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Dosing and Safety Study of E7820 in Patients With a Malignant Solid Tumor or Lymphoma

Primary Purpose

Neoplasms, Lymphoma, Malignant

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
E7820
Sponsored by
Eisai Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients must have a histologically or cytologically confirmed malignant solid tumor or lymphoma. Malignancy must be advanced and require systemic therapy. Malignancy must be one for which no standard therapy is available or the patient must not be a candidate for standard therapy. Patients must have a Karnofsky Performance Status of >= 70%, Patients must have a life expectancy of >= 3 months, Patients must be aged >= 18 years, Patients must have adequate renal function as evidenced by serum creatinine <= 1.5 mg/dL or creatinine clearance >= 60 mL/minute/1.73m2, Patients must have adequate bone marrow function as evidenced by ANC >= 1,500 mm3 and platelets >= 100,000 mm3, must have adequate liver function as evidenced by bilirubin <= 1.5 mg/dL and alanine transaminase (ALAT) and aspartate transaminase (ASAT) <= 2.5 times the upper limits of normal (ULN) (unless related to liver metastases in which case <= 5 x ULN), Patients must be willing and able to comply with the study protocol for the duration of the study, and Patients must give written informed consent prior to any study-specific screening procedures with the understanding that the patient may withdraw consent at any time without prejudice. Exclusion Criteria: Patients who have a history of previous hypersensitivity to sulfonamide derivatives, Patients who have received chemotherapy within 4 weeks (6 weeks if nitrosoureas were received) of commencing study treatment, Patients who have had radiation to >= 25% of their bone marrow (e.g., pelvic radiation) within 4 weeks of E7820 treatment, Patients who have not recovered from any clinically significant chemotherapy or radiotherapy related toxicity at study entry. Patients who have received investigational drugs or other antineoplastic therapy within 28 days of E7820 treatment, Patients who have had major surgery within 4 weeks of study drug administration, Women who are pregnant or breast-feeding. -- Women of childbearing potential with either a positive pregnancy test at screening or no pregnancy test. Women of childbearing potential unless (1) surgically sterile or (2) using adequate measures of contraception in the opinion of the Investigator (postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential), Fertile men and fertile women who are not willing to use contraception or fertile men or fertile women with a partner who is not willing to use contraception, Patients with active central nervous system (CNS) metastases (i.e., evidence of progressive clinical symptoms, edema requiring corticosteroids, or tumors exhibiting growth on sequential MRI or CT scans), Patients who are known to be positive for hepatitis B surface antigen, hepatitis B core antibody, hepatitis C antibody, or human immunodeficiency virus, Patients with severe uncontrolled intercurrent illness/infection (excluding malignancies), Patients with a history of unstable ischemic disease, Patients with a history of clinically significant thrombosis, Patients receiving antithrombotic (including aspirin) or therapeutic anticoagulant therapy (prior to study entry, patients receiving these types of drugs must have been off therapy for at least 7 days), Patients with a history of documented vascular headache with neurological changes, Patients < 30% of ideal weight for height and age according to the Metropolitan Life Insurance Company Statistical Bulletin, or Patients with significant disease, or any condition, which in the Investigator's opinion would exclude the patient from the study, or Patients who have pulmonary disease that puts them at risk of hemoptysis.

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
March 3, 2004
Last Updated
December 19, 2014
Sponsor
Eisai Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00078637
Brief Title
Dosing and Safety Study of E7820 in Patients With a Malignant Solid Tumor or Lymphoma
Official Title
Phase I and Pharmacokinetic Study of E7820 After Oral Administration to Patients With Malignancy
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
August 2006 (Actual)
Study Completion Date
February 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Eisai Inc.

4. Oversight

5. Study Description

Brief Summary
This is a first-in-man, open-label, non-randomized, multiple dose, multiple cycle, dose escalation study to determine the MTD, safety, PK, and pharmacodynamics of E7820 in patients with a malignant solid tumor or lymphoma.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neoplasms, Lymphoma, Malignant

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
E7820

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients must have a histologically or cytologically confirmed malignant solid tumor or lymphoma. Malignancy must be advanced and require systemic therapy. Malignancy must be one for which no standard therapy is available or the patient must not be a candidate for standard therapy. Patients must have a Karnofsky Performance Status of >= 70%, Patients must have a life expectancy of >= 3 months, Patients must be aged >= 18 years, Patients must have adequate renal function as evidenced by serum creatinine <= 1.5 mg/dL or creatinine clearance >= 60 mL/minute/1.73m2, Patients must have adequate bone marrow function as evidenced by ANC >= 1,500 mm3 and platelets >= 100,000 mm3, must have adequate liver function as evidenced by bilirubin <= 1.5 mg/dL and alanine transaminase (ALAT) and aspartate transaminase (ASAT) <= 2.5 times the upper limits of normal (ULN) (unless related to liver metastases in which case <= 5 x ULN), Patients must be willing and able to comply with the study protocol for the duration of the study, and Patients must give written informed consent prior to any study-specific screening procedures with the understanding that the patient may withdraw consent at any time without prejudice. Exclusion Criteria: Patients who have a history of previous hypersensitivity to sulfonamide derivatives, Patients who have received chemotherapy within 4 weeks (6 weeks if nitrosoureas were received) of commencing study treatment, Patients who have had radiation to >= 25% of their bone marrow (e.g., pelvic radiation) within 4 weeks of E7820 treatment, Patients who have not recovered from any clinically significant chemotherapy or radiotherapy related toxicity at study entry. Patients who have received investigational drugs or other antineoplastic therapy within 28 days of E7820 treatment, Patients who have had major surgery within 4 weeks of study drug administration, Women who are pregnant or breast-feeding. -- Women of childbearing potential with either a positive pregnancy test at screening or no pregnancy test. Women of childbearing potential unless (1) surgically sterile or (2) using adequate measures of contraception in the opinion of the Investigator (postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential), Fertile men and fertile women who are not willing to use contraception or fertile men or fertile women with a partner who is not willing to use contraception, Patients with active central nervous system (CNS) metastases (i.e., evidence of progressive clinical symptoms, edema requiring corticosteroids, or tumors exhibiting growth on sequential MRI or CT scans), Patients who are known to be positive for hepatitis B surface antigen, hepatitis B core antibody, hepatitis C antibody, or human immunodeficiency virus, Patients with severe uncontrolled intercurrent illness/infection (excluding malignancies), Patients with a history of unstable ischemic disease, Patients with a history of clinically significant thrombosis, Patients receiving antithrombotic (including aspirin) or therapeutic anticoagulant therapy (prior to study entry, patients receiving these types of drugs must have been off therapy for at least 7 days), Patients with a history of documented vascular headache with neurological changes, Patients < 30% of ideal weight for height and age according to the Metropolitan Life Insurance Company Statistical Bulletin, or Patients with significant disease, or any condition, which in the Investigator's opinion would exclude the patient from the study, or Patients who have pulmonary disease that puts them at risk of hemoptysis.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jantien Wanders, M.D.
Organizational Affiliation
Eisai Inc.
Official's Role
Study Director
Facility Information:
City
San Antonio
State/Province
Texas
Country
United States

12. IPD Sharing Statement

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Dosing and Safety Study of E7820 in Patients With a Malignant Solid Tumor or Lymphoma

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