Cancer, Malignant Tumors
Conditions
Keywords
Cancer, malignant tumors
Brief summary
The purpose of this study is to determine the maximum tolerated dose (MTD) of E7974 after bolus IV administration, on Day 1 of a 21-day cycle, to patients with advanced solid tumors that have progressed following effective therapy or for which no effective therapy exists.
Detailed description
The MTD for the Day 1 21-Day schedule was defined at the 0.45 mg/m2 dose level. The study was terminated prior to full enrollment of the colorectal cancer (CRC) expansion cohort, due to a lack of demonstrated activity resulting in Principal Investigator (PI) loss interest to continue enrollment. Collection of all outstanding data is ongoing and database lock is estimated to be complete in June 2008.
Interventions
DRUGE7974
Maximum Tolerated Dose defined as 0.45 mg/m\^2 administered on Day 1 only of a 21-day cycle; the E7974 compound is administered as a bolus infusion; no placebo is given.
Sponsors
Eisai Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
At this time, we are only enrolling patients for the MTD cohort that meet all study entry criteria, plus the CRC criterion (Inclusion Criterion #12).Patients who meet all of the inclusion criteria and none of the
Exclusion criteria
will be eligible for entry into the study. Patients must: 1. Have a histologically or cytologically confirmed advanced solid tumor that has progressed following effective therapy or for which no effective therapy exists (including surgery or radiation therapy). 2. Be \>= 18 years of age. 3. Have an Eastern Cooperative Oncology Group (ECOG) status of 0, 1, or 2. 4. Have a life expectancy of \>= 3 months. 5. Have adequate renal function as evidenced by serum creatinine \<= 1.5 mg/dL or creatinine clearance \>= 40 mL/minute. 6. Have adequate bone marrow function as evidenced by absolute neutrophil count \>= 1,500/µL, hemoglobin of \>= 9 g/dL (may be transfused), and platelet count (not transfused) \>= 100,000/µL. 7. Have adequate liver function as evidenced by bilirubin \<= 1.5 x ULN and alanine transaminase (ALT) and aspartate transaminase (AST) \<= 3 times the upper limits of normal (ULN), unless related to liver involvement by tumor, in which case \<= 5.0 x ULN. 8. Give written informed consent. 9. Be willing and able to comply with the study protocol for the duration of the study. 10. Be willing to undergo blood draw and urine sampling for PK in Cycle 1. 11. Can have either measurable or non-measurable disease. 12. If a CRC patient is being treated at the MTD, they must have \<= 4 prior regimens in the metastatic setting.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Determine the maximum tolerated dose of E7974 in patients with Advanced Solid Tumors. | Duration of each cycle will be 21 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
| Measure | Time frame |
|---|---|
| Assess E7974 for safety, pharmacokinetics (PK) and pharmacodynamics (PD) which will correlate AUC with clinical toxicity and efficacy. | Duration of each cycle will be 21 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. |
Countries
United States
Outcome results
None listed