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NCT00794781
A Phase 1, Multicenter, Open-Label, Dose-Escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of E6201 in Subjects With Advanced Solid Tumors
Phase 1 trial testing E6201 in Advanced Solid Tumors in 55 participants. Completed in 15 October 2015.
1 August 2011
Quick facts
| Lead sponsor | Eisai Inc. |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 55 |
| Start date | 22 June 2008 |
| Primary completion | 1 August 2011 |
| Estimated completion | 15 October 2015 |
| Sites | 12 locations across United States |
Drugs / interventions tested
- E6201 — full drug profile →
Conditions studied
- Advanced Solid Tumors — all drugs for Advanced Solid Tumors →
Sponsor
Eisai Inc. — full company profile →
Who can join
18 and older, any sex, with Advanced Solid Tumors. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of this study is to determine the maximum tolerated dose (MTD), safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary anti-tumor activity of E6201 in subjects with advanced solid tumors.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Current Advances in the Treatment of BRAF-Mutant Melanoma.
Patel H, Yacoub N, Mishra R, White A, et al · · 2020 · cited 133× · PMID 32092958 · DOI 10.3390/cancers12020482 -
MEK1/2 Inhibitors: Molecular Activity and Resistance Mechanisms.
Wu PK, Park JI. · · 2015 · cited 107× · PMID 26615130 · DOI 10.1053/j.seminoncol.2015.09.023 -
Targeting the RAS oncogene.
Takashima A, Faller DV. · · 2013 · cited 95× · PMID 23360111 · DOI 10.1517/14728222.2013.764990 -
Overcoming resistance to BRAF inhibition in BRAF-mutated metastatic melanoma.
Spagnolo F, Ghiorzo P, Queirolo P. · · 2014 · cited 92× · PMID 25344914 · DOI 10.18632/oncotarget.2602 -
Sensitivity to the MEK inhibitor E6201 in melanoma cells is associated with mutant BRAF and wildtype PTEN status.
Byron SA, Loch DC, Wellens CL, Wortmann A, et al · · 2012 · cited 35× · PMID 23039341 · DOI 10.1186/1476-4598-11-75 -
Use of kinase inhibitors to correct ΔF508-CFTR function.
Trzcinska-Daneluti AM, Nguyen L, Jiang C, Fladd C, et al · · 2012 · cited 28× · PMID 22700489 · DOI 10.1074/mcp.m111.016626 -
Anti-tumor and anti-metastasis efficacy of E6201, a MEK1 inhibitor, in preclinical models of triple-negative breast cancer.
Lee J, Lim B, Pearson T, Choi K, et al · · 2019 · cited 21× · PMID 30826934 · DOI 10.1007/s10549-019-05166-3 -
E6201, an intravenous MEK1 inhibitor, achieves an exceptional response in BRAF V600E-mutated metastatic malignant melanoma with brain metastases.
Babiker HM, Byron SA, Hendricks WPD, Elmquist WF, et al · · 2019 · cited 20× · PMID 30264293 · DOI 10.1007/s10637-018-0668-8
Verify or expand the search:
- PubMed search for NCT00794781
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of E6201
Trials testing the same drug.
- NCT03332589 — E6201 Plus Dabrafenib for the Treatment of Metastatic Melanoma Central Nervous System Metastases (CNS) · Phase 1 · terminated
- NCT02418000 — A Study of E6201 for the Treatment of Advanced Hematologic Malignancies With FLT3 and/or Ras Mutations · Phase 1, PHASE2 · terminated
Other recruiting trials for Advanced Solid Tumors
Currently open trials in the same condition.
- NCT07504445 — Clinical Study on the Efficacy and Safety of CAR-DC in the Treatment of Advanced Solid Tumors · EARLY_PHASE1 · recruiting
- NCT07589530 — Phase 1/2 Study of EB-NK-301 (Allogeneic TROP2-CAR NK Cells) in Advanced TROP2-Expressing Solid Tumors · Phase 1, PHASE2 · recruiting
- NCT07360314 — Anti-Ly6E Exatecan ADC M7437 in Advanced Solid Tumors · Phase 1 · recruiting
- NCT07414316 — A Single-Arm, Open-Label Clinical Study GK01 Cell Injection in Subjects With Advanced Solid Tumors. · EARLY_PHASE1 · recruiting
- NCT07222969 — A Clinical Study to Evaluate the Safety of VIB305 in Patients With Advanced Solid Tumors · Phase 1, PHASE2 · recruiting
Other Eisai Inc. trials
Trials by the same sponsor.
- NCT07493265 — A Study to Evaluate the Efficacy and Safety of E2086 in Adults With Narcolepsy · Phase 2 · not yet recruiting
- NCT07308236 — A Study to Determine the Metabolism and Excretion of [14C]E2086 in Healthy Male Participants · Phase 1 · recruiting
- NCT06854042 — A Study of Oral E1018 in Healthy Adult Participants · Phase 1 · recruiting
- NCT06744673 — A Study to Assess the Pregnancy Outcome in Women Exposed to Dayvigo® During Pregnancy Compared to an Unexposed Control P · active not recruiting
- NCT06602258 — A Study of E2814 With Concurrent Lecanemab Treatment in Participants With Early Alzheimer's Disease · Phase 2 · active not 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 NCT00794781 (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 Eisai Inc.
- Last refreshed: 14 October 2022
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/NCT00794781.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing