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

Inclusion Criteria

• •Signed written informed consent
• •Must consent to companion study MCC-14674 Immunohistochemical study of phosphorylated Akt in solid malignancies"
• •Histologically documented cancer which is p-Akt positive by immunohistochemistry (IHC).
• •Bi-dimensionally Measurable disease. If the only measurable disease is located in a previously irradiated area, definitive progression following irradiation must be documented.
• •Eastern Cooperative Oncology Group (ECOG) performance status 0 2 at study entry
• •Adequate recovery from recent surgery, chemotherapy and radiation therapy. At least 28 days must have elapsed from major surgery, prior chemotherapy, prior treatment with an investigational agent or prior radiation therapy.
• •Accessible for treatment and follow-up. Patients enrolled in this trial must be treated at the participating center.
• •Patients must be refractory to, or intolerant of, established therapy known to provide clinical benefit for their condition.
• •Tumor site that is accessible to repetitive biopsies. Four core biopsies of the primary or metastatic tumor sites (or recurrence) are required prior to treatment initiation, and approximately 16 days after treatment initiation.
• •Coagulation testing including Partial Thromboplastin Time (PTT), Prothrombin Time (PT), or International Normalization Ratio (INR) less than 1.5 times the upper limit of normal.
• •Life expectancy of at least 3 months (12 weeks).
• •Age greater than or equal to 18 years
• •Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 4 weeks after the study in such a manner that the risk of pregnancy is minimized. WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or is not postmenopausal \[defined as amenorrhea greater than or equal to 12 consecutive months; or women on hormone replacement therapy (HRT) with documented serum follicle stimulating hormone (FSH) level greater than 35 mIU/mL\]. Even women who are using oral, implanted or injectable contraceptive hormones or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy or practicing abstinence or where partner is sterile (e.g., vasectomy), should be considered to be of child bearing potential.
• •WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG, or in accordance with local regulations, whichever is more sensitive) within 72 hours prior to the start of study medication or in accordance with local regulations, whichever is of shorter duration.