Education and Training
Lurbinectedin Monotherapy in Participants With Advanced or Metastatic Solid Tumors (EMERGE-201)
This is an open-label, multicenter, phase 2 study of lurbinectedin monotherapy in participants with advanced (metastatic and/or unresectable) solid tumors.
Stanford is currently not accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: Lurbinectedin
Eligibility
Inclusion Criteria:
1. Signed informed consent
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:
1. Known symptomatic central nervous system (CNS) metastasis requiring steroids
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
Ages Eligible for Study
18 Years - N/A
Genders Eligible for Study
All
Not currently accepting new patients for this trial
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Paige Nicole Baker
650-736-3687
Not Recruiting