Trial Outcomes & Findings for Romidepsin and Abraxane in Treating Patients With Metastatic Inflammatory Breast Cancer (NCT NCT01938833)
NCT ID: NCT01938833
Last Updated: 2025-05-16
Results Overview
Determined according to incidence of dose-limiting toxicity, graded using the National Cancer Institute (NCI) CTCAE version 4.0
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
9 participants
Primary outcome timeframe
28 days
Results posted on
2025-05-16
Participant Flow
Participant milestones
| Measure |
Treatment (Romidepsin and Abraxane)
Patients receive abraxane IV over 30 minutes and romidepsin IV over 60 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Romidepsin
Abraxane
|
|---|---|
|
Overall Study
STARTED
|
9
|
|
Overall Study
COMPLETED
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Romidepsin and Abraxane in Treating Patients With Metastatic Inflammatory Breast Cancer
Baseline characteristics by cohort
| Measure |
Treatment (Romidepsin and Abraxane)
n=9 Participants
Patients receive abraxane IV over 30 minutes and romidepsin IV over 60 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Romidepsin
Abraxane
|
|---|---|
|
Age, Continuous
|
51.6 Years
STANDARD_DEVIATION 9.33 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 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
|
0 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
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
9 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 28 daysPopulation: Data were not collected and the Outcome will never be analyzed.
Determined according to incidence of dose-limiting toxicity, graded using the National Cancer Institute (NCI) CTCAE version 4.0
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: The duration of time from start of treatment to time of progression or death, whichever occurs first, assessed up to 5 yearsPopulation: Data were not collected and the Outcome will never be analyzed
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 30 daysPopulation: Data were not collected and the Outcome will never be analyzed.
Summary tables of grade 2, 3, and 4 toxicities, adverse events (AE), and serious adverse events (SAE) will be generated at the conclusion of the study as well as at the conclusion of phase I study and after 15 patients have been collected on at the interim evaluation time point of the phase 2 part of the study.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: Data were not collected and the Outcome will never be analyzed.
The 95% confidence intervals should be provided.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: Data were not collected and the Outcome will never be analyzed.
The 95% confidence intervals should be provided.
Outcome measures
Outcome data not reported
Adverse Events
Treatment (Romidepsin and Abraxane)
Serious events: 2 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment (Romidepsin and Abraxane)
n=9 participants at risk；n=7 participants at risk
Patients receive abraxane IV over 30 minutes and romidepsin IV over 60 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Romidepsin
Abraxane
|
|---|---|
|
Renal and urinary disorders
Catheter related Infection
|
14.3%
1/7 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash Acneiform
|
14.3%
1/7 • Number of events 1
|
|
Infections and infestations
Fever
|
14.3%
1/7 • Number of events 2
|
Other adverse events
| Measure |
Treatment (Romidepsin and Abraxane)
n=9 participants at risk；n=7 participants at risk
Patients receive abraxane IV over 30 minutes and romidepsin IV over 60 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Romidepsin
Abraxane
|
|---|---|
|
Blood and lymphatic system disorders
Alanine Aminotransferase Increased
|
33.3%
3/9 • Number of events 10
|
|
Blood and lymphatic system disorders
Alkaline phosphatase Increased
|
22.2%
2/9 • Number of events 2
|
|
Immune system disorders
Alopecia
|
55.6%
5/9 • Number of events 6
|
|
Blood and lymphatic system disorders
Anemia
|
77.8%
7/9 • Number of events 18
|
|
Psychiatric disorders
Anorexia
|
11.1%
1/9 • Number of events 1
|
|
Psychiatric disorders
Anxiety
|
11.1%
1/9 • Number of events 1
|
|
Blood and lymphatic system disorders
Aspartate Aminotransferase increased
|
11.1%
1/9 • Number of events 1
|
|
Eye disorders
Blurred Vision
|
11.1%
1/9 • Number of events 2
|
|
General disorders
Body Aches
|
11.1%
1/9 • Number of events 1
|
|
General disorders
Bone Pain
|
11.1%
1/9 • Number of events 1
|
|
General disorders
Chills
|
11.1%
1/9 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
44.4%
4/9 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
3/9 • Number of events 5
|
|
Psychiatric disorders
Depression
|
33.3%
3/9 • Number of events 3
|
|
Gastrointestinal disorders
Diarrhea
|
22.2%
2/9 • Number of events 2
|
|
General disorders
Dizziness
|
44.4%
4/9 • Number of events 4
|
|
General disorders
Dry mouth
|
11.1%
1/9 • Number of events 1
|
|
General disorders
Dsygeusia
|
33.3%
3/9 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Dyspenea
|
11.1%
1/9 • Number of events 2
|
|
Gastrointestinal disorders
Dyspepsia
|
11.1%
1/9 • Number of events 1
|
|
General disorders
Edema in the Limbs
|
44.4%
4/9 • Number of events 9
|
|
Blood and lymphatic system disorders
Epistaxis
|
11.1%
1/9 • Number of events 1
|
|
Eye disorders
Eye disorders
|
22.2%
2/9 • Number of events 4
|
|
General disorders
Fatigue
|
55.6%
5/9 • Number of events 11
|
|
Infections and infestations
Fever
|
11.1%
1/9 • Number of events 1
|
|
Infections and infestations
Flu like symptoms-Cold
|
11.1%
1/9 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Flushing
|
11.1%
1/9 • Number of events 1
|
|
Gastrointestinal disorders
Gastrointestinal other symptoms
|
11.1%
1/9 • Number of events 1
|
|
Gastrointestinal disorders
Gastrointestinal Pain
|
11.1%
1/9 • Number of events 1
|
|
General disorders
Headaches
|
55.6%
5/9 • Number of events 5
|
|
Gastrointestinal disorders
Heart Burn
|
11.1%
1/9 • Number of events 1
|
|
Blood and lymphatic system disorders
Hematoma
|
11.1%
1/9 • Number of events 1
|
|
Renal and urinary disorders
Hematuria
|
11.1%
1/9 • Number of events 2
|
|
Blood and lymphatic system disorders
Hypercalcemia
|
11.1%
1/9 • Number of events 1
|
|
Blood and lymphatic system disorders
Hyperglycemia
|
66.7%
6/9 • Number of events 14
|
|
Blood and lymphatic system disorders
Hyperphosphatemia
|
11.1%
1/9 • Number of events 2
|
|
Blood and lymphatic system disorders
Hypocalcemia
|
22.2%
2/9 • Number of events 2
|
|
Blood and lymphatic system disorders
Hypokalemia
|
11.1%
1/9 • Number of events 2
|
|
Blood and lymphatic system disorders
Hyponatremia
|
22.2%
2/9 • Number of events 4
|
|
Blood and lymphatic system disorders
Hypophosphatemia
|
11.1%
1/9 • Number of events 2
|
|
Blood and lymphatic system disorders
INR increased
|
11.1%
1/9 • Number of events 2
|
|
Nervous system disorders
Insomnia
|
22.2%
2/9 • Number of events 2
|
|
Renal and urinary disorders
Interstitial Cystitis
|
11.1%
1/9 • Number of events 1
|
|
Reproductive system and breast disorders
Irregular Menstruation
|
11.1%
1/9 • Number of events 1
|
|
Endocrine disorders
LDH increased
|
11.1%
1/9 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Lower Back Spasm
|
11.1%
1/9 • Number of events 1
|
|
Infections and infestations
Lower Jaw Infection
|
11.1%
1/9 • Number of events 1
|
|
Blood and lymphatic system disorders
Lymphocyte Count Decreased
|
11.1%
1/9 • Number of events 6
|
|
General disorders
Malaise
|
11.1%
1/9 • Number of events 1
|
|
General disorders
Mucositis oral
|
11.1%
1/9 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Lump
|
11.1%
1/9 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
44.4%
4/9 • Number of events 6
|
|
Nervous system disorders
Neuropathy
|
44.4%
4/9 • Number of events 7
|
|
Infections and infestations
Neutrophil count decreased
|
44.4%
4/9 • Number of events 7
|
|
Nervous system disorders
Numbness
|
11.1%
1/9 • Number of events 1
|
|
General disorders
Pain
|
77.8%
7/9 • Number of events 17
|
|
Blood and lymphatic system disorders
Platelet Count decreased
|
11.1%
1/9 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
11.1%
1/9 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
22.2%
2/9 • Number of events 2
|
|
Psychiatric disorders
Negative Thoughts
|
11.1%
1/9 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash
|
11.1%
1/9 • Number of events 2
|
|
General disorders
Right Foot Pain
|
11.1%
1/9 • Number of events 1
|
|
General disorders
Right leg pain
|
11.1%
1/9 • Number of events 1
|
|
General disorders
Runny Nose
|
11.1%
1/9 • Number of events 1
|
|
Nervous system disorders
Sensory Neuropathy
|
22.2%
2/9 • Number of events 2
|
|
General disorders
Shoulder pain
|
11.1%
1/9 • Number of events 1
|
|
Infections and infestations
Sinusitis
|
11.1%
1/9 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin Disorder - Hole
|
11.1%
1/9 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin Infection-Cellulitis
|
11.1%
1/9 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin Peeling
|
11.1%
1/9 • Number of events 1
|
|
General disorders
Sore Throat
|
11.1%
1/9 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Tightness
|
22.2%
2/9 • Number of events 9
|
|
Ear and labyrinth disorders
Tinnitus
|
11.1%
1/9 • Number of events 1
|
|
General disorders
Toothache
|
11.1%
1/9 • Number of events 2
|
|
Nervous system disorders
Tremor
|
11.1%
1/9 • Number of events 1
|
|
Renal and urinary disorders
Urine Culture Growth
|
11.1%
1/9 • Number of events 2
|
|
Reproductive system and breast disorders
Vaginal Dryness
|
11.1%
1/9 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
44.4%
4/9 • Number of events 4
|
|
Infections and infestations
White blood cell decreased
|
55.6%
5/9 • Number of events 12
|
|
Infections and infestations
Wound - Right Arm
|
11.1%
1/9 • Number of events 1
|
Additional Information
Dr. Maysa Abu-Khalaf
Sidney Kimmel Cancer Center at Thomas Jefferson University
Phone: 215 503-4685
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place