Trial Outcomes & Findings for Compassionate Use of Eribulin for the Treatment of Advanced Breast Cancer Refractory to All Other Marketed Therapies (NCT NCT01142661)
NCT ID: NCT01142661
Last Updated: 2013-09-20
Results Overview
General safety will be assessed by monitoring and recording the number of patients with adverse events (serious and nonserious) for duration of treatment which continued until disease progression, unacceptable toxicity or death.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
9 participants
Primary outcome timeframe
For duration of treatment, an average of 5 months
Results posted on
2013-09-20
Participant Flow
This study was recruited at 5 centers in the US during the period of Aug 2010 to Aug 2011.
Participant milestones
| Measure |
Eribulin Mesylate
Eribulin Mesylate : Eribulin Mesylate: A dose of 1.4 mg/m\^2 given intravenously on Day 1 and Day 8 of a 21 day cycle, continued until disease progression, unacceptable toxicity or death.
|
|---|---|
|
Overall Study
STARTED
|
9
|
|
Overall Study
COMPLETED
|
5
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
Eribulin Mesylate
Eribulin Mesylate : Eribulin Mesylate: A dose of 1.4 mg/m\^2 given intravenously on Day 1 and Day 8 of a 21 day cycle, continued until disease progression, unacceptable toxicity or death.
|
|---|---|
|
Overall Study
Adverse Event
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Physician Decision
|
1
|
Baseline Characteristics
Compassionate Use of Eribulin for the Treatment of Advanced Breast Cancer Refractory to All Other Marketed Therapies
Baseline characteristics by cohort
| Measure |
Eribulin Mesylate
n=9 Participants
Eribulin Mesylate : Eribulin Mesylate: A dose of 1.4 mg/m\^2 given intravenously on Day 1 and Day 8 of a 21 day cycle, continued until disease progression, unacceptable toxicity or death.
|
|---|---|
|
Age Continuous
|
55.2 years
STANDARD_DEVIATION 11.58 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
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
|
PRIMARY outcome
Timeframe: For duration of treatment, an average of 5 monthsGeneral safety will be assessed by monitoring and recording the number of patients with adverse events (serious and nonserious) for duration of treatment which continued until disease progression, unacceptable toxicity or death.
Outcome measures
| Measure |
Eribulin Mesylate
n=9 Participants
Eribulin Mesylate : Eribulin Mesylate: A dose of 1.4 mg/m\^2 given intravenously on Day 1 and Day 8 of a 21 day cycle, continued until disease progression, unacceptable toxicity or death.
|
|---|---|
|
Safety
|
9 participants
|
PRIMARY outcome
Timeframe: For duration of treatment, an average of 5 monthsGeneral safety will be assessed by monitoring and recording the number of patients with serious adverse events for duration of treatment which continued until disease progression, unacceptable toxicity or death.
Outcome measures
| Measure |
Eribulin Mesylate
n=9 Participants
Eribulin Mesylate : Eribulin Mesylate: A dose of 1.4 mg/m\^2 given intravenously on Day 1 and Day 8 of a 21 day cycle, continued until disease progression, unacceptable toxicity or death.
|
|---|---|
|
Safety
|
7 participants
|
Adverse Events
Eribulin Mesylate
Serious events: 7 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Eribulin Mesylate
n=9 participants at risk
Eribulin Mesylate : Eribulin Mesylate: A dose of 1.4 mg/m\^2 given intravenously on Day 1 and Day 8 of a 21 day cycle, continued until disease progression, unacceptable toxicity or death.
|
|---|---|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
11.1%
1/9
|
|
Blood and lymphatic system disorders
Neutropenia
|
11.1%
1/9
|
|
Cardiac disorders
Tachycardia
|
11.1%
1/9
|
|
Gastrointestinal disorders
Hematemesis
|
11.1%
1/9
|
|
Gastrointestinal disorders
Small Bowel Obstruction
|
11.1%
1/9
|
|
Infections and infestations
Pneumonia
|
11.1%
1/9
|
|
Musculoskeletal and connective tissue disorders
Alcohol Poisoning
|
11.1%
1/9
|
|
Metabolism and nutrition disorders
Hypokalemia
|
11.1%
1/9
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Progressive Disease
|
44.4%
4/9
|
|
Nervous system disorders
Syncope
|
11.1%
1/9
|
Other adverse events
| Measure |
Eribulin Mesylate
n=9 participants at risk
Eribulin Mesylate : Eribulin Mesylate: A dose of 1.4 mg/m\^2 given intravenously on Day 1 and Day 8 of a 21 day cycle, continued until disease progression, unacceptable toxicity or death.
|
|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
33.3%
3/9
|
|
Blood and lymphatic system disorders
Anemia
|
11.1%
1/9
|
|
Blood and lymphatic system disorders
Leukopenia
|
11.1%
1/9
|
|
Blood and lymphatic system disorders
Splenomegaly
|
11.1%
1/9
|
|
Congenital, familial and genetic disorders
Thrombocytopenia
|
11.1%
1/9
|
|
Eye disorders
Tachyarrhythmia
|
11.1%
1/9
|
|
Eye disorders
Lacrimation Increased
|
11.1%
1/9
|
|
Eye disorders
Photopsia
|
11.1%
1/9
|
|
Gastrointestinal disorders
Vision Blurred
|
11.1%
1/9
|
|
Eye disorders
Vision Impairment
|
11.1%
1/9
|
|
Gastrointestinal disorders
Constipation
|
44.4%
4/9
|
|
Gastrointestinal disorders
Nausea
|
44.4%
4/9
|
|
Gastrointestinal disorders
Abdominal Distension
|
22.2%
2/9
|
|
General disorders
Abdominal Hernia
|
11.1%
1/9
|
|
Gastrointestinal disorders
Ascites
|
11.1%
1/9
|
|
Gastrointestinal disorders
Gingival Bleeding
|
11.1%
1/9
|
|
Gastrointestinal disorders
Diarrhea
|
11.1%
1/9
|
|
Gastrointestinal disorders
Hypoaesthesia Oral
|
11.1%
1/9
|
|
Investigations
Mouth Ulceration
|
11.1%
1/9
|
|
Gastrointestinal disorders
Oral Discomfort
|
11.1%
1/9
|
|
Gastrointestinal disorders
Stomatitis
|
11.1%
1/9
|
|
Gastrointestinal disorders
Vomiting
|
11.1%
1/9
|
|
General disorders
Fatigue
|
66.7%
6/9
|
|
General disorders
Peripheral Edema
|
22.2%
2/9
|
|
General disorders
Cyst
|
11.1%
1/9
|
|
General disorders
Mucosal Inflammation
|
11.1%
1/9
|
|
Infections and infestations
Oral Herpes
|
11.1%
1/9
|
|
Injury, poisoning and procedural complications
Skin Infection
|
11.1%
1/9
|
|
Infections and infestations
Urinary Tract Infection
|
11.1%
1/9
|
|
Injury, poisoning and procedural complications
Contusion
|
11.1%
1/9
|
|
Investigations
Neutrophil Count Decreased
|
22.2%
2/9
|
|
Investigations
Blood Alkaline Phosphatase Increased
|
11.1%
1/9
|
|
Investigations
Blood Bilirubin Increased
|
11.1%
1/9
|
|
Investigations
Hemoglobin Decreased
|
11.1%
1/9
|
|
Investigations
Occult Blood Positive
|
11.1%
1/9
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Decreased Appetite
|
11.1%
1/9
|
|
Metabolism and nutrition disorders
Fluid Retention
|
11.1%
1/9
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
11.1%
1/9
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
22.2%
2/9
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
11.1%
1/9
|
|
Pregnancy, puerperium and perinatal conditions
Bone Pain
|
11.1%
1/9
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
11.1%
1/9
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
11.1%
1/9
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
11.1%
1/9
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
11.1%
1/9
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
11.1%
1/9
|
|
Nervous system disorders
Headache
|
22.2%
2/9
|
|
Nervous system disorders
Ataxia
|
11.1%
1/9
|
|
Nervous system disorders
Dysaesthesia
|
11.1%
1/9
|
|
Nervous system disorders
Neuropathy Peripheral
|
11.1%
1/9
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
11.1%
1/9
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
22.2%
2/9
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.1%
1/9
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
11.1%
1/9
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
11.1%
1/9
|
|
Respiratory, thoracic and mediastinal disorders
Upper Airway Cough Syndrome
|
11.1%
1/9
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
11.1%
1/9
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
11.1%
1/9
|
|
Hepatobiliary disorders
Jaundice
|
11.1%
1/9
|
|
Psychiatric disorders
Insomnia
|
11.1%
1/9
|
|
Vascular disorders
Phlebitis
|
11.1%
1/9
|
|
Vascular disorders
Phlebitis Superficial
|
11.1%
1/9
|
Additional Information
Prash Gopalakrishna
Eisai Inc.
Phone: 888-422-4743
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place