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Home > "S" Clinical Trials Conditions > Study of E7389 in Patients with Advanced Solid Tumors  Study of E7389 in Patients with Advanced Solid Tumors
Study of E7389 in Patients with Advanced Solid Tumors
For Condition: Advanced Solid Tumors
Status: Recruiting
Sponsor(s): Eisai Medical Research Inc ,
Synopsis: 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.
Details:
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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 (Appendix IV) 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 ant-coagulant therapy (revised per Amendment 01) - 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 corticosteriods 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
Total Enrollment: 55
Location and Contact Information:
Additional Information:
Study ID Numbers: E7389-A001-101; E7389,BOLD
Study Start Date: August 2003
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00069264
Other Advanced Solid Tumors Studies:
1. Study of E7389 in Patients with Advanced Solid Tumors
2. Study of E7389 Adminstered Once Every 3 Weeks In Patients With Advanced Solid Tumors
3. A Bioequivalence Study Of Two Oral Formulations Of An Investigational Drug In Patients With Advanced Solid Tumors.
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