Neoplasms

Digestive System Diseases

All Conditions

Gland and Hormone Related Diseases

Symptoms and General Pathology

Rare Diseases

Colorectal Neoplasms

Cholangiocarcinoma

Pancreatic Neoplasms

Neoplasm Metastasis

Carcinoma, Hepatocellular

Hypoxia

Biliary Tract Neoplasms

Liver Neoplasms

Carcinoma

Adenocarcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Endocrine Gland Neoplasms

Pancreatic Diseases

Endocrine System Diseases

Liver Diseases

Pancreatic Cancer

Bile Duct Cancer

Micronutrients

All Drugs and Chemicals

Hematinics

Other Dietary Supplements

Vitamins

Inositol

Folic Acid

Vitamin B Complex

Trace Elements

Folate

Vitamin B9

Add-on application of Myo-inositol trispyrophosphate, total of 9 times, 3 applications per week, over 3 weeks.

OXY111A

Pierre-Alain Clavien, MD, PhD

Perparim Limani, MD

Panagiotis Samaras, MD

Bernhard Pestalozzi, MD

Alexander Jetter, MD

Michael Linecker, MD

Rolf Graf, PhD

Bostjan Humar, PhD

Henrik Petrowsky, MD

Philipp Kron, MD

Roger Stupp, MD

Pierre Alain, Clavien

The purpose of the study is to evaluate whether the novel anti-cancer drug OXY111A is safe and tolerated in patients with primary and secondary hepato-pancreato-biliary and gastrointestinal neoplasia as measured by exploring the maximum tolerated dose (MTD). At level of MTD, additional patients will be included aimed for assessing the efficacy profile in these neoplasia entities.

The IMP OXY111A counteracts hypoxia-induced tumor aggressiveness showing decreased tumor burden and increased survival in five different animal solid tumor models both applied as monotherapy and increased beneficial effects when followed by standard chemotherapy. The unique ability of the IMP counteract hypoxic tumor behaviour along with its non-toxic side effects tested both in animals and healthy volunteers is of outmost interest to explore in patients with solid tumors.

The study seeks primarily to determine the safety and tolerability of OXY111A in patients with primary and secondary hepato-pancreato-biliary and gastrointestinal neoplasia as measured by exploring the MTD in a conservative 3+3 dose escalation schedule. The window for DLT assessment is from first dose of study drug until first dose of standard of care chemotherapy or 10 days following completion of last dose of study drug (whichever is shorter in duration). Additionally, we will assess efficacy of OXY111A on decreasing tumor volume, metabolic activity, as well as circulatory tumor and angiogenic markers.

Effects of OXY111A in Primary and Secondary Hepato-Pancreato-Biliary Neoplasm

A Phase IB/IIA, Single-centered Study of the Effects of OXY111A in Primary and Secondary Hepato-Pancreato-Biliary Neoplasia

Safety variables and patient tolerance as measured by collection of adverse effects information according to Common Terminology Criteria for Adverse Events (CTCAE)

Assessment of tumor response with 18F-FDG PET in FDG-avid tumors using EORTC criteria

Assessment of tumor response with MRI in non-FDG-avid tumors using RECIST criteria

University of Zurich

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Effects of OXY111A in Primary and Secondary Hepato-Pancreato-Biliary Neoplasm	NCT02528526	Pancreatic Neop... Hepatocellular ... Cholangiocarcin... Colorectal Neop...	OXY111A	18 Years -	University of Zurich
Effects of OXY111A in Primary and Secondary Hepato-Pancreato-Biliary Neoplasm	NCT02528526	Pancreatic Neop... Hepatocellular ... Cholangiocarcin... Colorectal Neop...	OXY111A	18 Years -	University of Zurich

Spots Global Cancer Trial Database for oxy111a

Every month we try and update this database with for oxy111a 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 oxy111a

Every month we try and update this database with for oxy111a 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 oxy111a 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.