| General information |
| Database: | DB00171 |
| Objective: | The A(3) adenosine receptor is overexpressed in the tumor and in the peripheral blood mononuclear cells of patients with hepatocellular carcinoma. The orally active drug candidate CF102, an A(3)AR agonist, induces apoptosis of hepatocellular carcinoma cells via deregulation of the Wnt signaling pathway. In this open labelphase I/II trial, the safety and clinical effects of CF102 were assessed in patients with advanced unresectable hepatocellular carcinoma |
| Authors: | Stemmer SM, et al |
| Title: | CF102 for the treatment of hepatocellular carcinoma: a phase I/II, openlabel, doseescalation study. |
| Journal: | Oncologist. |
| Year: | 2013 |
| PMID: | 23299770 |
| Trial Design |
| Clinical Trial Id: | NCT00790218 |
| Agent: | CF102
|
| Target: | A(3) adenosine receptor
|
| Cancer Type: | liver cancer |
| Cancer Subtype: | advanced hepatocellular carcinoma |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | a phase I/II, openlabel, doseescalation study |
| Key Patients Feature: | patients with advanced unresectable hepatocellular carcinoma |
| Biomarker: | receptor overexpression levels at baseline |
| Biomark Analysis: | A correlation between receptor overexpression levels at baseline and patients' overall survival was found. |
| Control Group Info: | single arm |
| Treatment Info: | patients received CF102six at each dose level |
| Primary End Point: | the safety and pharmacokinetic (PK) behavior. |
| Secondary End Point: | Evaluation of antitumor effects and the utilization of A(3)AR as a biological predictive marker of response to CF102 |
| Patients Number: | 18 |
| Trial Results |
| DLT_MTD: | No serious doselimiting toxicities were observed. |
| Objective Response Rate: | One of the patients who presented with skin nodules that were biopsyproven to be hepatocellular carcinoma metastases prior to the trial showed complete metastasis regression during three months of treatment with CF102. |
| Disease Control Rate: | Stable disease by RECIST was observed in four patients for at least 4 months. CF102 maintained liver function over a 6month period. |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | NA |
| Median OS A vs. C: | Median overall survival in the study population, 67% of whom had received prior sorafenib, was 7.8 months, and for Child Pugh B patients (28%) it was 8.1 months. |
| Adverse Event(agent arm): | No serious drugrelated adverse events or doselimiting toxicities were observed. |
| Conclusions: | CF102 is safe and welltolerated, showing favorable PK characteristics in Child Pugh A and B hepatocellular carcinoma patients, justifying further clinical development. |