Eribulin Mesylate for Bladder Cancer

Wright-Patterson Medical Center, Wright-Patterson Air Force Base, OH
Bladder Cancer+15 More ConditionsEribulin Mesylate - Drug
Eligibility
18+
All Sexes

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.

Eligible Conditions
  • Stage IV Bladder Cancer
  • Stage IV Urethral Cancer
  • Urethral Urothelial Carcinoma
  • Stage IVA Bladder Cancer
  • Stage IVB Bladder Cancer
  • Stage IV Ureter Cancer
  • Refractory Bladder Cancer
  • Stage IV Renal Pelvis and Ureter Cancer
  • Metastatic Urothelial Carcinoma of the Renal Pelvis
  • Refractory Renal Pelvis Urothelial Carcinoma
  • Bladder Cancer
  • Refractory Ureter Urothelial Carcinoma
  • Refractory Urethral Urothelial Carcinoma
  • Metastatic Urothelial Carcinoma of the Ureter
  • Refractory Urothelial Carcinoma
  • Stage IV Renal Pelvis Cancer

Treatment Effectiveness

Phase-Based Effectiveness

2 of 3
Phase 3
This is further along than 85% of similar trials

Similar Trials

1
Erdafitinib
1
Eribulin Mesylate
1
Pembrolizumab

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: 3 years

3 years
Overall response rate
Year 3
Duration of response
Year 3
Overall survival
Year 3
Progression free survival
Up to 3 years
Disease control rate

Trial Safety

Phase-Based Safety

3 of 3
This is further along than 85% of similar trials

Similar Trials

1
Erdafitinib
1
Eribulin Mesylate
1
Pembrolizumab

Side Effects for

Eribulin Mesylate 1.4 mg/m^2
54%Neutropenia
35%Alopecia
31%Leukopenia
22%Nausea
19%Anaemia
17%Fatigue
15%Asthenia
14%Diarrhoea
13%Peripheral Sensory Neuropathy
13%Decreased Appetite
12%Pyrexia
12%Vomiting
12%Headache
10%Back Pain
9%Bone Pain
9%Pain in Extremity
9%Dyspnoea
9%Alanine Aminotransferase Increased
8%Constipation
8%Arthralgia
8%Cough
8%Aspartate Aminotransferase Increased
6%Oedema Peripheral
6%Abdominal Pain
6%Abdominal Pain Upper
6%Dizziness
6%Myalgia
5%Thrombocytopenia
5%Mucosal Inflammation
5%Stomatitis
5%Urinary Tract Infection
5%Tumour Pain
2%Hyperbilirubinaemia
1%Pneumonia
1%Respiratory Failure
1%Febrile Neutropenia
1%Neoplasm Malignant
This histogram enumerates side effects from a completed 2017 Phase 3 trial (NCT00337103) in the Eribulin Mesylate 1.4 mg/m^2 ARM group. Side effects include: Neutropenia with 54%, Alopecia with 35%, Leukopenia with 31%, Nausea with 22%, Anaemia with 19%.

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.

Trial Design

3 Treatment Groups

Arm I (standard of care chemotherapy)
1 of 3
Arm II (eribulin)
1 of 3
Arm III (eribulin, gemcitabine)
1 of 3

Active Control

Experimental Treatment

465 Total Participants · 3 Treatment Groups

Primary Treatment: Eribulin Mesylate · No Placebo Group · Phase 3

Arm II (eribulin)
Drug
Experimental Group · 1 Intervention: Eribulin Mesylate · Intervention Types: Drug
Arm III (eribulin, gemcitabine)Experimental Group · 2 Interventions: Eribulin Mesylate, Gemcitabine Hydrochloride · Intervention Types: Drug, Drug
Arm I (standard of care chemotherapy)ActiveComparator Group · 3 Interventions: Docetaxel, Gemcitabine Hydrochloride, Paclitaxel · Intervention Types: Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Eribulin
FDA approved
Gemcitabine
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 3 years

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,279 Previous Clinical Trials
41,234,393 Total Patients Enrolled
Sarmad SadeghiPrincipal InvestigatorSWOG Cancer Research Network
2 Previous Clinical Trials
88 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 2 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have received treatment for your condition in the past, but it did not work, and your doctor has decided that you need a different treatment.
You may have had or currently have another type of cancer as long as it won't affect the safety or effectiveness of the experimental treatment, according to the doctor in charge of your care.
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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