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New treatment option for Ewing Sarcoma
Official title Lurbinectedin in FET-Fused Tumors
ClinicalTrials.gov ID: NCT05918640
What this study is testing
What is Lurbinectedin?
Lurbinectedin is an investigational medicine, being studied as a potential treatment for ewing sarcoma.
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
- The purpose of this study is to find out if a drug called lurbinectedin (the "study drug") is safe and effective at treating people with recurrent or relapsed solid tumors, including Ewing sarcoma.
- 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 10 and older
You may be able to join if
- Age ≥ 10 years.
- Phase 1: Histological confirmed diagnosis of recurrent or relapsed solid tumor failing primary therapy. Patients must have a known FET fusion (fusion...
- Phase 2: Histologically confirmed diagnosis of recurrent or relapsed Ewing sarcoma failing primary therapy with confirmation of EWS-FLI1 fusion and...
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 (age \>16 years) or Lansky of at least 70 (age \<16 years).
- Disease status (baseline imaging must be performed within 28 days of Day 1 of study treatment):
You likely can't join if
- Prior therapy with trabectedin or lurbinectedin.
- people with known brain metastases.
- people with a known bleeding diathesis.
- people who are pregnant or breastfeeding.
- Concurrent therapy:
- Patients who are currently receiving an investigational drug or another anticancer agent
See the full eligibility criteria
- Age ≥ 10 years.
- Phase 1: Histological confirmed diagnosis of recurrent or relapsed solid tumor failing primary therapy. Patients must have a known FET fusion (fusion that contains EWSR1, FUS, or TAF15) as documented by next generation...
- Phase 2: Histologically confirmed diagnosis of recurrent or relapsed Ewing sarcoma failing primary therapy with confirmation of EWS-FLI1 fusion and breakpoint by Next generation sequencing or PCR or EWSR1 rearrangement...
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 (age \>16 years) or Lansky of at least 70 (age \<16 years).
- Disease status (baseline imaging must be performed within 28 days of Day 1 of study treatment):
- Phase 1: At least one site of measurable disease on CT or MRI as defined by RECIST 1.1 OR evaluable disease with at least one site of disease that has not been previously radiated
- Phase 2: At least one site of measurable disease on CT or MRI as defined by RECIST 1.1
- Meets organ function requirements as outlined below:
- Liver: Alanine aminotransferase (ALT) ≤ 2.5X upper limit of normal. For the purposes of this study the upper limit of normal for ALT is 45 U/L. Aspartate aminotransferase (AST) ≤ 2.5X upper limit of normal. For the...
- Renal: Creatinine Calculated creatinine clearance (by the Schwartz equation for patients \<18 years of age and Cockroft-Gault formula (Appendix B) for patients ≥18 years of age) or radionuclide glomerular filtration...
- Bone marrow: Absolute Neutrophil Count (ANC) ≥ 1,000/µL (\>one week since last dose of short acting medications (e.g. filgrastim) and \> two weeks since last dose of long acting medications (e.g. peg-filgrastim))...
- Muscle: Creatine phosphokinase (CPK) CTCAE 5 Grade ≤ 1,
- Cardiac: Creatine phosphokinase CTCAE 5 Grade ≤ l, Left ventricular ejection fraction (LVEF) or shortening fraction (SF) per institutional norm LVEF ≥50% OR SF ≥28%.
- Written, voluntary informed consent
- Fertile males and females of childbearing potential must agree to use an effective method of birth control from screening, through 7 months after last study drug administration for females and 4 months for males. Women...
- Patients ≥18 years must be willing to undergo tumor biopsy at study entry. Patients with Ewing sarcoma or DSRCT must be willing to undergo biopsy post-treatment. If biopsy is contraindicated, enrollment must be approved...
- Time elapsed from previous therapy:
- Must be ≥ 3 weeks for systemic myelosuppressive therapy
- ≥ 2 weeks for local radiation therapy (small field), ≥ 150 days after thyrotropin binding inhibition (TBI), craniospinal external beam radiotherapy (XRT) or radiation to ≥50% of the pelvis
- ≥ 2 weeks for major surgery
- ≥ 2 weeks for monoclonal antibodies and oral kinase inhibitors.
- ≥ 6 weeks for autologous stem cell transplant. 6 months for allogeneic stem cell transplant.
- ≥ 6 weeks for any type of cellular therapy
- Patients must be recovered to baseline or Grade ≤1from the acute adverse effects of prior treatments, with the exception of alopecia and decreased deep tendon reflexes.
- Prior therapy with trabectedin or lurbinectedin.
- people with known brain metastases.
- people with a known bleeding diathesis.
- people who are pregnant or breastfeeding.
- Concurrent therapy:
- Patients who are currently receiving an investigational drug or another anticancer agent
- Patients receiving over the counter or herbal supplement with significant potential hepatotoxicity in the opinion of the investigator.
- Patients receiving a medically necessary strong or moderate CYP3A4 inhibitor or inducer within 14 days prior to the first dose of study drug.
- Clinically significant, unrelated illness or uncontrolled infection which would, in the opinion of the treating physician, compromise the patient's ability to tolerate the investigational agents or be likely to...
- people who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study, or in whom compliance is likely to be suboptimal, should be excluded.
- Patients with known active viral hepatitis (i.e. Hepatitis A, B, or C)
- Patients with Desmoplastic small round cell tumor (DSRCT) will be excluded from enrollment until at least 3 non-DSRCT patients have been enrolled without dose limiting toxicity.
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Iowa City, Iowa, United States
- Boston, Massachusetts, United States
- Ann Arbor, Michigan, United States
- New York, New York, United States
- Philadelphia, Pennsylvania, United States
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, 10 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; Iowa City, Iowa, United States; Boston, Massachusetts, United States; Ann Arbor, Michigan, United States; New York, New York, United States; Philadelphia, Pennsylvania, United States. 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.