Contact a Trial Coordinator for more information on our trials.
A Phase 1b Dose-escalation Study of the Safety and Pharmacokinetics of Fixed-dose PCS6422 With Escalating Doses of Capecitabine Administered Orally to Patients With Advanced, Refractory Gastrointestinal Tract Tumors
Actual Start Date
June 18, 2021
Actual Primary Completion Date
September 20, 2022
This study is an open label, multicenter study in patients who have advanced, relapsed refractory GI cancer or are not relapsed/refractory but are intolerant to other therapies who, in the judgment of investigators, are candidates for fluoropyrimidine monotherapy.
PCS6422 and capecitabine
- PCS6422 is an experimental drug that, when combined with capecitabine, may make the immune response more active against cancer. Capecitabine is a commonly used oral fluoropyrimidine.
Actual Study Completion Date
March 10, 2023
The following cities have PCS499 clinical trial sites. Please check back often as locations will be updated.
About Necrobiosis Lipoidica
Necrobiosis lipoidica (NL) is a chronic, disfiguring condition affecting the skin and tissue under the skin typically on the lower extremities with no currently approved FDA treatments. More severe complications can occur, such as deep tissue infections and osteonecrosis threatening life of the limb.
Approximately 74,000 - 185,000 people in the United States and more than 200,000 – 500,000 people outside the United States are affected by NL with the prevalence of open ulcers being approximately 30% of all NL patients.
The degeneration of tissue occurring at the NL lesion site is caused by a number of pathophysiological changes which has made it extremely difficult to develop effective treatments for this condition. At this time there is no approved FDA treatment for NL and PCS499 could be the first drug approved. PCS499 and its metabolites affect a number of biological pathways, several of which contribute to the pathophysiology associated with NL.
The safety and efficacy of the investigational use of this product have not been determined. There is no guarantee that the investigational use listed will be filed with and/or approved for marketing by a regulatory agency.