
21.4%
3/14 • Number of events 4 • Adverse events occured over a period of 1 year and 7 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
21.4%
3/14 • Number of events 3 • Adverse events occured over a period of 1 year and 7 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
7.1%
1/14 • Number of events 1 • Adverse events occured over a period of 1 year and 7 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
14.3%
2/14 • Number of events 2 • Adverse events occured over a period of 1 year and 7 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Headache
|
7.1%
1/14 • Number of events 1 • Adverse events occured over a period of 1 year and 7 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
14.3%
2/14 • Number of events 4 • Adverse events occured over a period of 1 year and 7 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Speech disorder
|
7.1%
1/14 • Number of events 1 • Adverse events occured over a period of 1 year and 7 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Psychiatric disorders
Anxiety
|
21.4%
3/14 • Number of events 3 • Adverse events occured over a period of 1 year and 7 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Psychiatric disorders
Depression
|
7.1%
1/14 • Number of events 1 • Adverse events occured over a period of 1 year and 7 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Psychiatric disorders
Insomnia
|
7.1%
1/14 • Number of events 3 • Adverse events occured over a period of 1 year and 7 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Renal and urinary disorders
Bladder pain
|
7.1%
1/14 • Number of events 2 • Adverse events occured over a period of 1 year and 7 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Renal and urinary disorders
Proteinuria
|
7.1%
1/14 • Number of events 1 • Adverse events occured over a period of 1 year and 7 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Renal and urinary disorders
Urinary frequency
|
7.1%
1/14 • Number of events 1 • Adverse events occured over a period of 1 year and 7 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Renal and urinary disorders
Urinary retention
|
7.1%
1/14 • Number of events 2 • Adverse events occured over a period of 1 year and 7 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
14.3%
2/14 • Number of events 2 • Adverse events occured over a period of 1 year and 7 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
7.1%
1/14 • Number of events 1 • Adverse events occured over a period of 1 year and 7 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.3%
2/14 • Number of events 6 • Adverse events occured over a period of 1 year and 7 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
21.4%
3/14 • Number of events 6 • Adverse events occured over a period of 1 year and 7 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
7.1%
1/14 • Number of events 1 • Adverse events occured over a period of 1 year and 7 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
21.4%
3/14 • Number of events 5 • Adverse events occured over a period of 1 year and 7 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
7.1%
1/14 • Number of events 1 • Adverse events occured over a period of 1 year and 7 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
14.3%
2/14 • Number of events 4 • Adverse events occured over a period of 1 year and 7 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
21.4%
3/14 • Number of events 4 • Adverse events occured over a period of 1 year and 7 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.1%
1/14 • Number of events 1 • Adverse events occured over a period of 1 year and 7 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
Rash desquamating
|
7.1%
1/14 • Number of events 2 • Adverse events occured over a period of 1 year and 7 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
7.1%
1/14 • Number of events 1 • Adverse events occured over a period of 1 year and 7 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Vascular disorders
Hypertension
|
7.1%
1/14 • Number of events 1 • Adverse events occured over a period of 1 year and 7 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60