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Safety and Efficacy Study of Glufosfamide in Ovarian Cancer

NCT00442598 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2015-03-10

Study results available
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Summary

Primary Objectives:

* To evaluate the effect of glufosfamide on the serum concentrations of CA125 in subjects with ovarian cancer
* To evaluate the safety of weekly glufosfamide dosing in subjects with ovarian cancer as compared with every 21-day dosing

Secondary objectives:

* To evaluate the efficacy of glufosfamide in subjects with ovarian cancer as measured by objective response rate, duration of response, progression-free survival, and overall survival
* To evaluate the pharmacokinetics of glufosfamide and isophosphoramide mustard during and after treatment

Exploratory objective:

* To correlate efficacy endpoints with expression of tumor-associated glucose transporter proteins

Conditions

Interventions

DRUG

Glufosfamide

Sponsors & Collaborators

  • Eleison Pharmaceuticals LLC.

    lead INDUSTRY

Principal Investigators

  • David Alberts, MD · University of Arizona

  • Michael Gordon, MD · Premiere Oncology of Arizona

  • Daniela Matei, MD · Indiana University School of Medicine

  • Peter D Eisenberg, MD · California Cancer Center

  • Larry Puls, MD · Gynecologic Oncology Research & Development, LLC

  • Krishnansu Tewari, MD · UCI Chao Family Comprehensive Cancer Center

  • Nashat Gabrail, MD · Gabrail Cancer Center

  • Jeffrey Goldberg, MD · Louisville Oncology Clinical Research Program

  • Claire Verschraegen, M.D. · New Mexico Cancer Research Alliance

  • William Robinson, MD · Harrington Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-01-31
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 NCT00442598 on ClinicalTrials.gov