Status:
TERMINATED
Randomized Phase 1/2 Open-Label Trial of PR104 and Sorafenib in Patients With Advanced Hepatocellular Carcinoma (HCC)
Lead Sponsor:
Proacta, Incorporated
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The current understanding of PR104 justifies the evaluation of PR104 with sorafenib in patients with hepatocellular carcinoma. These include: * Hypoxia. Hepatocellular Carcinoma (HCC) is likely to de...
Detailed Description
A randomized phase I/II, multi-center, open-label, study with a single arm phase I portion to determine the appropriate dose of PR104 combined with sorafenib, followed by a phase II portion with rando...
Eligibility Criteria
Inclusion
- Advanced-stage hepatocellular carcinoma considered non-operable that is suitable for treatment with sorafenib. Subjects who have demonstrated progression following initial surgical or locoregional therapy are eligible
- Confirmed hepatocellular carcinoma by pathological analysis (tissue aspirate or biopsy)
- No previous systemic therapy for hepatocellular carcinoma
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Child-Pugh liver function class A
- Life expectancy of 12 weeks or more
- Adequate hematologic function \[Absolute neutrophil count (ANC) ≥ 1.5 x 10\^9/L; platelet count ≥100×10\^9 per liter; hemoglobin ≥8.5 g per deciliter maintained in the absence of red blood cell transfusions; and prothrombin time international normalized ratio ≤1.7; or prothrombin time ≤2 seconds above control\]
- Adequate hepatic function (albumin ≥2.8 g per deciliter; total bilirubin ≤2 mg per deciliter \[51.3 μmol per liter\]; and alanine aminotransferase and aspartate aminotransferase ≤5 times the upper limit of the normal range)
- Adequate renal function (serum creatinine ≤1.5 times the upper limit of the normal range or creatinine clearance ≥60 mL/min).
- At least one untreated target lesion that could be measured in one dimension, according to the Response Evaluation Criteria in Solid Tumors (RECIST)
- Concomitant systemic antiviral therapy allowed
Exclusion
- Previous molecularly targeted therapies or any other systemic treatment for hepatocellular carcinoma
- Active concomitant malignancy likely to effect any of the primary or secondary outcome measures in the current study
- Women who are pregnant, breast-feeding or planning to become pregnant during the study
- Men or women of reproductive-potential who are unwilling to use an effective method of contraception during the study and for 30 days following the last dose of study medication
- Evidence of a significant medical disorder or laboratory finding that, in the opinion of the Investigator, compromises the subject's safety during study participation such as: uncontrolled infection or infection requiring a concomitant parenteral antibiotic; uncontrolled diabetes; congestive heart failure; myocardial infarction within 6 months of study; chronic renal disease; or coagulopathy (excluding prophylactic anticoagulation)
- Active central nervous system metastatic disease requiring intervention
- Less than four weeks since major surgery
- Known Human Immunodeficiency Virus (HIV) positivity
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT00862082
Start Date
March 1 2009
End Date
May 1 2010
Last Update
August 23 2013
Active Locations (17)
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1
University of Arizona
Tucson, Arizona, United States, 85724
2
Moores UCSD Cancer Center
La Jolla, California, United States, 92093
3
University of California, Irvine
Orange, California, United States, 92868
4
Sharp Clinical Oncology Research
San Diego, California, United States, 92123