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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04965818
Other study ID # TAS-120-204
Secondary ID
Status Terminated
Phase Phase 1
First received
Last updated
Start date September 20, 2021
Est. completion date September 21, 2023

Study information

Verified date October 2023
Source Taiho Oncology, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Phase 1b/2 study to evaluate the FGFRi futibatinib in combination with the MEKi binimetinib in patients with advanced KRASmt tumors.


Description:

This is an open-label, nonrandomized, uncontrolled Phase 1b/2 study to determine the recommended phase 2 dose (RP2D) of futibatinib in combination with binimetinib and to explore the preliminary antitumor activity of futibatinib in combination with binimetinib in patients with advanced KRASmt tumors. The study will consist of two parts: - Part 1: Dose-Escalation part to determine the RP2D and dosing schedule of futibatinib in combination with binimetinib in patients with advanced cancer disease - Part 2: Dose-Expansion part to evaluate the preliminary antitumor activity of futibatinib in combination with binimetinib at the RP2D in patients with advanced KRASmt NSCLC Patients will receive study treatment until progressive disease or any other discontinuation or withdrawal criterion is met.


Recruitment information / eligibility

Status Terminated
Enrollment 38
Est. completion date September 21, 2023
Est. primary completion date June 11, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Histologically confirmed advanced cancer of any tumor type (Part 1) or NSCLC with a confirmed KRAS mutation as determined by local results (Part 2) - Appropriate candidate for experimental therapy - For patients in Part 2 only: Patient has radiographically measurable disease per RECIST 1.1 criteria. - Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. - Adequate cardiac function (Left ventricular ejection fraction (LVEF) =50% ) - Adequate organ function - Must have tumor tissue specimen available (optional for patients in Part 1) Exclusion Criteria: - History or current evidence of calcium and phosphate hemostasis disorder or systemic mineral imbalance with ectopic calcification of soft tissues - Current evidence or history of clinically significant corneal or retinal disorder as confirmed by ophthalmologic examination. - Known untreated central nervous system (CNS) metastases or history of uncontrolled seizures. - Significant gastrointestinal disorder(s) that could interfere with absorption of futibatinib/binimetinib - Patients who have neuromuscular disorders that are associated with elevated creatinine kinase (CK)

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Futibatinib and Binimetinib
Patients will receive futibatinib once daily in combination with binimetinib twice daily by oral administration on a 21-day cycle

Locations

Country Name City State
United States The University of Texas MD Anderson Cancer Center Houston Texas
United States Community Cancer Center North Indianapolis Indiana
United States University of California Los Angeles UCLA Cancer Santa Monica California

Sponsors (1)

Lead Sponsor Collaborator
Taiho Oncology, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Recommended Phase 2 Dose (RP2D) in Part 1 Determine RP2D of futibatinib in combination with binimetinib based on Dose Limiting Toxicities 12 months
Primary Objective Response Rate (ORR) in Part 2 proportion of patients who have achieved a PR or complete response (CR) according to RECIST 1.1. approximately 24 months
Secondary Pharmacokinetics (PK): Maximum plasma concentration (Cmax) of futibatinib, binimetinib, and AR00426032 Plasma concentrations of futibatinib, binimetinib, and AR00426032 approximately 24 months
Secondary PK: Area under the plasma concentration-time curve (AUC) of futibatinib, binimetinib, and AR00426032 Plasma concentrations of futibatinib, binimetinib, and AR00426032 approximately 24 months
Secondary PK: Time to reach maximum plasma concentration (Tmax) of futibatinib, binimetinib, and AR00426032 Plasma concentrations of futibatinib, binimetinib, and AR00426032 approximately 24 months
Secondary PK: Terminal elimination half-life (T1/2) of futibatinib, binimetinib, and AR00426032 Plasma concentrations of futibatinib, binimetinib, and AR00426032 approximately 24 months
Secondary PK: Minimum plasma concentration before administration (Cmin) of futibatinib, binimetinib, and AR00426032 Plasma concentrations of futibatinib, binimetinib, and AR00426032 approximately 24 months
Secondary PK: Accumulation ratio of Cmax and AUC (R) of futibatinib, binimetinib, and AR00426032 Plasma concentrations of futibatinib, binimetinib, and AR00426032 approximately 24 months
Secondary Duration of response (DOR) DOR is defined as the length of time between first response and the date of objectively documented progression of disease or death approximately 24 months
Secondary Progression-free survival (PFS) PFS is defined as the time from date of first dose to objectively documented progression of disease or death approximately 24 months
Secondary Disease control rate (DCR) at 24 months DCR is defined as the percentage of patients who have achieved a CR, PR, or SD. approximately 24 months
Secondary Number of patients with treatment-emergent adverse events as assessed by CTCAE v5.0 Evaluate safety and tolerability of futibatinib in combination with binimetinib based on treatment-emergent adverse events per CTCAE v5.0(including serious adverse events),clinical laboratory parameters, ECGs, and vital signs Approximately 24 months
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