A Study of MORAb-009 in Patients With Solid Tumor

Phase 1

Completed

• Conditions: Cancer; Mesothelin-positive
• Interventions: Drug: MORAb-009

• Registration Number: NCT01018784
• Lead Sponsor: Eisai Co., Ltd.

Brief Summary

MORAb-009 is intravenously administered to patients with solid tumor once a week for 4 weeks as 1 cycle in order to investigate dose-limiting toxicity and estimate maximum tolerated dose.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2009-11-23
• Study First Submitted QC: 2009-11-23
• Study First Posted: 2009-11-25
• Primary Completion: 2012-05
• Study Completion: 2013-02
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-19
• Last Update Posted: 2016-01-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MORAb-009	MORAb-009	-

Primary Outcome Measures

Name	Time	Method
To investigate dose-limiting toxicity and estimate maximum tolerated dose.	4 Weeks

Secondary Outcome Measures

Name	Time	Method
The best overall response rate in the RECIST evaluation and the preliminary evaluation calculating the frequency of Completed response and Partial Response.	During Study