CAMPFIRE: A Study of Ramucirumab (LY3009806) in Children and Young Adults With Synovial Sarcoma

This study is being conducted to test the safety and efficacy of ramucirumab in combination with other chemotherapy in the treatment of relapsed, recurrent, or refractory synovial sarcoma (SS) in children and young adults. This trial is part of the CAMPFIRE master protocol which is a platform to accelerate the development of new treatments for pediatric and young adult participants with cancer.

Trial Summary

Age Range
12 months - 29 years
Conditions the trial is for
What the trial is testing?
Docetaxel, Gemcitabine, Ramucirumab
Could I receive a Placebo?
No
Enrollment Goal
23
Trial Dates
Mar 4, 2020 - Feb 23, 2023
How long will I be in the trial?
Your participation in this trial could last 12 months or longer, depending on how you and your tumor respond.
Trial Phase
II

Key Requirements

Clinical trials have inclusion and exclusion requirements to determine which individuals qualify for participation. Listed below are key requirements for this clinical trial, but there may be additional requirements to qualify.

Participants Must:

  • Participant must have relapsed, recurrent or refractory synovial sarcoma

  • Participant must have measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 at time of enrollment

  • Participant must have received at least one line of prior systemic treatment at the time of enrollment

  • Participant must have adequate organ function, including blood, blood clotting, liver, kidney, heart and blood pressure control

Participants Must Not:

  • Participant must not be a candidate for surgical tumor removal at the time of enrollment

  • Participant must not have had already taken ramucirumab

  • Participant must not have previously progressed on the combined regimen of gemcitabine/docetaxel and must not have known allergies to any of the agents in the regimen

  • Participant must not be at risk/history of serious bleeding/blood clot events; heart problems; blood pressure crises or brain disease; stomach or liver problems; fistulas, ulcers or perforations, abdominal abscesses; non-healing wounds or broken bones

  • Participant must not have symptomatic or radiologic findings of interstitial pneumonia or pulmonary fibrosis

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