Is NCT05734066 recruiting in Los Angeles, CA?

Yes, NCT05734066 is currently recruiting participants at its Los Angeles, CA location. This ewing sarcoma clinical trial is actively enrolling qualified participants.

How do I join the ewing sarcoma clinical trial in Los Angeles?

To join this clinical trial in Los Angeles, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Los Angeles clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Ewing Sarcoma Clinical Trial in Los Angeles, CA

About This Ewing Sarcoma Study in Los Angeles

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. This is followed by the phase 2 portion, to further assess the effectiveness and safety in pediatric and young adult participants with recurrent/refractory Ewing sarcoma.

Sponsor: Jazz Pharmaceuticals

Who Can Participate

Inclusion Criteria

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 and for at least 4 months after the last dose of study intervention:

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 (WOCBP) who is not currently pregnant.

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 eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies:

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 contraceptive method failure (eg, noncompliance, recently initiated) in relationship to the first dose of study intervention.

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

Exclusion Criteria

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 effects of radiation therapy or surgery prior to enrollment, have discontinued high dose steroid treatment for these metastases for at least 2 weeks, and are neurologically stable (physiologic doses of steroids and short courses of steroids for other indications are acceptable).

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 the investigator's judgement are acceptable.

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 illness/social situations that would limit compliance with study requirements.

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 that may affect the interpretation of the results or render the participant at high-risk for treatment complications. Prior/Concomitant Therapy

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 acid (mRNA) vaccines (for example, inactivated influenza vaccines or COVID-19 vaccines) are allowed.

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 enrollment.

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

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Los Angeles?

Yes, this clinical trial (NCT05734066) has an active research site in Los Angeles, CA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Ewing Sarcoma Treatment Options in Los Angeles, CA

If you're searching for ewing sarcoma treatment options in Los Angeles, CA, this clinical trial (NCT05734066) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Los Angeles research site is actively enrolling participants for this phase 1/2 clinical trial. You'll receive care from experienced ewing sarcoma specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all ewing sarcoma clinical trials near you to find additional studies recruiting in your area.

Ewing Sarcoma Clinical Trial in Los Angeles, CA

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