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Clinical Trials/NCT00921869
NCT00921869CompletedPhase 1

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

Eisai Co., Ltd.0 sites16 enrolledStarted: October 2009Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Completed
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)
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study 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.

Study Design

Study Type
Interventional
Allocation
Non-randomized
Intervention Model
Single group
Primary Purpose
Treatment
Masking
None (open label)

Eligibility Criteria

Ages
20 Years to 74 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Arms & Interventions

1

Experimental

Intervention: E7050 (Drug)

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

  • 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)
  • 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)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Identifiers

NCT ID
NCT00921869
Other Study IDs
E7050-J081-102

Dates

First Submitted
(17 years ago)
First Posted
(17 years ago)
Primary Completion
Study Completion
Last Verified
Last updated
(8 years ago)

Regulatory & Sharing

Has Results
No

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