Phase I Pharmacokinetic and Pharmacodynamic, Open-Label, Dose Escalation Study of Triciribine Phosphate Monohydrate (TCN-PM, VD-0002) in Adult Subjects With Metastatic Cancer Which Have Activated Akt Demonstrated by Immunohistochemistry
Phase I dose escalation study of Triciribine Phosphate Monohydrate (TCN-PM) in patients with
metastatic cancer. Study patients will be recruited from a companion study [MCC-14474
"Immunohistochemical study of phosphorylated Akt in solid malignancies"], and potential
subjects tumors' must be shown to be p-Akt positive.
Pretreatment evaluations are chest roentgenogram (CXR) and CT/MRI scans of the sites of
known disease, performance status, tumor biopsy, MUGA (EF only), and a pregnancy test. A
CT/MRI scan of the chest, abdomen, and pelvis known sites of disease is required at baseline
and an immunohistochemical (IHC) assay for determination of akt expression (positive) prior
to study drug administration.
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.
Palliative and supportive care for other disease-related symptoms and for toxicity
associated with treatment will be offered to all patients on this trial. Unless unacceptable
toxicity occurs, the duration of treatment will be based on tumor reassessment done every
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum Tolerated Dose (MTD)
To determine the dose of TCN-PM (VD-0002) (administered as a one-hour infusion days 1, 8, 15 every 28 days) which will inhibit by at least 50% Akt phosphorylation by ex vivo testing of tumor tissue samples
Dependent upon results of periodic testing
Robert Wenham, M.D.
H. Lee Moffitt Cancer Center and Research Institute
United States: Food and Drug Administration
|H. Lee Moffitt Cancer Center & Research Insitute||Tampa, Florida 33612|