Safety and Efficacy Study of PRI-724 in Subjects With Advanced Solid Tumors
PRI-724 is a new investigational drug being studied to treat subjects with cancer who have advanced solid tumors. PRI-724 is thought to work by blocking the Wnt signaling pathway that cancer cells need to grow and spread(metastasize).
Phase Ia: Patient cohorts with solid tumor malignancies will be treated with escalating doses (per cohort) of PRI-724 in order to identify the MTD of this single-agent regimen. PRI-724 dosing is to start at 40 mg/m2/day, CIV infusion over 24 hours × 7 days.
Phase Ib: This phase is to begin upon identification of the MTD in Phase 1a. Patient cohorts with CRC will be treated with escalating doses (per cohort) of PRI-724 administered in combination with a modified regimen of FOLFOX6 (mFOLFOX 6, standardized doses and schedule) in order to identify the MTD of this combined regimen. Up to 2 dose levels of PRI-724 are to be examined (640 and 905 mg/m2/day, CIV infusion over 24 hours × 7 days), with potential to evaluate a previously unexamined intermediate dose, if indicated, to more fully characterize tolerability. The MTD cohort (or maximum dose to be studied) will be expanded up to 12 patients.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase Ia/Ib Clinical Trial of PRI-724 in Patients With Advanced Solid Tumors|
- Maximum Therapeutic Dose, as defined by the highest dose identified in which ≤1/3 or ≤2/6 patients do not experience a dose limiting toxicity [ Time Frame: Assessed at the completion of each patient enrollment cohort. Each patient monitoring duration is 28 days. ] [ Designated as safety issue: Yes ]Maximum Therapeutic Dose (MTD) will be the highest dose in which no dose limiting toxicity (DLT) is seen in a accelerated enrollment cohort (1 patient) and then subsequently a 3-6 patient cohort following a 3+3 study design. MTD may also be determined by evaluation of PK and PD results of patients.
- Maximum Therapeutic Dose of combined regimen, as defined by the highest dose identified in which ≤1/3 or ≤2/6 patients do not experience a dose limiting toxicity [ Time Frame: Assessed at the completion of each patient enrollment cohort. Each patient monitoring duration is 28 days ] [ Designated as safety issue: Yes ]Maximum Therapeutic Dose (MTD) of the combined regimen will be the highest dose in which MTD is defined as the highest dose level tested in which no patient or only 1 patient experienced a DLT in a 3-6 patient cohort or less than 33.3% of 7 - 12 patients experienced a DLT in the 12-patient expansion cohort. MTD may also be determined by evaluation of PK and PD results of patients.
|Study Start Date:||February 2011|
|Estimated Study Completion Date:||June 2015|
|Primary Completion Date:||January 2015 (Final data collection date for primary outcome measure)|
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT01302405
|United States, Arizona|
|Scottsdale, Arizona, United States, 85259-5499|
|United States, California|
|University of Southern California, Norris Comprehensive Cancer Center|
|Los Angeles, California, United States, 90033|
|United States, Minnesota|
|Mayo Clinic, Department of Oncology|
|Rochester, Minnesota, United States, 55901|
|Principal Investigator:||Anthony El-Khoueiry, MD||University of Southern California|