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

NCT02069145 | Completed Phase 1

• 1 other identifier: 54F28-004
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 6

Brief Summary

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.

Conditions

Hepatocellular Cancer; Liver Cancer

Keywords

Hepatocellular Cancer; Liver Cancer

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability of OMP-54F28 in combination with sorafenib in patients with hepatocellular cancer

  The maximum tolerated dose (MTD) will be determined in patients treated with OMP-54F28 in combination with sorafenib in patients with hepatocellular cancer

  Subjects will be treated and observed for DLT through the end of the first cycle (from Day 0 - 21)

Secondary Outcomes (1)

• Pharmacokinetics (PK) of OMP-54F28 and sorafenib when administered in combination to patients with hepatocellular cancer

  OMP-54F28 will be administered IV on Day 1 of each 21 day cycle. Plasma sample for Parmacokinetics (PK) analysis to be obtained at various time points, 30 minutes after end of OMP-54F28 infusion and before sorafenib treatment

Study Arms (1)

Drug: OMP-54F28, with Sorafenib

EXPERIMENTAL

Drug: OMP-54F28 with Sorafenib

Interventions

OMP-54F28 with Sorafenib DRUG

Also known as: OMP-54F28, Sorafenib

Drug: OMP-54F28, with Sorafenib

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• OncoMed Pharmaceuticals, Inc.: lead

Study Sites (6)

USC/Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

University of Colorado Cancer Center

Aurora, Colorado, 80045, United States

Location

Indiana University Simon Cancer Center

Indianapolis, Indiana, 46202, United States

Location

Massachussetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Mount Sinai Medical Center

New York, New York, 10029, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

MeSH Terms

Conditions

Liver Neoplasms

Interventions

OMP-54F28; Sorafenib

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2014
• First Posted: February 24, 2014
• Study Start: January 1, 2014
• Primary Completion: May 1, 2017
• Study Completion: July 1, 2017
• Last Updated: August 11, 2020

Record last verified: 2020-08

Locations

US (6)