Neoplasms

Symptoms and General Pathology

All Conditions

Skin and Connective Tissue Diseases

Gland and Hormone Related Diseases

Nervous System Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Diseases and Abnormalities at or Before Birth

Rare Diseases

Neoplasm Metastasis

Breast Neoplasms

Thyroid Neoplasms

Thyroid Diseases

Glioma

Sarcoma

Brain Neoplasms

Wilms Tumor

Thyroid Cancer, Papillary

Central Nervous System Neoplasms

Medulloblastoma

Neuroblastoma

Sarcoma, Ewing

Fibrosarcoma

Nephroma, Mesoblastic

Nervous System Neoplasms

Soft Tissue Sarcoma

Wilms' Tumor

Papillary Thyroid Carcinoma

Ewing Sarcoma

Congenital Mesoblastic Nephroma

All Drugs and Chemicals

Amino Acids

Entrectinib

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

Arm closed for further enrollment

ROS1, ALK non-gene fusion molecular alterations

Oral entrectinib (RXDX-101)

Arm closed for further enrollment

molecular alterations, including gene fusions

Oral entrectinib (RXDX-101)

Arm closed for further enrollment

Oral entrectinib (RXDX-101)

Arm closed for further enrollment

harboring - NTRK1/2/3, ROS1, ALK gene fusions

Oral entrectinib (RXDX-101)

Arm closed for further enrollment

Any participant who otherwise meet all other eligibility criteria

Oral entrectinib (RXDX-101)

gene fusions

Oral entrectinib (RXDX-101)

NTRK 1,2,3 and ROS1 fusions

Oral entrectinib (RXDX-101)

Clinical Trials

This is an open-label, Phase 1/2 multicenter dose escalation study in pediatric patients with relapsed or refractory extracranial solid tumors (Phase 1), with additional expansion cohorts (Phase 2) in patients with primary brain tumors harboring NTRK1/2/3 or ROS1 gene fusions, and extracranial solid tumors harboring NTRK1/2/3 or ROS1 gene fusions.

Study Of Entrectinib (Rxdx-101) in Children and Adolescents With Locally Advanced Or Metastatic Solid Or Primary CNS Tumors And/Or Who Have No Satisfactory Treatment Options

A Phase 1/2, Open-Label, Dose-Escalation And Expansion Study Of Entrectinib (Rxdx-101) In Pediatrics With Locally Advanced Or Metastatic Solid Or Primary CNS Tumors And/Or Who Have No Satisfactory Treatment Options

Assessed by National Cancer Institute Common Terminology for Adverse Events Criteria (NCI CTCAE v4.03)

AE, ECG and Labs assessed by NCI CTCAE v4.03

Assessed by plasma concentrations obtained on Days 1, 2, 8, 15, 22 (Cycle 1), Days 1, 2 (Cycle 2) and on Day 1 of every cycle thereafter

Assessed by RECIST v1.1 per the BICR and investigator

Assessed by RANO per the BICR and investigator

Assessed by the Curie scale per the BICR and investigator

Assessed by RECIST v1.1 per the investigator

Hoffmann-La Roche

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Nootropic Agents

Gastrointestinal Agents

Lipid Regulating Agents

Vitamins

Choline

Hypolipidemic Agents

Antimetabolites

3T MR Imaging

C-Choline PET Scanning

Gene Rearrangement

Nawaid Usmani, MD, FRCPC

This study will use high field MRI (3 Tesla), PET and biomarker to follow prostate cancers and determine if these tests can detect cancers that become aggressive.

This study may lead to the identification of additional investigations that can monitor for signs of disease progression in active surveillance protocols. This can directly benefit patients by providing them with greater confidence that their disease is being accurately monitored. In addition, this study may be beneficial to the general management of prostate cancers by adding to our knowledge of these investigations characterizing prostate cancers.

Biological Investigations in Active Surveillance (BIAS) IGAR 2008 I 19 in Prostate Cancer Using High Field MRI (3 Tesla), PET, and Biomarkers

Biological Investigations in Active Surveillance (BIAS) IGAR 2008 I 19

AHS Cancer Control Alberta

Genetic Predisposition to Disease

Disease Susceptibility

Genomic Instability

Disease Attributes

In order to proceed with molecular characterization, the tumor sample already taken for histological diagnosis will undergo DNA and RNA extraction, which will be analyzed for qualitative and quantitative evaluation. Based on the quantitative data, the method to be used for profiling will be decided.

Multigenic genomic profiling will be performed for each patient on already taken tumor tissue using different panels depending on the quality and quantity of nucleic acids, in particular the following will be used: comprehensive Genome Profiling (CGP, ≥500 genes), if at least 40 ng of material is available; Profiling with identification of actionable mutations by targeted sequencing with panels of size \>50 genes, if \<40 ng material available.

Diagnostic Test

Giovanni Scambia

Camilla Nero

The study of biological profiling is of fundamental importance in the diagnosis and treatment of many diseases, particularly oncological ones, and for this reason, the integration of molecular characterization into clinical practice becomes essential. NGS allows a high number of samples to be sequenced simultaneously, generating a great deal of genomic information in a short time and at reasonable cost. This information is of fundamental importance for the study of oncogenic drivers and gene alterations that may have a prognostic and/or predictive role in response to new molecularly targeted drugs.

Policlinico A. Gemelli has begun a process of internal reorganization of the research infrastructure following its recognition in 2018 as an Institute of Hospitalization and Treatment with Scientific Character (IRCCS) for its commitment to the disciplines of "Personalized Medicine" and "Innovative Biotechnology." In particular, with regard to genomics, will be equipped with a state-of-the-art technological asset that includes a fully automated process for sample preparation and the highest gene sequencing power available today. This condition makes it possible to perform extensive genomic profiling for large numbers of patients at low cost and in reasonable time.

Mutational Oncology in Clinical Practice

Mutational Oncology in Clinical Practice: Development of a Comprehensive Cancer Genome Profile Pathway.

Evaluate the impact and efficacy of a 500 cancer genes profiling in an Italian referral centre

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study Of Entrectinib (Rxdx-101) in Children and Adolescents With Locally Advanced Or Metastatic Solid Or Primary CNS Tumors And/Or Who Have No Satisfactory Treatment Options	NCT02650401	Solid Tumors CNS Tumors	Entrectinib	0 Years - 18 Years	Hoffmann-La Roche
Biological Investigations in Active Surveillance (BIAS) IGAR 2008 I 19 in Prostate Cancer Using High Field MRI (3 Tesla), PET, and Biomarkers	NCT00676286	Prostate Cancer	3T MR Imaging C-Choline PET S... Gene Rearrangem...	18 Years -	AHS Cancer Control Alberta
Biological Investigations in Active Surveillance (BIAS) IGAR 2008 I 19 in Prostate Cancer Using High Field MRI (3 Tesla), PET, and Biomarkers	NCT00676286	Prostate Cancer	3T MR Imaging C-Choline PET S... Gene Rearrangem...	18 Years -	AHS Cancer Control Alberta
Study Of Entrectinib (Rxdx-101) in Children and Adolescents With Locally Advanced Or Metastatic Solid Or Primary CNS Tumors And/Or Who Have No Satisfactory Treatment Options	NCT02650401	Solid Tumors CNS Tumors	Entrectinib	0 Years - 18 Years	Hoffmann-La Roche
Mutational Oncology in Clinical Practice	NCT06020625	Genome Instabil... Genetic Predisp... Gene Rearrangem...	Diagnostic Test	18 Years -	Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Mutational Oncology in Clinical Practice	NCT06020625	Genome Instabil... Genetic Predisp... Gene Rearrangem...	Diagnostic Test	18 Years -	Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Spots Global Cancer Trial Database for gene rearrangement