A Phase I Study of Triciribine Phosphate Monohydrate (TCN-PM, VD-0002) in Adult Patients With Advanced Hematologic Malignancies
Sponsor study identifier
interventional
20
1 country
2
Study Start
August 2006
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
October 2012
Actual (reported)Study Completion
October 2012
Actual (reported)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
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2012
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 2006
Date type not reportedThis date has not been verified as actual or estimated.
March 18, 2008
Actual (reported)March 24, 2008
Actual (reported)October 2012
Actual (reported)October 2012
Actual (reported)Maximum tolerated dose (MTD) of TCN-PM (Triciribine)
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).
28 day cycle
Triciribine 15 mg/m\^2 intravenous (IV) Weekly Over 1 Hour On Days 1, 8, and 15.
15 mg/m\^2 IV Weekly Over 1 Hour On Days 1, 8, and 15.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
H. Lee Moffitt Cancer Center
Tampa, Florida, 33612, United States
UT MD Anderson Cancer Center
Houston, Texas, 77030, United States
Sampath D, Malik A, Plunkett W, Nowak B, Williams B, Burton M, Verstovsek S, Faderl S, Garcia-Manero G, List AF, Sebti S, Kantarjian HM, Ravandi F, Lancet JE. Phase I clinical, pharmacokinetic, and pharmacodynamic study of the Akt-inhibitor triciribine phosphate monohydrate in patients with advanced hematologic malignancies. Leuk Res. 2013 Nov;37(11):1461-7. doi: 10.1016/j.leukres.2013.07.034. Epub 2013 Aug 6.
Farhad Ravandi-Kashani, MD
M.D. Anderson Cancer Center
20 participants (actual enrollment reported by the registry).
First Submitted
March 18, 2008
First Posted
March 24, 2008
Study Start
August 2006
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
October 2012
Actual (reported)Study Completion
October 2012
Actual (reported)Last Updated
August 9, 2016
Record last verified: 2016-08
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Source: ClinicalTrials.gov.
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