A Phase 2 Study of IMC-A12 (NSC742460) in Hepatocellular Carcinoma
I. To determine the progression-free survival (PFS) at 4 months in patients with advanced
hepatocellular carcinoma (HCC) treated with anti-IGF-1R recombinant monoclonal antibody
II. To determine the best overall response rate in patients treated with this drug.
I. To determine the median overall survival of patients treated with this drug. II. To
evaluate the safety, tolerability, and adverse events profile of this drug in these
III. To perform a subgroup analysis to compare PFS of patients with advanced HCC who are
hepatitis B positive/hepatitis C negative versus patients who are hepatitis B
negative/hepatitis C positive treated with this drug.
IV. To store pre-therapy paraffin embedded tumor tissue for future tissue-based correlative
V. To evaluate tumor necrotic areas using a new volumetric method of assessing non-viable
tumor as a correlate for response.
VI. To prospectively validate and compare the CLIP and the GDETCH staging systems and
additional prognostic factors.
OUTLINE: Patients receive anti-IGF-1R recombinant monoclonal antibody IMC-A12 IV over 1 hour
once weekly. Treatment continues in the absence of disease progression or unacceptable
Patients undergo serum sample collection at baseline for future tissue-based correlative
studies. Previously collected paraffin embedded tumor tissue samples are also stored for
future correlative studies.
After completion of study treatment, patients are followed every 3 months for at least 1
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
PFS defined as the time from first date of first treatment on the study until such time as progressive disease is confirmed or upon patient death if disease progression has not been evident at that time. A Simon's optimal two stage design will be used with the following assumption: a 4 months PFS of 62% is considered acceptable while a 4 months PFS of 42% is not acceptable.
At 4 months
Memorial Sloan-Kettering Cancer Center
United States: Food and Drug Administration
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