TiFFANY Study

Phase 2

Completed

• Conditions: solid malignancies

• Registration Number: JPRN-jRCT2080224555
• Lead Sponsor: ational Cancer Center Hospital East

Brief Summary

TAS-120 demonstrated promising efficacy in refractory advanced solid malignancies with FGFR alterations in circulating tumor DNA with an acceptable toxicity profile.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-02-07
• Study Completion: 2022-10-03
• Last Update Posted: 22 January 2024

Recruitment & Eligibility

• Status: completed
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

1.Informed consent for participation in the study is obtained at the discretion of the patient.
2.The patient is 20 years of age or older on the date of informed consent.
3.Histologically or cytologically confirmed an unresectable advanced or recurrent solid malignancy without standard treatment remains.
4.The following genomic alteration is detected by analysis of blood sample using Guardant360:
I.FGFR fusion
II.FGFR amplification
III.FGFR mutation
5.The disease is measurable based on the Response Evaluation Criteria in Solid Tumours (RECIST) guidelines version 1.1

Exclusion Criteria

1.History and/or current evidence of endocrine alteration of calcium-phosphate homeostasis.
2.History and/or current evidence of ectopic mineralization/calcification including but not limited to the soft tissue, kidneys, intestine, myocard and lung with the exception of calcified lymph nodes and asymptomatic coronary calcification.
3.Current evidence of corneal disorder/keratopathy including but not limited to bullous/ band keratopathy, corneal abrasion, inflammation/ulceration, keratoconjunctivitis etc., confirmed by ophthalmologic examination.
4.History or current evidence of cardiac arrhythmia and/or conduction abnormality.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
efficacy<br>objective response rate(ORR) assessed by investigators

Secondary Outcome Measures

Name	Time	Method
safety<br>efficacy<br>Progression-free survival(PFS),Duration of response(DoR), Time to treatment failure(TTF),Disease control rate(DCR),Overall survival(OS),ORR by central assessment(ORR),AE