Safety and Efficacy Study of PRI-724 in Subjects With Advanced Solid Tumors
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|ClinicalTrials.gov Identifier: NCT01302405|
Recruitment Status : Terminated (closing due to low enrollment, no safety issues)
First Posted : February 24, 2011
Last Update Posted : August 17, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Advanced Solid Tumors||Drug: PRI-724||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||23 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase Ia/Ib Clinical Trial of PRI-724 in Patients With Advanced Solid Tumors|
|Study Start Date :||February 2011|
|Actual Primary Completion Date :||January 2015|
|Actual Study Completion Date :||June 2015|
- 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. ]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 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|