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Phase I Trial of ZIO-101 in Patients With Solid Tumors

NCT00509782 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2012-08-01

No results posted yet for this study

Summary

Primary Objectives:

1. To determine the toxicities and maximum tolerated dose (MTD) of ZIO-101 when administered intravenously once a day for 5 consecutive days every 4 weeks in subjects with advanced solid tumors.
2. To determine the pharmacokinetic profile of ZIO-101 when administered intravenously once a day for 5 consecutive days every 4 weeks.

Secondary Objective:

1\. To determine the anti-tumor effects of ZIO-101.

Conditions

Interventions

DRUG

ZIO-101

Starting Dose 78 mg/m\^2 intravenously daily for 5 consecutive days repeated every 4 weeks.

Sponsors & Collaborators

  • Alaunos Therapeutics

    collaborator INDUSTRY

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Razelle Kurzrock, MD · M.D. Anderson Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-05-31
Primary Completion
2008-04-30
Completion
2008-04-30

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 NCT00509782 on ClinicalTrials.gov