Clinical trial · Interventional
A Study of LY3039478 in Japanese Participants With Advanced Solid Tumors
A Phase 1 Study of LY3039478 in Japanese Patients With Advanced Solid Tumors
NCT02836600CI-TRIAL-00093235completedPhase 1Results postedClinicalTrials.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 purpose of this study is to evaluate the tolerability of the study drug LY3039478 in Japanese participants with advanced solid tumors.
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 |
|---|---|---|---|
| Advanced Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| LY3039478 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 25 mg LY3039478
- description
- Participants received 25 milligrams (mg) of LY3039478, administered orally three times per week (TIW) in a 28-day cycle, until disease progression, development of unacceptable toxicity, or any other discontinuation criteria were met.
- interventionNames
- Drug: LY3039478
- type
- EXPERIMENTAL
- label
- 50 mg LY3039478
- description
- Participants received 50 mg of LY3039478, administered orally TIW in a 28-day cycle, until disease progression, development of unacceptable toxicity, or any other discontinuation criteria were met.
- interventionNames
- Drug: LY3039478
Primary outcomes (1)
- measure
- Number of Participants With LY3039478 Dose-Limiting Toxicities (DLTs)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * Histological or cytological evidence of a diagnosis of solid tumor that is advanced and/or metastatic. * In the judgment of the investigator, participants must be appropriate candidates for experimental therapy after available standard therapies have failed or for whom standard therapy is not appropriate. * Performance status of less than or equal to (≤) 1 on the Eastern Cooperative Oncology Group (ECOG) scale. * Adequate organ function, including hematologic, hepatic, and renal. * Estimated life expectancy of greater than or equal to (≥) 12 weeks. Exclusion Criteria: * Received previous therapy for cancer within 14 or 21 days of the initial dose of study drug for a nonmyelosuppressive or myelosuppressive agents, respectively. * Have serious preexisting medical conditions. * Have current or recent (within 3 months of study drug administration) gastrointestinal disease with chronic or intermittent diarrhea. * Have an active bacterial, fungal, and/or known viral infection. * Have known acute or chronic leukemia or current hematologic malignancies that may affect the interpretation of results.
References
Publications (1)
- DERIVEDDoi T, Tajimi M, Mori J, Asou H, Inoue K, Benhadji KA, Naito Y. A phase 1 study of crenigacestat (LY3039478), the Notch inhibitor, in Japanese patients with advanced solid tumors. Invest New Drugs. 2021 Apr;39(2):469-476. doi: 10.1007/s10637-020-01001-5. Epub 2020 Sep 16. PMID 32939607