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Trial record 1 of 1 for:    JZP712-201
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Lurbinectedin Monotherapy in Participants With Advanced or Metastatic Solid Tumors (EMERGE-201)

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ClinicalTrials.gov Identifier: NCT05126433
Recruitment Status : Recruiting
First Posted : November 19, 2021
Last Update Posted : July 15, 2022
Sponsor:
Information provided by (Responsible Party):
Jazz Pharmaceuticals

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 Carcinoma Large Cell Neuroendocrine Carcinoma of the Lung Homologous Recombination Deficiency 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), large cell neuroendocrine tumor (LCNET) of lung, and a tumor agnostic cohort of participants with homologous recombination deficient (HRD) positive malignancies.

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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


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: Large Neuroendocrine Tumor of the Lung Cohort
Participants with advanced (metastatic and/or unresectable) large neuroendocrine tumor of the lung who have progressed on platinum-containing regimen (prior treatment with immune checkpoint is allowed) 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 Solid Tumor Malignancy 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 no more than 3 prior lines of chemotherapies for advanced/metastatic disease 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)




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.



Information from the National Library of Medicine

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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 large cell neuroendocrine tumor of lung
    3. Histologically or cytologically confirmed homologous recombination deficient (HRD) positive 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

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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United States, Connecticut
Eastern Connecticut Hematology and Oncology Recruiting
Norwich, Connecticut, United States, 06360
United States, Florida
Sarah Cannon, Florida Cancer Specialist Recruiting
Saint Petersburg, Florida, United States, 33705
United States, Massachusetts
Dana Farber Recruiting
Boston, Massachusetts, United States, 02215
United States, Nebraska
Oncology Hematology West, PC dba Nebraska Cancer Specialists Recruiting
Omaha, Nebraska, United States, 68124
United States, New York
Icahn School of Medicine at Mount Sinai Recruiting
New York, New York, United States, 10029
United States, Ohio
Sarah Cannon, Zangmeister Cancer Center Recruiting
Columbus, Ohio, United States, 43219
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
UPMC Hillman Cancer Center Investigational Drug Service Recruiting
Pittsburgh, Pennsylvania, United States, 15232
United States, South Carolina
Bon Secours Hematology and Oncology Recruiting
Greenville, South Carolina, United States, 29607
United States, Tennessee
Sarah Cannon, Tennesse Oncology Recruiting
Nashville, Tennessee, United States, 37203
United States, Texas
MD Anderson Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
Jazz Pharmaceuticals
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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: July 15, 2022
Last Verified: July 2022
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
HRD positive tumors
Additional relevant MeSH terms:
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Carcinoma
Neoplasms
Carcinoma, Neuroendocrine
Lung Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Adenocarcinoma
Neoplasms, Nerve Tissue
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases