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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00280397 |
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Date of registration:
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20/01/2006 |
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Primary sponsor: |
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Public title:
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An Open Label Phase I Dose Escalation Study of E7080 Administered to Patients With Solid Tumors
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Scientific title:
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An Open Label Phase I Dose Escalation Study of E7080 Administered to Patients With Solid Tumors |
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Date of first enrolment:
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January 2006 |
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Target sample size:
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30 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00280397 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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Japan
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Contacts
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Name:
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Wataru Yusa |
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Address:
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Telephone:
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Email:
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Affiliation:
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Eisai Co., Ltd. |
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Key inclusion & exclusion criteria
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Inclusion criteria:
1. Patients who have histologically and/or cytologically confirmed solid tumors
requiring treatment.
2. Patients with solid tumors which are resistant to approved conventional anti-tumor
therapies, or for which no appropriate treatment is available.
3. Patients who had completed all previous treatments (including surgery and
radiotherapy) and supportive care (such as transfusion of blood, blood components and
granulocyte colony-stimulating factor [G-CSF] treatment) at least 4 weeks before
registration, and no sign or symptom of acute toxicity occurred in previous
treatments.
4. Patients 20 years or older and less than 75 years of age at the time of registration.
5. Patients with 0 or 1 Performance Status (PS) established by Eastern Cooperative
Oncology Group (ECOG.)
6. Patients who can stay in hospital for more than 1 cycle of treatment.
7. Patients who are expected to survive for more than 3 months from the start of study
drug administration.
8. Patients who have provided written informed consent for the participation in the
study.
Exclusion criteria:
1. Patients with clinical symptoms due to brain metastases requiring treatment.
2. Patients who have any of the following laboratory test findings:
1. Hemoglobin < 9.0 g/dL
2. Neutrophil count < 1.5 × 10 9 /L
3. Platelet count < 100 × 10 9 /L
4. Serum bilirubin > 1.5 mg/dL
5. AST, ALT > 100 IU/L
6. Serum creatinine > 1.5 mg/dL or creatinine clearance < 50 mL/minute
3. Patients with positive reaction for human immunodeficiency virus (HIV) or hepatitis
virus C (HCV) antibody or hepatitis B virus surface (HBs) antigen, or patients with
untreated serious infections.
4. Patients with clinically significant cardiac disorders or unstable ischemic heart
diseases including myocardial infarction within six months before the registration
for the study.
5. Patients with marked Baseline prolongation of QT/QTc interval (QTc interval > 450
msec for males or > 470 msec for females) using the Fridericia method for QTc
analysis.
6. Patients with hemorrhagic or thrombotic diseases or who are using therapeutic doses
of anticoagulants such as aspirin, warfarin, or ticlopidine.
7. Patients who are diagnosed with hypertension (defined as repeatedly measured blood
pressure = 160/90 mmHg) at Screening, irrespective of use of antihypertensive drugs.
8. Patients who have proteinuria > +1 on bedside testing.
9. Patients who have history of insufficient gastrointestinal absorption, or patients
who received gastric or intestinal anastomoses within 4 weeks before registration.
10. Patients who have history of alcoholism, drug addiction or mental or physical
disorders, which, in the investigator's opinion, may impair study compliance.
11. Patients who received any investigational drug within 30 days before the registration
of the study.
12. Patients who received CYP3A4 inhibitors including itraconazole, erythromycin,
clarithromycin, diltiazem or verapamil during screening and who have to use these
drugs during the study.
13. Pregnant or nursing patients (all female patients with pregnancy potential must have
negative pregnancy test performed before registration, and post-menopausal women must
be amenorrheic for at least 12 months.) Female patients must use appropriate
contraception.
14. Fertile male patients who refuse to use contraception, or whose female partners are
not using appropriate contraception.
15. Patients who are judged by the investigator to be inappropriate for the study.
Age minimum:
20 Years
Age maximum:
75 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Cancer: Solid Tumors
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Intervention(s)
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Drug: E7080
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Primary Outcome(s)
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To determine the maximum tolerable dose (MTD) and the dose-limiting toxicities (DLT) of E7080 repeatedly administered twice a day.
[Time Frame: Every 4 weeks.]
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Secondary Outcome(s)
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Determine the clinical dose for Phase II study based on safety and pharmacokinetic profile.
[Time Frame: Every 3 weeks.]
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Evaluate the anti-tumor activity of E7080.
[Time Frame: Every 3 weeks.]
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Evaluate the safety and tolerability of E7080.
[Time Frame: Every 3 weeks.]
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To elucidate the pharmacokinetic profile of E7080.
[Time Frame: Every 3 weeks.]
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To make exploratory analyses of pharmacodynamic markers.
[Time Frame: Every 3 weeks.]
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Secondary ID(s)
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E7080-J081-103
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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