Status:
WITHDRAWN
Phase 1b/2 Study of Oprozomib in Combination With Sorafenib in Subjects With Advanced Hepatocellular Carcinoma
Lead Sponsor:
Amgen
Conditions:
Advanced Hepatocellular Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of Phase 1b of the study is to determine the maximum tolerated dose, pharmacokinetics (PK) and pharmacodynamics (PDn) and assess the safety, tolerability and activity of oprozomib in combi...
Eligibility Criteria
Inclusion
- Key
- Patients with advanced HCC
- For the Phase 2 portion of the study, at least 1 measurable tumor lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, which has not been previously treated with local therapy
- Cirrhotic status of Child-Pugh Class A only
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- The following laboratory parameters:
- Albumin ≥ 2.8 g/dL
- Platelet count ≥ 60,000/mm3
- Absolute neutrophil count (ANC) ≥ 1500/mm3
- Hemoglobin ≥ 8.5 g/dL
- Total bilirubin ≤ 3 mg/dL
- Alanine aminotransaminase (ALT) and aspartate aminotransferase (AST) ≤ 3 times upper limit of normal (ULN)
- Amylase and lipase ≤ 1.5 times ULN
- Calculated or measured creatinine clearance (CrCl) ≥ 30 mL/min
- Prothrombin time (PT)-international normalized ratio (INR) ≤ 2.3 or PT ≤ 6 seconds above control
- Key
Exclusion
- Previous or concurrent cancer that is distinct in primary site or histology from HCC, EXCEPT cervical and breast carcinoma in situ, adequately treated basal cell or squamous cell carcinoma of the skin, or superficial bladder tumors (Ta, Tis \& T1)
- Renal failure requiring hemo- or peritoneal dialysis
- History of cardiac disease
- Active clinically serious infections. Hepatitis B is allowed if no active replication is present. Hepatitis C is allowed if no antiviral treatment is required
- Known history of human immunodeficiency virus (HIV) infection
- Known history or symptomatic metastatic brain or meningeal tumors
- Clinically significant gastrointestinal (GI) bleeding, serious nonhealing wound and ulcer within 3 months prior to study entry, or bone fracture within 30 days prior to study entry
- History of organ allograft
- Known or suspected allergy to the investigational agent or any agent given in association with this trial
- Inability to swallow medication, inability or unwillingness to comply with the drug administration requirements, or GI condition that could interfere with the oral absorption or tolerance of treatment
- Uncontrolled diabetes
- Any contraindication to oral hydration (e.g., preexisting cardiac impairment or fluid restriction)
- Uncontrolled ascites
- Pleural effusion or ascites that causes respiratory compromise (NCI-CTCAE ≥ Grade 2 dyspnea).
- Women who are pregnant and/or breastfeeding
- Prior use of any systemic anticancer chemotherapy for HCC
- Prior use of systemic investigational agents for HCC
- Concomitant treatment with strong cytochrome P450 3A4 (CYP3A4) inhibitors
- Known hypersensitivity or intolerance to dexamethasone or 5-HT3 antagonist
Key Trial Info
Start Date :
December 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2015
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT02227914
Start Date
December 1 2014
End Date
March 1 2015
Last Update
May 2 2017
Active Locations (6)
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1
Lahey Hospital & Medical Center
Burlington, California, United States
2
Rocky Mountain Cancer Centers
Denver, Colorado, United States
3
University of Miami Hospital & Clinics
Miami, Florida, United States
4
The University of Chicago Medical Center
Chicago, Illinois, United States