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.
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 eight weeks.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
19
8 Cycles @ 28 days. Level 1: 15 mg/m\^2; Level 2: 25 mg/m\^2; 35 mg/m\^2; 45 mg/m\^2.
H. Lee Moffitt Cancer Center & Research Insitute
Tampa, Florida, United States
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
Time frame: Dependent upon results of periodic testing
Pharmacokinetics of TCN-PM,VD-0002
To characterize the pharmacokinetics of TCN-PM (VD-0002) when administered as a one-hour infusion days 1, 8 and 15 every 28 days
Time frame: Dependent upon results of periodic testing
Radiologic response rate
To monitor for drug efficacy, as determined by: radiologic response rate (RECIST criteria)
Time frame: Dependent upon results of periodic testing
Biochemical response rate
To monitor for drug efficacy, as determined by: biochemical response rate (if a serum tumor marker is present)
Time frame: Dependent upon results of periodic testing
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