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Pbi-shRNA™ EWS/FLI1 Type 1 LPX in Subjects With Advanced Ewing's Sarcoma

NCT02736565 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2023-11-13

No results posted yet for this study

Summary

The purpose of this study is to determine the safety and the maximum tolerated dose of of pbi-shRNA™ EWS/FLI1 Type 1 lipoplex in patients with advanced Ewing's sarcoma.

Conditions

  • Ewing's Sarcoma
  • Ewing Family of Tumors
  • Ewing's Tumor Metastatic
  • Ewing's Sarcoma Metastatic
  • Ewing's Tumor Recurrent
  • Rare Diseases
  • Sarcoma

Interventions

BIOLOGICAL

pbi-shRNA™ EWS/FLI1 Type 1 Lipoplex

Lipoplex is given intravenously as a single administration twice a week for 4 weeks for a total of 8 infusions per cycle followed by 2 weeks of rest. Treatment may continue as long as there is clinical benefit, no evidence of disease progression, and no other withdrawal criteria are met. First dose started on Cycle 1 Week 1 Day 1 followed by observation and safety assessment for 13 days. If no toxicity was observed, then another single administration of study agent was given at Cycle 1 Week 3 Day 1 followed by observation and safety for 6 days. If no toxicity was observed, then study agent was given twice a week on Days 1 and 4 over 3 weeks, for a total of 8 infusions per cycle, followed by a 2-week washout before starting each subsequent cycle. Cycle 1 = 8 weeks. Each subsequent cycles = 6 weeks.

Sponsors & Collaborators

  • Gradalis, Inc.

    lead INDUSTRY

Principal Investigators

  • John Nemunaitis, MD · Gradalis, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
8 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-31
Primary Completion
2019-08-12
Completion
2020-08-04
FDA Drug
Yes

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 NCT02736565 on ClinicalTrials.gov