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Sponsors and Collaborators: |
H. Lee Moffitt Cancer Center and Research Institute VioQuest Pharmaceuticals |
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Information provided by: | H. Lee Moffitt Cancer Center and Research Institute |
ClinicalTrials.gov Identifier: | NCT00363454 |
Phase I dose escalation study of Triciribine Phosphate Monohydrate (TCN-PM) in subjects with metastatic cancer whose tumors must be shown to be p-Akt positive. Study patients will be recruited from a Moffitt Cancer Center companion study (MCC-14474) "Immunohistochemical study of phosphorylated Akt in solid malignancies."
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. Unless unacceptable toxicity occurs, the duration of treatment will be based on tumor reassessment.
Condition | Intervention | Phase |
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Cancer |
Drug: Triciribine Phosphate Monohydrate |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety Study |
Official Title: | 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 |
Estimated Enrollment: | 30 |
Study Start Date: | April 2006 |
Estimated Study Completion Date: | March 2010 |
Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental
Phase I: Triciribine
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Drug: Triciribine Phosphate Monohydrate
8 Cycles @ 28 days
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Phase I dose escalation study of Triciribine Phosphate Monohydrate (TCN-PM)in subjects 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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Florida | |
H. Lee Moffitt Cancer Center & Research Insitute | |
Tampa, Florida, United States, 33612 |
Principal Investigator: | Robert Wenham, M.D. | H. Lee Moffitt Cancer Center and Research Institute |
Responsible Party: | H. Lee Moffitt Cancer Center and Research Institute ( Robert Wenham, M.D. ) |
Study ID Numbers: | MCC-14675, VQ-TCN-05-001 |
Study First Received: | August 10, 2006 |
Last Updated: | August 3, 2009 |
ClinicalTrials.gov Identifier: | NCT00363454 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Phase I Pharmacokinetics of TCN-PM (VD-0002) Immunohistochemistry |
Serum tumor marker Akt phosphorylation Ex vivo testing |
Neoplasm Metastasis |
Neoplasms Neoplastic Processes Pathologic Processes Neoplasm Metastasis |