Spots Global Cancer Trial Database for Phase 2, Randomized, Double-Blind, Placebo-Controlled of the Efficacy and Safety of CF102 in Hepatocellular Carcinoma (HCC)
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Trial Identification
Brief Title: Phase 2, Randomized, Double-Blind, Placebo-Controlled of the Efficacy and Safety of CF102 in Hepatocellular Carcinoma (HCC)
Official Title: A Phase 2 Study in the Second-Line Treatment of Advanced Hepatocellular Carcinoma in Subjects With Child-Pugh Class B Cirrhosis
Study ID: NCT02128958
Conditions
Study Description
Brief Summary: This is a multicenter, randomized, double-blind, placebo-controlled clinical trial in subjects with advanced HCC and CPB cirrhosis whose disease has progressed while taking 1 prior systemic drug therapy for HCC.
Detailed Description: The trial will evaluate the efficacy and safety of CF102 as compared to placebo. Subjects will be randomly assigned in a 2:1 ratio to treatment with oral doses of either CF102 25 mg or matching placebo administered twice daily (BID) for consecutive, 28-day cycles. Subjects will be evaluated regularly for safety. Tumor imaging will be performed every 8 weeks. Treatment will continue until the subject experiences unacceptable drug-related intolerability. Subjects will return for a follow-up visit 28 days after completion of the last dose of study drug, and every attempt will be made to obtain survival data on all randomized subjects. Subjects who discontinue will be followed indefinitely for survival status. The trial will continue until 75 deaths have been recorded.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Colorado Cancer Center, Aurora, Colorado, United States
Simmons Cancer Center, Dallas, Texas, United States
Complex Oncology Center - Plovdiv, Plovdiv, , Bulgaria
Multiprofile Hospital for Active Treatment Central Onco Hospita, Plovdiv, , Bulgaria
Multiprofile Hospital for Active Treatment "Tokuda Hospital Sofia" AD, Sofia, , Bulgaria
Multiprofile Hospital for Active Treatment for women's health - Nadezhda, Sofia, , Bulgaria
Multiprofile Hospital for Active Treatment Serdica, Sofia, , Bulgaria
Multiprofile Hospital for Active Treatment "Sveta Marina" EAD, Varna, , Bulgaria
Rabin Medical Center, Petach Tikva, , Israel
Institutul Clinic Fundeni - Sectia Oncologie Medicala, Bucuresti, , Romania
Clinica Bendis - Oncologie Medicala, Cluj, , Romania
Centrul de Oncologie ONCOLAB, Craiova, , Romania
Institutul Regional de Oncologie Iasi - Sectia Oncologie Medicala, Iaşi, , Romania
Spitalul Pelican Impex SRL- Sectia Oncologie Medicala, Oradea, , Romania
SC DACMED SRL - Oncologie, Ploieşti, , Romania
Spitalului Clinic Judetean de Urgenta - Sectia Oncologie Medicala, Sibiu, , Romania
Spitalul Judetean de Urgenta "Sf. Ioan Cel Nou" - sectia Oncologie Medicala, Suceava, , Romania
Vojnomedicinska Akademija Beograd, Belgrade, , Serbia
Zdravstveni Centar Kladovo Služba Onkologije, Kladovo, , Serbia
Klinički Centar Niš Klinika za Onkologiju, Niš, , Serbia
Institut za Onkologiju Vojvodine, Sremska Kamenica, , Serbia
Contact Details
Name: Michael H Silverman
Affiliation: Can-Fite BioPharma Ltd
Role: STUDY_DIRECTOR
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