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Efficacy and Safety Study of GPX-150 to Treat Soft Tissue Sarcoma

NCT02267083 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2018-01-10

Study results available
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Summary

This study will assess the safety and efficacy of GPX-150 administered intravenously every 3 weeks in the treatment of patients with soft tissue sarcoma.

Conditions

  • Soft Tissue Sarcoma

Interventions

DRUG

GPX-150 for Injection

GPX-150 at a starting dose of 265 mg/m2 every 21 days for 16 cycles or until death, disease progression, or unacceptable toxicity. The dose of GPX-150 may be reduced by 25% if any dose reduction criteria are met. Two reductions are allowed per subject during the course of the study.

Sponsors & Collaborators

  • Gem Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Mohammed Milhem, MD · University of Iowa Holden Comprehensive Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-07
Primary Completion
2015-11-11
Completion
2016-08-18

Countries

  • United States

Study Locations

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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 NCT02267083 on ClinicalTrials.gov