Recruiting
CAMPFIRE: A Study of Ramucirumab (LY3009806) in Children and Young Adults With Synovial Sarcoma
J1S-MC-JV02 - ClinicalTrials.gov - NCT04145700
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.
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.
Recruiting
CAMPFIRE: A Study of Ramucirumab (LY3009806) in Children and Young Adults With Synovial Sarcoma
J1S-MC-JV02 - ClinicalTrials.gov - NCT04145700
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.
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.
Key Requirements
Age :
1-29
Sex:
All
Key Requirements
Use the following checklist to help determine if this trial may be a good fit for you. Place a checkmark next to each criteria that you successfully meet.
Age
1-29
Sex
All
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
Trial Summary
Conditions the trial is for
Pediatric Solid Tumors, Soft Tissue Sarcoma, Pediatric Cancer
What the trial is testing?
Ramucirumab, Gemcitabine, Docetaxel
Could I receive a Placebo?
no
Enrollment Goal
33
Trial Dates
March 2020 - January 2024
Trial Phase
2
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Key Requirements
Use the following checklist to help determine if this trial may be a good fit for you. Place a checkmark next to each criteria that you successfully meet.
Age
1-29
Sex
All
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
Trial Summary
Conditions the trial is for
Pediatric Solid Tumors, Soft Tissue Sarcoma, Pediatric Cancer
What the trial is testing?
Ramucirumab, Gemcitabine, Docetaxel
Could I receive a Placebo?
no
Enrollment Goal
33
Trial Dates
March 2020 - January 2024
Trial Phase
2
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Trial Locations
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