A Phase 1-2 Study of CF102 in Patients With Advanced Hepatocellular Carcinoma
This trial will test the safety and efficacy of CF102 in patients with advanced liver cancer. Successive groups of patients will be given higher doses of CF102 by mouth on a twice-daily basis. Treatment will be assessed for adverse effects and for effects on the tumor.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase 1-2, Open-label, Dose-escalation Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Orally Administered CF102 in Patients With Advanced Hepatocellular Carcinoma|
- Dose Limiting Toxicity [ Time Frame: From start of treatment until Day 28 of Cycle 1 ] [ Designated as safety issue: Yes ]Dose-limiting toxicity was defined as a clinically significant AE or laboratory abnormality occurring in Cycle 1
- Repeat-dose Pharmacokinetic Behavior of CF102 [ Time Frame: 1 month ] [ Designated as safety issue: No ]
- Maximum Tolarated Dose [ Time Frame: first 28 days (Cycle 1) ] [ Designated as safety issue: Yes ]The MTD was defined as the highest dose level at which < 2 of 6 patients developed Cycle 1 DLT.
- Therapeutic Effect of CF102 in Hepatocellular Carcinoma [ Time Frame: Every 2 months ] [ Designated as safety issue: No ]
- Relationship Between Biomarkers of Peripheral Blood Mononuclear Cell (PBMC) Adenosine A3 Receptor (A3AR) Expression and Clinical Effects of CF102 [ Time Frame: Baseline ] [ Designated as safety issue: No ]
|Study Start Date:||February 2009|
|Study Completion Date:||December 2012|
|Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
An open-label trial (1, 5, and 25 mg BID) in 28-day cycles.
CF102 capsules twice daily by mouth
This is a multicenter, open-label, non-randomized, dose-escalation study, to be conducted in 2 phases: a dose-escalation phase, to determine the MTD of CF102 and to evaluate its safety/tolerability, PK, pharmacodynamic, and preliminary clinical activity; and a dose-confirmation phase, which will be a cohort expansion at or below the MTD (ie, the RP2D) of CF102. Subjects will be treated with oral doses of CF102 in consecutive, 28-day cycles. The initial dose of CF102 will be 1 mg twice daily (BID), with subsequent escalations to 5 and 25 mg BID, unless limited by toxicity. Subjects will be evaluated weekly for the first cycle, every 2 weeks for Cycles 2 and 3, and at the end of each subsequent cycle, up to 6 cycles of CF102 treatment. Subjects will return for a follow-up visit 28 days after completion of the last dose of study drug.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00790218
|Rabin Medical Center|
|Tel Aviv, Israel|
|Study Director:||Michael H Silverman, MD||Can-Fite BioPharma Ltd|
|Principal Investigator:||Salomon Shtemmer, MD||Rabin Medical Center|