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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05126433
Other study ID # JZP712-201
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date March 3, 2022
Est. completion date December 20, 2023

Study information

Verified date February 2024
Source Jazz Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is an open-label, multicenter, phase 2 study of lurbinectedin monotherapy in participants with advanced (metastatic and/or unresectable) solid tumors.


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.


Recruitment information / eligibility

Status Completed
Enrollment 47
Est. completion date December 20, 2023
Est. primary completion date December 20, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
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

Study Design


Intervention

Drug:
Lurbinectedin
Lurbinectedin 3.2 mg/m^2 intravenous (IV) every 3 weeks (Q3W)

Locations

Country Name City State
United States Dana Farber Boston Massachusetts
United States Levine Cancer Institute Charlotte North Carolina
United States Sarah Cannon, Zangmeister Cancer Center Columbus Ohio
United States Inova Schar Cancer Institute Fairfax Virginia
United States Florida Cancer Specialists Fort Myers Florida
United States Bon Secours Hematology and Oncology Greenville South Carolina
United States MD Anderson Houston Texas
United States Sarah Cannon, Tennesse Oncology Nashville Tennessee
United States Icahn School of Medicine at Mount Sinai New York New York
United States Eastern Connecticut Hematology and Oncology Norwich Connecticut
United States Oncology Hematology West, PC dba Nebraska Cancer Specialists Omaha Nebraska
United States University of Pennsylvania Philadelphia Pennsylvania
United States Pikeville Medical Center Pikeville Kentucky
United States UPMC Hillman Cancer Center Investigational Drug Service Pittsburgh Pennsylvania
United States Sarah Cannon, Florida Cancer Specialist Saint Petersburg Florida
United States Stanford Cancer Center Stanford California
United States Moffitt Cancer Center Tampa Florida

Sponsors (1)

Lead Sponsor Collaborator
Jazz Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Investigator-Assessed Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 The ORR is defined as the proportion of participants whose best overall response (BOR) is investigator-assessed confirmed complete response (CR) or partial response (PR) using the RECIST v1.1 criteria. BOR is defined as the best response recorded between the date of first dose and the date of objectively documented progression per RECIST v1.1, or the date of subsequent anticancer therapy, death due to any cause, loss to follow-up, or study discontinuation, whichever occurs first. Baseline to disease progression or death, up to 36 weeks.
Secondary Investigator-Assessed Progression Free Survival (PFS) as assessed per Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 PFS is defined as the time from the first dosing date to the date of first documented disease progression or death due to any cause, whichever occurs first. Baseline to disease progression or death, up to 36 weeks.
Secondary Investigator-Assessed Time-To-Response (TTR) as assessed per Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 TTR is defined as the time from the first dosing date to the date of the first confirmed response (complete response [CR] or partial response [PR]), as assessed by the investigators. Baseline to disease progression or death, up to 36 weeks.
Secondary Investigator-Assessed Duration of response (DOR) as assessed per Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 DOR is defined as the time from the first confirmed response (complete response [CR] or partial response [PR]) to the date of the first documented tumor progression as determined using RECIST v1.1 criteria or death due to any cause, whichever occurs first. Baseline to disease progression or death, up to 36 weeks.
Secondary Investigator-assessed Disease Control Rate (DCR) as assessed per Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 DCR is defined as the proportion of participants whose best overall response (BOR) is confirmed complete response (CR), or partial response (PR), or stable disease (SD) using the RECIST v1.1 criteria. Baseline to disease progression or death, up to 36 weeks.
Secondary Overall Survival (OS) in Participants Treated with Lurbinectedin OS is defined as the time from the first dosing date to the date of death from any cause. A participant who has not died will be censored at the last known alive date. Baseline and every 3 months, up to 16 months.
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