AEG35156 is a second generation antisense which targets XIAP mRNA to lower XIAP levels and the apoptotic threshold of cancer cells, enhancing their sensitivity to intrinsic death and chemotherapy. Advanced HCC is an attractive target for AEG35156 since XIAP is highly expressed in HCC and may prevent cancer cells from undergoing apoptosis. Second generation antisense molecules are known to accumulate in liver where AEG35156 may down regulate XIAP protein expression in HCC cells thus promoting their apoptotic death.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
75
Dose escalation (100, 200 and 300 mg/day) over 2 hr infusion, once weekly over 21 days (Day 1, 8, 15)
Sorafenib will be administered at 400 mg BID every day
Tuen Mun Hospital
Tuenmen, New Territories, Hong Kong, China
Queen Elizabeth Hospital
Hong Kong, China
Queen Mary Hospital
Hong Kong, China
To determine the recommended dose of AEG35156 in combination with sorafenib patients with advanced HCC
13 patients were enrolled into the phase 1 dose escalation part of the study. The recommended dose was determined to be 300 mg.
Time frame: 12 months
To evaluate the efficacy of AEG35156 in combination with sorafenib based on PFS(PII) using sorafenib alone for comparison
Time frame: 12 months
To determine the safety profile of AEG35156 in combination with sorafenib in advanced HCC
Time frame: 12 months
To determine the response rate of AEG35156 in combination with sorafenib in advanced HCC
Time frame: 12 months
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