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Eribulin Mesylate for Bladder Cancer

Phase 3
Recruiting
Led By Sarmad Sadeghi
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participant must have had prior systemic therapy in metastatic setting that included a PD1/PDL1 antibody
Participant must have predominant histologically and cytologically proven urothelial carcinoma in a metastatic site
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights

Study Summary

This trial is testing whether adding the drug eribulin to standard chemotherapy drugs may work better in treating patients with metastatic urothelial cancer.

Who is the study for?
This trial is for adults with metastatic urothelial cancer who've had platinum-based and PD1/PDL1 antibody therapy, possibly enfortumab vedotin. They should have good organ function, no immediate CNS treatment needs, not be pregnant or breastfeeding, and willing to use contraception. Excluded are those with recent gemcitabine progression or unresolved toxicities from past treatments.Check my eligibility
What is being tested?
The study compares standard chemotherapy alone versus adding the drug Eribulin either alone or with Gemcitabine in treating metastatic urothelial cancer. It aims to find out if Eribulin can improve outcomes when combined with usual chemotherapy drugs.See study design
What are the potential side effects?
Eribulin may cause fatigue, nausea, hair loss, numbness in hands/feet (neuropathy), low white blood cell count (neutropenia) which increases infection risk. Gemcitabine's side effects include flu-like symptoms, rash and liver enzyme changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have received a PD1/PDL1 antibody treatment for my metastatic cancer.
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My cancer, found in a distant part of my body, is mainly urothelial carcinoma.
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I am on HIV treatment and my recent tests show no detectable virus.
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My hepatitis B virus load is undetectable as of the last month.
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I have finished all my scheduled surgeries or radiation treatments.
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I don't have major side effects from past surgeries or radiation.
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I am 18 years old or older.
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I can take care of myself and am up and about more than 50% of my waking hours.
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I have received enfortumab vedotin as part of my previous treatment for metastatic cancer.
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My kidney function is good, with a creatinine clearance rate of at least 20 mL/min.
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My liver tests are within the required range.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall survival
Secondary outcome measures
Disease control rate
Duration of response
Overall response rate
+1 more

Side effects data

From 2017 Phase 3 trial • 1276 Patients • NCT00337103
54%
Neutropenia
35%
Alopecia
31%
Leukopenia
22%
Nausea
19%
Anaemia
17%
Fatigue
15%
Asthenia
14%
Diarrhoea
13%
Decreased Appetite
13%
Peripheral Sensory Neuropathy
12%
Headache
12%
Vomiting
12%
Pyrexia
10%
Back Pain
9%
Alanine Aminotransferase Increased
9%
Bone Pain
9%
Pain in Extremity
9%
Dyspnoea
8%
Aspartate Aminotransferase Increased
8%
Constipation
8%
Arthralgia
8%
Cough
6%
Myalgia
6%
Dizziness
6%
Oedema Peripheral
6%
Abdominal Pain Upper
6%
Abdominal Pain
5%
Thrombocytopenia
5%
Urinary Tract Infection
5%
Tumour Pain
5%
Mucosal Inflammation
5%
Stomatitis
2%
Hyperbilirubinaemia
1%
Pneumonia
1%
Respiratory Failure
1%
Febrile Neutropenia
1%
Neoplasm Malignant
100%
80%
60%
40%
20%
0%
Study treatment Arm
Eribulin Mesylate 1.4 mg/m^2
Capecitabine 2.5 g/m^2/Day

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Arm III (eribulin, gemcitabine)Experimental Treatment6 Interventions
Patients receive eribulin IV over 2-5 minutes and gemcitabine IV on days 1 and 8. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT, MRI and bone scan throughout the trial. Patients also undergo blood and urine sample collection on the trial.
Group II: Arm II (eribulin)Experimental Treatment5 Interventions
Patients receive eribulin IV over 2-5 minutes on days 1 and 8. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT, MRI and bone scan throughout the trial. Patients also undergo blood and urine sample collection on the trial. (CLOSED TO ACCRUAL)
Group III: Arm I (standard of care chemotherapy)Active Control8 Interventions
Patients receive 1 of the 4 standard of care chemotherapy regimens based on treating investigator's choice: Choice A: Patients receive docetaxel IV on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Choice B: Patients receive gemcitabine IV on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Choice C: Patients receive paclitaxel IV on days 1, 8, and 15. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Choice D: Patients receive sacituzumab govitecan IV on days 1 and 8. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT, MRI and bone scan throughout the trial. Patients also undergo blood and urine sample collection on the trial.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Computed Tomography
2017
Completed Phase 2
~2720
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190
Biospecimen Collection
2004
Completed Phase 2
~1730
Eribulin Mesylate
2014
Completed Phase 4
~3420
Gemcitabine Hydrochloride
2005
Completed Phase 3
~5420

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,658 Previous Clinical Trials
40,924,305 Total Patients Enrolled
Sarmad SadeghiPrincipal InvestigatorSWOG Cancer Research Network
2 Previous Clinical Trials
88 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there a lot of locations where this research is taking place within the state?

"There are a hundred participating centres in this study, like the Regional Cancer Center at Indian Path Community Hospital in Kingsport, Advanced Breast Care Centre PLLC in Warren, and Genesys Hurley Cancer Institute in Flint."

Answered by AI

For what purpose is Eribulin Mesylate most often employed?

"kaposi sarcoma can often be effectively treated with Eribulin Mesylate. However, this medication is also useful for other issues such as fallopian tubes cancer, brca1 gene, and advance directives."

Answered by AI

Can you tell me if Eribulin Mesylate has been used in other research studies?

"At the moment, there are a total of 1431 clinical studies underway that involve Eribulin Mesylate. Of these active investigations, 420 are in Phase 3. The concentration of research is based in Shanghai but this treatment is being trialled at 70,778 locations globally."

Answered by AI

Could you speak to the side effects that come with Eribulin Mesylate?

"Eribulin Mesylate has gone through multiple rounds of testing and there is some evidence supporting efficacy, so it received a safety score of 3."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Comparing the New Anti-cancer Drug Eribulin With Chemotherapy Against the Usual Chemotherapy Alone in Metastatic Urothelial Cancer
2021. "Comparing the New Anti-cancer Drug Eribulin With Chemotherapy Against the Usual Chemotherapy Alone in Metastatic Urothelial Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04579224.
~98 spots leftby Aug 2027
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