Ignite Creation Date:
2024-05-05 @ 4:59 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00363454
Status:
COMPLETED
Last Update Posted:
2016-08-09
First Post:
2006-08-10
Brief Title:
Phase I Study of Triciribine Phosphate Monohydrate TCN-PM VD-0002 in Adult Subjects With Metastatic Cancer
Sponsor:
Prescient Therapeutics Ltd
Organization:
Prescient Therapeutics Ltd
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2015-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Phase I dose escalation study of Triciribine Phosphate Monohydrate TCN-PM in patients 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 andor prior to each treatment dose Body Surface Area BSA should be calculated approximately every 8 weeks Imaging studies CTMRI 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
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 andor prior to each treatment dose Body Surface Area BSA should be calculated approximately every 8 weeks Imaging studies CTMRI 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
Detailed Description:
Phase I dose escalation study of Triciribine Phosphate Monohydrate TCN-PM in patients 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 CTMRI scans of the sites of known disease performance status tumor biopsy MUGA EF only and a pregnancy test A CTMRI 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 weeklydays 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 andor prior to each treatment dose Body Surface Area BSA should be calculated approximately every 8 weeks Imaging studies CTMRI 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
Pretreatment evaluations are chest roentgenogram CXR and CTMRI scans of the sites of known disease performance status tumor biopsy MUGA EF only and a pregnancy test A CTMRI 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 weeklydays 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 andor prior to each treatment dose Body Surface Area BSA should be calculated approximately every 8 weeks Imaging studies CTMRI 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| VQ-TCN-05-001 | OTHER | Vioquest | None |