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Phase I and Pharmacokinetic Study of E7820 After Oral Administration to Patients With Malignancy

Phase 1
18 Years
Not Enrolling
Neoplasms, Lymphoma, Malignant

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Trial Information

Phase I and Pharmacokinetic Study of E7820 After Oral Administration to Patients With Malignancy

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

- 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Jantien Wanders, M.D.

Investigator Role:

Study Director

Investigator Affiliation:

Eisai Inc.


United States: Food and Drug Administration

Study ID:




Start Date:

January 2004

Completion Date:

Related Keywords:

  • Neoplasms
  • Lymphoma, Malignant
  • Neoplasms
  • Lymphoma



Austin, Texas  78705