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Phase I Study of Triciribine Phosphate Monohydrate (TCN-PM, VD-0002) in Adult Subjects With Metastatic Cancer

NCT00363454 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2016-08-09

No results posted yet for this 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.

Conditions

Interventions

DRUG

Triciribine Phosphate Monohydrate

8 Cycles @ 28 days. Level 1: 15 mg/m\^2; Level 2: 25 mg/m\^2; 35 mg/m\^2; 45 mg/m\^2.

Sponsors & Collaborators

  • VioQuest Pharmaceuticals

    collaborator INDUSTRY

  • Prescient Therapeutics, Ltd.

    lead INDUSTRY

Principal Investigators

  • Robert Wenham, M.D. · H. Lee Moffitt Cancer Center and Research Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-04-30
Primary Completion
2010-09-30
Completion
2010-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00363454 on ClinicalTrials.gov