Study of E7389 in Patients With Advanced Solid Tumors

Eisai

Status and phase

Completed

Phase 1

Conditions

Advanced Solid Tumors

Treatments

Drug: E7389

Study type

Interventional

Funder types

Industry

Identifiers

NCT00069264

BOLD

E7389

E7389-A001-101

Details and patient eligibility

About

To determine the maximum tolerated dose of E7389 in patients with advanced solid tumors that have progressed following standard therapy or for which no standard therapy exists.

Enrollment

33 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

Patients must have a histologically or cytologically confirmed and measurable advanced solid tumor that has progressed following standard therapy or for which no standard therapy exists (including surgery or radiation therapy)
Patients may have received prior chemotherapy
Patients must be aged > 18 years
Patients must have a Karnofsky Performance Status of > 70%
Patients must have a life expectancy of > 3 months
Patients must have adequate renal function as evidenced by serum creatinine <1.5mg/dL or creatinine clearance >= 45mL/minute
Patients must have adequate bone marrow function as evidenced by absolute neutrophil count > 1,500/µL and platelets > 100,000/µL
Patients must have adequate liver function as evidenced by bilirubin < 1.5mg/dL and alanine transaminase (ALAT) and aspartate transaminase (ASAT) <= 2 times the upper limits of normal (ULN)unless related to liver involvement by tumor, in which case <= 5.0 times ULN
Patients must be willing and able to comply with the study protocol for the duration of the study
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 received chemotherapy within three weeks (six weeks if nitrosoureas were received) of E7389 treatment start
Patients who have not recovered from any chemotherapy related or other therapy related toxicity at study entry
Patients who require active anti-coagulant therapy
Women who are pregnant or breastfeeding. 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 who are not willing to use contraception or fertile men with a female partner who is not willing to use contraception
Patients who have not successfully completed local therapy for previously treated central nervous system (CNS) metastases and who have not been discontinued from corticosteroids for at least four weeks before starting treatment with E7389. Patients with asymptomatic brain metastases who have no evidence of midline shift on CT scan or MRI may be enrolled without initiation of local therapy for the CNS metastases. In this case, a repeat scan must be performed within four weeks of the original scan to ensure that disease progression is not occurring.
Patients who have tested positive for HIV
Patients with severe uncontrolled intercurrent illness/infection (excluding malignancies)
Patients with uncontrolled cardiovascular illness defined as unstable angina, myocardial infarction within 6 months prior to study entry, symptomatic congestive heart failure (CHF) (NYHA II or higher) clinical evidence of CHF, or clinical evidence of serious cardiac arrhythmia
Patients with organ allografts
Patients who have received investigational drugs, including immunotherapy, gene therapy, hormone therapy, or other biologic therapy; anti-neoplastic therapy; or radiation therapy (other than required for palliation) within three weeks of E7389 treatment start
Patients who have had major surgery within four weeks of E7389 treatment start without a full recovery
Patients with a hypersensitivity to Halichondrin B and/or Halichondrin B-like compounds
Patients with other significant disease that, in the Investigator's opinion, would exclude the patient from the study