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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 1
18 Years
Not Enrolling

Thank you

Trial Information

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
eight weeks.

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

- Bi-dimensionally Measurable disease. If the only measurable disease is located in a
previously irradiated area, definitive progression following irradiation must be

- 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.

Exclusion Criteria:

- A baseline prolongation of QT/QTc interval >450 milliseconds (ms)

- A history of additional risk factors for torsades des pointes (e.g., heart failure,
hypokalemia, family history of Long QT Syndrome)

- The use of concomitant medications that prolong the QT/QTc interval

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum Tolerated Dose (MTD)

Outcome Description:

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

Outcome Time Frame:

Dependent upon results of periodic testing

Safety Issue:


Principal Investigator

Robert Wenham, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

H. Lee Moffitt Cancer Center and Research Institute


United States: Food and Drug Administration

Study ID:




Start Date:

April 2006

Completion Date:

September 2010

Related Keywords:

  • Cancer
  • Phase I
  • Pharmacokinetics
  • TCN-PM
  • VD-0002
  • Immunohistochemistry
  • Serum tumor marker
  • Akt phosphorylation
  • Ex vivo testing
  • metastatic
  • Neoplasm Metastasis



H. Lee Moffitt Cancer Center & Research Insitute Tampa, Florida  33612