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
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.
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)|
|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|
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.
- 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).
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
|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|
|Principal Investigator:||Farhad Ravandi-Kashani, MD||M.D. Anderson Cancer Center|