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Safety Study of a Liposomal Docetaxel Formulation in Patients With Solid Tumors Who Have Failed Previous Therapies

NCT01041235 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2012-09-06

No results posted yet for this study

Summary

The purpose of this study is to determine the safety profile, including the maximum tolerated dose (MTD), of ATI-1123 a liposomal formulation of docetaxel, in the treatment of cancer patients with advanced solid tumors.

Conditions

Interventions

DRUG

ATI-1123 (active drug = docetaxel)

Dose escalation starting at 15 mg/m2 given once every 3 weeks via IV

Sponsors & Collaborators

  • Azaya Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Anthony W Tolcher, MD · South Texas Accelerated Research Therapeutics (START)

  • John Nemunaitis, MD · Mary Crowley Cancer Research Center

  • Jon M Rogers, MD · Azaya Therapeutics, Inc (Medical Monitor)

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
2009-12-31
Primary Completion
2011-10-31
Completion
2011-12-31

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 NCT01041235 on ClinicalTrials.gov