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

Eisai Co., Ltd.0 sites16 target enrollmentOctober 2009

ConditionsSolid Tumors

InterventionsE7050

DrugsE7050

Overview

Phase: Phase 1
Intervention: E7050
Conditions: Solid Tumors
Sponsor: Eisai Co., Ltd.
Enrollment: 16
Primary Endpoint: 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)
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 2009

End Date

June 2011

Last Updated

8 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Eisai Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arms & Interventions

1

Intervention: E7050

Outcomes

Primary Outcomes

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)

Time Frame: During the Run-in Phase and the first 5 weeks of treatment

Secondary Outcomes

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)
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)
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)
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)