Trials / Terminated
TerminatedNCT05126433
Lurbinectedin Monotherapy in Participants With Advanced or Metastatic Solid Tumors
EMERGE-201: A Phase 2, Multicenter, Open-label Study of Lurbinectedin Efficacy and Safety in Participants With Advanced or Metastatic Solid Tumors
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 47 (actual)
- Sponsor
- Jazz Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is an open-label, multicenter, phase 2 study of lurbinectedin monotherapy in participants with advanced (metastatic and/or unresectable) solid tumors.
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), poorly differentiated neuroendocrine carcinomas (PD-NEC), and a homologous recombination deficient-positive malignancies agnostic cohort.
Conditions
- Advanced Solid Tumor
- Metastatic Solid Tumor
- Urothelial Cancer
- Poorly Differentiated Neuroendocrine Carcinomas
- Homologous Recombination Deficient-Positive Malignancies Agnostic
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Lurbinectedin | Lurbinectedin 3.2 mg/m\^2 intravenous (IV) every 3 weeks (Q3W) |
Timeline
- Start date
- 2022-03-03
- Primary completion
- 2023-12-20
- Completion
- 2023-12-20
- First posted
- 2021-11-19
- Last updated
- 2025-02-28
- Results posted
- 2025-02-28
Locations
17 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05126433. Inclusion in this directory is not an endorsement.