Study on Lurbinectedin for Children and Young Adults with Relapsed or Hard-to-Treat Ewing Sarcoma

Sponsor: Jazz Pharmaceuticals

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05734066

Provider View

This clinical trial is testing the safety and effectiveness of the drug lurbinectedin in children and young adults with Ewing Sarcoma that has returned or is not responding to treatment. The study is conducted in two phases to evaluate the drug's impact on solid tumors.

Patient Parameters

Program Overview

The study is divided into two parts. The first part focuses on understanding how safe and tolerable lurbinectedin is for children with solid tumors that have been treated before. It also looks at how the body processes the drug and determines the best dose for future studies. The second part of the study further examines the drug's effectiveness and safety in children and young adults with Ewing Sarcoma that has come back or is not responding to treatment.

Eligibility Criteria

Inclusion Criteria

  • Age requirements vary by study phase:
    • Phase 1 Part 1: 2 to under 18 years old.
    • Phase 1 Part 2 and Phase 2: 2 to 30 years old.
  • Must have a confirmed solid tumor.
  • Must have a performance status score of 50% or higher, indicating the ability to carry out daily activities.
  • Must have adequate liver function, with specific lab values within normal limits.
  • Must have adequate bone marrow function, with specific blood counts within normal limits.
  • Must have adequate kidney function, with a creatinine clearance of 60 mL/min or higher.
  • Must have adequate heart function, with normal heart pumping ability.
  • Must weigh at least 15 kg.
  • Male participants must agree to use contraception and refrain from donating sperm during and after the study.
  • Female participants must not be pregnant or breastfeeding and must use contraception if of childbearing potential.
  • Must be able to give informed consent and agree to follow study requirements.

Exclusion Criteria

  • Heart rhythm issues with a QTc of 470 ms or higher.
  • Active brain metastases requiring steroids, unless stable and treated.
  • Ongoing side effects from previous treatments, except for certain mild conditions.
  • Uncontrolled illnesses, such as infections or heart problems, that could interfere with the study.
  • Previous treatment with lurbinectedin or trabectedin.
  • Recent treatment with other investigational drugs or live vaccines.
  • Recent major surgery or radiation therapy unless fully recovered.
  • Previous bone marrow or organ transplant.
  • Recent chemotherapy within 3 weeks of starting the study.
  • Active hepatitis B or C, or HIV infection.
  • Allergies to study drug components.
  • Inability to comply with study requirements.

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