A Phase 1 Open-Label Study of E7974 Administered on Days 1 and 15 of a 28-Day Cycle in Patients With Solid Malignancies

Eisai Inc.2 sites in 1 country30 target enrollmentJanuary 2006

ConditionsCancer, Malignant Tumors

InterventionsE7974

DrugsE7974

Overview

Phase: Phase 1
Intervention: E7974
Conditions: Cancer, Malignant Tumors
Sponsor: Eisai Inc.
Enrollment: 30
Locations: 2
Primary Endpoint: Determine the maximum tolerated dose of E7974 in patients with solid malignancies.
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to determine the maximum tolerated dose (MTD) of E7974 administered on Days 1 and 15 of a 28-day cycle in subjects with solid malignancies that have progressed following effective therapy or for which no effective therapy exists.

Registry

clinicaltrials.gov

Start Date

January 2006

End Date

August 2009

Last Updated

10 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Eisai Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients who meet all of the inclusion criteria and none of the exclusion criteria will be eligible for entry into the study:
•Patients must have a pathologically diagnosed, histologically or cytologically confirmed solid malignancy that has progressed following effective therapy or for which no effective therapy exists (including surgery or radiation therapy).
•Patients must be \>= 18 years of age.
•Patients must have an Eastern Cooperative Oncology Group (ECOG) status of 0, 1 or
•Patients must have a life expectancy of \>= 3 months.
•Patients must have adequate renal function as evidenced by serum creatinine \<= 1.5 mg/dL or creatinine clearance \>= 40 mL/minute (min)
•Patients must have adequate bone marrow function as evidenced by absolute neutrophil count \>= 1,200/µL, hemoglobin of \>= 9 g/dL (may be transfused), and platelet count (not transfused) \>= 100,000/µL.
•Patients must have adequate liver function as evidenced by bilirubin \<= 1.5 mg/dL and alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \<= 3 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 sign written informed consent and be able to comply with the study protocol for the duration of the study.
•Patients must be willing and able to undergo blood draw and urine sampling for PK in Cycle

Exclusion Criteria

•The presence of one or more of the following criteria will disqualify a patient from enrollment in the study:
•Patients who have received chemotherapy within three weeks of E7974 treatment start (6 weeks for a nitrosourea).
•Patients who have not recovered from any chemotherapy-related or other therapy-related toxicity to \<= Grade 1 at study entry (excluding Grade 2 alopecia).
•Patients who have received radiotherapy \<= 3 weeks prior to study enrollment, whose marrow exposure has exceeded 25% and who have not recovered from the toxic effects of the treatment prior to study enrollment (except for alopecia).
•Patients who have had major surgery without full recovery or major surgery within three weeks of E7974 treatment start.
•Patients with primary brain tumors or metastasis at study entry must have controlled them for \>= 1 month by previous treatment, including radiation therapy and corticosteroids.
•Women who are pregnant or breastfeeding.
•Women of childbearing potential with either a positive serum pregnancy test at screening or no pregnancy test.
•Women of childbearing potential unless (1) surgically sterile, (2) physiologically postmenopausal for \>= 12 months, or (3) using adequate measures (including barrier methods) of contraception.
•Fertile men or their partners who are not willing to use contraception.

Arms & Interventions

1

Intervention: E7974

Outcomes

Primary Outcomes

Determine the maximum tolerated dose of E7974 in patients with solid malignancies.

Time Frame: Duration of each cycle will be 28 days; patients will attend a follow-up visit 30 days after last study treatment. Follow-up for safety and efficacy will occur 6 months after the last patient is accrued to the study.

Secondary Outcomes

Assess E7974 for safety, efficacy, pharmacokinetics and pharmacodynamics; evaluate the efficacy of E7974 in patients with metastatic, refractory prostate cancer.(Duration of each cycle will be 28 days; patients will attend a follow-up visit 30 days after last study treatment. Follow-up for safety and efficacy will occur 6 months after the last patient is accrued to the study.)