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A Study of ZYC300 Administered With Cyclophosphamide Pre-Dosing

NCT00381173 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2013-05-14

No results posted yet for this study

Summary

The purpose of this study is to evaluate the feasibility, safety, and tolerability of administering ZYC300 with Cyclophosphamide (Cytoxan).

Conditions

Interventions

DRUG

Cyclophosphamide & ZYC300 (ZYC300 with cyclophosphamide pre-dosing)

Patients who meet all entry criteria will be administered 600 mg/m\^2 cyclophosphamide intravenously 3 days before each dose of ZYC300. ZYC300 will be administered at 400 micrograms DNA/total dose every two weeks for a maximum of six doses (6 cycles).

Sponsors & Collaborators

  • Eisai Inc.

    lead INDUSTRY

Principal Investigators

  • Michael Silverman, MD · Eisai 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
2006-11-30
Primary Completion
2008-10-31
Completion
2008-10-31

Countries

  • United States

Study Locations

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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 NCT00381173 on ClinicalTrials.gov