Trial Outcomes & Findings for Valproic Acid in Combination With FEC100 for Primary Therapy in Patients With Breast Cancer (NCT NCT01010854)
NCT ID: NCT01010854
Last Updated: 2018-03-09
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
6 participants
Primary outcome timeframe
after 4 cycles of therapy
Results posted on
2018-03-09
Participant Flow
Participant milestones
| Measure |
VPA FEC100
Valproic Acid with FEC100
oral VPA (60 mg/kg bid) q 12h X 6 with IV 5-Fluorouracil (500 mg/m2) Epirubicin (100 mg/m2) and Cyclophosphamide (500 mg/m2)
|
|---|---|
|
Overall Study
STARTED
|
6
|
|
Overall Study
COMPLETED
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Valproic Acid in Combination With FEC100 for Primary Therapy in Patients With Breast Cancer
Baseline characteristics by cohort
| Measure |
VPA FEC100
n=6 Participants
Valproic Acid with FEC100
VPA FEC100: oral VPA (60 mg/kg bid) q 12h X 6 with IV 5-Fluorouracil (500 mg/m2) Epirubicin (100 mg/m2) and Cyclophosphamide (500 mg/m2)
|
|---|---|
|
Age, Continuous
|
56 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: after 4 cycles of therapyOutcome measures
| Measure |
VPA FEC100
n=6 Participants
Valproic Acid with FEC100
oral VPA (60 mg/kg bid) q 12h X 6 with IV 5-Fluorouracil (500 mg/m2) Epirubicin (100 mg/m2) and Cyclophosphamide (500 mg/m2)
|
|---|---|
|
Pathologic Response at Definitive Surgery
|
3 Participants
|
SECONDARY outcome
Timeframe: after 4 cycles of therapyOutcome measures
| Measure |
VPA FEC100
n=6 Participants
Valproic Acid with FEC100
oral VPA (60 mg/kg bid) q 12h X 6 with IV 5-Fluorouracil (500 mg/m2) Epirubicin (100 mg/m2) and Cyclophosphamide (500 mg/m2)
|
|---|---|
|
Clinical Response Based on Tumor Measurement
|
3 Participants
|
Adverse Events
VPA FEC100
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
VPA FEC100
n=6 participants at risk
Valproic Acid with FEC100
oral VPA (60 mg/kg bid) q 12h X 6 with IV 5-Fluorouracil (500 mg/m2) Epirubicin (100 mg/m2) and Cyclophosphamide (500 mg/m2)
|
|---|---|
|
Nervous system disorders
Dizziness
|
16.7%
1/6
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
16.7%
1/6
|
Other adverse events
| Measure |
VPA FEC100
n=6 participants at risk
Valproic Acid with FEC100
oral VPA (60 mg/kg bid) q 12h X 6 with IV 5-Fluorouracil (500 mg/m2) Epirubicin (100 mg/m2) and Cyclophosphamide (500 mg/m2)
|
|---|---|
|
Blood and lymphatic system disorders
Hemoglobin
|
100.0%
6/6
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
33.3%
2/6
|
|
Blood and lymphatic system disorders
Lymphopenia
|
33.3%
2/6
|
|
Blood and lymphatic system disorders
Platelets
|
16.7%
1/6
|
|
General disorders
Fatigue
|
100.0%
6/6
|
|
General disorders
Insomnia
|
16.7%
1/6
|
|
General disorders
Rigors
|
33.3%
2/6
|
|
Skin and subcutaneous tissue disorders
Hair loss/alopecia
|
66.7%
4/6
|
|
Endocrine disorders
Thyroid function, low
|
16.7%
1/6
|
|
Gastrointestinal disorders
Anorexia
|
33.3%
2/6
|
|
Gastrointestinal disorders
Constipation
|
50.0%
3/6
|
|
Gastrointestinal disorders
Dehydration
|
16.7%
1/6
|
|
Gastrointestinal disorders
Diarrhea
|
16.7%
1/6
|
|
Gastrointestinal disorders
Nausea
|
66.7%
4/6
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
2/6
|
|
Blood and lymphatic system disorders
Febrile neutrophenia
|
33.3%
2/6
|
|
Blood and lymphatic system disorders
Infection
|
16.7%
1/6
|
|
Investigations
Alkaline phosphatase
|
16.7%
1/6
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
16.7%
1/6
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
33.3%
2/6
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
16.7%
1/6
|
|
Metabolism and nutrition disorders
hypophosphatemia
|
16.7%
1/6
|
|
Nervous system disorders
Cognitive disturbance
|
33.3%
2/6
|
|
Nervous system disorders
Dizziness
|
33.3%
2/6
|
|
Nervous system disorders
Memory impairment
|
33.3%
2/6
|
|
Psychiatric disorders
Agitation
|
16.7%
1/6
|
|
Psychiatric disorders
Anxiety
|
33.3%
2/6
|
|
Eye disorders
Watering Eyes
|
16.7%
1/6
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
33.3%
2/6
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
16.7%
1/6
|
|
Reproductive system and breast disorders
Breast Pain
|
16.7%
1/6
|
|
Nervous system disorders
Headache
|
16.7%
1/6
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
50.0%
3/6
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
16.7%
1/6
|
Additional Information
Pamela Munster, MD
University of California, San Francisco
Phone: 877-827-3222
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place