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New treatment option for Refractory Ewing Sarcoma
Official title Study of Lurbinectedin Monotherapy in Pediatric and Young Adult Participants With Relapsed/Refractory Ewing Sarcoma
ClinicalTrials.gov ID: NCT05734066
What this study is testing
What is Lurbinectedin?
Lurbinectedin is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for refractory ewing sarcoma.
Also referred to as JZP712.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is conducted in two phases. The phase 1 portion of the study evaluates the safety, tolerability, pharmacokinetics (PK), recommended phase 2 dose (RP2D), and effectiveness of lurbinectedin monotherapy in pediatric participants with previously treated solid tumors.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 2 to 30
You may be able to join if
- Key Age
- Participant must meet the following age requirements at the time the informed consent form (ICF) (and assent form, if applicable) is signed:
- Phase 1 Part 1: participants must be ≥ 2 to \< 18 years of age.
- Phase 1 Part 2: participants must be ≥ 2 to ≤ 30 years of age.
- Phase 2: participants must be ≥ 2 to ≤ 30 years of age. Type of Participant and Disease Characteristics
You likely can't join if
- Medical Conditions
- corrected QT interval (QTc) prolongation defined as a QTc ≥ 460 ms using the Bazett formula in age \< 18 years and QTc ≥ 470 ms using the Bazett...
- Known symptomatic Central nervous system (CNS) metastases requiring steroids. Participants with previously diagnosed CNS metastases are eligible if...
- Persisting toxicity related to prior therapy; however, alopecia, sensory neuropathy, hypothyroidism, and rash Grade ≤ 2 are acceptable, and other...
- An uncontrolled intercurrent illness including but not limited to ongoing or active infection requiring antibiotic, antifungal, or antiviral therapy...
- Any other major illness that, in the investigator's judgment, could substantially increase the risk associated with participation in this study.
See the full eligibility criteria
Who can join
- Key Age
- Participant must meet the following age requirements at the time the informed consent form (ICF) (and assent form, if applicable) is signed:
- Phase 1 Part 1: participants must be ≥ 2 to \< 18 years of age.
- Phase 1 Part 2: participants must be ≥ 2 to ≤ 30 years of age.
- Phase 2: participants must be ≥ 2 to ≤ 30 years of age. Type of Participant and Disease Characteristics
- Participant has a confirmed solid tumor
- The participant has a Lansky/Karnofsky performance status score of ≥ 50%.
- The participant has adequate liver function, evidenced by the following laboratory values:
- Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 2.5 × upper limit of normal (ULN).
- Total bilirubin ≤ 1.5 × institutional ULN (with the exception of participants with Gilbert's syndrome who must have bilirubin \< 3 × institutional ULN).
- The participant has adequate bone marrow function, evidenced by the following:
- Absolute neutrophil count (ANC) ≥ 1.0 × 10\^9/L (independent of growth factor support within 1 week of screening laboratories).
- Platelets ≥ 100 × 10\^9/L (without platelet transfusion within previous 7 days of screening laboratories).
- Hemoglobin ≥ 8 g/dL (note: may have been transfused).
- The participant has an adequate renal function:
- Calculated creatinine clearance (use Cockcroft-Gault formula for participants ≥ 18 years; Schwartz equation for participants \< 18 years) ≥ 60 mL/min.
- The participant has an adequate cardiac function:
- Left ventricular ejection fraction or shortening fraction per institutional norm ≥ institutional lower level of normal.
- The participant has creatine phosphokinase ≤ 2.5 × institutional ULN. Weight
- The participant has body weight ≥ 15 kg. Sex and Contraceptive/Barrier Requirements Male participants: Male participants are eligible to participate if they agree to the following during the study intervention period...
- Refrain from donating sperm. PLUS, either:
- Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent. OR
- Must agree to use contraception/barrier as detailed below:
- Agree to use a male condom with female partner and use of an additional highly effective contraceptive method with a failure rate of \< 1% per year when having sexual intercourse with a Woman of childbearing potential...
- Note: male participants who are azoospermic (vasectomized or due to a medical cause) are still required to follow the protocol-specified contraception/barrier criteria. Female participants: A female participant is...
- Is a Woman of nonchildbearing potential (WONCBP). OR
- Is a WOCBP and using an acceptable contraceptive method during the study intervention period (at least 7 months after the last dose of study intervention). The investigator should evaluate the potential for...
- A WOCBP must have a negative highly sensitive pregnancy test (urine or serum as required by local regulations) within 7 days before the first dose of study intervention.
- If a urine test cannot be confirmed as negative (eg, an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.
- Additional requirements for pregnancy testing during and after study intervention.
- The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy. Informed Consent
- Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol. Key
What rules you out
- Medical Conditions
- corrected QT interval (QTc) prolongation defined as a QTc ≥ 460 ms using the Bazett formula in age \< 18 years and QTc ≥ 470 ms using the Bazett formula in age ≥ 18 years.
- Known symptomatic Central nervous system (CNS) metastases requiring steroids. Participants with previously diagnosed CNS metastases are eligible if they have completed their treatment and have recovered from the acute...
- Persisting toxicity related to prior therapy; however, alopecia, sensory neuropathy, hypothyroidism, and rash Grade ≤ 2 are acceptable, and other Grade ≤ 2 adverse events (AEs) not constituting a safety risk based on...
- An uncontrolled intercurrent illness including but not limited to ongoing or active infection requiring antibiotic, antifungal, or antiviral therapy, symptomatic heart failure, cardiac arrhythmia, or psychiatric...
- Any other major illness that, in the investigator's judgment, could substantially increase the risk associated with participation in this study.
- Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or...
- Received prior treatment with lurbinectedin or trabectedin.
- Received prior treatment with any investigational product within 4 weeks of first infusion of study intervention. Observational studies are permitted.
- Received live or live attenuated vaccines within 4 weeks of the first dose of study treatment or plans to receive live vaccines during study participation. Administration of inactive vaccines or messenger ribonucleic...
- Had major surgery ≤ 4 weeks or radiation therapy ≤ 2 weeks prior to enrollment unless fully recovered. Prior palliative radiotherapy is permitted, provided it was completed at least 2 weeks prior to participant...
- Received prior allogeneic bone marrow transplantation or solid organ transplant.
- Received chemotherapy ≤ 3 weeks prior to start of study intervention. Diagnostic Assessments
- Hepatitis B virus (HBV) or Hepatitis C virus (HCV) infection at screening (positive HBV surface antigen or Polymerase chain reaction (PCR) test for HCV RNA if HCV antibody test is positive).
- Human immunodeficiency infection at screening (positive anti-HIV antibody). Other Exclusions
- Has a known or suspected hypersensitivity to any of the components of the study intervention.
- The participant or parent(s)/guardian(s) is/are unable to comply with the study visit schedule and other protocol requirements, in the opinion of the investigator
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Palo Alto, California, United States
- Washington D.C., District of Columbia, United States
- St. Petersburg, Florida, United States
- Atlanta, Georgia, United States
- Baltimore, Maryland, United States
- Grand Rapids, Michigan, United States
- New York, New York, United States
- Cincinnati, Ohio, United States
- Columbus, Ohio, United States
- Philadelphia, Pennsylvania, United States
- Memphis, Tennessee, United States
- Dallas, Texas, United States
- Houston, Texas, United States
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 2 years to 30 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; Palo Alto, California, United States; Washington D.C., District of Columbia, United States; St. Petersburg, Florida, United States; Atlanta, Georgia, United States; Baltimore, Maryland, United States and 9 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.