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NCT02180698 · ClinicalTrials.gov registry record · Phase 1

TLR4 Agonist GLA-SE and Radiation Therapy in Treating Patients With Soft Tissue Sarcoma That Is Metastatic or Cannot Be Removed by Surgery

A Phase 1 study, sponsored by Fred Hutchinson Cancer Center.

Completed
Registry status
Phase 1
Development phase
16
Enrollment target

NCT02180698: Completed Phase 1 study, sponsored by Fred Hutchinson Cancer Center.

NCT02180698 is a Phase 1 study that has completed, run by Fred Hutchinson Cancer Center. The registered enrollment target is 16 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02180698, a Phase 1 study, has completed, sponsored by Fred Hutchinson Cancer Center.

COMPLETED
Registry status
Phase 1
Development phase
16 participants
Enrollment target

Study Summary

This pilot phase I clinical trial studies the side effects and best dose of toll-like receptor 4 (TLR4) agonist glucopyranosyl lipid A (GLA)-stable-emulsion (SE) when given together with radiation therapy in treating patients with soft tissue sarcoma that has spread to other parts of the body (metastatic) or cannot be removed by surgery (unresectable). TLR4 agonist GLA-SE may stimulate the immune system to kill sarcoma cells. Radiation therapy uses high energy x rays to kill tumor cells. Giving TLR4 agonist GLA-SE with radiation therapy may be a better treatment to treat sarcoma that cannot be removed by surgery.

Primary Outcome

The highest toxicity grades per patient will be tabulated for AEs and laboratory measurements as will the numbers and percentages of patients reporting AEs.

Interventions

  • OTHER Laboratory Biomarker Analysis
  • RADIATION Radiation Therapy
  • DRUG TLR4 Agonist GLA-SE

Trial Details

FieldValue
Enrollment Target 16 participants
Start Date 2014-11-17
Est. Completion 2016-10-07
Phase Phase 1
Fred Hutchinson Cancer Center

483 total trials

What the finished NCT02180698 record still lists

NCT02180698 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower).

The record links to 0 conditions, and to 3 interventions - of which Laboratory Biomarker Analysis is the first listed.

NCT02180698 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02180698 about?

NCT02180698 is a clinical study titled "TLR4 Agonist GLA-SE and Radiation Therapy in Treating Patients With Soft Tissue Sarcoma That Is Metastatic or Cannot Be Removed by Surgery". This pilot phase I clinical trial studies the side effects and best dose of toll-like receptor 4 (TLR4) agonist glucopyranosyl lipid A (GLA)-stable-emulsion (SE) when given together with radiation therapy in treating patients with soft tissue sarcoma that has spread to other parts of the body (metas...

What is the current status of trial NCT02180698?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2014-11-17. Estimated completion is 2016-10-07.

What interventions are being tested in trial NCT02180698?

The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Radiation Therapy (RADIATION), TLR4 Agonist GLA-SE (DRUG).

Who is sponsoring clinical trial NCT02180698?

This trial is sponsored by Fred Hutchinson Cancer Center, which has 483 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02180698's enrollment target sits among peer trials

16 1786th of 2000 higher than 203 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02180698, the US trial registry maintained by the National Library of Medicine. NCT02180698 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.