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NCT00363454 · ClinicalTrials.gov registry record · Phase 1
Phase I Study of Triciribine Phosphate Monohydrate (TCN-PM, VD-0002) in Adult Subjects With Metastatic Cancer
A Phase 1 study, sponsored by Prescient Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 19
- Enrollment target
NCT00363454 is a Phase 1 study that has completed, run by Prescient Therapeutics. The registered enrollment target is 19 participants.
The verdict
NCT00363454, a Phase 1 study, has completed, sponsored by Prescient Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 19 participants
- Enrollment target
Study 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 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.
Interventions
- DRUG Triciribine Phosphate Monohydrate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2006-04 |
| Est. Completion | 2010-09 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00363454
The ClinicalTrials.gov registry entry for NCT00363454 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 19 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Prescient Therapeutics, which has 6 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Triciribine Phosphate Monohydrate is the first listed.
NCT00363454 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00363454 about?
NCT00363454 is a clinical study titled "Phase I Study of Triciribine Phosphate Monohydrate (TCN-PM, VD-0002) in Adult Subjects With Metastatic Cancer". 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 i...
What is the current status of trial NCT00363454?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 19 participants. The study started on 2006-04. Estimated completion is 2010-09.
What interventions are being tested in trial NCT00363454?
The interventions under investigation include: Triciribine Phosphate Monohydrate (DRUG).
Who is sponsoring clinical trial NCT00363454?
This trial is sponsored by Prescient Therapeutics, which has 6 total clinical trials registered on ClinicalTrials.gov.
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