Phase 2 Study of G-202 in Patients With Chemotherapy-Naïve Metastatic Castrate-Resistant Prostate Cancer
Status:
Withdrawn
Trial end date:
2015-01-01
Target enrollment:
Participant gender:
Summary
Prostate cancer that has returned after local treatment usually responds to hormone blocking
treatment, but most patients eventually experience disease progression. Further chemotherapy
does not normally lead to a cure or dramatic improvement in the disease and there is a need
to identify new 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 tumour location whilst
avoiding general side effects. G-202 is an example of prodrug chemotherapy. It does not have
many general side effects because it is converted to a cell toxin only at the tumour or other
specific locations in the body. G-202 is activated by Prostate Specific Memory Antigen
(PSMA), a substance expressed by prostate cancer cells and in the blood vessels of most solid
tumours, 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, particularly
prostate cancer cells. This study will evaluate the activity and safety of G-202 in men with
castration-resistant prostate cancer (CRPC), which means the cancer has progressed after
hormone blocking treatment, but who have not yet received chemotherapy and who have no or
only a few symptoms from their CRPC. The study will evaluate clinical activity and safety of
G-202 administered on three consecutive days of a 28-day cycle.