Phase II study of TAS-120

Phase 2

Completed

• Conditions: Cancer with specific FGFR aberrations

• Registration Number: JPRN-jRCT2080225216
• Lead Sponsor: Taiho Pharmaceutical Co., Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-06-02
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: completed
• Sex: All
• Target Recruitment: 155

Inclusion Criteria

1. Provide written informed consent
2. >=18 years of age
3. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
4. Adequate organ function
5. Known FGFR aberration status and tumor type that meet all of the criteria for 1 of the following cohorts:
Cohort A
Histologically-confirmed, locally-advanced, advanced, or metastatic solid tumors harboring a FGFR1-4 rearrangement. Patients with primary brain tumor or intrahepatic cholangiocarcinoma are not eligible
Measurable disease per RECIST 1.1
Had disease progression/recurrence after standard treatment for their advanced or metastatic cancer
Cohort B
Histologically-confirmed, locally-advanced, advanced, or metastatic gastric or GEJ cancer harboring a FGFR2 amplification
Measurable disease per RECIST 1.1
Received at least 2 prior systemic regimens for advanced/metastatic disease
Experienced disease progression/recurrence during or after the most recent prior systemic treatment for advanced/metastatic gastric or GEJ cancer
Cohort C
Confirmed myeloid/ lymphoid neoplasms with a FGFR1 rearrangement
Not a candidate for hematological stem cell transplant (HSCT) or relapsed after HSCT and donor lymphocyte infusion, and progressed and not a candidate for other therapies

Exclusion Criteria

1. A serious illness or medical condition
2. History and/or current evidence of any of the following disorders:
Non-tumor related alteration of the calcium-phosphorus homeostasis
Ectopic mineralization/calcification including, but not limited to, soft tissue, kidneys, intestine, or myocardia and lung
Retinal or corneal disorder confirmed by retinal/corneal examination
3. Prior treatment with an FGFR inhibitor
4. Active central nervous system metastasis and/or carcinomatous meningitis

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
efficacy<br>Efficacy

Secondary Outcome Measures

Name	Time	Method
safety<br>efficacy<br>pharmacokinetics<br>pharmacodynamics<br>pharmacogenomics<br>Safety, Efficacy, Pharmacokinetic analysis, Pharmacodynamic analysis, Pharmacogenomics analysis