A Study of E7050 Administered Orally to Patients With Advanced Solid Tumors

Solid Tumors Clinical Trial

Official title:

A Phase I Dose-finding Study of E7050 Administered Orally to Patients With Advanced Solid Tumors.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00921869
• Other study ID #: E7050-J081-102
• Status: Completed
• Phase: Phase 1
• First received: June 15, 2009
• Last updated: December 21, 2017
• Start date: October 2009
• Est. completion date: June 2011

Study information

• Verified date: December 2017
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 74 Years

Eligibility

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.

Related Conditions & MeSH terms

• Solid Tumors

Intervention

Drug:
• E7050
The starting dose of E7050 will be 50 mg given orally, twice-daily, in patients with advanced tumors that have progressed following effective therapy.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Eisai Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Dose-limiting toxicities.		During the Run-in Phase and the first 5 weeks of treatment
Secondary	Incidence and severity of adverse events and their drug relationship.		Throughout the entire study
Secondary	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
Secondary	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
Secondary	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