Lurbinectedin Monotherapy in Participants With Advanced or Metastatic Solid Tumors
Stopped early · Phase 2
Conditions studied: Advanced Solid Tumor, Metastatic Solid Tumor, Urothelial Cancer, Poorly Differentiated Neuroendocrine Carcinomas, Homologous Recombination Deficient-Positive Malignancies Agnostic
In brief
This is an open-label, multicenter, phase 2 study of lurbinectedin monotherapy in participants with advanced (metastatic and/or unresectable) solid tumors.
Key facts
- Study ID
- NCT05126433
- Run by
- Jazz Pharmaceuticals
- People needed
- 47
- Starts
- 2022-03-03
- Expected to finish
- 2023-12-20
- Last updated by the study team
- 2025-02-28
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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 poorly differentiated neuroendocrine carcinoma
- 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
- Adequate contraceptive precautions
You may not qualify if…
- 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
Where it is running
- 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
Full record on ClinicalTrials.gov
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