A Safety and Pharmacokinetic Study of TAK-285 in Patients With Advanced Cancer

Phase 1

Completed

• Conditions: Cancer
• Interventions: Drug: TAK-285 Dose Escalation Cohorts; Drug: TAK-285 Recommended Phase 2 Dosing Cohort

• Registration Number: NCT00535522
• Lead Sponsor: Millennium Pharmaceuticals, Inc.

Brief Summary

The purpose of this study is to determine the safety and pharmacokinetics of TAK-285 in patients with advanced cancer.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08
• Study First Submitted: 2007-09-21
• Study First Submitted QC: 2007-09-21
• Study First Posted: 2007-09-26
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Status Verified: 2011-12
• Last Update Submitted: 2011-12-07
• Last Update Posted: 2011-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TAK-285	TAK-285 Dose Escalation Cohorts	-
TAK-285	TAK-285 Recommended Phase 2 Dosing Cohort	-

Primary Outcome Measures

Name	Time	Method
Safety profile, including dose-limiting toxicities, maximum tolerated dose, recommended Phase II dose; and the pharmacokinetic profile.	Duration of study

Secondary Outcome Measures

Name	Time	Method
Objective disease response by modified Response Evaluation Criteria in Solid Tumors.	Duration of study

Trial Locations

Locations (3)

Indiana University Cancer Center; 🇺🇸 Indianapolis, Indiana, United States

University of Maryland Greenbaum Cancer Center; 🇺🇸 Baltimore, Maryland, United States

Karmanos Cancer Center; 🇺🇸 Detroit, Michigan, United States