Phase 2, Randomized, Double-Blind, Placebo-Controlled of the Efficacy and Safety of CF102 in Hepatocellular Carcinoma (HCC)

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.

Timeline

Start

2014-09

Primary completion

2017-11-27

Completion

2021-12-31

Outcome

Sources disagree · no verdict is set; each source's reading is shown below

registry analysis (other test); CF102 vs Placebo Tablets of CF102; p = 0.536; Log Rank reads as missed primary endpoint NCT02128958 ↗

release “While the Phase II study did not achieve its primary endpoint of overall survival in the whole population (n=78)” reads as missed primary endpoint canfite.com ↗

release “Even though the trial did not meet its primary endpoint, in patients with a CPB score of 7, Namodenoson was associated with a significant improvement” reads as missed primary endpoint canfite.com ↗

release “Namodenoson-treated CPB7 patients had statistically significant overall survival gain” reads as met primary endpoint canfite.com ↗

Publications

• Background Stemmer SM, Manojlovic NS, Marinca MV, Petrov P, Cherciu N, Ganea D, Ciuleanu TE, Pusca IA, Beg MS, Purcell WT, Croitoru AE, Ilieva RN, Natosevic S, Nita AL, Kalev DN, Harpaz Z, Farbstein M, Silverman MH, Bristol D, Itzhak I, Fishman P. Namodenoson in Advanced Hepatocellular Carcinoma and Child-Pugh B Cirrhosis: Randomized Placebo-Controlled Clinical Trial. Cancers (Basel). 2021 Jan 7;13(2):187. doi: 10.3390/cancers13020187.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Namodenoson	Small molecule	25 mg	Oral

Indications