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Lurbinectedin for Ewing Sarcoma (EMERGE 101 Trial)
EMERGE 101 Trial Summary
This trial studies lurbinectedin to treat pediatric/young adult cancer patients with recurrent/refractory Ewing sarcoma. It evaluates safety, effectiveness, and dose.
EMERGE 101 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowEMERGE 101 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.EMERGE 101 Trial Design
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Who is running the clinical trial?
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- I weigh at least 15 kilograms.I do not have any major illnesses that could worsen my health significantly.I have a confirmed solid tumor.I have lasting side effects from previous treatments, but not including certain conditions.I have received chemotherapy recently.I am following the required birth control measures.I have not had major surgery or radiation therapy recently.I need steroids for my brain cancer symptoms.I have been treated with specific drugs before.I agree to follow the required contraceptive measures.I have had an organ or tissue transplant.I do not have any health issues that prevent me from taking new medications.I have not received any live vaccines recently.My liver is functioning well.I meet the age requirements for the trial phase.I can do most activities but need help with some.My bone marrow is functioning well.My kidneys are working well.I am able to understand and sign the consent form.My heart is functioning well.I do not have any unmanaged ongoing illnesses.
- Group 1: Phase 1 Part 1: Dose Selection
- Group 2: Phase 1 Part 2: RP2D
- Group 3: Phase 2
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Does this research project include participants aged 45 and older?
"As per the study's entrance requirements, only those aged between 2 and 30 are eligible for enrollment."
Is this endeavor presently taking on new participants?
"Clinicaltrials.gov reveals that this medical trial is actively searching for patients, having been initially posted on March 1st 2023 and last edited on March 9th of the same year."
What is the cap on the number of participants in this clinical experiment?
"Affirmative. According to the clinicaltrials.gov records, this research endeavor is actively recruiting participants. The investigation was initially posted on March 1st 2023 and was last revised 9 days later; thus far, 60 individuals across a single site are needed for completion of the trial."
What are the requirements for participation in this research project?
"This clinical trial is currently open to 60 patients that have experienced a relapse of ewing sarcoma and are aged between 2-30. Essential criteria for admittance include: Phase 1 Part 1 requiring ages ≥2 to <18 years, Phase 1 Part 2 needing participants ≥2 to ≤30 years old, the same age requirement in Phase 2, confirmed solid tumor diagnosis with Lansky/Karnofsky performance status score at or above 50%, aspartate aminotransferase (AST) & alanine aminotransferase (ALT) levels below twice the upper limit of normal values; total bilir"
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