Efficacy, Safety and CNS Exposure of G-202 (Mipsagargin) in Patients With Recurrent or Progressive Glioblastoma
Status:
Completed
Trial end date:
2017-02-01
Target enrollment:
Participant gender:
Summary
Glioblastoma (GBM) comprises about 16% of all malignancies of the nervous system and over 50%
of all gliomas. Standard of care for newly-diagnosed GBM is a combination of surgical
debulking followed by concurrent radiotherapy and chemotherapy with temozolomide. Efforts to
improve second-line therapy in GBM have met with only marginal success and there is a large
unmet medical need for new therapies. G-202 (mipsagargin) is an example of prodrug
chemotherapy. It is activated by Prostate Specific Membrane Antigen (PSMA), which is
expressed by some cancer cells and in the blood vessels of most solid tumors, including GBM,
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, safety and CNS exposure of G-202 in patients with recurrent or progressive GMB
receiving G-202 by intravenous infusion on three consecutive days of a 28-day cycle. Funding
Source - FDA OOPD