Expired Study
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Clinical Trial 11855

Encinitas, CA 92024

Study Summary:

This is a Phase I dose escalation safety study utilizing an IV form of Ubidecarenone, also known as Coenzyme Q10, for the treatment of unresectable or metastatic solid cancer tumors. The study drug, also referred to as "31510" will be administered daily, Monday - Friday over the course of a 4 hour infusion. The study is conducted at a private hospital called Hospital Angeles in Tijuana, Mexico, located approximately 5 minutes South of the U.S. border crossing. The treatments are performed on an outpatient basis, allowing for U.S. patients to travel to and from San Diego, CA. Patients enrolled in the study should be prepared for 2 - 3 months of treatment. Most significantly, study drug “31510’” is an endogenous compound to the human body and there have been no toxicities compared to chemotherapy and radiology. This trial is sponsored by a U.S. pharmaceutical company and is approved by both the U.S. FDA and Mexican FDA.

Qualified Participants Must:

• Have a histologically confirmed solid tumor that is metastatic or unresectable
• Be at least 18 years of age
• Be active (up and about) at least 50% of waking hours
• Have a life expectancy of greater than 3 months
• Have a negative pregnancy test at enrollment (if applicable)
• Have not received chemotherapy or radiotherapy within 4 weeks
• Be HIV negative
• Not have not taken Vitamin D3 supplements in the last 30 days
• Not be on on HMG-CoA Reductase Inhibitors
• Not be receiving digoxin, digitoxin, lanatoside C or any type of digitalis alkaloids
• Not be receiving Colony Stimulating factors
• Not be receiving Warfarin

Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.