Dose Escalation Study of OMP-54F28 in Combination With Sorafenib in Patients With Hepatocellular Cancer

Completed · Phase 1

Conditions studied: Hepatocellular Cancer, Liver Cancer

In brief

This is an open-label Phase 1b dose-escalation study to assess the safety, tolerability, and PK of OMP-54F28 when combined with sorafenib. OMP-54F28 will be administered IV on Day 1 of each 21-day cycle. The planned dose levels of OMP-54F28 are 5 and 10 mg/kg. Depending on safety in this study, additional lower or intermediate dose levels may be evaluated.

Key facts

Study ID

NCT02069145

Run by

OncoMed Pharmaceuticals, Inc.

People needed

10

Starts

2014-01-01

Expected to finish

2017-07-01

Last updated by the study team

2020-08-11

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Signed Informed Consent Form
• Age ≥18 years
• Histologically documented hepatocellular carcinoma
• Locally advanced or metastatic disease
• Availability of FFPE tumor tissue, either archival or obtained at study entry through fresh biopsy
• o Tumor tissue from fine needle aspiration is not acceptable.
• ECOG performance status of 0 or 1 (see Appendix C)
• All acute treatment-related toxicity from prior therapy must have resolved to Grade ≤ 1 prior to study entry
• Adequate hematologic and end-organ function
• Child-Pugh Classification A (see Appendix D)
• Evaluable or measurable disease per RECIST v1.1
• For women of childbearing potential and men with partners of childbearing potential, agreement to use two effective forms of contraception

You may not qualify if…

• Inability to take oral medications
• Prior systemic therapy for locally advanced or metastatic hepatocellular cancer
• Prior adjuvant therapy with sorafenib or another Raf/VEGF inhibitor
• Prior history of allografts, including, but not limited to, liver and bone marrow transplants
• Esophageal or gastric variceal bleeding within last 3 months
• Risk for varices, based on known history of esophageal or gastric varices, evidence of hepatic cirrhosis and/or portal hypertension including biopsy-proven cirrhosis, hypersplenism, or radiographic findings of varices
• Clinically evident ascites
• Evidence of encephalopathy within last 3 months
• Treatment with inducers of cytochrome P450 3A4 (CYP3A4) within 7 days prior to first dose of study treatment
• Treatment with interferon within 4 weeks prior to first dose of study treatment
• Treatment with any anti-cancer therapy, including radiotherapy, chemotherapy, biologic therapy, or herbal therapy within 3 weeks or 5 half-lives (for systemic agents), whichever is shorter
• Known hypersensitivity to any component of study treatments that resulted in drug discontinuation
• Uncontrolled seizure disorder or active neurologic disease
• Untreated brain metastases
• Leptomeningeal disease as a manifestation of cancer
• Active infection requiring antibiotics
• Bisphosphonate therapy for symptomatic hypercalcemia
• Significant intercurrent illness including, but not limited to, unstable angina pectoris, and cardiac arrhythmia, or psychiatric illness/social situation that would limit compliance with study requirements
• Pregnancy, lactation, or breastfeeding
• Known HIV infection
• Active Hepatitis B infection in the absence of adequate antiviral therapy
• Uncontrolled hypertension, defined as systolic blood pressure >140 mm Hg or diastolic blood pressure >90 mm Hg, despite medical management
• Pulmonary hemorrhage of Grade ≥2 within 28 days prior to first dose of study treatment
• Any other hemorrhage or bleeding of Grade ≥3 within 28 days prior to first dose of study treatment
• Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation)

Where it is running

• USC/Norris Comprehensive Cancer Center — Los Angeles, California, United States
• University of Colorado Cancer Center — Aurora, Colorado, United States
• Indiana University Simon Cancer Center — Indianapolis, Indiana, United States
• Massachussetts General Hospital — Boston, Massachusetts, United States
• Mount Sinai Medical Center — New York, New York, United States
• Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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