Trial Outcomes & Findings for A Study of E7080 in Subjects With Solid Tumor (NCT NCT01268293)
NCT ID: NCT01268293
Last Updated: 2023-06-22
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
9 participants
Primary outcome timeframe
Up to 4 weeks
Results posted on
2023-06-22
Participant Flow
Participant milestones
| Measure |
E7080
E7080 was administered orally once day (QD) in the morning. The initial dose of E7080 was 20 mg QD and increased to 24 mg QD if 20 mg was confirmed to be tolerable.
|
|---|---|
|
Overall Study
STARTED
|
9
|
|
Overall Study
Completed Cycle 1
|
9
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
9
|
Reasons for withdrawal
| Measure |
E7080
E7080 was administered orally once day (QD) in the morning. The initial dose of E7080 was 20 mg QD and increased to 24 mg QD if 20 mg was confirmed to be tolerable.
|
|---|---|
|
Overall Study
Disease progression
|
7
|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Subject choice
|
1
|
Baseline Characteristics
A Study of E7080 in Subjects With Solid Tumor
Baseline characteristics by cohort
| Measure |
E7080
n=9 Participants
E7080 was administered orally once day (QD) in the morning. The initial dose of E7080 was 20 mg QD and increased to 24 mg QD if 20 mg was confirmed to be tolerable.
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|---|---|
|
Age, Continuous
|
43.6 Years
STANDARD_DEVIATION 11.5 • n=93 Participants
|
|
Sex/Gender, Customized
Male
|
2 Participants
n=93 Participants
|
|
Sex/Gender, Customized
Female
|
7 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Up to 4 weeksPopulation: Subjects with less than 75% compliance in Cycle 1 for reasons other than the toxicity of the study drug and who discontinued prior to confirmation of tolerability in Cycle 1 were excluded from the analysis of DLT. All 9 participants completed Cycle 1 (DLT monitoring period) and were included in the analysis of DLT.
Outcome measures
| Measure |
E7080
n=9 Participants
E7080 was administered orally once day (QD) in the morning. The initial dose of E7080 was 20 mg QD and increased to 24 mg QD if 20 mg was confirmed to be tolerable.
|
|---|---|
|
Number of Participants With Dose Limiting Toxicity (DLT)
|
0 Participants
|
PRIMARY outcome
Timeframe: Until participants met discontinuation criteria such as disease progression, intolerable toxicity, and withdrawal of study consent or up to 19 cycles (1 cycle = 28 days).Population: The Safety Analysis Set consisted of subjects who had received at least 1 dose of study drug and had at least 1 postdose safety assessment.
Treatment emergent adverse events (AEs) and serious adverse events (SAEs) were evaluated by determining the AE grade according to Common Terminology Criteria for Adverse Events \[CTCAE\] version 4.0, laboratory tests, vital signs (blood pressure \[mm Hg\], heart rate \[beats per minute\], body temperature \[degree C\], and body weight \[kg\]), 12-lead electrocardiograms (ECGs; heart rate \[bpm\], QT \[msec\] and QTc \[msec\]) and Eastern Cooperative Oncology Group performance status (ECOG-PS).
Outcome measures
| Measure |
E7080
n=9 Participants
E7080 was administered orally once day (QD) in the morning. The initial dose of E7080 was 20 mg QD and increased to 24 mg QD if 20 mg was confirmed to be tolerable.
|
|---|---|
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Number of Participants With Adverse Events
|
9 Participants
|
Adverse Events
E7080
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
E7080
n=9 participants at risk
E7080 was administered orally once day (QD) in the morning. The initial dose of E7080 was 20 mg QD and increased to 24 mg QD if 20 mg was confirmed to be tolerable.
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|---|---|
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Gastrointestinal disorders
Diarrhoea
|
11.1%
1/9 • Until participants met discontinuation criteria such as disease progression, intolerable toxicity, and withdrawal of study consent or up to 19 cycles (1 cycle = 28 days).
|
Other adverse events
| Measure |
E7080
n=9 participants at risk
E7080 was administered orally once day (QD) in the morning. The initial dose of E7080 was 20 mg QD and increased to 24 mg QD if 20 mg was confirmed to be tolerable.
|
|---|---|
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Blood and lymphatic system disorders
Anaemia
|
22.2%
2/9 • Until participants met discontinuation criteria such as disease progression, intolerable toxicity, and withdrawal of study consent or up to 19 cycles (1 cycle = 28 days).
|
|
Blood and lymphatic system disorders
Leukopenia
|
77.8%
7/9 • Until participants met discontinuation criteria such as disease progression, intolerable toxicity, and withdrawal of study consent or up to 19 cycles (1 cycle = 28 days).
|
|
Blood and lymphatic system disorders
Lymphopenia
|
22.2%
2/9 • Until participants met discontinuation criteria such as disease progression, intolerable toxicity, and withdrawal of study consent or up to 19 cycles (1 cycle = 28 days).
|
|
Blood and lymphatic system disorders
Neutropenia
|
55.6%
5/9 • Until participants met discontinuation criteria such as disease progression, intolerable toxicity, and withdrawal of study consent or up to 19 cycles (1 cycle = 28 days).
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
88.9%
8/9 • Until participants met discontinuation criteria such as disease progression, intolerable toxicity, and withdrawal of study consent or up to 19 cycles (1 cycle = 28 days).
|
|
Endocrine disorders
Hyperthyroidism
|
33.3%
3/9 • Until participants met discontinuation criteria such as disease progression, intolerable toxicity, and withdrawal of study consent or up to 19 cycles (1 cycle = 28 days).
|
|
Endocrine disorders
Hypothyroidism
|
33.3%
3/9 • Until participants met discontinuation criteria such as disease progression, intolerable toxicity, and withdrawal of study consent or up to 19 cycles (1 cycle = 28 days).
|
|
Eye disorders
Eye pruritus
|
11.1%
1/9 • Until participants met discontinuation criteria such as disease progression, intolerable toxicity, and withdrawal of study consent or up to 19 cycles (1 cycle = 28 days).
|
|
Eye disorders
Eyelid oedema
|
22.2%
2/9 • Until participants met discontinuation criteria such as disease progression, intolerable toxicity, and withdrawal of study consent or up to 19 cycles (1 cycle = 28 days).
|
|
Gastrointestinal disorders
Abdominal discomfort
|
44.4%
4/9 • Until participants met discontinuation criteria such as disease progression, intolerable toxicity, and withdrawal of study consent or up to 19 cycles (1 cycle = 28 days).
|
|
Gastrointestinal disorders
Abdominal distension
|
11.1%
1/9 • Until participants met discontinuation criteria such as disease progression, intolerable toxicity, and withdrawal of study consent or up to 19 cycles (1 cycle = 28 days).
|
|
Gastrointestinal disorders
Abdominal pain
|
22.2%
2/9 • Until participants met discontinuation criteria such as disease progression, intolerable toxicity, and withdrawal of study consent or up to 19 cycles (1 cycle = 28 days).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
33.3%
3/9 • Until participants met discontinuation criteria such as disease progression, intolerable toxicity, and withdrawal of study consent or up to 19 cycles (1 cycle = 28 days).
|
|
Gastrointestinal disorders
Constipation
|
11.1%
1/9 • Until participants met discontinuation criteria such as disease progression, intolerable toxicity, and withdrawal of study consent or up to 19 cycles (1 cycle = 28 days).
|
|
Gastrointestinal disorders
Diarrhoea
|
55.6%
5/9 • Until participants met discontinuation criteria such as disease progression, intolerable toxicity, and withdrawal of study consent or up to 19 cycles (1 cycle = 28 days).
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
11.1%
1/9 • Until participants met discontinuation criteria such as disease progression, intolerable toxicity, and withdrawal of study consent or up to 19 cycles (1 cycle = 28 days).
|
|
Gastrointestinal disorders
Nausea
|
66.7%
6/9 • Until participants met discontinuation criteria such as disease progression, intolerable toxicity, and withdrawal of study consent or up to 19 cycles (1 cycle = 28 days).
|
|
Gastrointestinal disorders
Stomatitis
|
22.2%
2/9 • Until participants met discontinuation criteria such as disease progression, intolerable toxicity, and withdrawal of study consent or up to 19 cycles (1 cycle = 28 days).
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
3/9 • Until participants met discontinuation criteria such as disease progression, intolerable toxicity, and withdrawal of study consent or up to 19 cycles (1 cycle = 28 days).
|
|
General disorders
Malaise
|
66.7%
6/9 • Until participants met discontinuation criteria such as disease progression, intolerable toxicity, and withdrawal of study consent or up to 19 cycles (1 cycle = 28 days).
|
|
General disorders
Oedema peripheral
|
44.4%
4/9 • Until participants met discontinuation criteria such as disease progression, intolerable toxicity, and withdrawal of study consent or up to 19 cycles (1 cycle = 28 days).
|
|
General disorders
Pyrexia
|
22.2%
2/9 • Until participants met discontinuation criteria such as disease progression, intolerable toxicity, and withdrawal of study consent or up to 19 cycles (1 cycle = 28 days).
|
|
Infections and infestations
Cystitis
|
22.2%
2/9 • Until participants met discontinuation criteria such as disease progression, intolerable toxicity, and withdrawal of study consent or up to 19 cycles (1 cycle = 28 days).
|
|
Infections and infestations
Infection
|
11.1%
1/9 • Until participants met discontinuation criteria such as disease progression, intolerable toxicity, and withdrawal of study consent or up to 19 cycles (1 cycle = 28 days).
|
|
Infections and infestations
Nasopharyngitis
|
11.1%
1/9 • Until participants met discontinuation criteria such as disease progression, intolerable toxicity, and withdrawal of study consent or up to 19 cycles (1 cycle = 28 days).
|
|
Infections and infestations
Oral herpes
|
11.1%
1/9 • Until participants met discontinuation criteria such as disease progression, intolerable toxicity, and withdrawal of study consent or up to 19 cycles (1 cycle = 28 days).
|
|
Infections and infestations
Paronychia
|
22.2%
2/9 • Until participants met discontinuation criteria such as disease progression, intolerable toxicity, and withdrawal of study consent or up to 19 cycles (1 cycle = 28 days).
|
|
Injury, poisoning and procedural complications
Wound complication
|
11.1%
1/9 • Until participants met discontinuation criteria such as disease progression, intolerable toxicity, and withdrawal of study consent or up to 19 cycles (1 cycle = 28 days).
|
|
Investigations
Alanine aminotransferase increased
|
55.6%
5/9 • Until participants met discontinuation criteria such as disease progression, intolerable toxicity, and withdrawal of study consent or up to 19 cycles (1 cycle = 28 days).
|
|
Investigations
Aspartate aminotransferase increased
|
66.7%
6/9 • Until participants met discontinuation criteria such as disease progression, intolerable toxicity, and withdrawal of study consent or up to 19 cycles (1 cycle = 28 days).
|
|
Investigations
Blood alkaline phosphatase increased
|
33.3%
3/9 • Until participants met discontinuation criteria such as disease progression, intolerable toxicity, and withdrawal of study consent or up to 19 cycles (1 cycle = 28 days).
|
|
Investigations
Blood bilirubin increased
|
11.1%
1/9 • Until participants met discontinuation criteria such as disease progression, intolerable toxicity, and withdrawal of study consent or up to 19 cycles (1 cycle = 28 days).
|
|
Investigations
Blood cholesterol increased
|
66.7%
6/9 • Until participants met discontinuation criteria such as disease progression, intolerable toxicity, and withdrawal of study consent or up to 19 cycles (1 cycle = 28 days).
|
|
Investigations
Blood creatinine increased
|
11.1%
1/9 • Until participants met discontinuation criteria such as disease progression, intolerable toxicity, and withdrawal of study consent or up to 19 cycles (1 cycle = 28 days).
|
|
Investigations
Blood lactate dehydrogenase increased
|
44.4%
4/9 • Until participants met discontinuation criteria such as disease progression, intolerable toxicity, and withdrawal of study consent or up to 19 cycles (1 cycle = 28 days).
|
|
Investigations
Blood thyroid stimulating hormone increased
|
88.9%
8/9 • Until participants met discontinuation criteria such as disease progression, intolerable toxicity, and withdrawal of study consent or up to 19 cycles (1 cycle = 28 days).
|
|
Investigations
Blood urine present
|
11.1%
1/9 • Until participants met discontinuation criteria such as disease progression, intolerable toxicity, and withdrawal of study consent or up to 19 cycles (1 cycle = 28 days).
|
|
Investigations
Electrocardiogram T wave inversion
|
44.4%
4/9 • Until participants met discontinuation criteria such as disease progression, intolerable toxicity, and withdrawal of study consent or up to 19 cycles (1 cycle = 28 days).
|
|
Investigations
Gamma-glutamyltransferase increased
|
22.2%
2/9 • Until participants met discontinuation criteria such as disease progression, intolerable toxicity, and withdrawal of study consent or up to 19 cycles (1 cycle = 28 days).
|
|
Investigations
Occult blood
|
11.1%
1/9 • Until participants met discontinuation criteria such as disease progression, intolerable toxicity, and withdrawal of study consent or up to 19 cycles (1 cycle = 28 days).
|
|
Investigations
Urine ketone body present
|
11.1%
1/9 • Until participants met discontinuation criteria such as disease progression, intolerable toxicity, and withdrawal of study consent or up to 19 cycles (1 cycle = 28 days).
|
|
Investigations
Weight decreased
|
22.2%
2/9 • Until participants met discontinuation criteria such as disease progression, intolerable toxicity, and withdrawal of study consent or up to 19 cycles (1 cycle = 28 days).
|
|
Investigations
Weight increased
|
11.1%
1/9 • Until participants met discontinuation criteria such as disease progression, intolerable toxicity, and withdrawal of study consent or up to 19 cycles (1 cycle = 28 days).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
44.4%
4/9 • Until participants met discontinuation criteria such as disease progression, intolerable toxicity, and withdrawal of study consent or up to 19 cycles (1 cycle = 28 days).
|
|
Metabolism and nutrition disorders
Dehydration
|
11.1%
1/9 • Until participants met discontinuation criteria such as disease progression, intolerable toxicity, and withdrawal of study consent or up to 19 cycles (1 cycle = 28 days).
|
|
Metabolism and nutrition disorders
Hyperchloraemia
|
11.1%
1/9 • Until participants met discontinuation criteria such as disease progression, intolerable toxicity, and withdrawal of study consent or up to 19 cycles (1 cycle = 28 days).
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
11.1%
1/9 • Until participants met discontinuation criteria such as disease progression, intolerable toxicity, and withdrawal of study consent or up to 19 cycles (1 cycle = 28 days).
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
66.7%
6/9 • Until participants met discontinuation criteria such as disease progression, intolerable toxicity, and withdrawal of study consent or up to 19 cycles (1 cycle = 28 days).
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
44.4%
4/9 • Until participants met discontinuation criteria such as disease progression, intolerable toxicity, and withdrawal of study consent or up to 19 cycles (1 cycle = 28 days).
|
|
Metabolism and nutrition disorders
Hypoproteinaemia
|
22.2%
2/9 • Until participants met discontinuation criteria such as disease progression, intolerable toxicity, and withdrawal of study consent or up to 19 cycles (1 cycle = 28 days).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
55.6%
5/9 • Until participants met discontinuation criteria such as disease progression, intolerable toxicity, and withdrawal of study consent or up to 19 cycles (1 cycle = 28 days).
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
11.1%
1/9 • Until participants met discontinuation criteria such as disease progression, intolerable toxicity, and withdrawal of study consent or up to 19 cycles (1 cycle = 28 days).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.1%
1/9 • Until participants met discontinuation criteria such as disease progression, intolerable toxicity, and withdrawal of study consent or up to 19 cycles (1 cycle = 28 days).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
55.6%
5/9 • Until participants met discontinuation criteria such as disease progression, intolerable toxicity, and withdrawal of study consent or up to 19 cycles (1 cycle = 28 days).
|
|
Nervous system disorders
Dysgeusia
|
11.1%
1/9 • Until participants met discontinuation criteria such as disease progression, intolerable toxicity, and withdrawal of study consent or up to 19 cycles (1 cycle = 28 days).
|
|
Nervous system disorders
Headache
|
77.8%
7/9 • Until participants met discontinuation criteria such as disease progression, intolerable toxicity, and withdrawal of study consent or up to 19 cycles (1 cycle = 28 days).
|
|
Psychiatric disorders
Insomnia
|
11.1%
1/9 • Until participants met discontinuation criteria such as disease progression, intolerable toxicity, and withdrawal of study consent or up to 19 cycles (1 cycle = 28 days).
|
|
Renal and urinary disorders
Haematuria
|
33.3%
3/9 • Until participants met discontinuation criteria such as disease progression, intolerable toxicity, and withdrawal of study consent or up to 19 cycles (1 cycle = 28 days).
|
|
Renal and urinary disorders
Proteinuria
|
77.8%
7/9 • Until participants met discontinuation criteria such as disease progression, intolerable toxicity, and withdrawal of study consent or up to 19 cycles (1 cycle = 28 days).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.1%
1/9 • Until participants met discontinuation criteria such as disease progression, intolerable toxicity, and withdrawal of study consent or up to 19 cycles (1 cycle = 28 days).
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
55.6%
5/9 • Until participants met discontinuation criteria such as disease progression, intolerable toxicity, and withdrawal of study consent or up to 19 cycles (1 cycle = 28 days).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
11.1%
1/9 • Until participants met discontinuation criteria such as disease progression, intolerable toxicity, and withdrawal of study consent or up to 19 cycles (1 cycle = 28 days).
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
11.1%
1/9 • Until participants met discontinuation criteria such as disease progression, intolerable toxicity, and withdrawal of study consent or up to 19 cycles (1 cycle = 28 days).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
44.4%
4/9 • Until participants met discontinuation criteria such as disease progression, intolerable toxicity, and withdrawal of study consent or up to 19 cycles (1 cycle = 28 days).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
11.1%
1/9 • Until participants met discontinuation criteria such as disease progression, intolerable toxicity, and withdrawal of study consent or up to 19 cycles (1 cycle = 28 days).
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
22.2%
2/9 • Until participants met discontinuation criteria such as disease progression, intolerable toxicity, and withdrawal of study consent or up to 19 cycles (1 cycle = 28 days).
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
66.7%
6/9 • Until participants met discontinuation criteria such as disease progression, intolerable toxicity, and withdrawal of study consent or up to 19 cycles (1 cycle = 28 days).
|
|
Skin and subcutaneous tissue disorders
Rash
|
44.4%
4/9 • Until participants met discontinuation criteria such as disease progression, intolerable toxicity, and withdrawal of study consent or up to 19 cycles (1 cycle = 28 days).
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
11.1%
1/9 • Until participants met discontinuation criteria such as disease progression, intolerable toxicity, and withdrawal of study consent or up to 19 cycles (1 cycle = 28 days).
|
|
Vascular disorders
Hot flush
|
11.1%
1/9 • Until participants met discontinuation criteria such as disease progression, intolerable toxicity, and withdrawal of study consent or up to 19 cycles (1 cycle = 28 days).
|
|
Vascular disorders
Hypertension
|
88.9%
8/9 • Until participants met discontinuation criteria such as disease progression, intolerable toxicity, and withdrawal of study consent or up to 19 cycles (1 cycle = 28 days).
|
Additional Information
Tatsuya Sasaki
Eisai Co., Ltd.
Phone: 81-3-3817-5252
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER