Spots Global Cancer Trial Database for A Study of the Safety and PK of PCS6422 (Eniluracil) With Capecitabine in Patients With Advanced, Refractory GI Tract Tumors
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Trial Identification
Brief Title: A Study of the Safety and PK of PCS6422 (Eniluracil) With Capecitabine in Patients With Advanced, Refractory GI Tract Tumors
Official Title: 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
Study ID: NCT04861987
Interventions
Study Description
Brief Summary: 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.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Processa Clinical Site, Omaha, Nebraska, United States
Processa Clinical Site, New Brunswick, New Jersey, United States
Processa Clinical Site, Santa Fe, New Mexico, United States
Processa Clinical Site, New York, New York, United States
Processa Clinical Site, Cleveland, Ohio, United States
Processa Clinical Site, Fairfax, Virginia, United States
Contact Details
Name: Sian Bigora, Pharm. D
Affiliation: Processa Pharmaceuticals
Role: STUDY_DIRECTOR
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