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

NCT00078637 | Completed Phase 1

• 1 other identifier: E7820-A001-102
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Neoplasms; Lymphoma, Malignant

Interventions

E7820 DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Eisai Inc.: lead

Study Sites (1)

Unknown Facility

San Antonio, Texas, United States

Location

MeSH Terms

Conditions

Neoplasms; Lymphoma

Interventions

N-(3-cyano-4-methyl-1H-indol-7-yl)-3-cyanobenzene-sulfonamide

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Jantien Wanders, M.D.

  Eisai Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 3, 2004
• First Posted: March 5, 2004
• Study Start: January 1, 2004
• Primary Completion: August 1, 2006
• Study Completion: February 1, 2007
• Last Updated: December 23, 2014

Record last verified: 2014-12

Locations

US (1)