CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 22 enrolled
Drug / intervention
Glufosfamidedrug
Likely dose
Glufosfamide 5000 mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00441467
NCT00441467Phase 2Completed

An Open-Label Phase 2 Study of the Efficacy and Safety of Glufosfamide in Previously Treated Advanced Soft Tissue Sarcoma

Eleison Pharmaceuticals LLC.·interventional·Posted Mar 1, 2007·Updated Mar 25, 2015

In Brief

A Phase 2 clinical trial evaluating Glufosfamide for Soft Tissue Sarcoma. Completed, enrolled 22 participants across 7 sites.

Detailed Summary

Primary Objective: 1\. To evaluate the efficacy of glufosfamide in subjects with advanced soft tissue sarcoma as measured by objective response rate Secondary Objectives: 1. To evaluate the efficacy of glufosfamide in subjects with advanced soft tissue sarcoma as measured by duration of response, progression-free survival and overall survival 2. To evaluate the safety of glufosfamide in subjects with advanced soft tissue sarcoma Exploratory Objectives: 1. To evaluate the biological effect of glufosfamide on the metabolic profile in subjects with advanced soft tissue sarcomas, as determined by FDG-PET 2. To correlate efficacy endpoints with expression of tumor-associated glucose transporter proteins

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 1, 2007
Enrollment StartMar 1, 2007
Primary CompletionOct 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 19.3 years ago

Interventions

Glufosfamidedrug

5000 mg/m2 of glufosfamide on Day 1 of each three-week cycle for up to 6 cycles.