Solid Tumor Malignancies, Cancer
Conditions
Brief summary
The purpose of this study is to determine the maximum tolerated dose (MTD) of E7974 administered as an intravenous bolus dose on Days 1, 8, and 15 of a 28-day cycle (Arm A) or on Days 1 and 8 of a 21-day cycle (Arm B) to patients with solid tumors that have progressed following effective therapy or for which no effective therapy exists.
Detailed description
This is a two-arm, open-label, non-randomized, dose-escalation study to determine the MTD of E7974 administered as an intravenous bolus dose on Days 1, 8, and 15 of a 28-day cycle (Arm A) or on Days 1 and 8 of a 21-day cycle (Arm B) to patients with solid tumors that have progressed following effective therapy or for which no effective therapy exists. Response and progression will be evaluated in this study using Response Evaluation Criteria In Solid Tumors (RECIST) criteria.
Interventions
DRUGE7974
Maximum tolerated dose = 0.15 mg/m\^2 administered on Days 1, 8, 15 of 28-day cycle.
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
Patients who meet all of the inclusion criteria and none of the
Exclusion criteria
will be eligible for entry into the study: 1. Patients must have a pathologically diagnosed, histologically or cytologically confirmed solid tumor that has progressed following effective therapy or for which no effective therapy exists (including surgery or radiation therapy). 2. Patients must be \>= 18 years of age. 3. Patients must have an Eastern Cooperative Oncology Group (ECOG) status of 0 or 1. 4. Patients must have a life expectancy of \>= 3 months. 5. Patients must have adequate renal function as evidenced by serum creatinine \<= 1.5 mg/dL or creatinine clearance \>= 40 mL/minute (min). 6. Patients must 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. 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. 8. 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. 9. Patients must be willing and able to undergo blood draw and urine sampling for PK in Cycle 1. 10. Patients may have either measurable or non-measurable disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Determine the maximum tolerated dose of E7974 in patients with solid malignancies. | Duration of each cycle will be 28 or 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 |
|---|---|
| 1) Assess E7974 for safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD); 2) Evaluate the correlation of AUC with clinical toxicity and efficacy in both arms. | Duration of each cycle will be 28 or 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