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Hepatocellular CancerPhase 1NCT02069145

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

A Phase 1 study testing OMP-54F28 with Sorafenib in people with Hepatocellular Cancer and Liver Cancer, run by OncoMed Pharmaceuticals, Inc. at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Hepatocellular Cancer, Liver Cancer
What is being tested?
OMP-54F28 with Sorafenib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
6 sitesUnited States
Study dates
Jan 2014to Jul 2017
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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

Who cannot join

  • 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
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  • 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)
  • Concurrent use of therapeutic warfarin
  • New York Heart Association Classification III or IV (see Appendix F)
  • Congenital long QT syndrome
  • Known clinically significant gastrointestinal disease including, but not limited to, inflammatory bowel disease
  • Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to the first dose of study treatment or anticipation of need for major surgical procedure during the course of the study
  • Osteoporosis based on a T-score of <-2.5 at the left or right total hip, left or right femoral neck or lumbar spine (L1-L4) as determined by DEXA scan
  • Bone metastases and one of the following:
  • Prior history of a pathologic fracture
  • Lytic lesion requiring an impending orthopedic intervention
  • Lack of treatment with a bisphosphonate or denosumab
  • Treatment with a thiazolidinedione PPAR gamma inhibitor; e.g. Actos® (pioglitazone) and Avandia® (rosiglitzone)
  • Active treatment with an oral or IV glucocortocoid for ≥4 weeks at a daily dose equivalent to or greater than 7.5 mg of oral prednisone
  • Fasting β-CTX of >1000 pg/mL
  • Metabolic bone disease, such as hyperparathyroidism, Paget's disease or osteomalacia

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites

  • University of Colorado Cancer Center

    Aurora, Colorado, 80045

  • Massachussetts General Hospital

    Boston, Massachusetts, 02114

  • Indiana University Simon Cancer Center

    Indianapolis, Indiana, 46202

  • USC/Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

  • Mount Sinai Medical Center

    New York, New York, 10029

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

Other trials in United States

About this study

Official title: A Phase 1b Dose Escalation Study of OMP-54F28 in Combination With Sorafenib in Patients With Hepatocellular Cancer

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.

Read the detailed description

Depending on emerging safety data from the Phase 1a study 54F28-001 with continuing dose escalation, additional higher dose levels of OMP-54F28 may be evaluated in this study. Alternative dosing schedules of OMP-54F28 may be explored based on emerging nonclinical and clinical data for safety, PD, PK and efficacy. The starting dose for a new dosing schedule will be chosen to result in an AUC equivalent to the highest dose level that cleared on the previously studied dosing schedule. No dose escalation of OMP-54F28 will be allowed within a dose cohort. Sorafenib 400 mg will be given orally twice daily (PO BID). Sorafenib dosing schedules with a total daily dose <800 mg (e.g. Sorafenib 400 mg once daily) may be evaluated in this study depending on emerging safety data from this study.

Being tested
OMP-54F28 with Sorafenib
Keywords
Hepatocellular Cancer, Liver Cancer
Medical subject headings
Liver Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OMP-54F28 with SorafenibDrug

    Also called OMP-54F28, Sorafenib

Study groups in NCT02069145
Study groupRoleWhat they receive
Drug: OMP-54F28, with SorafenibExperimentalNot described
Receives: Drug: OMP-54F28 with Sorafenib

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

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

Secondary outcomes (1)

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

    Apparent half life, AUC, clearance, volume of distribution

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Feb 2014 (estimated)
  2. Study startJan 2014
  3. Primary completionMay 2017
  4. Study completionJul 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02069145
Sponsor's protocol ID
54F28-004
Status last verified
Aug 2020
First submitted
18 Feb 2014
Last updated
11 Aug 2020
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing OMP-54F28 with Sorafenib in people with Hepatocellular Cancer and Liver Cancer, run by OncoMed Pharmaceuticals, Inc. at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 39 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and tolerability of OMP-54F28 in combination with sorafenib in patients with hepatocellular cancer (time frame: Subjects will be treated and observed for DLT through the end of the first cycle (from Day 0 - 21)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02069145.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2020.

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