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Study of Lurbinectedin Monotherapy in Pediatric and Young Adult Participants With Relapsed/Refractory Ewing Sarcoma (EMERGE 101)

Primary Purpose

Refractory Ewing Sarcoma, Relapsed Ewing Sarcoma, Ewing Sarcoma

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Lurbinectedin
Sponsored by
Jazz Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Refractory Ewing Sarcoma focused on measuring Solid Tumors, lurbinectedin, ewing's sarcoma, soft tissue sarcoma, sarcomas

Eligibility Criteria

2 Years - 30 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria: 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 × 109/L (independent of growth factor support within 1 week of screening laboratories). Platelets ≥ 100 × 109/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 6 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 ≥ 470 ms using the Bazett formula. 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

Sites / Locations

  • Johns Hopkins All Children's HospitalRecruiting
  • Memorial Sloan KetteringRecruiting
  • Cincinnati Children's Hospital Medical CenterRecruiting
  • Children's Hospital of PhiladelphiaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Phase 1 Part 1: Dose Selection

Phase 1 Part 2: RP2D

Phase 2

Arm Description

Pediatric participants ≥ 2 to < 18 years of age with previously treated solid tumors of any histology at 5 dose levels to determine the RP2D, followed by a safety expansion cohort. Participants aged ≥ 6 to < 18 years will be enrolled at the starting dose of 3.2 mg/m^2 lurbinectedin. After the drug is deemed safe based safety and PK data from the older participants, participants aged ≥ 2 to < 6 years are enrolled at the same starting dose. After this, the study opens to all participants (aged ≥ 2 to < 18 years) for all dose levels. Upon completion of the cohort at all dose levels, participants may be eligible to enroll in a safety expansion cohort.

Participants aged ≥ 2 to ≤ 30 years with recurrent/refractory Ewing sarcoma at the RP2D to assess safety and efficacy signals.

If a signal of efficacy is observed in Phase 1 Part 2, additional participants aged ≥ 2 to ≤ 30 years with recurrent/refractory Ewing sarcoma will be enrolled. Phase 2 will further assess the safety and efficacy of lurbinectedin monotherapy.

Outcomes

Primary Outcome Measures

Phase 1: Number of Participants Experiencing Dose-limiting Toxicities (DLTs)
Phase 1: Number of Participants Experiencing Treatment Emergent Adverse Events (TEAEs)
TEAEs are defined as adverse events (AEs) with an onset date on or after the date of the first dose of study treatment. An AE is a TEAE if it occurs up to 30 days after the last dose of study intervention.
Phase 2: Objective Response Rate (ORR) Based on Investigator Assessment (IA)

Secondary Outcome Measures

Phase 1: Maximum Plasma Concentration (Cmax) of Lurbinectedin
Phase 1: Plasma Trough Concentration (Ctrough) of Lurbinectedin
Phase 1: Plasma Concentration at the End of Infusion (CEOI) of Lurbinectedin
Phase 1: Area Under the Plasma Concentration-Time Curve (AUC) of Lurbinectedin
Phase 1: Clearance (CL) of Lurbinectedin
Phase 1: Volume of Distribution at Steady-State (Vss) of Lurbinectedin
Phase 1: Objective Response Rate (ORR) Based on Investigator Assessment (IA)
Phase 1: Progression-Free Survival (PFS) Based on Investigator Assessment (IA)
Phase 1: Duration of Response (DOR) in Participants with Confirmed Complete Response (CR) or Partial Response (PR)
Phase 1: Disease Control Rate (DCR)
Phase 1: Clinical Benefit Rate (CBR) With Stable Disease (SD) for At Least 12 Weeks
Phase 1: Overall Survival (OS)
Phase 2: Plasma Concentration of Lurbinectedin
Phase 2: Plasma Trough Concentration (Ctrough) of Lurbinectedin
Phase 2: Plasma Concentration at the End of Infusion (CEOI) of Lurbinectedin
Phase 2: Clearance (CL) of Lurbinectedin
Phase 2: Volume of Distribution at Steady-State (Vss) of Lurbinectedin
Phase 2: Progression-Free Survival (PFS) Based on IA
Phase 2: Duration of Response (DOR) in Participants with Confirmed Complete Response (CR) or Partial Response (PR)
Phase 2: Disease Control Rate (DCR)
Phase 2: Clinical Benefit Rate (CBR) With Stable Disease (SD) for At Least 12 Weeks
Phase 2: Overall Survival (OS)

Full Information

First Posted
February 2, 2023
Last Updated
July 26, 2023
Sponsor
Jazz Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT05734066
Brief Title
Study of Lurbinectedin Monotherapy in Pediatric and Young Adult Participants With Relapsed/Refractory Ewing Sarcoma
Acronym
EMERGE 101
Official Title
A Phase 1/2, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), Recommended Phase 2 Dose (RP2D), and Efficacy of Lurbinectedin Monotherapy in Pediatric Participants With Previously Treated Solid Tumors Followed by Expansion to Assess Efficacy and Safety in Pediatric and Young Adult Participants With Relapsed/Refractory Ewing Sarcoma.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 23, 2023 (Actual)
Primary Completion Date
December 2026 (Anticipated)
Study Completion Date
June 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jazz Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractory Ewing Sarcoma, Relapsed Ewing Sarcoma, Ewing Sarcoma
Keywords
Solid Tumors, lurbinectedin, ewing's sarcoma, soft tissue sarcoma, sarcomas

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Phase 1 Part 1: Dose Selection
Arm Type
Experimental
Arm Description
Pediatric participants ≥ 2 to < 18 years of age with previously treated solid tumors of any histology at 5 dose levels to determine the RP2D, followed by a safety expansion cohort. Participants aged ≥ 6 to < 18 years will be enrolled at the starting dose of 3.2 mg/m^2 lurbinectedin. After the drug is deemed safe based safety and PK data from the older participants, participants aged ≥ 2 to < 6 years are enrolled at the same starting dose. After this, the study opens to all participants (aged ≥ 2 to < 18 years) for all dose levels. Upon completion of the cohort at all dose levels, participants may be eligible to enroll in a safety expansion cohort.
Arm Title
Phase 1 Part 2: RP2D
Arm Type
Experimental
Arm Description
Participants aged ≥ 2 to ≤ 30 years with recurrent/refractory Ewing sarcoma at the RP2D to assess safety and efficacy signals.
Arm Title
Phase 2
Arm Type
Experimental
Arm Description
If a signal of efficacy is observed in Phase 1 Part 2, additional participants aged ≥ 2 to ≤ 30 years with recurrent/refractory Ewing sarcoma will be enrolled. Phase 2 will further assess the safety and efficacy of lurbinectedin monotherapy.
Intervention Type
Drug
Intervention Name(s)
Lurbinectedin
Other Intervention Name(s)
JZP712
Intervention Description
Administered as intravenous (IV) infusion once every 3 weeks (Q3W)
Primary Outcome Measure Information:
Title
Phase 1: Number of Participants Experiencing Dose-limiting Toxicities (DLTs)
Time Frame
Day -28 up to 15 months postdose.
Title
Phase 1: Number of Participants Experiencing Treatment Emergent Adverse Events (TEAEs)
Description
TEAEs are defined as adverse events (AEs) with an onset date on or after the date of the first dose of study treatment. An AE is a TEAE if it occurs up to 30 days after the last dose of study intervention.
Time Frame
Post-baseline (Day 1) up to approximately 30 months.
Title
Phase 2: Objective Response Rate (ORR) Based on Investigator Assessment (IA)
Time Frame
Day -28 up to a total of 31 months postdose.
Secondary Outcome Measure Information:
Title
Phase 1: Maximum Plasma Concentration (Cmax) of Lurbinectedin
Time Frame
Day 1: Predose up to approximately 168 hours postdose; Days 16, 31, 46: Predose up to approximately 5 minutes postdose.
Title
Phase 1: Plasma Trough Concentration (Ctrough) of Lurbinectedin
Time Frame
Day 1: Predose up to approximately 168 hours postdose; Days 16, 31, 46: Predose up to approximately 5 minutes postdose.
Title
Phase 1: Plasma Concentration at the End of Infusion (CEOI) of Lurbinectedin
Time Frame
Day 1: Predose up to approximately 168 hours postdose; Days 16, 31, 46: Predose up to approximately 5 minutes postdose.
Title
Phase 1: Area Under the Plasma Concentration-Time Curve (AUC) of Lurbinectedin
Time Frame
Day 1: Predose up to approximately 168 hours postdose; Days 16, 31, 46: Predose up to approximately 5 minutes postdose.
Title
Phase 1: Clearance (CL) of Lurbinectedin
Time Frame
Day 1: Predose up to approximately 168 hours postdose; Days 16, 31, 46: Predose up to approximately 5 minutes postdose.
Title
Phase 1: Volume of Distribution at Steady-State (Vss) of Lurbinectedin
Time Frame
Day 1: Predose up to approximately 168 hours postdose; Days 16, 31, 46: Predose up to approximately 5 minutes postdose.
Title
Phase 1: Objective Response Rate (ORR) Based on Investigator Assessment (IA)
Time Frame
Day -28 up to a total of 31 months postdose.
Title
Phase 1: Progression-Free Survival (PFS) Based on Investigator Assessment (IA)
Time Frame
Day -28 up to a total of 31 months postdose.
Title
Phase 1: Duration of Response (DOR) in Participants with Confirmed Complete Response (CR) or Partial Response (PR)
Time Frame
Day -28 up to a total of 31 months postdose.
Title
Phase 1: Disease Control Rate (DCR)
Time Frame
Day -28 up to a total of 31 months postdose.
Title
Phase 1: Clinical Benefit Rate (CBR) With Stable Disease (SD) for At Least 12 Weeks
Time Frame
Day -28 up to a total of 31 months postdose.
Title
Phase 1: Overall Survival (OS)
Time Frame
Post-baseline (Day 1) up to 31 months postdose.
Title
Phase 2: Plasma Concentration of Lurbinectedin
Time Frame
Day 1: Predose up to approximately 168 hours postdose; Days 16, 31, 46: Predose up to approximately 5 minutes postdose.
Title
Phase 2: Plasma Trough Concentration (Ctrough) of Lurbinectedin
Time Frame
Day 1: Predose up to approximately 168 hours postdose; Days 16, 31, 46: Predose up to approximately 5 minutes postdose.
Title
Phase 2: Plasma Concentration at the End of Infusion (CEOI) of Lurbinectedin
Time Frame
Day 1: Predose up to approximately 168 hours postdose; Days 16, 31, 46: Predose up to approximately 5 minutes postdose.
Title
Phase 2: Clearance (CL) of Lurbinectedin
Time Frame
Day 1: Predose up to approximately 168 hours postdose; Days 16, 31, 46: Predose up to approximately 5 minutes postdose.
Title
Phase 2: Volume of Distribution at Steady-State (Vss) of Lurbinectedin
Time Frame
Day 1: Predose up to approximately 168 hours postdose; Days 16, 31, 46: Predose up to approximately 5 minutes postdose.
Title
Phase 2: Progression-Free Survival (PFS) Based on IA
Time Frame
Day -28 up to a total of 31 months postdose.
Title
Phase 2: Duration of Response (DOR) in Participants with Confirmed Complete Response (CR) or Partial Response (PR)
Time Frame
Day -28 up to a total of 31 months postdose.
Title
Phase 2: Disease Control Rate (DCR)
Time Frame
Day -28 up to a total of 31 months postdose.
Title
Phase 2: Clinical Benefit Rate (CBR) With Stable Disease (SD) for At Least 12 Weeks
Time Frame
Day -28 up to a total of 31 months postdose.
Title
Phase 2: Overall Survival (OS)
Time Frame
Post-baseline (Day 1) up to 31 months postdose.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: 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 × 109/L (independent of growth factor support within 1 week of screening laboratories). Platelets ≥ 100 × 109/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 6 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 ≥ 470 ms using the Bazett formula. 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clinical Trial Disclosure & Transparency
Phone
215-832-3750
Email
ClinicalTrialDisclosure@JazzPharma.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jazz Study Director
Organizational Affiliation
Jazz Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Johns Hopkins All Children's Hospital
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33701
Country
United States
Individual Site Status
Recruiting
Facility Name
Memorial Sloan Kettering
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Individual Site Status
Recruiting
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

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Study of Lurbinectedin Monotherapy in Pediatric and Young Adult Participants With Relapsed/Refractory Ewing Sarcoma

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