Clinical trial · Interventional
Phase 1 Study of E7090 in Subjects With Solid Tumor
A Phase 1 Study of E7090 in Subjects With Solid Tumor
NCT02275910CI-TRIAL-00098992completedPhase 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)
This is a Phase 1 study of E7090 in subjects with advanced solid tumors. This study will be conducted in 2 parts: 1. Part 1 will be the dose escalation portion of this study to determine the maximum tolerated dose in subjects with solid tumors, and 2. Part 2 will comprise cohort expansions to further characterize the safety and tolerability of E7090 and to assess preliminary efficacy of E7090 in subjects with solid tumors characterized by genetic abnormalities in FGF/FGFR pathway.
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 |
|---|---|---|---|
| Tumors | Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| E7090 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- E7090 Arm
- description
- Oral, starting dose 1 mg once a day, dose escalation in part 1. Cycle 0 is for 7 days. For Cycle 1 and onward, each cycle is 28 days long. The Cycle 0 is set up for PK analysis of a single dose of E7090. In the following Cycle 1, subjects will be administered E7090 QD, and the PK and safety will be assessed for 28 days. One or two doses may be selected from part 1 for Part 2. E7090 will be administered continuously once a daily. Subjects can continue treatment unless they meet discontinuation criteria.
- interventionNames
- Drug: E7090
Primary outcomes (2)
- measure
- Part 1: Number of Participants With Dose-limiting Toxicities (DLTs)
- timeFrame
- Cycle 0 (Cycle length= 7 days) up to Cycle 1 (Cycle length= 28 days)
- description
- DLT was graded using Common Terminology Criteria for Adverse Events version 4.03 as follows: a. febrile neutropenia, or Grade 4 neutropenia persisting for greater than or equal to (\>=) 7 days, b. Grade 4 thrombocytopenia, or Grade 3 thrombocytopenia requiring platelet transfusions, c. Grade \>=3 non-hematological toxicity, except for: clinically insignificant laboratory abnormalities, toxicity Grade less than or equal to (\<=) 2 by best supportive care; d. potentially clinically significant, new radiographic mineralization in soft tissue, kidneys, intestines, heart, lungs, or other organs; e. Hyperphosphatemia meeting either for: serum phosphate level greater than (\>) 7 milligram per deciliter (mg/dL) persisting for \>=7 days despite best treatment, serum phosphate level \>9 mg/dL despite best treatment; f. treatment interruption for \>=8 days during Cycle 0; Cycle 1 required by E7090-related toxicity, except for treatment interruption for \>=8 days for reasons other than toxicity.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: Part 1and Part 2 1. Provide written informed consent 2. Male or female subjects age \>= 20 years at the time of informed consent 3. Subjects with a histological and/or cytological diagnosis of solid tumor 4. Subjects who failed standard therapies, or for which no appropriate treatment is available. 5. Subjects with Performance Status (PS) score of 0-1 established by Eastern Cooperative Oncology Group (ECOG) 6. Subjects who are expected to survive for 3 months or longer after starting administration of the investigational drug. Inclusion Criteria: Part 2 only 7. Subjects with tumor expressing genetic abnormality in FGF/FGFR (fibroblast growth factor/ fibroblast growth factor receptor)pathway. Exclusion criteria 1. Patients with brain metastasis who have clinical symptoms or requiring treatment. 2. Medical history of clinically significant cardiovascular impairment 3. Concomitant systemic infection requiring medical treatment 4. Effusion requiring drainage 5. Known intolerance to the study drug (or any of excipients) 6. Subjects whose toxicity of previous treatment has not recovered to Grade 1 or lower (except for alopecia). 7. Inability to take oral medication, or malabsorption syndrome, or any other uncontrolled gastrointestinal condition (e.g., nausea, diarrhea, or vomiting) that might impair the bioavailability of E7090. 8. Psychiatric disorder (e.g., alcohol or drug dependency) judged to be ineligible for study entry by the investigator or subinvestigator 9. Females who are pregnant or breastfeeding 10. Any subjects who are judged by the principal investigator or the other investigators to be inappropriate as subjects in this clinical study.
References
Publications (0)
Data not yet available
No reference posted for this study.