Trial Outcomes & Findings for Eribulin Mesylate Phase IV Clinical Trial in Korean Patients With Metastatic or Locally Advanced Breast Cancer (NCT NCT01961544)
NCT ID: NCT01961544
Last Updated: 2016-10-07
Results Overview
An AE is defined as any harmful, untoward sign (including abnormal laboratory value, etc.), symptom, or disease in a participant administered investigational product that does not necessarily have a causal relationship with treatment. An SAE is defined as an AE that is life threatening or results in death, results in hospitalization (initial or prolonged), results in a disability (significant, persistent, or permanent change, impairment, damage or disruption in the participant's body function/structure, physical activities, or quality of life), results in a congenital anomaly, or requires intervention to prevent permanent impairment or damage. TEAEs are defined as those events that started on or after the date and time of administration of the first dose of study drug and those events that were present prior to the administration of the first dose of study drug and increased in severity during the study.
COMPLETED
PHASE4
101 participants
mean of 3.76 months
2016-10-07
Participant Flow
Participant milestones
| Measure |
Eribulin Mesylate 1.4 mg/m^2
Participants received 1.4 milligrams per meters squared (mg/m\^2) eribulin mesylate intravenously over the course of 2 to 5 minutes on Day 1 and Day 8 of each 21-day cycle.
|
|---|---|
|
Overall Study
STARTED
|
101
|
|
Overall Study
COMPLETED
|
88
|
|
Overall Study
NOT COMPLETED
|
13
|
Reasons for withdrawal
| Measure |
Eribulin Mesylate 1.4 mg/m^2
Participants received 1.4 milligrams per meters squared (mg/m\^2) eribulin mesylate intravenously over the course of 2 to 5 minutes on Day 1 and Day 8 of each 21-day cycle.
|
|---|---|
|
Overall Study
Protocol Violation
|
1
|
|
Overall Study
Withdrawal by Subject
|
7
|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Physician Decision
|
2
|
|
Overall Study
Poor Tolerance
|
1
|
|
Overall Study
Aggravation of Steral Pain
|
1
|
Baseline Characteristics
Eribulin Mesylate Phase IV Clinical Trial in Korean Patients With Metastatic or Locally Advanced Breast Cancer
Baseline characteristics by cohort
| Measure |
Eribulin Mesylate 1.4 mg/m^2
n=101 Participants
Participants received 1.4 milligrams per meters squared (mg/m\^2) eribulin mesylate intravenously over the course of 2 to 5 minutes on Day 1 and Day 8 of each 21-day cycle.
|
|---|---|
|
Age, Continuous
|
50.36 Years
STANDARD_DEVIATION 10.71 • n=93 Participants
|
|
Sex: Female, Male
Female
|
101 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: mean of 3.76 monthsPopulation: Safety Set: all participants who are administered investigational product at least once for the analysis
An AE is defined as any harmful, untoward sign (including abnormal laboratory value, etc.), symptom, or disease in a participant administered investigational product that does not necessarily have a causal relationship with treatment. An SAE is defined as an AE that is life threatening or results in death, results in hospitalization (initial or prolonged), results in a disability (significant, persistent, or permanent change, impairment, damage or disruption in the participant's body function/structure, physical activities, or quality of life), results in a congenital anomaly, or requires intervention to prevent permanent impairment or damage. TEAEs are defined as those events that started on or after the date and time of administration of the first dose of study drug and those events that were present prior to the administration of the first dose of study drug and increased in severity during the study.
Outcome measures
| Measure |
Eribulin Mesylate 1.4 mg/m^2
n=101 Participants
Participants received 1.4 milligrams per meters squared (mg/m\^2) eribulin mesylate intravenously over the course of 2 to 5 minutes on Day 1 and Day 8 of each 21-day cycle.
|
|---|---|
|
Number of Participants With Any Treatment-emergent Adverse Event (TEAE) and Any Treatment-emergent Serious Adverse Event (SAE)
TEAE
|
101 Participants
|
|
Number of Participants With Any Treatment-emergent Adverse Event (TEAE) and Any Treatment-emergent Serious Adverse Event (SAE)
Treatment-emergent SAE
|
20 Participants
|
SECONDARY outcome
Timeframe: mean of 3.76 monthsPopulation: Full Analysis Set: participants who were administered investigational product at least once after enrollment and had at least one primary efficacy data value since Baseline
DCR is defined as the number of participants with complete response (CR), partial response (PR), and stable disease (SD). The Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 was used to assess the tumor response. Tumor response was evaluated by investigators. CR is defined as the disappearance of all extranodal target lesions. All pathological lymph nodes must have decreased to \<10 millimeters (mm) in the short axis. PR is defined as at least a 30% decrease in the sum of the longest diameters (SLD) of target lesions, taking as reference the baseline sum diameters. SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (SLD increased by at least 20% from the smallest value on study \[including baseline, if that is the smallest\]. The SLD must also demonstrate an absolute increase of at least 5 mm. \[Two lesions increasing from 2 mm to 3 mm, for example, does not qualify\]).
Outcome measures
| Measure |
Eribulin Mesylate 1.4 mg/m^2
n=96 Participants
Participants received 1.4 milligrams per meters squared (mg/m\^2) eribulin mesylate intravenously over the course of 2 to 5 minutes on Day 1 and Day 8 of each 21-day cycle.
|
|---|---|
|
Disease Control Rate (DCR)
CR
|
1 Participants
|
|
Disease Control Rate (DCR)
PR
|
15 Participants
|
|
Disease Control Rate (DCR)
SD
|
33 Participants
|
Adverse Events
Eribulin Mesylate 1.4 mg/m^2
Serious adverse events
| Measure |
Eribulin Mesylate 1.4 mg/m^2
n=101 participants at risk
Participants received 1.4 milligrams per meters squared (mg/m\^2) eribulin mesylate intravenously over the course of 2-5 minutes on Day 1 and Day 8 of each 21-day cycle.
|
|---|---|
|
Nervous system disorders
Consciousness fluctuating
|
0.99%
1/101
|
|
Nervous system disorders
Dizziness
|
0.99%
1/101
|
|
Nervous system disorders
Headache
|
0.99%
1/101
|
|
Nervous system disorders
Neuropathy peripheral
|
0.99%
1/101
|
|
Nervous system disorders
Syncope
|
0.99%
1/101
|
|
Gastrointestinal disorders
Abdominal distension
|
0.99%
1/101
|
|
Gastrointestinal disorders
Abdominal pain
|
0.99%
1/101
|
|
Gastrointestinal disorders
Ascites
|
0.99%
1/101
|
|
Gastrointestinal disorders
Gastritis
|
0.99%
1/101
|
|
Infections and infestations
Pneumonia
|
0.99%
1/101
|
|
Infections and infestations
Pseudomonal sepsis
|
0.99%
1/101
|
|
Infections and infestations
Septic shock
|
0.99%
1/101
|
|
Infections and infestations
Subcutaneous abscess
|
0.99%
1/101
|
|
Blood and lymphatic system disorders
Neutropenia
|
2.0%
2/101
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.99%
1/101
|
|
Cardiac disorders
Pericardial effusion
|
2.0%
2/101
|
|
General disorders
Asthenia
|
0.99%
1/101
|
|
General disorders
Pyrexia
|
0.99%
1/101
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.99%
1/101
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.99%
1/101
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.99%
1/101
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.99%
1/101
|
|
Injury, poisoning and procedural complications
Wound secretion
|
0.99%
1/101
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.99%
1/101
|
|
Metabolism and nutrition disorders
Hypophagia
|
0.99%
1/101
|
Other adverse events
| Measure |
Eribulin Mesylate 1.4 mg/m^2
n=101 participants at risk
Participants received 1.4 milligrams per meters squared (mg/m\^2) eribulin mesylate intravenously over the course of 2-5 minutes on Day 1 and Day 8 of each 21-day cycle.
|
|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
91.1%
92/101
|
|
Blood and lymphatic system disorders
Anaemia
|
11.9%
12/101
|
|
Blood and lymphatic system disorders
Leukopenia
|
10.9%
11/101
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
4.0%
4/101
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.99%
1/101
|
|
General disorders
Fatigue
|
26.7%
27/101
|
|
General disorders
Pyrexia
|
16.8%
17/101
|
|
General disorders
Chest pain
|
9.9%
10/101
|
|
General disorders
Asthenia
|
7.9%
8/101
|
|
General disorders
Mucosal inflammation
|
7.9%
8/101
|
|
General disorders
Pain
|
6.9%
7/101
|
|
General disorders
Chills
|
5.0%
5/101
|
|
General disorders
Influenza like illness
|
4.0%
4/101
|
|
General disorders
Oedema peripheral
|
2.0%
2/101
|
|
General disorders
Peripheral swelling
|
2.0%
2/101
|
|
General disorders
Application site pain
|
0.99%
1/101
|
|
General disorders
Face oedema
|
0.99%
1/101
|
|
General disorders
Localised oedema
|
0.99%
1/101
|
|
General disorders
Non-cardiac chest pain
|
0.99%
1/101
|
|
General disorders
Oedema
|
0.99%
1/101
|
|
Gastrointestinal disorders
Nausea
|
24.8%
25/101
|
|
Gastrointestinal disorders
Vomiting
|
10.9%
11/101
|
|
Gastrointestinal disorders
Diarrhoea
|
9.9%
10/101
|
|
Gastrointestinal disorders
Dyspepsia
|
9.9%
10/101
|
|
Gastrointestinal disorders
Constipation
|
8.9%
9/101
|
|
Gastrointestinal disorders
Stomatitis
|
7.9%
8/101
|
|
Gastrointestinal disorders
Abdominal pain
|
5.0%
5/101
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.0%
5/101
|
|
Gastrointestinal disorders
Toothache
|
3.0%
3/101
|
|
Gastrointestinal disorders
Abdominal discomfort
|
2.0%
2/101
|
|
Gastrointestinal disorders
Abdominal distension
|
2.0%
2/101
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
2.0%
2/101
|
|
Gastrointestinal disorders
Dry mouth
|
0.99%
1/101
|
|
Gastrointestinal disorders
Epigastric discomfort
|
0.99%
1/101
|
|
Gastrointestinal disorders
Food poisoning
|
0.99%
1/101
|
|
Gastrointestinal disorders
Gastritis
|
0.99%
1/101
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.99%
1/101
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.99%
1/101
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.99%
1/101
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.99%
1/101
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
45.5%
46/101
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.9%
6/101
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.0%
5/101
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.99%
1/101
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.99%
1/101
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.99%
1/101
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
15.8%
16/101
|
|
Nervous system disorders
Headache
|
11.9%
12/101
|
|
Nervous system disorders
Neuropathy peripheral
|
10.9%
11/101
|
|
Nervous system disorders
Dizziness
|
6.9%
7/101
|
|
Nervous system disorders
Lethargy
|
4.0%
4/101
|
|
Nervous system disorders
Hypoaesthesia
|
3.0%
3/101
|
|
Nervous system disorders
Paraesthesia
|
2.0%
2/101
|
|
Nervous system disorders
Dysgeusia
|
0.99%
1/101
|
|
Nervous system disorders
Hemiparesis
|
0.99%
1/101
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.99%
1/101
|
|
Metabolism and nutrition disorders
Decreased appetite
|
40.6%
41/101
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
4.0%
4/101
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.99%
1/101
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.99%
1/101
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.99%
1/101
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.99%
1/101
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.99%
1/101
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
24.8%
25/101
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.9%
6/101
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.0%
4/101
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
4.0%
4/101
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
3.0%
3/101
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
2.0%
2/101
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.99%
1/101
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.99%
1/101
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.99%
1/101
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.99%
1/101
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.99%
1/101
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.99%
1/101
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis of jaw
|
0.99%
1/101
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
18.8%
19/101
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
9.9%
10/101
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.0%
5/101
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
5.0%
5/101
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
2.0%
2/101
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.99%
1/101
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.99%
1/101
|
|
Respiratory, thoracic and mediastinal disorders
Nasal obstruction
|
0.99%
1/101
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.99%
1/101
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.99%
1/101
|
|
Infections and infestations
Nasopharyngitis
|
6.9%
7/101
|
|
Infections and infestations
Upper respiratory tract infection
|
5.9%
6/101
|
|
Infections and infestations
Urinary tract infection
|
3.0%
3/101
|
|
Infections and infestations
Cystitis
|
2.0%
2/101
|
|
Infections and infestations
Herpes zoster
|
2.0%
2/101
|
|
Infections and infestations
Pneumonia
|
2.0%
2/101
|
|
Infections and infestations
Device related infection
|
0.99%
1/101
|
|
Infections and infestations
Infection
|
0.99%
1/101
|
|
Infections and infestations
Paronychia
|
0.99%
1/101
|
|
Infections and infestations
Pyuria
|
0.99%
1/101
|
|
Psychiatric disorders
Insomnia
|
7.9%
8/101
|
|
Psychiatric disorders
Depression
|
3.0%
3/101
|
|
Psychiatric disorders
Anxiety
|
2.0%
2/101
|
|
Psychiatric disorders
Eating disorder symptom
|
0.99%
1/101
|
|
Investigations
Aspartate aminotransferase increased
|
7.9%
8/101
|
|
Investigations
Alanine aminotransferase increased
|
5.0%
5/101
|
|
Investigations
Electrocardiogram QT prolonged
|
2.0%
2/101
|
|
Investigations
Haemoglobin decreased
|
0.99%
1/101
|
|
Investigations
Blood creatinine increased
|
0.99%
1/101
|
|
Investigations
Neutrophil count increased
|
0.99%
1/101
|
|
Investigations
Weight decreased
|
0.99%
1/101
|
|
Investigations
White blood cell count increased
|
0.99%
1/101
|
|
Reproductive system and breast disorders
Pelvic pain
|
3.0%
3/101
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
3.0%
3/101
|
|
Reproductive system and breast disorders
Breast pain
|
2.0%
2/101
|
|
Eye disorders
Eye pain
|
4.0%
4/101
|
|
Eye disorders
Blepharitis
|
0.99%
1/101
|
|
Eye disorders
Dry age-related macular degeneration
|
0.99%
1/101
|
|
Eye disorders
Dry eye
|
0.99%
1/101
|
|
Eye disorders
Vision blurred
|
0.99%
1/101
|
|
Eye disorders
Xerophthalmia
|
0.99%
1/101
|
|
Vascular disorders
Lymphoedema
|
2.0%
2/101
|
|
Vascular disorders
Embolism
|
0.99%
1/101
|
|
Vascular disorders
Flushing
|
0.99%
1/101
|
|
Vascular disorders
Hypotension
|
0.99%
1/101
|
|
Renal and urinary disorders
Dysuria
|
2.0%
2/101
|
|
Renal and urinary disorders
Haematuria
|
0.99%
1/101
|
|
Renal and urinary disorders
Oliguria
|
0.99%
1/101
|
|
Ear and labyrinth disorders
Ear pain
|
0.99%
1/101
|
|
Ear and labyrinth disorders
External ear pain
|
0.99%
1/101
|
|
Ear and labyrinth disorders
Tinnitus
|
0.99%
1/101
|
|
Cardiac disorders
Palpitations
|
0.99%
1/101
|
|
Injury, poisoning and procedural complications
Eye injury
|
0.99%
1/101
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.99%
1/101
|
Additional Information
Eisai Medical Services
Eisai Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER