Clinical trial · Interventional
An Open-label Phase I Study of Orally Available Novel Small-molecule Fibroblast Growth Factor Receptors (FGFR) 1,2,3 and 4 Inhibitor, ASP5878 at Single and Multiple Doses in Patients With Solid Tumors
An Open-label Phase I Study of Oral ASP5878 at Single and Multiple Doses in Patients With Solid Tumors
NCT02038673CI-TRIAL-00082116completedPhase 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 objectives of this study are to determine the tolerability, safety, pharmacokinetics (PK), pharmacodynamics (PD), and efficacy of oral ASP5878 in participants with 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 |
|---|---|---|---|
| ASP5878 | Drug | FGFR Inhibitor ASP5878 | ALIAS |
Design
Arms and outcomes
Arms (12)
- type
- EXPERIMENTAL
- label
- Dose escalation part 0.5 mg QD
- description
- Oral
- interventionNames
- Drug: ASP5878
- type
- EXPERIMENTAL
- label
- Dose escalation part 1.0 mg QD
- description
- Oral
- interventionNames
- Drug: ASP5878
- type
- EXPERIMENTAL
- label
- Dose escalation part 2.0 mg QD
- description
- Oral
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed solid tumor. * Participant must meet at least one of the following criteria in the judgment of the investigator or sub-investigator: * Disease progression despite standard therapies * Progressive disease without any standard therapies established * Standard therapies are considered intolerable * Eastern Cooperative Oncology Group performance status 0 or 1. * Predicted life expectancy ≥ 12 weeks in the judgment of the investigator or sub-investigator. Exclusion Criteria: * Participant with ≥ Grade 2 (CTCAE v 4.0-JCOG) persistent symptoms and objective findings due to the toxicity attributable to prior treatment with antitumor effect (except alopecia). * Participant who received a prior treatment intended for antitumor effect (medication, surgery, radiotherapy, etc.) within 4 weeks prior to the planned first day of study drug dosing (or participant who received mitomycin C or Nitrosourea within 6 weeks prior to the planned first day of study drug dosing). * A major surgical procedure within 4 weeks prior to the planned first day of study drug dosing or a surgical procedure is planned during the course of the study. * Participant who were treated with other investigational drug or medical device within 4 weeks prior to the planned first day of study drug dosing. * Participant who has a history of organ transplantation. * Participant with a brain metastasis with symptoms or requiring treatment.
References
Publications (0)
Data not yet available
No reference posted for this study.