ClinicalTrials.gov
ClinicalTrials.gov Menu

Romidepsin and Abraxane in Treating Patients With Metastatic Inflammatory Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01938833
Recruitment Status : Terminated (Closed by Sponsor)
First Posted : September 10, 2013
Results First Posted : September 29, 2017
Last Update Posted : December 28, 2017
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
Thomas Jefferson University ( Sidney Kimmel Cancer Center at Thomas Jefferson University )

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions HER2-negative Breast Cancer
Inflammatory Breast Cancer
Male Breast Cancer
Recurrent Breast Cancer
Stage IV Breast Cancer
Interventions Drug: Romidepsin
Drug: Abraxane
Enrollment 9
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment (Romidepsin and Abraxane)
Hide Arm/Group Description

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

Period Title: Overall Study
Started 9
Completed 9
Not Completed 0
Arm/Group Title Treatment (Romidepsin and Abraxane)
Hide Arm/Group Description

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 Number of Baseline Participants 9
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 9 participants
51.6  (9.33)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants
Female
9
 100.0%
Male
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
9
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
9
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 9 participants
9
 100.0%
1.Primary Outcome
Title Maximum-Tolerated Dose of Romidepsin (Phase I)
Hide Description Determined according to incidence of dose-limiting toxicity, graded using the National Cancer Institute (NCI) CTCAE version 4.0
Time Frame 28 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Data were not collected and the Outcome will never be analyzed.
Arm/Group Title Treatment (Romidepsin and Abraxane)
Hide Arm/Group Description:

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 Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Primary Outcome
Title Progression-Free Survival (PFS)
Hide Description [Not Specified]
Time Frame The duration of time from start of treatment to time of progression or death, whichever occurs first, assessed up to 5 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Data were not collected and the Outcome will never be analyzed
Arm/Group Title Treatment (Romidepsin and Abraxane)
Hide Arm/Group Description:

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 Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Incidence of Adverse Events, Graded According to NCI CTCAE Version 4.0
Hide Description 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.
Time Frame Up to 30 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Data were not collected and the Outcome will never be analyzed.
Arm/Group Title Treatment (Romidepsin and Abraxane)
Hide Arm/Group Description:

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 Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Overall Response Rate (ORR)
Hide Description The 95% confidence intervals should be provided.
Time Frame Up to 5 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Data were not collected and the Outcome will never be analyzed.
Arm/Group Title Treatment (Romidepsin and Abraxane)
Hide Arm/Group Description:

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 Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Clinical Benefit Rate (CBR)
Hide Description The 95% confidence intervals should be provided.
Time Frame Up to 5 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Data were not collected and the Outcome will never be analyzed.
Arm/Group Title Treatment (Romidepsin and Abraxane)
Hide Arm/Group Description:

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 Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment (Romidepsin and Abraxane)
Hide Arm/Group Description

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

All-Cause Mortality
Treatment (Romidepsin and Abraxane)
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Treatment (Romidepsin and Abraxane)
Affected / at Risk (%) # Events
Total   2/7 (28.57%)    
Infections and infestations   
Fever *  1/7 (14.29%)  2
Renal and urinary disorders   
Catheter related Infection *  1/7 (14.29%)  1
Skin and subcutaneous tissue disorders   
Rash Acneiform *  1/7 (14.29%)  1
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Treatment (Romidepsin and Abraxane)
Affected / at Risk (%) # Events
Total   7/9 (77.78%)    
Blood and lymphatic system disorders   
Alanine Aminotransferase Increased *  3/9 (33.33%)  10
Alkaline phosphatase Increased *  2/9 (22.22%)  2
Anemia *  7/9 (77.78%)  18
Aspartate Aminotransferase increased *  1/9 (11.11%)  1
Epistaxis *  1/9 (11.11%)  1
Hematoma *  1/9 (11.11%)  1
Hypercalcemia *  1/9 (11.11%)  1
Hyperglycemia *  6/9 (66.67%)  14
Hyperphosphatemia *  1/9 (11.11%)  2
Hypocalcemia *  2/9 (22.22%)  2
Hypokalemia *  1/9 (11.11%)  2
Hyponatremia *  2/9 (22.22%)  4
Hypophosphatemia *  1/9 (11.11%)  2
INR increased *  1/9 (11.11%)  2
Lymphocyte Count Decreased *  1/9 (11.11%)  6
Platelet Count decreased *  1/9 (11.11%)  1
Ear and labyrinth disorders   
Tinnitus *  1/9 (11.11%)  1
Endocrine disorders   
LDH increased *  1/9 (11.11%)  1
Eye disorders   
Blurred Vision *  1/9 (11.11%)  2
Eye disorders *  2/9 (22.22%)  4
Gastrointestinal disorders   
Constipation *  4/9 (44.44%)  4
Diarrhea *  2/9 (22.22%)  2
Dyspepsia *  1/9 (11.11%)  1
Gastrointestinal other symptoms *  1/9 (11.11%)  1
Gastrointestinal Pain *  1/9 (11.11%)  1
Heart Burn *  1/9 (11.11%)  1
Nausea *  4/9 (44.44%)  6
Vomiting *  4/9 (44.44%)  4
General disorders   
Body Aches *  1/9 (11.11%)  1
Bone Pain *  1/9 (11.11%)  1
Chills *  1/9 (11.11%)  1
Dizziness *  4/9 (44.44%)  4
Dry mouth *  1/9 (11.11%)  1
Dsygeusia *  3/9 (33.33%)  4
Edema in the Limbs *  4/9 (44.44%)  9
Fatigue *  5/9 (55.56%)  11
Headaches *  5/9 (55.56%)  5
Malaise *  1/9 (11.11%)  1
Mucositis oral *  1/9 (11.11%)  1
Pain *  7/9 (77.78%)  17
Right Foot Pain *  1/9 (11.11%)  1
Right leg pain *  1/9 (11.11%)  1
Runny Nose *  1/9 (11.11%)  1
Shoulder pain *  1/9 (11.11%)  1
Sore Throat *  1/9 (11.11%)  1
Toothache *  1/9 (11.11%)  2
Immune system disorders   
Alopecia *  5/9 (55.56%)  6
Infections and infestations   
Fever *  1/9 (11.11%)  1
Flu like symptoms-Cold *  1/9 (11.11%)  1
Lower Jaw Infection *  1/9 (11.11%)  1
Neutrophil count decreased *  4/9 (44.44%)  7
Sinusitis *  1/9 (11.11%)  1
White blood cell decreased *  5/9 (55.56%)  12
Wound - Right Arm *  1/9 (11.11%)  1
Musculoskeletal and connective tissue disorders   
Lower Back Spasm *  1/9 (11.11%)  1
Lump *  1/9 (11.11%)  1
Tightness *  2/9 (22.22%)  9
Nervous system disorders   
Insomnia *  2/9 (22.22%)  2
Neuropathy *  4/9 (44.44%)  7
Numbness *  1/9 (11.11%)  1
Sensory Neuropathy *  2/9 (22.22%)  2
Tremor *  1/9 (11.11%)  1
Psychiatric disorders   
Anorexia *  1/9 (11.11%)  1
Anxiety *  1/9 (11.11%)  1
Depression *  3/9 (33.33%)  3
Negative Thoughts *  1/9 (11.11%)  1
Renal and urinary disorders   
Hematuria *  1/9 (11.11%)  2
Interstitial Cystitis *  1/9 (11.11%)  1
Urine Culture Growth *  1/9 (11.11%)  2
Reproductive system and breast disorders   
Irregular Menstruation *  1/9 (11.11%)  1
Vaginal Dryness *  1/9 (11.11%)  1
Respiratory, thoracic and mediastinal disorders   
Cough *  3/9 (33.33%)  5
Dyspenea *  1/9 (11.11%)  2
Pleural Effusion *  1/9 (11.11%)  1
Skin and subcutaneous tissue disorders   
Flushing *  1/9 (11.11%)  1
Pruritus *  2/9 (22.22%)  2
Rash *  1/9 (11.11%)  2
Skin Disorder - Hole *  1/9 (11.11%)  1
Skin Infection-Cellulitis *  1/9 (11.11%)  1
Skin Peeling *  1/9 (11.11%)  1
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Maysa Abu-Khalaf
Organization: Sidney Kimmel Cancer Center at Thomas Jefferson University
Phone: 215 503-4685
Publications:
Desai N, Trieu V, Yao R, et al. Increased transport of nanoparticle albumin-bound paclitaxel (ABI-007) by endothelial gp60-mediated caveolar transcytosis: a pathway inhibited by Taxol. Eur J Cancer Suppl. 2004;2:182.
Responsible Party: Thomas Jefferson University ( Sidney Kimmel Cancer Center at Thomas Jefferson University )
ClinicalTrials.gov Identifier: NCT01938833     History of Changes
Other Study ID Numbers: 13C.387
2013-035 ( Other Identifier: CCRRC )
First Submitted: September 5, 2013
First Posted: September 10, 2013
Results First Submitted: September 5, 2017
Results First Posted: September 29, 2017
Last Update Posted: December 28, 2017