Clinical trial · Interventional
A Study of E7050 Administered Orally to Patients With Advanced Solid Tumors
A Phase I Dose-finding Study of E7050 Administered Orally to Patients With Advanced Solid Tumors.
NCT00921869CI-TRIAL-00030912completedPhase 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 purpose of this study is to determine the maximum tolerated dose (MTD), safety, pharmacokinetics (PK), pharmacodynamics (PD) and anti-tumor activity of E7050 when administered orally twice daily to patients 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 |
|---|---|---|---|
| Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| E7050 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- interventionNames
- Drug: E7050
Primary outcomes (1)
- measure
- Determination of the MTD of E7050 given orally twice daily. MTD is the highest dose at which no more than 1 out of 6 patients experiences dose-limiting toxicity (DLT)
- timeFrame
- During the Run-in Phase and the first 5 weeks of treatment
Secondary outcomes (5)
- measure
- Dose-limiting toxicities.
- timeFrame
- During the Run-in Phase and the first 5 weeks of treatment
- measure
- Incidence and severity of adverse events and their drug relationship.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 74 Years
Show eligibility criteria text
Inclusion criteria: 1. Subjects with a histological or cytological diagnosis of solid tumors or gastric cancer. 2. Subjects who have progressed after treatment with approved therapies or for whom there are no standard effective therapies available. 3. Subjects with adequate organ function. 4. Patients who have no carryover of effect from prior therapy or no adverse drug reactions (excluding alopecia) that may affect the safety evaluation of the investigational drug. 5. Subjects with Performance Status (PS) 0-1 established by Eastern Cooperative Oncology Group (ECOG). Exclusion criteria: 1. Subjects who have brain metastases with clinical symptoms or which requires treatment. 2. Subjects with the serious complications or disease history. 3. Subjects who cannot take oral medication. 4. Subjects who need continuous use of drugs or foods that strongly inhibit or induce CYP3A4/5 or CYP2D6 during the study period. 5. Female subjects who are pregnant or breast-feeding.
References
Publications (0)
Data not yet available
No reference posted for this study.