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NCT00410553
Eribulin Mesylate and Gemcitabine Hydrochloride in Treating Patients With Metastatic Solid Tumors or Solid Tumors That Cannot be Removed by Surgery
Phase 1 trial testing Eribulin Mesylate in Adult Solid Neoplasm in 45 participants. Completed in 24 October 2012.
24 October 2012
Quick facts
| Lead sponsor | National Cancer Institute (NCI) |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 45 |
| Start date | 14 November 2006 |
| Primary completion | 24 October 2012 |
| Estimated completion | 24 October 2012 |
| Sites | 2 locations across Canada |
Drugs / interventions tested
- Eribulin Mesylate — full drug profile →
- Gemcitabine Hydrochloride — full drug profile →
Conditions studied
- Adult Solid Neoplasm — all drugs for Adult Solid Neoplasm →
- Recurrent Ovarian Carcinoma — all drugs for Recurrent Ovarian Carcinoma →
- Recurrent Uterine Corpus Carcinoma — all drugs for Recurrent Uterine Corpus Carcinoma →
- Stage III Ovarian Cancer AJCC v6 and v7 — all drugs for Stage III Ovarian Cancer AJCC v6 and v7 →
Sponsor
National Cancer Institute (NCI)
Who can join
18 and older, any sex, with Adult Solid Neoplasm or Recurrent Ovarian Carcinoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This phase I trial is studying the side effects and best dose of eribulin mesylate and gemcitabine hydrochloride in treating patients with metastatic or unresectable solid tumors. Drugs used in chemotherapy, such as eribulin mesylate and gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Marine Sponge Natural Products with Anticancer Potential: An Updated Review.
Calcabrini C, Catanzaro E, Bishayee A, Turrini E, et al · · 2017 · cited 91× · PMID 29027954 · DOI 10.3390/md15100310 -
Advances in the management of metastatic breast cancer: options beyond first-line chemotherapy.
Ayoub JP, Verma Sh, Verma S. · · 2012 · cited 14× · PMID 22514495 · DOI 10.3747/co.19.1024 -
A phase I combination dose-escalation study of eribulin mesylate and gemcitabine in patients with advanced solid tumours: a study of the Princess Margaret Consortium.
Lheureux S, Oza AM, Laurie SA, Halford R, et al · · 2015 · cited 8× · PMID 26554651 · DOI 10.1038/bjc.2015.343
Verify or expand the search:
- PubMed search for NCT00410553
- 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 Adult Solid Neoplasm
Currently open trials in the same condition.
- NCT02432963 — Vaccine Therapy and Pembrolizumab in Treating Patients With Solid Tumors That Have Failed Prior Therapy · Phase 1 · active not recruiting
- NCT01375829 — Ixabepilone and Temsirolimus in Treating Patients With Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery · Phase 1 · active not recruiting
- NCT01281176 — High-Dose or Low-Dose Vorinostat in Combination With Carboplatin or Paclitaxel in Treating Patients With Advanced Solid · Phase 1 · active not recruiting
- NCT00878163 — GDC-0449 and Erlotinib Hydrochloride With or Without Gemcitabine Hydrochloride in Treating Patients With Metastatic Panc · Phase 1 · active not recruiting
- NCT00045201 — Erlotinib Hydrochloride and Irinotecan Hydrochloride in Treating Patients With Advanced Solid Tumors · Phase 1 · active not 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 NCT00410553 (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: 3 October 2018
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/NCT00410553.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing