Phase I Study of Triciribine Phosphate Monohydrate (TCN-PM, VD-0002) in Adult Subjects With Metastatic Cancer

Summary

Phase I dose escalation study of Triciribine Phosphate Monohydrate (TCN-PM) in patients with metastatic cancer whose tumors must be shown to be p-Akt positive. Study patients will be recruited from a Moffitt Cancer Center companion study (MCC-14474) "Immunohistochemical study of phosphorylated Akt in solid malignancies." Each treatment cycle will consist of four weeks with TCN-PM being administered weekly (days 1, 8 and 15 every 28 days). Labs, vital signs (BP, HR, Resp Rate, Temp), and hematology and serum chemistry profile are to be performed weekly and/or prior to each treatment dose. Body Surface Area (BSA) should be calculated approximately every 8 weeks. Imaging studies (CT/MRI of chest, abdomen, and pelvis) and tumor response assessments will be performed every eight weeks or more frequently if indicated. Unless unacceptable toxicity occurs, the duration of treatment will be based on tumor reassessment.

Timeline

Start

2006-04

Primary completion

2010-09

Completion

2010-09

Drugs

Indications