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

• Status: Completed
• Trial end date: 2017-07-19
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astellas Pharma Inc
• Collaborator: Astellas Pharma Global Development, Inc.

Criteria

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.