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ONO-7579

Protein Kinase Inhibitors

Enzyme Inhibitors

Drug Development Division

This study will determine the safety and maximum tolerated dose of ONO-7579 in patients with advanced solid tumors, and evaluate efficacy of ONO-7579 in patients with advanced solid tumors harboring NTRK gene fusions.

The trial was designed to be a Phase 1/2 trial, but was terminated without progressing to Phase 2.

Study of ONO-7579 in Patients With Advanced Solid Tumors/ NTRK Gene Fusion Positive Advanced Solid Tumors

An Open-label, Multi-center, Dose-escalation and Expansion Study to Evaluate the Safety and Efficacy of ONO-7579 in Patients With Advanced Solid Tumors/ NTRK Gene Fusion Positive Advanced Solid Tumors

To investigate the safety and tolerability of ONO-7579 to determine MTD/RCD

Assessed by Independent Central Review using RECIST 1.1 or RANO criteria

Assessment of the maximum plasma concentration of ONO-7579

Assessment of the time to reach maximum observed plasma concentration of ONO-7579

Assessment of the plasma area under the curve from time zero to 24 hours after dosing

Assessment of the plasma decay half life of ONO-7579

Assessment of the trough concentration of ONO-7579 in plasma

Assessed by investigator using RECIST 1.1 or RANO criteria

To determine the safety and tolerability of ONO-7579

Ono Pharmaceutical Co. Ltd

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Symptoms and General Pathology

Prostatic Neoplasms

Pain

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

In Group 1, Patients detected with a PI-RADS (Prostate Imaging Reporting and Data System) ≥3 lesion on MpMRI underwent MpMRI-guided MRI- US fusion prostate biopsy. In this fusion biopsy, 12 core standard biopsy and 2-4 cores of biopsies from lesions defined on multiparametric prostate MRI

In Group 2, patients who had no suspected lesions or had a PI-RADS \<3 lesion on MpMRI underwent Transrectal ultrasound guided 12 core prostate biopsy (SPB).

TRUS-guided SPB was performed by obtaining 12 core samples in each patient. 6 cores from left and right. the cores labeled as, apex, mid, base, apex far lateral, mid far lateral and base far lateral

Standard transrectal 12 core biopsy

FPB was performed by obtaining 10-12 core samples in each patient, followed by the acquisition of 2-4 core samples for each suspected lesion detected on MpMRI (combined biopsy)

MRI- US fusion prostate biopsy (FPB)

Abdullah T Demirtaş, MD

The aim of this study was to compare the pain levels in transrectal ultrasound (TRUS)-guided standard 12-core prostate biopsy (SPB) and multiparametric prostate magnetic resonance imaging (MpMRI)-guided fusion prostate biopsy (FPB).

The study included patients that underwent prostate biopsy under local anesthesia (intrarectal 2% lidocaine gel + periprostatic nerve block) due to suspected prostate cancer. Patients detected with a Prostate Imaging Reporting and Data System score (PIRADS) ≥3 lesion on MpMRI underwent MpMRI-guided FPB (Group I) and the patients who had no suspected lesions or had a PI-RADS \<3 lesion on MpMRI underwent TRUS-guided SPB (Group II). Pain assessment was performed using Visual Analog Scale (VAS) 5 min after the procedure. Following the procedure, the patients were asked to indicate the most painful biopsy step among the three steps (1: insertion of the probe into the rectum, 2: probe manipulation, 3: the piercing of the biopsy needle).

pain levels after standard transrectal prostate 12 core biopsy and MRI -US fusion prostate biopsy were detected and compared in 2 groups.

Comparison of Pain Levels in Fusion Prostate Biopsy and Standard TRUS-Guided Biopsy

to ask patients most painful step of procedure that verbally defined them before biopsy as 1: insertion of the probe into the rectum, 2: probe manipulation, and 3: the piercing of the biopsy needle

pain assessment was performed using Visual Analogue Scale (VAS)

TC Erciyes University

Abdullah Demirtas, Md, Assoc. Prof.

Behaviors and Mental Disorders

Recurrence

Quality of Life

Biopsy proven Prostate Cancer is delimited and defined by MP-MRI. The MRI study is fused with transrectal ultrasound in realtime. The cryogenic "cryoprobes/devices" are employed to freeze and all "circuled or noted" cancer lesions. Two freeze 8 min/ thaw 10 min clycles are performed. Thermocouples are used to monitor treatment areas and safety margins

FUSE IMAGE MRI GUIDED PROSTATE CRYOTHERAPY

CIELO D GUERRA, BS

LUANDA SIANO, PA

FERNANDO J BIANCO, MD

EDWARD L GHEILER, MD

ARIEL M KAUFMAN, MD

EUSEBIO J LUNA, MD

EUSEBIO LUNA, MD

Isabel H Lopez, MD

Registration of Prostate Cancer patients undergoing Prostate Cryotherapy guided by Mutiparametric-MRI (MP-MRI) highlighting biopsy confirmed regions. The primary outcome measure is 5 year oncological control. Secondary aim is lack of progression beyond the prostate gland. The aim of intervention is to eradicate prostate cancer disease in the treated area while imposing no or minimal deleterious effects in quality of life.

CLINICAL TRIAL OF OBSERVATION NATURE

PRIMARY OUTCOME

Cancer control of treated areas 5, 10, 15 years after intervention based on prostate biopsy of initial treated area, progression requiring conversion to radical prostate surgery or radiation or other forms of whole gland treatment (ej, HIFU), Metastatic Free survival: CT Scan and Bone Scans, Cancer-Specific and Overall Survival

SECONDARY OUTCOMES

Secondary Interventions focal interventions due to de-novo lesions. Focal or target therapy rescue with other technologies (ej HIFU); Short, Intermediate and Long-Term Urinary and Sexual Function changes in quality of life measured by validated inventories; Anxiety related to cancer and cancer control. Treatment tolerance to local anesthesia. Patient App compliance and activity to monitor care

DATA COLLECTION

* Complete H\&P, family history, past medical and surgical history, social history, allergies, and medications
* As of July 2016, voluntary measurement thru Focalyx App for smartphones and tablets
* Imaging Specifics Assessing Prostate, Seminal Vesicles and Urethral Contouring by Multi-parametric-MRI. Dominant lesions and secondary lesions contouring my MP-MRI.
* Procedure specific Co-Registration quality with ultrasound denoting quality
* Specific ablative description and digitalization of critical measures such as: ablation type (ej cryotherapy, equipment used) procedure, cryoprobes used, freeze/thaw cycles timing, temperatures at neurovascular bundles, denonvilliers fascia. Urethral warmer requirements
* Follow up information: 30 day perioperative outcomes (incidence of UTI, urinary retention, failure of local anesthetic, pain measures). 6 week, 3,6,9,12 month and then every 6 month measures of PSA, Testosterone levels, Urinary Function and Sexual Function inventories, Overall anxiety and regret related to diagnosis and treatment
* Uroflow and PVR measurements by 3 to 6 month of treatment
* MP MRI on a yearly basis, for years 2,3,4 after treatment, biopsy driven by new suspicious MRI findings
* MP MRI triggered by elevation in PSA velocity or PSA level 10% above diagnosis
* Transperineal Fusion Guided Prostate biopsy at 1st year - emphasis on treated areas, suspicious MRI areas
* Transperineal Fusion Guided Prostate biopsy at 5th year - emphasis on treated areas, suspicious MRI areas
* 5, 10, 15 Yr CT Scans, PET Scan/Bone Scan

SAFETY MEASURES

* Periodic evaluation of registry to ensure consistency in follow up
* Patient remainders of tests required

MRI/Ultrasound Fusion Guided Prostate Cryotherapy

Office Based MRI/Ultrasound Guided Prostate Cryotherapy: Outcomes Registry

Non identifiable pertinent information will be shared for other scientists to evaluate other pertinent questions

Type of treatments required after initial intervention over time

Lack of prostate cancer presence in treated area after MRI/US FUSION Biopsy

Lack of prostate cancer presence in the gland after MRI/US FUSION Biopsy

Lack of prostate cancer presence in gland measured by MP-MRI

Evaluation of urinary function outcomes when compared to baseline using expanded prostate composite index and AUA symptoms scores. Urinary function also by objective measurements - uroflow and post void residuals

Procedure tolerance, need for hospital admission or ER consultation, incidence of urinary tract infection, urinary retention, any significant side effect that may occur and perioperative survivel

Evaluation of sexual function outcomes when compared to baseline using Sexual Inventory for men questionnaires

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of ONO-7579 in Patients With Advanced Solid Tumors/ NTRK Gene Fusion Positive Advanced Solid Tumors	NCT03182257	Solid Tumor	ONO-7579	18 Years -	Ono Pharmaceutical Co. Ltd
Comparison of Pain Levels in Fusion Prostate Biopsy and Standard TRUS-Guided Biopsy	NCT03859804	Pain Due to Cer... Prostate Cancer Biopsy	Standard transr... MRI- US fusion ...	50 Years - 75 Years	TC Erciyes University
Comparison of Pain Levels in Fusion Prostate Biopsy and Standard TRUS-Guided Biopsy	NCT03859804	Pain Due to Cer... Prostate Cancer Biopsy	Standard transr... MRI- US fusion ...	50 Years - 75 Years	TC Erciyes University
MRI/Ultrasound Fusion Guided Prostate Cryotherapy	NCT02381990	Neoplasms Prost... Cancer of the P...	FUSE IMAGE MRI ...	55 Years -	Urological Research Network, LLC
Comparison of Pain Levels in Fusion Prostate Biopsy and Standard TRUS-Guided Biopsy	NCT03859804	Pain Due to Cer... Prostate Cancer Biopsy	Standard transr... MRI- US fusion ...	50 Years - 75 Years	TC Erciyes University
MRI/Ultrasound Fusion Guided Prostate Cryotherapy	NCT02381990	Neoplasms Prost... Cancer of the P...	FUSE IMAGE MRI ...	55 Years -	Urological Research Network, LLC
Study of ONO-7579 in Patients With Advanced Solid Tumors/ NTRK Gene Fusion Positive Advanced Solid Tumors	NCT03182257	Solid Tumor	ONO-7579	18 Years -	Ono Pharmaceutical Co. Ltd

Spots Global Cancer Trial Database for fusion

Every month we try and update this database with for fusion cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for fusion

Every month we try and update this database with for fusion cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for fusion cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.