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| Sponsor: | Proacta, Incorporated |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | Proacta, Incorporated |
| ClinicalTrials.gov Identifier: | NCT00349167 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Unspecified Adult Solid Tumor, Protocol Specific |
Drug: PR-104 Other: laboratory biomarker analysis Other: pharmacological study |
Phase I |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| 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 |
| Estimated Enrollment: | 30 |
| Study Start Date: | December 2005 |
| Primary Completion Date: | July 2007 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
Tertiary
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed solid tumor, meeting 1 of the following criteria:
PATIENT CHARACTERISTICS:
No significant cardiac comorbidity including any of the following:
PRIOR CONCURRENT THERAPY:
Concurrent steroids allowed provided dose is stable for ≥ 2 weeks and clinical condition is stable for 1 month
No concurrent radiotherapy, including local palliative radiotherapy or systemic radioisotopes
Contacts and Locations| United States, California | |
| Jonsson Comprehensive Cancer Center at UCLA | |
| Los Angeles, California, United States, 90095-1781 | |
| Principal Investigator: | Mark D. Pegram, MD | Jonsson Comprehensive Cancer Center |
More Information
| Responsible Party: | Brenda Gibson, Assoc. Director, Proacta, Inc. |
| ClinicalTrials.gov Identifier: | NCT00349167 History of Changes |
| Other Study ID Numbers: | PR104-1001, P30CA016042, UCLA-0512034-01A, PROACTA-PR-104-1001 |
| Study First Received: | July 5, 2006 |
| Last Updated: | February 28, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
unspecified adult solid tumor, protocol specific |
|
Neoplasms |