Lurbinectedin Monotherapy in Participants With Advanced or Metastatic Solid Tumors
NCT ID: NCT05126433
Last Updated: 2025-02-28
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
47 participants
INTERVENTIONAL
2022-03-03
2023-12-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
Lurbinectedin
Lurbinectedin 3.2 mg/m\^2 intravenous (IV) every 3 weeks (Q3W)
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.
Lurbinectedin
Lurbinectedin 3.2 mg/m\^2 intravenous (IV) every 3 weeks (Q3W)
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.
Lurbinectedin
Lurbinectedin 3.2 mg/m\^2 intravenous (IV) every 3 weeks (Q3W)
Interventions
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Lurbinectedin
Lurbinectedin 3.2 mg/m\^2 intravenous (IV) every 3 weeks (Q3W)
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Jazz Pharmaceuticals Ireland Limited
INDUSTRY
Jazz Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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Stanford Cancer Center
Stanford, California, United States
Eastern Connecticut Hematology and Oncology
Norwich, Connecticut, United States
Florida Cancer Specialists
Fort Myers, Florida, United States
Sarah Cannon, Florida Cancer Specialist
St. Petersburg, Florida, United States
Moffitt Cancer Center
Tampa, Florida, United States
Pikeville Medical Center
Pikeville, Kentucky, United States
Dana Farber
Boston, Massachusetts, United States
Oncology Hematology West, PC dba Nebraska Cancer Specialists
Omaha, Nebraska, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Levine Cancer Institute
Charlotte, North Carolina, United States
Sarah Cannon, Zangmeister Cancer Center
Columbus, Ohio, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
UPMC Hillman Cancer Center Investigational Drug Service
Pittsburgh, Pennsylvania, United States
Bon Secours Hematology and Oncology
Greenville, South Carolina, United States
Sarah Cannon, Tennesse Oncology
Nashville, Tennessee, United States
MD Anderson
Houston, Texas, United States
Inova Schar Cancer Institute
Fairfax, Virginia, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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JZP712-201
Identifier Type: -
Identifier Source: org_study_id
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