Solid Tumors
Conditions
Keywords
Cancer, Gastrointestinal Cancer
Brief summary
The purpose of this study is to determine the maximum tolerated dose (MTD), safety, pharmacokinetics (PK), pharmacodynamics (PD) and anti-tumor activity of E7050 when administered orally twice daily to patients with advanced solid tumors.
Detailed description
Phase I, open-label, dose-escalation study to determine the maximum tolerated dose (MTD) of E7050 given orally, twice-daily, in patients with advanced tumors that have progressed following effective therapy.
Interventions
DRUGE7050
The starting dose of E7050 will be 50 mg given orally, twice-daily, in patients with advanced tumors that have progressed following effective therapy.
Sponsors
Eisai Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 74 Years
Healthy volunteers
No
Inclusion criteria
1. Subjects with a histological or cytological diagnosis of solid tumors or gastric cancer. 2. Subjects who have progressed after treatment with approved therapies or for whom there are no standard effective therapies available. 3. Subjects with adequate organ function. 4. Patients who have no carryover of effect from prior therapy or no adverse drug reactions (excluding alopecia) that may affect the safety evaluation of the investigational drug. 5. Subjects with Performance Status (PS) 0-1 established by Eastern Cooperative Oncology Group (ECOG).
Exclusion criteria
1. Subjects who have brain metastases with clinical symptoms or which requires treatment. 2. Subjects with the serious complications or disease history. 3. Subjects who cannot take oral medication. 4. Subjects who need continuous use of drugs or foods that strongly inhibit or induce CYP3A4/5 or CYP2D6 during the study period. 5. Female subjects who are pregnant or breast-feeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Determination of the MTD of E7050 given orally twice daily. MTD is the highest dose at which no more than 1 out of 6 patients experiences dose-limiting toxicity (DLT) | During the Run-in Phase and the first 5 weeks of treatment |
Secondary
| Measure | Time frame |
|---|---|
| Dose-limiting toxicities. | During the Run-in Phase and the first 5 weeks of treatment |
| Incidence and severity of adverse events and their drug relationship. | Throughout the entire study |
| PK of blood and urine | During the Run-in Phase, Cycle 1 (28 days) and Day 15 of Cycle 2 for blood; Day 28 of Cycle 1 for urine |
| Pharmacodynamic (PD) biomarker analysis of blood and tumor tissue samples. | During Cycle 1 (28 days) and Day 15 of Cycle 2 for blood; on Day 22 of Cycle 1 for optional tumor biopsies |
| Best overall tumor response, duration of response and stable disease, assessed by Response Evaluation Criteria in Solid Tumors. | Every 4 weeks for complete and partial response; by 7th week for stable disease |
Countries
Japan
Outcome results
None listed