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

NCT00535522 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2011-12-09

No results posted yet for this study

Summary

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

Conditions

Interventions

DRUG

TAK-285 Dose Escalation Cohorts

TAK-285 50 mg tablet, orally, once or twice daily for three weeks, followed by seven days off. Dose escalation to maximum tolerated dose, with possibility of continuous dosing per cycle (daily dosing for four weeks without a break between cycles).

DRUG

TAK-285 Recommended Phase 2 Dosing Cohort

Expanded cohort with dose and regimen dependent upon the safety profile of the maximally tolerated dose and schedule determined in the dose escalation phase of the study.

Sponsors & Collaborators

  • Millennium Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Medical Monitor · Millennium Pharmaceuticals, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-08-31
Primary Completion
2011-06-30
Completion
2011-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00535522 on ClinicalTrials.gov