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NCT00365157
Eribulin Mesylate in Treating Patients With Locally Advanced or Metastatic Cancer of the Urothelium and Kidney Dysfunction
Phase 1, PHASE2 trial testing Eribulin Mesylate in Advanced Urothelial Carcinoma in 132 participants. Participants enrolled and being followed up; not accepting new ones.
9 July 2025
Quick facts
| Lead sponsor | National Cancer Institute (NCI) |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 132 |
| Start date | 23 October 2006 |
| Primary completion | 9 July 2025 |
| Estimated completion | 9 July 2026 |
| Sites | 26 locations across United States |
Drugs / interventions tested
- Eribulin Mesylate — full drug profile →
- Laboratory Biomarker Analysis — full drug profile →
- Pharmacological Study — full drug profile →
Conditions studied
- Advanced Urothelial Carcinoma — all drugs for Advanced Urothelial Carcinoma →
- Locally Advanced Urothelial Carcinoma — all drugs for Locally Advanced Urothelial Carcinoma →
- Metastatic Urothelial Carcinoma — all drugs for Metastatic Urothelial Carcinoma →
- Recurrent Urothelial Carcinoma — all drugs for Recurrent Urothelial Carcinoma →
Sponsor
National Cancer Institute (NCI)
Who can join
18 and older, any sex, with Advanced Urothelial Carcinoma or Locally Advanced Urothelial Carcinoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This phase I/II trial studies the effect of eribulin mesylate and to see how well it works in treating patients with cancer of the urothelium that has spread to nearby tissue (locally advanced) or to other places in the body (metastatic)and kidney dysfunction. Drugs used in chemotherapy, such as eribulin mesylate, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Chemotherapy drugs may have different effects in patients who have changes in their kidney function.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Cytoskeletal Proteins in Cancer and Intracellular Stress: A Therapeutic Perspective.
Ong MS, Deng S, Halim CE, Cai W, et al · · 2020 · cited 90× · PMID 31963677 · DOI 10.3390/cancers12010238 -
Current Strategies and Novel Therapeutic Approaches for Metastatic Urothelial Carcinoma.
Mollica V, Rizzo A, Montironi R, Cheng L, et al · · 2020 · cited 75× · PMID 32498352 · DOI 10.3390/cancers12061449 -
Eribulin in Cancer Treatment.
Swami U, Shah U, Goel S. · · 2015 · cited 46× · PMID 26262627 · DOI 10.3390/md13085016 -
Targeted therapies in urothelial carcinoma.
Ghosh M, Brancato SJ, Agarwal PK, Apolo AB. · · 2014 · cited 37× · PMID 24685646 · DOI 10.1097/cco.0000000000000064 -
Current therapeutic strategies for invasive and metastatic bladder cancer.
Vishnu P, Mathew J, Tan WW. · · 2011 · cited 35× · PMID 21792316 · DOI 10.2147/ott.s22875 -
Eribulin mesylate in the treatment of metastatic breast cancer.
Jain S, Cigler T. · · 2012 · cited 27× · PMID 22291464 · DOI 10.2147/btt.s19811 -
Elevating the Horizon: Emerging Molecular and Genomic Targets in the Treatment of Advanced Urothelial Carcinoma.
Kurtoglu M, Davarpanah NN, Qin R, Powles T, et al · · 2015 · cited 15× · PMID 25862322 · DOI 10.1016/j.clgc.2015.02.009 -
Systemic therapy in bladder cancer.
Pinto IG. · · 2017 · cited 9× · PMID 28469299 · DOI 10.4103/iju.iju_294_16
Verify or expand the search:
- PubMed search for NCT00365157
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Eribulin Mesylate
Trials testing the same drug.
- NCT06590558 — Testing the Addition of an Investigational Anti-Cancer Drug, ASTX660 (Tolinapant), to a Usual Chemotherapy Treatment (Er · Phase 1 · withdrawn
- NCT05041101 — Grapiprant and Eribulin for the Treatment of Metastatic Inflammatory Breast Cancer · Phase 1, PHASE2 · terminated
- NCT04579224 — Comparing the New Anti-cancer Drug Eribulin With Chemotherapy Against the Usual Chemotherapy Alone in Metastatic Urothel · Phase 3 · active not recruiting
- NCT04345913 — Testing the Addition of Copanlisib to Eribulin in Metastatic Triple Negative Breast Cancer · Phase 1, PHASE2 · active not recruiting
- NCT05206656 — Safety and Efficacy of Eribullin or Eribulin Combined With Anlotinib in Metastatic Breast Cancer · Phase 2 · completed
Other recruiting trials for Advanced Urothelial Carcinoma
Currently open trials in the same condition.
- NCT07221942 — Pembrolizumab Maintenance After Enfortumab Vedotin (EV)/Pembro Induction in Front-Line Metastatic Urothelial Carcinoma · Phase 2 · recruiting
- NCT07241793 — Phase II Study of Trastuzumab Rezetecan or in Combination With Adebrelimab in HER2-Expressing Locally Advanced or Metast · Phase 2 · recruiting
- NCT07063758 — A Biomarker Study to Predict Treatment Outcomes of Enfortumab Vedotin in Advanced Urothelial Carcinoma · active not recruiting
- NCT06904573 — Probiotics in Advanced Urothelial Carcinoma · Phase 2 · recruiting
- NCT06639347 — A Trial of SHR-A2102 With Antitumor Therapy in Advanced Urothelial Carcinoma · Phase 1, PHASE2 · recruiting
Other National Cancer Institute (NCI) trials
Trials by the same sponsor.
- NCT07147231 — Testing the Effectiveness of the Anti-cancer Drug Pidnarulex (CX-5461), in Combination With Another Anti-cancer Drug Cem · Phase 1, PHASE2 · recruiting
- NCT07572123 — Evaluating the Addition of Maintenance Immunotherapy Compared to the Usual Treatment of Chemotherapy and Autologous Stem · Phase 2, PHASE3 · not yet recruiting
- NCT07281417 — Testing the Addition of Cemiplimab (REGN2810) to Chemotherapy Treatment Given Prior to Surgery in Patients With Sinonasa · Phase 2 · recruiting
- NCT07012044 — A Study to Find the Highest Dose of Cedazuridine and Decitabine Combination With Filgrastim as a Treatment Option After · Phase 1 · not yet recruiting
- NCT07437950 — Comparing Different Treatment Lengths for Venetoclax in Older People With Newly Diagnosed Acute Myeloid Leukemia (A Myel · Phase 2 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00365157 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by National Cancer Institute (NCI)
- Last refreshed: 11 July 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00365157.
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