Phase I Study of Triciribine Phosphate Monohydrate (TCN-PM, VD-0002) in Adult Subjects With Metastatic Cancer
Status:
Completed
Trial end date:
2010-09-01
Target enrollment:
Participant gender:
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.