Ignite Creation Date:
2025-12-25 @ 12:52 AM
Ignite Modification Date:
2025-12-25 @ 11:07 PM
Study NCT ID:
NCT00349167
Status:
COMPLETED
Last Update Posted:
2012-11-30
First Post:
2006-07-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
PR-104 in Treating Patients With Advanced Solid Tumors
Sponsor:
Proacta, Incorporated
Organization:
Study Overview
Official Title:
A Phase I, Multi-Center, Open Label, Dose Escalation Trial of the Safety and Pharmacokinetics of Intravenous PR-104 Given Every 3 Weeks in Patients With Solid Tumors
Status:
COMPLETED
Status Verified Date:
2012-11
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:
RATIONALE: Drugs used in chemotherapy, such as PR-104, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase I trial is studying the side effects and best dose of PR-104 in treating patients with advanced solid tumors.
PURPOSE: This phase I trial is studying the side effects and best dose of PR-104 in treating patients with advanced solid tumors.
Detailed Description:
OBJECTIVES:
Primary
* Evaluate the safety and tolerability of PR-104 in patients with advanced solid tumors.
* Determine the maximum tolerated dose of PR-104 in these patients.
Secondary
* Characterize the pharmacokinetics of PR-104 and its alcohol metabolite in these patients.
* Assess evidence of antitumor activity of this drug in these patients.
Tertiary
* Examine metabolic changes in tumors of these patients using fludeoxyglucose F 18 positron emission tomography scanning.
OUTLINE: This is a multicenter, open-label, prospective, uncontrolled, dose-escalation study.
Patients receive PR-104 IV over 60 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of PR-104 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Blood is collected at baseline and then periodically during study treatment for pharmacokinetic and tumor marker studies. Patients undergo fludeoxyglucose F 18 positron emission tomography scanning before beginning study treatment and after completion of course 2 to assess metabolic activity of the tumor.
After completion of study treatment, patients are followed at 30 days.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
Primary
* Evaluate the safety and tolerability of PR-104 in patients with advanced solid tumors.
* Determine the maximum tolerated dose of PR-104 in these patients.
Secondary
* Characterize the pharmacokinetics of PR-104 and its alcohol metabolite in these patients.
* Assess evidence of antitumor activity of this drug in these patients.
Tertiary
* Examine metabolic changes in tumors of these patients using fludeoxyglucose F 18 positron emission tomography scanning.
OUTLINE: This is a multicenter, open-label, prospective, uncontrolled, dose-escalation study.
Patients receive PR-104 IV over 60 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of PR-104 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Blood is collected at baseline and then periodically during study treatment for pharmacokinetic and tumor marker studies. Patients undergo fludeoxyglucose F 18 positron emission tomography scanning before beginning study treatment and after completion of course 2 to assess metabolic activity of the tumor.
After completion of study treatment, patients are followed at 30 days.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
Study Oversight
Has Oversight DMC:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| P30CA016042 | NIH | None | https://reporter.nih.gov/quic… | View |
| UCLA-0512034-01A | None | None | View | |
| PROACTA-PR-104-1001 | None | None | View |