Neoplasms

All Conditions

Digestive System Diseases

Gland and Hormone Related Diseases

Rare Diseases

Adenocarcinoma

Pancreatic Neoplasms

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Antineoplastic Agents

All Drugs and Chemicals

Gemcitabine

Antibodies

Antibodies, Monoclonal

Immunoglobulins

Antimetabolites

Participants will receive simtuzumab 700 mg plus gemcitabine in cycles of 28 days for up to 3 years.

Participants will receive simtuzumab 200 mg plus gemcitabine in cycles of 28 days for up to 3 years.

Participants will receive placebo to match simtuzumab plus gemcitabine in cycles of 28 days for up to 3 years.

Simtuzumab administered intravenously every 2 weeks for a total of 2 infusions (Days 1 and 15)

Simtuzumab

Gemcitabine 1000 mg/m\^2 administered intravenously on Days 1, 8, and 15 of each 28-day cycle

Placebo to match simtuzumab administered intravenously every 2 weeks for a total of 2 infusions (Days 1 and 15)

Placebo to match simtuzumab

Zung Thai, MD

This study will compare the efficacy of simtuzumab (GS-6624) versus placebo in combination with gemcitabine in adults with pancreatic cancer. The treatment phase of this study will be comprised of 2 sequential parts: an open label treatment phase and a double-blinded treatment phase.

A Study to Evaluate the Efficacy and Safety of Simtuzumab Combined With Gemcitabine for Metastatic Pancreatic Adenocarcinoma

A Phase 2 Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Efficacy and Safety of GS-6624 Combined With Gemcitabine as First Line Treatment for Metastatic Pancreatic Adenocarcinoma

Progression free survival is measured as time from date of randomization to the earliest event time of death regardless of cause or first indication of disease progression.

Overall survival is measured as time from date of randomization to death regardless of cause.

Objective response is assessed by the Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.1 as complete response, partial response, stable disease, or progressive disease.

Gilead Sciences

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Six-month, daily oral dosing in softgel capsules throughout the first 6 months of treat.

Twice daily, self administered, oral dosing of OMN54. A daily diary log will be prepared by each participant and reviewed by the Investigator.

OMN54

Alan So, MD

Assessment of the effects of OMN54 (Aneustat) in a population of men with indolent prostate cancer who are otherwise healthy and free of significant co-morbidities and have chosen active surveillance for disease management. The investigators will assess how OMN54 affects PSA, overall tumor burden in addition to any changes in urinary flow. Other biomarkers will be tested to follow disease evolution.

Aneustat Treatment of Localized Prostate Cancer Under Active Surveillance

Phase IIA, Single-Center, Single-Arm Clinical Study of OMN54 (Aneustat) in Men Diagnosed With Prostate Cancer Being Followed by Active Surveillance

This is undecided and will be decided in consultation with the PI.

Quarterly assessment of serum Prostate Specific Antigen (PSA)

Changes in tumor size based on semi-annual MRI

Quartelry assessment of patient urinary flow based on patient IPSS Questionnaire

Vancouver Prostate Centre

Omnitura Therapeutics, Inc.

Herbal and Botanical

Cola

Subjects affected by Pancreatic carcinoma (PC) confirmed by tissue biopsy

Healthy Subject enrolled following colon cancer screening via colonoscopy

Detection and quantification of EMT-transcription factor mRNA levels in blood

Liquid biopsy

Luigi AG Laghi, MD, PhD

Luana Greco, MD, MSci

Luigi Laghi, MD

The present study is aimed at detecting and measuring mRNA levels of genes involved in epithelial to mesenchymal transition (EMT) in biological samples, i.e. in peripheral blood samples of pancreatic cancer (PC) patients and healthy controls, to determine the presence of disease, its progression and risk of recurrence.

The investigators first provided evidence that human pancreatic cancer (PC) cells can undergo EMT during local invasion, and that EMT transcription factors (i.e.Twist family basic helix-loop-helix transcription factor 1 (TWIST1)) are increased in the blood of PC patients. In addressing the relevance of EMT in the metastatic process, the prognostic role of M-like cancer cells entering into the circulation remains to be determined.

Currently, the notion that cancer disseminates via the circulation led to increased attention on the identification of circulating tumor cells (CTCs) in blood samples ("liquid biopsy"; LB), so far exclusively based upon epithelial (E) markers. However, an un-biased evaluation of CTCs, providing meaningful information for cancer diagnosis up to therapy, cannot exclude cells with M features. LB data show that circulating TWIST1, zinc finger E-box binding homeobox 2 (ZEB2) and E-Cadherin (CDH1) messenger ribonucleic acids (mRNA) are significantly and steadily increased in the blood of PC patients.These findings indicate that high levels of EMT players in the circulation efficiently discriminate PC patients, irrespectively of tumor resectability.

The present study is aimed at detecting and measuring mRNA levels of genes involved in epithelial to mesenchymal transition in biological samples, i.e. in peripheral blood samples of tumor patients, to determine the presence of disease, its progression and risk of recurrence.

Aim of the study is to depict the molecular profile of EMT-Transcription factor (EMT-TFs) variations in the blood of patients with early, intermediate or advanced PC, with respect to disease progression and delivered treatments.

Primary endpoint: to determ the stage, the remission or the progression of a pancreatic cancer in a pancreatic cancer affected subjects. This end-point comprising the step of assaying a biological sample from said subject for the presence of a panel of mRNAs encoding for transcription factors involved in epithelial to mesenchymal transition.

Secondary endpoint: to identify biomarkers suitable for the selection of patients amenable of responsiveness to medical and surgical treatment.

Detection of High Expression Levels of EMT-Transcription Factor mRNAs in Patients With Pancreatic Cancer and Their Diagnostic Potential

Data patent covered. No. Patent: EP13197367.9 - December 16, 2013

To determine the stage, the remission or the progression of a pancreatic cancer in a pancreatic cancer affected subject not administered with an appropriate antitumor treatment (e.g., neo-adjuvant therapy) comprising the step of assaying a biological sample from said subject for the presence of a panel of mRNAs encoding for transcription factors involved in epithelial to mesenchymal transition.

To identify biomarkers suitable for the selection of PC patients amenable of responsiveness to medical and surgical treatment.

IRCCS San Raffaele

Istituto Clinico Humanitas

Anti-Inflammatory Agents

Relugolix

Abiraterone Acetate

Prednisone

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Enzyme Inhibitors

Cytochrome P-450 Enzyme Inhibitors

Androgens

Androgen Antagonists

* ZYTIGA - Abiraterone
* Combined Chemotherapy (high dose)
* ZYTIGA - abiraterone acetate tablet, film coated plus RAYOS - prednisone tablet, delayed release plus ORGOVYX - relugolix tablet, film coated
* Usual Approach Group (high dose)

* ZYTIGA - Abiraterone
* Combined Chemotherapy (low dose)
* ZYTIGA - abiraterone acetate tablet
* ZYTIGA - abiraterone acetate tablet plus RAYOS - prednisone tablet, delayed release plus ORGOVYX - relugolix tablet, film coated
* Usual Approach Group (low dose)

* Oral
* Abiraterone Combined Chemotherapy (high dose)

Abiraterone - Usual

* Oral
* Abiraterone Combined Chemotherapy (low dose)

Abiraterone - Study

HAN XU, MD/PhD/FAPCR

The usual approach group, 300 double blind random group separated PC patients currently used the Combined Chemotherapy on ZYTIGA - abiraterone acetate tablet, film coated plus RAYOS - prednisone tablet, delayed release plus ORGOVYX - relugolix tablet, film coated, it will try to look for the relationship between the Abiraterone therapeutic efficacy and the CYP17 SNP Genotyping, and the relationship between the Abiraterone therapeutic safety and the SULT2A1 SNP Genotyping, based on Oxford precisely sequencing drug targets' genes.

The study approach group, 300 double blind random group separated PC patients currently used the Combined Chemotherapy on ZYTIGA - abiraterone acetate tablet plus RAYOS - prednisone tablet, delayed release plus ORGOVYX - relugolix tablet, film coated, it will try to look for the relationship between the Abiraterone therapeutic efficacy and the CYP17 SNP Genotyping, and the relationship between the Abiraterone therapeutic safety and the SULT2A1 SNP Genotyping, based on Oxford precisely sequencing drug targets' genes.

1. Detect drug target whole gene precision sequence of everyone patient for all 600 recruited double blind prostate cancer patients.
2. Mutually compare everyone patient drug target whole gene precision sequence for a total of 600 recruited double blind prostate cancer patients.
3. Calculate drug target gene SNPs in all 600 recruited double blind prostate cancer patients.
4. Correlate everyone patient drug target gene SNP to everyone patient drug efficacy.
5. Correlate everyone patient drug target gene SNP to everyone patient drug safety.
6. Mutually compare the usual approach group SNPs (300 double blind random group separated prostate cancer patients) with the study approach group SNPs (300 double blind random group separated prostate cancer patients).
7. Confirm the relationship between drug target gene SNPs and drug efficacy.
8. Confirm the relationship between drug target gene SNPs and drug safety.

* The usual approach group (high dose)
* The study approach group (low dose)

Pharmacogenomics IND EXEMPT SNP Clinical Study - Abiraterone and Single Nucleotide Polymorphisms

Explore the Relationship Between Single Nucleotide Polymorphisms and Abiraterone Response and Toxicity in Patients With Prostate Cancer.

* Recruit 300 double blind random group separated PC patients currently using the Combined Chemotherapy High Dose on ZYTIGA - Abiraterone plus RAYOS - Prednisone plus ORGOVYX - Relugolix to be the usual approach group.
* Recruit 300 double blind random group separated PC patients currently using the Combined Chemotherapy Low Dose on ZYTIGA - Abiraterone plus RAYOS - Prednisone plus ORGOVYX - Relugolix to be the study approach group.
* Measure above every PC patient specific Abiraterone drug target (CYP17) SNP genotype in his or her WBC cell whole genome DNA with Oxford precisely sequencing.
* Report every PC patient specific CYP17 SNP genotype in whole genome DNA sequence.
* Measure above every PC patient specific Abiraterone drug target (SULT2A1) SNP genotype in his or her WBC cell whole genome DNA with Oxford precisely sequencing.
* Report every PC patient specific SULT2A1 SNP genotype in whole genome DNA sequence.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study to Evaluate the Efficacy and Safety of Simtuzumab Combined With Gemcitabine for Metastatic Pancreatic Adenocarcinoma	NCT01472198	Pancreatic Canc...	Simtuzumab Gemcitabine Placebo to matc...	18 Years -	Gilead Sciences
Aneustat Treatment of Localized Prostate Cancer Under Active Surveillance	NCT03495479	Prostate Cancer	OMN54	18 Years - 72 Years	Omnitura Therapeutics, Inc.
Detection of High Expression Levels of EMT-Transcription Factor mRNAs in Patients With Pancreatic Cancer and Their Diagnostic Potential	NCT04323917	Pancreatic Canc...	Liquid biopsy	18 Years -	Istituto Clinico Humanitas
Pharmacogenomics IND EXEMPT SNP Clinical Study - Abiraterone and Single Nucleotide Polymorphisms	NCT03348670	Prostate Cancer	Abiraterone - U... Abiraterone - S...	22 Years - 75 Years	Medicine Invention Design, Inc
A Study to Evaluate the Efficacy and Safety of Simtuzumab Combined With Gemcitabine for Metastatic Pancreatic Adenocarcinoma	NCT01472198	Pancreatic Canc...	Simtuzumab Gemcitabine Placebo to matc...	18 Years -	Gilead Sciences
Pharmacogenomics IND EXEMPT SNP Clinical Study - Abiraterone and Single Nucleotide Polymorphisms	NCT03348670	Prostate Cancer	Abiraterone - U... Abiraterone - S...	22 Years - 75 Years	Medicine Invention Design, Inc
Detection of High Expression Levels of EMT-Transcription Factor mRNAs in Patients With Pancreatic Cancer and Their Diagnostic Potential	NCT04323917	Pancreatic Canc...	Liquid biopsy	18 Years -	Istituto Clinico Humanitas

Spots Global Cancer Trial Database for pc

Every month we try and update this database with for pc 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 pc

Every month we try and update this database with for pc 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 pc 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.