University of Southern California
USC Norris Comprehensive Cancer Center
If you are a patient, please contact Keck Medical Center of USC at 800-USC-CARE.

Trial 0C-10-4


A Phase Ia/Ib Clinical Trial of PRI-724 in Patients with Advanced Solid Tumors.

Type: Cancer Therapy
Phase: Phase I
Status: Open to Accrual
Treatments: Chemotherapy: Systemic
Randomized: No
Defintions of terms and FAQ about clinical trials.
Trial Leaders/Researchers:  Anthony El-Khoueiry, M.D.
Other Trial Staff:  Anayansi Miloud, D.M., Xiomara Menendez, R.N., Jubilee Acap, R.N., Molly Oswald, R.N., Jennifer Berg, D.M.

Staff may log in to see study documents.


You may participate in this study if:
 Requirement
1In the dose-escalation part of the study (Phase Ia), patients must have histological or cytological evidence of solid tumor malignancy; in the MTD-expansion (Phase Ib) cohort, patients must have histological or cytological evidence of colorectal or pancreatic cancer.
2Patients must have neoplastic disease that is metastatic or unresectable, that has recurred or progressed following standard therapy, not be candidates for standard therapy, or have a malignancy for which no standard therapy exists. In the Phase Ib, patients must have tumors accessible for biopsy, and they must have measurable disease according per RECIST 1.1 criteria.
3Patients must agree, as part of the informed consent, to provide blood samples for molecular correlative studies. In the Phase Ib cohort, patients must agree to pre-and post-treatment biopsies of their malignant disease.
4At least 18 years of age
5Karnofsky performance status 70 - 100%
6Life expectancy of at least 12 weeks
7WBC = / > 3.0; AGC = / > 1.5; platelets = / > 100,000
8Bilirubin <1.5; SGOT and SGPT <3 x uln (<5 x uln if with hepatic involvement by malignant disease)
9Creatinine < uln or calculated CrCl >60 ml/min
10Recovered to Gr 1 from the effects (excluding alopecia) of any prior therapy for their malignancies
11Signed an approved study-specific informed consent and HIPAA


You may not participate in this study if:
1Infection requiring systemic antibiotics 72 hours prior to the first dose of PRI-724
2Known hypersensitivity to any of the components of PRI-724
3Pregnant or lactating women. Women of childbearing potential (WOCBP) and male patients with WOCBP partner must use an adequate method of contraception throughout the study and for up to 12 weeks after the last dose of investigational product. WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or is not post-menopausal. Post-menopause is defined as: [a] amenorrhea for at least 12 consecutive months without another cause, or [b] for women with irregular menstrual periods and on hormone replacement therapy (HRT), a documented serum FSH level >35 mIU/ml. Women who are using oral contraceptives, other hormonal contraceptives (vaginal products, skin patches, or implanted or injectable products), or mechanical products such as an IUD or barrier methods (diaphragm, condoms, spermicides), or are practicing abstinence or where their partner is sterile (e.g., vasectomy) should be considered to be of childbearing potential. WOCBP must have a negative serum test (HCG) within 72 hours prior to the start of investigational product.
4Untreated CNS metastases; patients whose CNS metastases have been treated by surgery or radiotherapy, who are no longer on corticosteroids, and who are neurologically stable may be enrolled in the dose escalation portion of the trial but not in the Phase Ib cohort.
5Treatment with any investigational agent within a period of 28 days between the last dose of the investigational agent and the first dose of PRI-724
6QTcF intervals >470 msec (females) or >450 msec (males)
7Active hepatitis B, hepatitis C
8NYHA Class 3 or 4; MI, acute coronary syndrome, DM with ketoacidosis or COPD requiring hospitalization in the preceding 6 months; or any other inter-current medical condition that contraindicates treatment with PRI-724 or places the patient at undue risk for treatment-related complications
9Any other condition, including mental illness or substance abuse, deemed by the investigator to be likely to interfere with a patient’s ability to sign informed consent, cooperate, and participate in the study, or interferes with the interpretation of the results
10Known osteopenia or osteoporosis
11On full dose anti-coagulants or any dose of warfarin. Patients on prophylactic doses of LMW heparin are allowed.
12Given the potential interaction between C82, the metabolite of PRI-724, and CYP3A4 inhibitors, treating physicians should exercise caution and switch patients to equivalent drugs that are not potent CYP3A4 inhibitors whenever feasible.



For further information on a study, please contact the Clinical Investigation Support Office at (323) 865-0451, or clinical.trials@med.usc.edu.

To schedule a consultation with the hospital, please call our New Patient Referrals Office at (323) 865-3111.