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Lurbinectedin Monotherapy in Participants With Advanced or Metastatic Solid Tumors (EMERGE-201)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05126433
Recruitment Status : Recruiting
First Posted : November 19, 2021
Last Update Posted : May 19, 2023
Sponsor:
Information provided by (Responsible Party):
Jazz Pharmaceuticals

Study Description
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Brief Summary:
This is an open-label, multicenter, phase 2 study of lurbinectedin monotherapy in participants with advanced (metastatic and/or unresectable) solid tumors.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumor Metastatic Solid Tumor Urothelial Cancer Poorly Differentiated Neuroendocrine Carcinomas Homologous Recombination Deficient-Positive Malignancies Agnostic Drug: Lurbinectedin Phase 2

Detailed Description:
This phase 2, multicenter, open-label study is designed to assess the safety and efficacy of lurbinectedin monotherapy in 3 cohorts of participants with high-unmet medical need: advanced (metastatic and/or unresectable) urothelial cancer (UC), poorly differentiated neuroendocrine carcinomas (PD-NEC), and a homologous recombination deficient-positive malignancies agnostic cohort.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: EMERGE-201: A Phase 2, Multicenter, Open-label Study of Lurbinectedin Efficacy and Safety in Participants With Advanced or Metastatic Solid Tumors
Actual Study Start Date : March 3, 2022
Estimated Primary Completion Date : November 23, 2023
Estimated Study Completion Date : June 23, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Urothelial Cancer Cohort
Participants with advanced (metastatic and/or unresectable) urothelial carcinoma who have progressed on platinum-containing regimen (prior therapies may include but are not limited to immune checkpoint inhibitor, enformumab vendotin, or sacituzumab govitecan) will receive Lurbinectedin 3.2 mg/m^2 intravenous (IV) on Day 1 of every 3 weeks (Q3W) cycle until confirmed disease progression, withdrawal of participant consent, participant lost to follow-up, unacceptable toxicity, or the study or individual cohort may be terminated by the sponsor for lack of efficacy signal or any other reason.
 Drug: Lurbinectedin
Lurbinectedin 3.2 mg/m^2 intravenous (IV) every 3 weeks (Q3W)
Experimental: Poorly Differentiated Neuroendocrine Carcinomas Cohort
Participants with advanced (metastatic and/or unresectable) poorly differentiated neuroendocrine carcinomas who received at least 1 prior line of therapy will receive Lurbinectedin 3.2 mg/m^2 intravenous (IV) on Day 1 of every 3 weeks (Q3W) cycle until confirmed disease progression, withdrawal of participant consent, participant lost to follow-up, unacceptable toxicity, or the study or individual cohort may be terminated by the sponsor for lack of efficacy signal or any other reason.
 Drug: Lurbinectedin
Lurbinectedin 3.2 mg/m^2 intravenous (IV) every 3 weeks (Q3W)
Experimental: Homologous Recombination Deficient-Positive Malignancies Agnostic Cohort
Participants with advanced (metastatic and/or unresectable) endometrial, biliary tract, urothelial, breast (TNBC or HR+HER2- breast cancer), pancreas, gastric, or esophageal solid tumors with preidentified germline and/or somatic pathogenic mutation and received at least 1 prior line of therapy will receive Lurbinectedin 3.2 mg/m^2 intravenous (IV) on Day 1 of every 3 weeks (Q3W) cycle until confirmed disease progression, withdrawal of participant consent, participant lost to follow-up, unacceptable toxicity, or the study or individual cohort may be terminated by the sponsor for lack of efficacy signal or any other reason.
 Drug: Lurbinectedin
Lurbinectedin 3.2 mg/m^2 intravenous (IV) every 3 weeks (Q3W)


Outcome Measures
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Primary Outcome Measures :
  1. Investigator-Assessed Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 [ Time Frame: Baseline to disease progression or death, up to 36 weeks. ]
    The ORR is defined as the proportion of participants whose best overall response (BOR) is investigator-assessed confirmed complete response (CR) or partial response (PR) using the RECIST v1.1 criteria. BOR is defined as the best response recorded between the date of first dose and the date of objectively documented progression per RECIST v1.1, or the date of subsequent anticancer therapy, death due to any cause, loss to follow-up, or study discontinuation, whichever occurs first.


Secondary Outcome Measures :
  1. Investigator-Assessed Progression Free Survival (PFS) as assessed per Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 [ Time Frame: Baseline to disease progression or death, up to 36 weeks. ]
    PFS is defined as the time from the first dosing date to the date of first documented disease progression or death due to any cause, whichever occurs first.

  2. Investigator-Assessed Time-To-Response (TTR) as assessed per Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 [ Time Frame: Baseline to disease progression or death, up to 36 weeks. ]
    TTR is defined as the time from the first dosing date to the date of the first confirmed response (complete response [CR] or partial response [PR]), as assessed by the investigators.

  3. Investigator-Assessed Duration of response (DOR) as assessed per Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 [ Time Frame: Baseline to disease progression or death, up to 36 weeks. ]
    DOR is defined as the time from the first confirmed response (complete response [CR] or partial response [PR]) to the date of the first documented tumor progression as determined using RECIST v1.1 criteria or death due to any cause, whichever occurs first.

  4. Investigator-assessed Disease Control Rate (DCR) as assessed per Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 [ Time Frame: Baseline to disease progression or death, up to 36 weeks. ]
    DCR is defined as the proportion of participants whose best overall response (BOR) is confirmed complete response (CR), or partial response (PR), or stable disease (SD) using the RECIST v1.1 criteria.

  5. Overall Survival (OS) in Participants Treated with Lurbinectedin [ Time Frame: Baseline and every 3 months, up to 16 months. ]
    OS is defined as the time from the first dosing date to the date of death from any cause. A participant who has not died will be censored at the last known alive date.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Signed informed consent
  2. ≥ 18 years of age
  3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  4. Adequate organ and bone marrow function
  5. Has measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

  6. Have advanced (metastatic/unresectable) cancers in one of the following:

    1. Histologically or cytologically confirmed urothelial cancer
    2. Histologically or cytologically confirmed poorly differentiated neuroendocrine carcinoma
    3. Histologically or cytologically confirmed homologous recombination deficient-positive malignancies agnostic, which may include endometrial, biliary tract, urothelial, breast (TNBC or HR+HER2- breast cancer), pancreas, gastric, or esophageal solid tumors with preidentified germline and/or somatic pathogenic mutation
  7. Adequate contraceptive precautions

Exclusion Criteria:

  1. Known symptomatic central nervous system (CNS) metastasis requiring steroids
  2. History of prior malignancy within 2 years of enrollment
  3. Clinically significant cardiovascular disease
  4. Active infection requiring systemic therapy
  5. Significant non-neoplastic liver disease
  6. Prior treatment with trabectedin or lurbinectedin
  7. Treatment with an investigational agent within 4 weeks of enrollment
  8. Received live vaccine with 4 weeks of first dose
  9. Prior allogeneic bone marrow or solid organ transplant
  10. Positive hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at screening
  11. Positive human immunodeficiency virus (HIV) infection at screening
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05126433


Contacts
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Contact: Clinical Trial Disclosure & Transparency 215-832-3750 ClinicalTrialDisclosure@JazzPharma.com

Locations
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Sponsors and Collaborators
Jazz Pharmaceuticals
More Information
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Responsible Party: Jazz Pharmaceuticals
ClinicalTrials.gov Identifier: NCT05126433    
Other Study ID Numbers: JZP712-201
First Posted: November 19, 2021    Key Record Dates
Last Update Posted: May 19, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jazz Pharmaceuticals:
Lurbinectedin
Monotherapy
Urothelial cancer
Poorly differentiated neuroendocrine carcinomas
Homologous recombination deficient-positive malignancies agnostic
Additional relevant MeSH terms:
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Neoplasms
Carcinoma, Neuroendocrine
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
 Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Adenocarcinoma
Neoplasms, Nerve Tissue