Triciribine Phosphate Monohydrate (TCN-PM, VD-0002) in Adult Patients With Advanced Hematologic Malignancies

• Status: Completed
• Trial end date: 2012-10-01
• Target enrollment: 0
• Participant gender: All

Summary

Primary objective:

To determine the dose limiting toxicity (DLT) and maximum tolerated dose (MTD) of TCN-PM (Triciribine) when administered as an approximately one-hour intravenous infusion on a weekly schedule on days 1, 8 and 15 in a 28 day cycle in patients with advanced hematologic malignancies;

To determine the pharmacokinetics (PK) of Triciribine following study drug administration.

Secondary objective:

To observe the anti-tumor effects of Triciribine, if any occur

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Prescient Therapeutics, Ltd.
• Collaborator: VioQuest Pharmaceuticals

Criteria

Inclusion Criteria:

1. Patients must have relapsed/refractory leukemias for which no standard therapies are anticipated to result in a durable remission. Patients with poor-risk myelodysplasia (MDS) [i.e. refractory anemia with excess blasts (RAEB-1 or RAEB-2) by WHO classification] and chronic myelomonocytic leukemia (CMML) are also candidates for this protocol.

2. CONTINUATION # 1: Relapsed/refractory leukemias include acute non-lymphocytic leukemia (AML) by World Health Organization (WHO) classification, acute lymphocytic leukemia (ALL), chronic lymphocytic leukemia (CLL), or chronic myelogenous leukemia (CML) in blast crisis. Patients with agnogenic myeloid metaplasia (AMM) are also eligible;

3. ECOG performance status of 0- 3;

4. Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must use acceptable contraceptive methods (abstinence, intrauterine device [IUD], oral contraceptive or double barrier device), and must have a negative serum or urine pregnancy test within 2 weeks prior to beginning treatment on this trial. Nursing patients are excluded. Sexually active men must also use acceptable contraceptive methods for the duration of time on study. Pregnant and nursing patients are excluded because the effects of Triciribine on a fetus or nursing child are unknown;

5. Must be able and willing to give written informed consent;

6. In the absence of rapidly progressing disease, the interval from prior treatment to time of study drug administration should be at least 2 weeks for cytotoxic agents, or at least 5 half-lives for noncytotoxic agents. If the patient is on hydroxyurea to control peripheral blood leukemic cell counts, the patient must be off hydroxyurea for at least 48hours before initiation of treatment on this protocol. Persistent chronic clinically significant toxicities from prior chemotherapy must not be greater than grade 1; and

7. Patients must have the following clinical laboratory values, unless abnormal parameter level is considered related to leukemia: Creatinine (Cr) less than or equal to 2.0 mg/dL, Bilirubin Normal limits (less than or equal to 1.5 * Upper Limit of Normal (ULN) with liver metastases) unless considered due to Gilbert's syndrome, Aspartate aminotransferase (AST) less than or equal to 3.0 * ULN, Alanine aminotransferase (ALT) less than or equal to 3.0 * ULN

Exclusion Criteria:

1. Uncontrolled intercurrent illness including, but not limited to uncontrolled infection, symptomatic congestive heart failure, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements;

2. Active heart disease including myocardial infarction within previous 3 months, symptomatic coronary artery disease, arrhythmias not controlled by medication, or uncontrolled congestive heart failure; and

3. Patients receiving any other standard or investigational treatment for their hematologic malignancy.