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Clinical Trial 21698

Cancer Type: Multiple
Study Type: Treatment
NCT#: NCT05126433

Phase: Phase II
Principal Investigator: Shafique, Michael

Call 813-745-6100
or 1-800-679-0775 Learn More

Overview

Study Title

A Phase 2, Multicenter, Open-Label Study of Lurbinectedin Efficacy and Safety 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.

Objective

Primary * To evaluate the antitumor activity of lurbinectedin in the selected advanced solid tumors Secondary * To evaluate the overall safety profile of lurbinectedin in the selected advanced solid tumors * To assess other antitumor efficacy parameters of lurbinectedin in the selected advanced solid tumors. * To assess OS in participants treated with lurbinectedin in the selected advanced solid tumors.

Treatments

Therapies

Chemotherapy (NOS); Therapy (NOS)

Medications

Dexamethasone (); Metoclopramide (); Ondansetron (); PM01183 (lurbinectedin); Zofran (Ondansetron); lurbinectedin ()

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

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