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

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ClinicalTrials.gov Identifier: NCT00642031
Recruitment Status : Completed
First Posted : March 24, 2008
Last Update Posted : August 9, 2016
Sponsor:
Collaborator:
VioQuest Pharmaceuticals
Information provided by (Responsible Party):
Prescient Therapeutics, Ltd.

Brief 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


Condition or disease Intervention/treatment Phase
Hematologic Malignancies Leukemia Drug: Triciribine Phase 1

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Study of Triciribine Phosphate Monohydrate (TCN-PM, VD-0002) in Adult Patients With Advanced Hematologic Malignancies
Study Start Date : August 2006
Actual Primary Completion Date : October 2012
Actual Study Completion Date : October 2012


Arm Intervention/treatment
Experimental: Triciribine
Triciribine 15 mg/m^2 intravenous (IV) Weekly Over 1 Hour On Days 1, 8, and 15.
Drug: Triciribine
15 mg/m^2 IV Weekly Over 1 Hour On Days 1, 8, and 15.
Other Names:
  • Triciribine Phosphate Monohydrate
  • TCN-PM
  • VD-0002




Primary Outcome Measures :
  1. Maximum tolerated dose (MTD) of TCN-PM (Triciribine) [ Time Frame: 28 day cycle ]
    The MTD is the highest dose level in which <2 patients of 6 develop first cycle dose-limiting toxicity (DLT). Evaluations after each dose level (28 day cycle).



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00642031


Locations
United States, Florida
H. Lee Moffitt Cancer Center
Tampa, Florida, United States, 33612
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Prescient Therapeutics, Ltd.
VioQuest Pharmaceuticals
Investigators
Principal Investigator: Farhad Ravandi-Kashani, MD M.D. Anderson Cancer Center

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prescient Therapeutics, Ltd.
ClinicalTrials.gov Identifier: NCT00642031     History of Changes
Other Study ID Numbers: 2006-0249
First Posted: March 24, 2008    Key Record Dates
Last Update Posted: August 9, 2016
Last Verified: August 2016

Keywords provided by Prescient Therapeutics, Ltd.:
Hematologic Malignancies
Leukemia
Chronic Myelomonocytic Leukemia
Acute Lymphocytic Leukemia
Chronic Lymphocytic Leukemia
Chronic Myelogenous Leukemia
Agnogenic Myeloid Metaplasia
Triciribine Phosphate Monohydrate
Triciribine
TCN-PM
VD-0002

Additional relevant MeSH terms:
Leukemia
Neoplasms
Neoplasms by Histologic Type