Neoplasms

All Conditions

Rare Diseases

Carcinoma

Carcinoma, Transitional Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Transitional Cell Carcinoma

When a preliminary RP2D has been identified (this dose may be equal to or below the MTD) evaluate the antitumor activity in locally advanced (unresectable) and metastatic urothelial carcinoma.

FX-909 is an orally available new molecular entity that inhibits basal- and ligand-activated transcription by PPARG.

FX-909

Melissa Moles, VP Clinical Operations

Jennifer Tepper, Senior Clinical Trial Associate

HonorHealth Nurse Navigation Team

Sunil Sharma, MD

Amanda Davis, LPN

Daniel Petrylak, MD

Xin Gao, MD

Brian Rasp

Charlene Mantia, MD, Ph.D.

Lindsay Diamond

Erin Heath

Matthew Galsky, MD

Gopakumar V Iyer, MD

Gopa Iyer, MD

Matthew Milowsky, MD

Cancer Answer

Shilpa Gupta, MD

askSARAH

Benjamin Garmezy, MD

Brianna Flores, BSN, RN

Ildefonso Ismael Rodriguez Rivera, MD

Angela Galindo

Jessie Fernandez

Drew Rasco, MD

The goal of this clinical trial is to study the safety and tolerability in all advanced solid tumors, including advanced urothelial carcinoma.

The main question\[s\] it aims to answer are:

* Is FX-909 safe and tolerable
* What is the right dose level for patients

Participants will be asked to take FX-909 daily , in tablet form and record any outcomes from taking the drug. Participants will also be asked to return for multiple site visits for various blood tests and to collect blood and tumor samples as well as have regular CT/MRI scans

This is an open-label Phase 1 study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary clinical activity of FX-909 given orally (PO) in patients with advanced solid malignancies. Initially, FX-909 will be given in a dose-escalation phase (Part A) to determine the preliminary recommended phase 2 dose (RP2D). Part B will be a monotherapy expansion phase to further evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and clinical activity of FX-909 in patients with locally advanced (unresectable) and metastatic urothelial carcinoma. Throughout the study patients will be treated in 28-day cycles.

3+3 dose escalation design with 1 expansion arm at RP2D

A Study of FX-909 in Patients With Advanced Solid Malignancies, Including Advanced Urothelial Carcinoma

A Phase 1, First-in-Human, Dose-Escalation and Expansion Study of FX-909 in Patients With Advanced Solid Malignancies, Including Advanced Urothelial Carcinoma

Incidence of dose-limiting toxicities (DLTs); Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)

Assess patients' safety measures (AEs/SAEs) in comparison with patients' objective response rates

Plasma pharmacokinetic parameters of FX-909 via AUC

Plasma pharmacokinetic parameters of FX-909, via Cmax

Plasma pharmacokinetic parameters of FX-909, via Tmax

Plasma pharmacokinetic parameters of FX-909 via T½

Plasma pharmacokinetic parameters of FX-909 via renal clearance in urine

Plasma pharmacokinetic parameters of FX-909 via percentage of FX-909 in urine

Progression-Free Survival (PFS) based on Investigator assessment using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria

Flare Therapeutics Inc.

Blood and Lymph Conditions

Hematologic Neoplasms

Hematologic Diseases

At the baseline visit, each patient assigned to arm A will be provided with the electronic diary (installed on a smart phone or tablet), the oral medication for the first treatment cycle and the appointment for the next cycle. The patient will be instructed on how to use the electronic diary, and the user manual will also be given. This app allows patients to record parameters related to their health state (e.g. medications, blood pressure, weight, fever, side effects or other symptoms) and through the "alarm" function, it reminds the patient to take the tablets, indicating the exact dosage. In addition, the patient can also indicate the dose reduction or the omission.

Patients assigned to arm B will be provided with a paper diary, oral medication for the first treatment cycle and the appointment for the next cycle. The patient will be instructed on how to use the paper diary.

TreC-Onco

Paper diary

Patrizia Serra, Dr

Oriana Nanni, PhD

Orazio Caffo, MD

Alessandro Passardi, MD

This is a multicenter, interventional, non-pharmacological study on a app for oral anticancer therapy management.

A total of 124 patients will be considered.

Patients will be randomized 1:1 to one of the following interventions:

A. electronic diary B. paper diary The primary aim of the study is to assess the effectiveness of the electronic diary in improving adherence to oral therapy treatment compared to the paper diary, in patients with solid and haematological tumors.

This is a multicenter, interventional, non-pharmacological study on a app for oral anticancer therapy management.

The primary aim of the study is to assess the effectiveness of the electronic diary in improving adherence to oral therapy treatment compared to the paper diary, in patients with solid and haematological tumors.

The secondary objectives of the study are:

1. describe the reasons for non-adherence in each group (eg. forgetfulness, side effects, misunderstanding of prescription),
2. describe the patient's compliance with the instrument and modalities (electronic diary, paper diary) through a short questionnaire
3. description of the costs related to therapeutic non-adherence. A total of 124 patients will be considered: enrollment will take place consecutively until the predetermined number is reached.

Eligible patients will be randomized in a 1:1 ratio using a balanced procedure a blocks exchanged to one of the following interventions, stratified by type of therapy (chemotherapy vs. biological therapy): A. electronic diary B. paper diary The electronic diary consist of an Android app (for Android version 2.2 and later) for mobile devices, which acts as a diary for the patient.

Adherence will be assessed at each treatment cycle by counting the remaining tablets. For patients with disease progression within six treatment cycles, the assessment of adherence and therefore the count of the remaining tablets will end on the date of progression.

Clinical Study Comparing Different Strategies to Increase Adherence to Oral Therapies in Oncohematology

Data available for sharing: Individual participant data that underlie the results reported in the pubblication, after deindentification (text, tables, figures and appendices

To assess the effectiveness of the electronic diary in improving adherence to oral therapy.

Adherence will be assessed at each treatment cycle by counting the remaining tablets, and tested using Fisher's exact test. The number of pills counted by the system will be compared with that counted by the physician as residual pills returned by the patient at the hospital visit.

to describe the reasons for non-adherence to treatment in each group (e.g. forgetfulness, side effects, misunderstanding of the prescription) through descriptive statistics: mean ± standard deviation (sd) or median and interquartile range for the variables continuous and absolute and relative frequency for categorical variables.

describe the patient's compliance with the different strategies (paper diary or electronic) through a short questionnaire. Data are analysed through descriptive statistics: mean ± standard deviation (sd) or median and interquartile range for the variables continuous and absolute and relative frequency for categorical variables.

description of the costs associated with the lack of therapeutic adherence, both in terms of costs for drugs and overall health costs (hospitalizations, health services, access to the Emergency Department) (IRST center only). Data are analysed through descriptive statistics: mean ± standard deviation (sd) or median and interquartile range for the variables continuous and absolute and relative frequency for categorical variables.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of FX-909 in Patients With Advanced Solid Malignancies, Including Advanced Urothelial Carcinoma	NCT05929235	Advanced Solid ... Advanced Urothe... Oral Drug Admin... Open Label	FX-909	18 Years -	Flare Therapeutics Inc.
Clinical Study Comparing Different Strategies to Increase Adherence to Oral Therapies in Oncohematology	NCT04826458	Cancer Solid Tumor Hematologic Mal... Oral Drug Admin...	TreC-Onco Paper diary	18 Years -	Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
A Study of FX-909 in Patients With Advanced Solid Malignancies, Including Advanced Urothelial Carcinoma	NCT05929235	Advanced Solid ... Advanced Urothe... Oral Drug Admin... Open Label	FX-909	18 Years -	Flare Therapeutics Inc.
Clinical Study Comparing Different Strategies to Increase Adherence to Oral Therapies in Oncohematology	NCT04826458	Cancer Solid Tumor Hematologic Mal... Oral Drug Admin...	TreC-Onco Paper diary	18 Years -	Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori

Spots Global Cancer Trial Database for oral drug administration