An Open Label Phase I Dose Escalation Study of E7080 Administered to Patients With Solid Tumors

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )
ClinicalTrials.gov Identifier:
NCT00280397
First received: January 20, 2006
Last updated: May 10, 2013
Last verified: January 2010
  Purpose

The purpose of this study is to determine the maximum tolerable dose (MTD) and the related effects of E7080 administered to patients with solid tumors that are resistant to approved existing anti-tumor therapies, or for which no appropriate treatment is available.


Condition Intervention Phase
Cancer: Solid Tumors
Drug: E7080
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label Phase I Dose Escalation Study of E7080 Administered to Patients With Solid Tumors

Resource links provided by NLM:


Further study details as provided by Eisai Inc.:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To elucidate the pharmacokinetic profile of E7080. [ Time Frame: Every 3 weeks. ] [ Designated as safety issue: No ]
  • Evaluate the safety and tolerability of E7080. [ Time Frame: Every 3 weeks. ] [ Designated as safety issue: Yes ]
  • Determine the clinical dose for Phase II study based on safety and pharmacokinetic profile. [ Time Frame: Every 3 weeks. ] [ Designated as safety issue: Yes ]
  • Evaluate the anti-tumor activity of E7080. [ Time Frame: Every 3 weeks. ] [ Designated as safety issue: No ]
  • To make exploratory analyses of pharmacodynamic markers. [ Time Frame: Every 3 weeks. ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: January 2006
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: E7080
E7080 is administered orally twice a day for 2 weeks to patients with solid tumors that are resistant to approved conventional therapies or for which no appropriate treatment is available.

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00280397

Locations
Japan
Tokyo, Japan, 104-0045
Sponsors and Collaborators
Eisai Co., Ltd.
Investigators
Study Director: Wataru Yusa Eisai Co., Ltd.
  More Information

No publications provided by Eisai Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Eisai Inc. ( Eisai Co., Ltd. )
ClinicalTrials.gov Identifier: NCT00280397     History of Changes
Other Study ID Numbers: E7080-J081-103
Study First Received: January 20, 2006
Last Updated: May 10, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Eisai Inc.:
Cancer, solid tumors

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on July 22, 2014