Lurbinectedin Monotherapy in Participants With Advanced or Metastatic Solid Tumors
Reason given: Termination of this study was a business decision made during portfolio review.
Key facts
- Where
- Boston, Charlotte, Columbus, Fairfax, Fort Myers, Greenville, Houston, Nashville, New York, Norwich, Omaha, Philadelphia, Pikeville, Pittsburgh, St. Petersburg, Stanford, and Tampa, United StatesSee the 17 sites
- Phase
- Phase 2
Where in United States
- Dana FarberBoston, United StatesNo longer taking part
- Levine Cancer InstituteCharlotte, United StatesNo longer taking part
- Sarah Cannon, Zangmeister Cancer CenterColumbus, United StatesNo longer taking part
- Inova Schar Cancer InstituteFairfax, United StatesNo longer taking part
- Florida Cancer SpecialistsFort Myers, United StatesNo longer taking part
- Bon Secours Hematology and OncologyGreenville, United StatesNo longer taking part
- MD AndersonHouston, United StatesNo longer taking part
- Sarah Cannon, Tennesse OncologyNashville, United StatesNo longer taking part
- Icahn School of Medicine at Mount SinaiNew York, United StatesNo longer taking part
- Eastern Connecticut Hematology and OncologyNorwich, United StatesNo longer taking part
- Oncology Hematology West, PC dba Nebraska Cancer SpecialistsOmaha, United StatesNo longer taking part
- University of PennsylvaniaPhiladelphia, United StatesNo longer taking part
- Pikeville Medical CenterPikeville, United StatesNo longer taking part
- UPMC Hillman Cancer Center Investigational Drug ServicePittsburgh, United StatesNo longer taking part
- Sarah Cannon, Florida Cancer SpecialistSt. Petersburg, United StatesNo longer taking part
- Stanford Cancer CenterStanford, United StatesNo longer taking part
- Moffitt Cancer CenterTampa, United StatesNo longer taking part
Trial details
- Who runs it
- Jazz Pharmaceuticals
- Trial code
- NCT05126433
- Record updated
- 28 February 2025
- Original description
This is an open-label, multicenter, phase 2 study of lurbinectedin monotherapy in participants with advanced (metastatic and/or unresectable) solid tumors.Read full original descriptionShow less
EMERGE-201: A Phase 2, Multicenter, Open-label Study of Lurbinectedin Efficacy and Safety in Participants With Advanced or Metastatic Solid Tumors
This is an open-label, multicenter, phase 2 study of lurbinectedin monotherapy in participants with advanced (metastatic and/or unresectable) solid tumors.
Inclusion: 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.
Exclusion: Known symptomatic central nervous system (CNS) metastasis requiring steroids; 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; History of prior malignancy within 2 years of enrollment; Clinically significant cardiovascular disease; Active infection requiring systemic therapy; Significant non-neoplastic liver disease; Positive hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at screening; Positive human immunodeficiency virus (HIV) infection at screening.