TABLE 1.
Drug (Target) | Clinical trial (Phase) | Status | Cancer type | Patients enrolled | Arms | Outcomes |
AP 12009 (TGF-β2) | NCT00431561 (Phase II) | Completed | Glioblastoma and anaplastic astrocytoma | 141 | AP 12009 (10 μM) AP 12009 (80 μM) Temozolomide or procarbazine, lomustine, and vincristine |
Improved PFS Improved OS (Results for responders regardless drug concentration administered) |
AP 12009 (TGF-β2) | NCT00761280 (Phase III) | Terminated | Glioblastoma and anaplastic astrocytoma | 27 | AP 12009 (10 μM) Temozolomide or carmustine or lomustine |
NA |
AP 12009 (TGF-β2) | NCT00844064 (Phase I) | Completed | Melanoma, pancreatic and colorectal neoplasms | 62 | Single-arm: AP 12009 (dose escalation) | NA |
PFS, progression-free survival; OS, overall survival. NA, not available.