Eribulin Mesylate for Pelvic Neoplasms

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Pelvic Neoplasms+27 More
Eribulin Mesylate - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing atezolizumab with or without eribulin mesylate to see if it can help people with urothelial cancer that has come back or spread to other parts of the body.

Eligible Conditions
  • Pelvic Neoplasms
  • Metastatic Ureter Urothelial Carcinoma
  • Renal pelvis
  • Metastatic Renal Pelvis Urothelial Carcinoma
  • Ureter
  • Locally Advanced Ureter Urothelial Carcinoma
  • Urinary Bladder
  • Malignant neoplasm of ureter
  • Stage III Urethral Cancer AJCC v7
  • Unresectable Urethral Urothelial Carcinoma
  • Stage IV Ureter Cancer AJCC v7
  • Metastatic Urethral Urothelial Carcinoma
  • Stage IV Urethral Cancer AJCC v7
  • Locally Advanced Urethral Urothelial Carcinoma
  • Malignant Neoplasms
  • Recurrent Urethral Urothelial Carcinoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

3 Primary · 6 Secondary · Reporting Duration: Up to 52 weeks

Baseline
Analysis of baseline tumor
Week 6
Changes in tumor based on biopsies, radiomics and circulating tumor cells
Week 52
Overall survival (OS)
Week 52
Progression-free survival (PFS)
Week 52
Duration of response (DOR)
Up to 52 weeks
Analysis based on PD-L1 expression
Best overall response rate (immune-related best overall response [irBOR] rate) using the immune-related response criteria (irRC)
Disease control rate (DCR: complete response [CR] + partial response [PR] + stable disease [SD])
Incidence of adverse events
Objective tumor response
Overall response rate (probability of complete response [CR] or partial response [PR])

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

Arm II (atezolizumab, eribulin mesylate)
1 of 2
Arm I (atezolizumab)
1 of 2

Experimental Treatment

72 Total Participants · 2 Treatment Groups

Primary Treatment: Eribulin Mesylate · No Placebo Group · Phase 2

Arm II (atezolizumab, eribulin mesylate)Experimental Group · 4 Interventions: Computed Tomography with Contrast, Laboratory Biomarker Analysis, Eribulin Mesylate, Atezolizumab · Intervention Types: Procedure, Other, Drug, Drug
Arm I (atezolizumab)Experimental Group · 3 Interventions: Computed Tomography with Contrast, Laboratory Biomarker Analysis, Atezolizumab · Intervention Types: Procedure, Other, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Eribulin
FDA approved
Atezolizumab
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 52 weeks

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
12,995 Previous Clinical Trials
41,299,864 Total Patients Enrolled
15 Trials studying Pelvic Neoplasms
2,348 Patients Enrolled for Pelvic Neoplasms
David I QuinnPrincipal InvestigatorCity of Hope Comprehensive Cancer Center LAO
1 Previous Clinical Trials
132 Total Patients Enrolled
Anishka A D'SouzaPrincipal InvestigatorCity of Hope Comprehensive Cancer Center LAO

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are eligible for enrollment in this study if you are aged 18 years or older and have an unresectable or metastatic solid tumor that is not amenable to surgery.
You have received two or more lines of chemotherapy for advanced disease.
Lesions that have had radiotherapy must show radiographic evidence of disease progression based on RECIST 1.
At least one lesion of ≥ 1.0 cm in long axis diameter or ≥ 1.5 cm in short axis diameter for lymph nodes that is serially measurable according to RECIST 1.1 using either computerized tomography or magnetic resonance imaging or panoramic and close-up color photography with caliper measurement; if there is only one target lesion and it is a not a lymph node, it should have a long-axis diameter of at least 1.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 11th, 2021

Last Reviewed: November 13th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.