Clinical trial NCT00921869: A Study of E7050 Administered Orally to Patients With Advanced Solid Tumors
Official title: A Phase I Dose-finding Study of E7050 Administered Orally to Patients With Advanced Solid Tumors.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Solid Tumors
Keywords: Cancer
Gastrointestinal Cancer
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2009-06-16
Enrollment: 16
Sex: ALL
Minimum age (years): 20
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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)
timeFrame: During the Run-in Phase and the first 5 weeks of treatment
Secondary outcomes:
measure: Dose-limiting toxicities.
timeFrame: During the Run-in Phase and the first 5 weeks of treatment
measure: Incidence and severity of adverse events and their drug relationship.
timeFrame: Throughout the entire study
measure: PK of blood and urine
timeFrame: During the Run-in Phase, Cycle 1 (28 days) and Day 15 of Cycle 2 for blood; Day 28 of Cycle 1 for urine
measure: Pharmacodynamic (PD) biomarker analysis of blood and tumor tissue samples.
timeFrame: During Cycle 1 (28 days) and Day 15 of Cycle 2 for blood; on Day 22 of Cycle 1 for optional tumor biopsies
measure: Best overall tumor response, duration of response and stable disease, assessed by Response Evaluation Criteria in Solid Tumors.
timeFrame: Every 4 weeks for complete and partial response; by 7th week for stable disease
Other outcomes:
Locations:
city: Kashiwa-shi
country: Japan
state: Chiba
Study officials:
affiliation: Oncology Clinical Development Section. JAC PCU. Eisai Co., Ltd.
name: Takashi Sawada
role: STUDY_DIRECTOR
References: