Breast Cancer Clinical Trial

Lurbinectedin Monotherapy in Participants With Advanced or Metastatic Solid Tumors

Summary

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

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Full 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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Eligibility Criteria

Inclusion Criteria:

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

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

Histologically or cytologically confirmed urothelial cancer
Histologically or cytologically confirmed large cell neuroendocrine tumor of lung
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
Adequate contraceptive precautions

Exclusion Criteria:

Known symptomatic central nervous system (CNS) metastasis requiring steroids
History of prior malignancy within 2 years of enrollment
Clinically significant cardiovascular disease
Active infection requiring systemic therapy
Significant non-neoplastic liver disease
Prior treatment with trabectedin or lurbinectedin
Treatment with an investigational agent within 4 weeks of enrollment
Received live vaccine with 4 weeks of first dose
Prior allogeneic bone marrow or solid organ transplant
Positive hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at screening
Positive human immunodeficiency virus (HIV) infection at screening

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

60

Study ID:

NCT05126433

Recruitment Status:

Recruiting

Sponsor:

Jazz Pharmaceuticals

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There are 13 Locations for this study

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Eastern Connecticut Hematology and Oncology
Norwich Connecticut, 06360, United States
Sarah Cannon, Florida Cancer Specialist
Saint Petersburg Florida, 33705, United States
Pikeville Medical Center
Pikeville Kentucky, 41501, United States
Dana Farber
Boston Massachusetts, 02215, United States
Oncology Hematology West, PC dba Nebraska Cancer Specialists
Omaha Nebraska, 68124, United States
Icahn School of Medicine at Mount Sinai
New York New York, 10029, United States
Levine Cancer Institute
Charlotte North Carolina, 28203, United States
Sarah Cannon, Zangmeister Cancer Center
Columbus Ohio, 43219, United States
University of Pennsylvania
Philadelphia Pennsylvania, 19104, United States
UPMC Hillman Cancer Center Investigational Drug Service
Pittsburgh Pennsylvania, 15232, United States
Bon Secours Hematology and Oncology
Greenville South Carolina, 29607, United States
Sarah Cannon, Tennesse Oncology
Nashville Tennessee, 37203, United States
MD Anderson
Houston Texas, 77030, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

60

Study ID:

NCT05126433

Recruitment Status:

Recruiting

Sponsor:


Jazz Pharmaceuticals

How clear is this clinincal trial information?

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