Clinical trial · Interventional
A Study of LY2523355 in Patients With Solid Cancer
A Phase 1 Study of LY2523355 in Patients With Solid Cancer
NCT01358019CI-TRIAL-000091672523355-001completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The primary objective of this study is to examine a recommended dose for subsequent phase trial(s), by the observation of the safety and toxicity profiles of LY2523355 in patients with advanced and/or metastatic cancer. The secondary objectives are to study the pharmacokinetics and antitumor effect.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| LY2523355 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- LY2523355
- interventionNames
- Drug: LY2523355
Primary outcomes (2)
- measure
- Dose limiting toxicity based on the Common Terminology Criteria for Adverse Events v4.0
- measure
- Number of patients with adverse events
Secondary outcomes (2)
- measure
- Pharmacokinetics
- description
- Plasma concentration of LY2523355 and metabolite
- measure
- Antitumor effect
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * Histological and/or cytological evidence of solid tumors * A diagnosis of advanced and/or metastatic solid tumors * Patients who are refractory to standard therapy or for which no proven effective therapy exists * Written informed consent * Appropriate bone marrow, hepatic and renal functions * ECOG PS =\< 1 Exclusion Criteria: * Have serious preexisting complication * Have active infection which requires intravenous antibiotics * Have symptomatic central nervous system metastases * Have current acute or chronic leukemia * Have had an autologous or allogenic hematopoietic stem cell transplantation * Have active multiple cancers
References
Publications (1)
- DERIVEDWakui H, Yamamoto N, Kitazono S, Mizugaki H, Nakamichi S, Fujiwara Y, Nokihara H, Yamada Y, Suzuki K, Kanda H, Akinaga S, Tamura T. A phase 1 and dose-finding study of LY2523355 (litronesib), an Eg5 inhibitor, in Japanese patients with advanced solid tumors. Cancer Chemother Pharmacol. 2014 Jul;74(1):15-23. doi: 10.1007/s00280-014-2467-z. Epub 2014 Apr 22. PMID 24752449