Hepatocellular carcinoma (HCC) is the fifth most common type of cancer worldwide and the third most common cause of death from cancer. Sorafenib is the only approved therapy for treatment of advanced HCC, and there is a need to identify more drugs that are beneficial for these patients without unacceptable side effects. Prodrug chemotherapy is an approach in which an inactive non-toxic agent is administered to the patient and gets activated within the body at specific locations, resulting in a higher concentration of the cytotoxic form at a tumor location while avoiding general side effects. G-202 (mipsagargin) is an example of prodrug chemotherapy. It is activated by Prostate Specific Memory Antigen (PSMA), which is expressed by some cancer cells and in the blood vessels of most solid tumors, but not by normal cells or blood vessels in normal tissue. It is believed that activation of the prodrug G-202 will allow the drug to kill cancer cells. This study will evaluate the activity and safety of G-202 in patients with hepatocellular carcinoma who have progressed after taking sorafenib. The study will evaluate clinical activity and safety of G-202 administered by intravenous infusion on three consecutive days of a 28-day cycle.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
G-202 administered by intravenous infusion (IV, in the vein) on Days 1, 2 and 3 of each 28-day cycle until progression or development of unacceptable toxicity
Mary Crowley Cancer Research Center
Dallas, Texas, United States
Oncology Consultants, PA
Houston, Texas, United States
University of Texas Health Sciences Center at Houston, Memorial Hermann Cancer Center
Houston, Texas, United States
The University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Time to progression
Duration of time from the first administration of G-202 to the time of radiologic progression
Time frame: every 8 weeks, until disease progression (estimated up to 2 years)
Overall response rate
Percentage of patients with complete response (CR), partial response (PR) or stable disease (SD) after treatment with G-202
Time frame: every 8 weeks, until disease progression (estimated up to 2 years)
Progression-free survival
Duration of time from the first administration of G-202 to the time of radiologic progression or death
Time frame: every 8-12 weeks, until disease progression or death (estimated up to 3 years)
Overall survival
Duration of time from the first administration of G-202 to the time of death
Time frame: every 12 weeks for approximately 3 years or until patient death
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