Solid TumorsPhase 1NCT01608867
A Dose Escalation Study of OMP-54F28 in Subjects With Solid Tumors
A Phase 1 study testing OMP-54F28 in people with Solid Tumors, run by OncoMed Pharmaceuticals, Inc. at 3 sites in United States.
Trial summary
This is an open-label Phase 1 dose escalation study of OMP-54F28 in subjects with a solid tumor for which there is no remaining standard curative therapy. Subjects will be assessed for safety, immunogenicity, pharmacokinetics, biomarkers, and efficacy. No formal interim analyses will be performed. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Solid Tumors
- What is being tested?
- OMP-54F28
- Type of treatment
- Injection or infusion
- How many people
- 26 participants
- Where
- 3 sitesUnited States
- Study dates
- Jun 2012to Jun 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
- Subjects must meet all of the following criteria to be eligible for the study:
- Subjects must have a histologically confirmed malignancy that is metastatic or unresectable and must have received the standard therapies for their malignancy. In addition, subjects must have a tumor that is at least 1 cm in a single dimension and is radiographically apparent on CT or MRI.
- Subjects must have received their last chemotherapy, biologic, or investigational therapy at least 4 weeks prior to enrollment, 6 weeks if the last regimen included BCNU or mitomycin C.
- Age >18 years
- ECOG performance status <2 (see APPENDIX B)
- Estimated life expectancy of more than 3 months
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- Subjects must have adequate organ and marrow function as defined below:
- Absolute neutrophil count >1000/µL Hemoglobin >9.0 g/dL Platelets >100,000/µL Total bilirubin <1.5 X institutional upper limit of normal (ULN) AST (SGOT) and ALT (SGPT) <3 X institutional ULN (for subjects with hepatic metastases <5 X institutional ULN) PT and PTT within 1.5 X institutional ULN Creatinine <1.5 X institutional ULN OR Creatinine clearance >60 mL/min/1.73 m2
- Women of childbearing potential must have had a prior hysterectomy or have a negative serum pregnancy test and be using adequate contraception prior to study entry and must agree to use adequate contraception from study entry through at least 6 months after discontinuation of study drug. Men must also agree to use adequate contraception (barrier method of birth control, abstinence) prior to study entry and from study entry through at least 6 months after discontinuation of study drug. Should a woman enrolled in the study or a female partner of a man enrolled in the study become pregnant or suspect she is pregnant while participating in this study or within 6 months after discontinuation of study, she should inform the Investigator immediately.
- Ability to understand and the willingness to sign a written informed consent document
Who cannot join
- Subjects who meet any of the following criteria will not be eligible for participation in the study:
- Subjects receiving any other investigational agents
- Subjects with brain metastases (subjects must have a CT scan or MRI of the head within 28 days prior to enrollment to rule out brain metastases), uncontrolled seizure disorder, or active neurologic disease
- History of a significant allergic reaction attributed to humanized or human monoclonal antibody therapy or Fc fusion protein
- Significant intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Pregnant women or nursing women
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- Subjects with known HIV, Hepatitis B or Hepatitis C infection
- Known bleeding disorder or coagulopathy
- Subjects receiving heparin, warfarin, or other similar anticoagulants, except for subjects on low molecular weight heparin for DVT/PE prophylaxis. Note: Subjects may be receiving low-dose aspirin and/or non-steroidal anti-inflammatory agents.
- New York Heart Association Classification III, or IV (see APPENDIX D)
- Subjects with known clinically significant gastrointestinal disease including, but not limited to, inflammatory bowel disease.
- Subjects with osteopenia or osteoporosis on their screening DEXA bone density scan.
- Subjects with bone metastases that:
- have a prior history of a pathologic fracture,
- have a lytic lesion requiring an orthopedic intervention or
- are not receiving a bisphosphonate zoledronic acid or denosumab as per institutional guidelines All other subjects with bone metastases are eligible.
- Subjects receiving a thiazolidinedione PPAR gamma inhibitor; i.e. Actos® (pioglitazone), Avandia® (rosiglitazone), and Rezulin® (troglitazone).
- Subjects who have received ≥4 weeks of an oral or intravenous glucocorticoid at a dose that is equivalent to or greater than 5 mg of oral prednisone within the last 8 weeks.
- Subjects with a fasting β-CTX of >1000 pg/mL.
- Subjects with metabolic bone disease, such as hyperparathyroidism, Paget's disease or osteomalacia.
- Subjects with a history of or a newly diagnosed insufficiency fracture or morphometric (asymptomatic) vertebral fracture on the screening lateral lumbosacral spine film.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Michigan Health System
Ann Arbor, Michigan, 48109
University of Colorado Hospital
Aurora, Colorado, 80045
Pinnacle Oncology Hematology,
Scottsdale, Arizona, 85258
About this study
Official title: A Phase 1 Dose Escalation Study of OMP-54F28 in Subjects With Solid Tumors
This is an open-label Phase 1 dose escalation study of OMP-54F28 in subjects with a solid tumor for which there is no remaining standard curative therapy. Subjects will be assessed for safety, immunogenicity, pharmacokinetics, biomarkers, and efficacy. No formal interim analyses will be performed.
Prior to enrollment, subjects will undergo screening to determine study eligibility. Upon enrollment, subjects will receive OMP-54F28 until disease progression. All subjects will receive Vitamin D3 daily and calcium carbonate twice daily from Day 0 through 30 days following the discontinuation of OMP-54F28.
Dose escalation will be conducted to determine the maximum tolerated dose (MTD). Subjects will be dosed at 0.5, 1, 2.5, 5, and 10 mg/kg administered IV once every 3 weeks. No dose escalation or reduction will be allowed within a dose cohort. Intermediate doses (i.e., doses between the dose levels listed above) may also be tested upon agreement with the investigators and the study sponsor. In addition, alternate dosing schedule cohorts of OMP-54F28 (eg. every 4 week or every 6 week dosing) can be studied upon agreement with the investigators and the study sponsor. These alternative less frequent dosing schedules may be evaluated if emerging data suggest that once every 3 week dosing results in tolerability concerns. The first 2 subjects enrolled in a cohort will not be treated on the same day. The dose may be administered at any time during the day. Three subjects will be treated at each dose level if no dose-limiting toxicities (DLTs) are observed. If 1 of 3 subjects experiences a DLT, that dose level will be expanded to 6 subjects. If 2 or more subjects experience a DLT, no further subjects will be dosed at that level and 3 additional subjects will be added to the preceding dose cohort unless 6 subjects have already been treated at that dose level. Subjects will be assessed for DLTs from Days 0-28. Dose escalation for newly enrolled subjects, if appropriate, will occur after all subjects in a cohort have completed their Day 28 DLT assessment. Subjects who have a >2-fold increase of their fasting β-CTX or a decline of >3% in their bone mineral density (BMD) from screening or a T-score decline to <-2.5 in the total femur or L1-L4 DEXA scan measurement will be started on zoledronic acid. Subjects with stable disease or a response at Day 56 will be allowed to continue to receive OMP-54F28 until disease progression. An additional 6 subjects will be enrolled in an expansion cohort at the highest dose level that results in <2 of the 6 subjects experiencing a Grade 3 (not including a Grade 3 infusion reaction that resolves in 24 hours) or Grade 4 adverse event (DLT). Tumors of particular interest for inclusion in the expansion cohort include sarcomas, basal cell carcinoma, ovarian cancer, desmoid tumors and prostate cancer given the known importance of the Wnt pathway in these malignancies.
- Conditions
- Solid Tumors
- Being tested
- OMP-54F28
- Keywords
- Phase 1, dose escalation, histologically confirmed, malignancy, metastatic
- Medical subject headings
- Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OMP-54F28Biological
dose escalation of 0.5, 1, 2.5, 5, and 10 mg/kg administered IV once every 3 weeks
What is being measured
The primary outcome is the main question the study is designed to answer.
• To determine the safety of OMP-54F28 in subjects with previously treated solid tumors
Measured: Subjects will be assessed for dose limiting toxicities from Days 0-28. Adverse events will be reported through 30 days after the last dose.
Secondary outcomes (3)
To determine the pharmacokinetics of OMP-54F28 in subjects with previously treated solid tumors
The pharmacokinetic (PK) parameters to be assessed are study drug half-life (t½), volume of distribution (Vd), and clearance (CL).
Measured: Baseline,end of infusion,0.5,1,3,6,24, and 72 hours post-infusion (1st infusion) 0.5, 1, 3, 6, 24, 72, and 168 hours (3rd infusion),before/end 2nd infusion,Days 7, 14, 28, and 35. After termination: Weekly for the first 4 weeks, then at Week 8 and 12
To determine the immunogenicity of OMP-54F28 in subjects with previously treated solid tumors
Measured: Subjects will be assessed during screening ,every 4 weeks while on study drug, at the time of treatment termination, then weekly for the first 4 weeks, then at Week 8 and 12 following discontinuation of study drug
To assess the preliminary efficacy of OMP-54F28 in subjects with previously treated solid tumors
The response outcome in patients will be determined.
Measured: Every 56 days until disease progression
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2012 (estimated)
- Study startJun 2012
- Primary completionAug 2016
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- OncoMed Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bayer
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01608867
- Sponsor's protocol ID
- 54F28-001
- Status last verified
- Aug 2020
- First submitted
- 29 May 2012
- Last updated
- 11 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Dose Escalation Study of OMP-54F28 in Subjects With Solid Tumors
- ClinicalTrials.gov ID
- NCT01608867
- Acronym / sponsor ID
- 54F28-001
- Conditions
- Solid Tumors
- Keywords
- Phase 1, dose escalation, histologically confirmed, malignancy, metastatic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- OncoMed Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Bayer
- Study start
- Jun 2012
- Primary completion
- Aug 2016 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 31 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label Phase 1 dose escalation study of OMP-54F28 in subjects with a solid tumor for which there is no remaining standard curative therapy. Subjects will be assessed for safety, immunogenicity, pharmacokinetics, biomarkers, and efficacy. No formal interim analyses will be performed.
Prior to enrollment, subjects will undergo screening to determine study eligibility. Upon enrollment, subjects will receive OMP-54F28 until disease progression. All subjects will receive Vitamin D3 daily and calcium carbonate twice daily from Day 0 through 30 days following the discontinuation of OMP-54F28.
Dose escalation will be conducted to determine the maximum tolerated dose (MTD). Subjects will be dosed at 0.5, 1, 2.5, 5, and 10 mg/kg administered IV once every 3 weeks. No dose escalation or reduction will be allowed within a dose cohort. Intermediate doses (i.e., doses between the dose levels listed above) may also be tested upon agreement with the investigators and the study sponsor. In addition, alternate dosing schedule cohorts of OMP-54F28 (eg. every 4 week or every 6 week dosing) can be studied upon agreement with the investigators and the study sponsor. These alternative less frequent dosing schedules may be evaluated if emerging data suggest that once every 3 week dosing results in tolerability concerns. The first 2 subjects enrolled in a cohort will not be treated on the same day. The dose may be administered at any time during the day. Three subjects will be treated at each dose level if no dose-limiting toxicities (DLTs) are observed. If 1 of 3 subjects experiences a DLT, that dose level will be expanded to 6 subjects. If 2 or more subjects experience a DLT, no further subjects will be dosed at that level and 3 additional subjects will be added to the preceding dose cohort unless 6 subjects have already been treated at that dose level. Subjects will be assessed for DLTs from Days 0-28. Dose escalation for newly enrolled subjects, if appropriate, will occur after all subjects in a cohort have completed their Day 28 DLT assessment. Subjects who have a >2-fold increase of their fasting β-CTX or a decline of >3% in their bone mineral density (BMD) from screening or a T-score decline to <-2.5 in the total femur or L1-L4 DEXA scan measurement will be started on zoledronic acid. Subjects with stable disease or a response at Day 56 will be allowed to continue to receive OMP-54F28 until disease progression. An additional 6 subjects will be enrolled in an expansion cohort at the highest dose level that results in <2 of the 6 subjects experiencing a Grade 3 (not including a Grade 3 infusion reaction that resolves in 24 hours) or Grade 4 adverse event (DLT). Tumors of particular interest for inclusion in the expansion cohort include sarcomas, basal cell carcinoma, ovarian cancer, desmoid tumors and prostate cancer given the known importance of the Wnt pathway in these malignancies.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Subjects must have a histologically confirmed malignancy that is metastatic or unresectable and must have received the standard therapies for their malignancy. In addition, subjects must have a tumor that is at least 1 cm in a single dimension and is radiographically apparent on CT or MRI.
- Subjects must have received their last chemotherapy, biologic, or investigational therapy at least 4 weeks prior to enrollment, 6 weeks if the last regimen included BCNU or mitomycin C.
- Age >18 years
- ECOG performance status <2 (see APPENDIX B)
- Estimated life expectancy of more than 3 months
Key exclusion criteria (21 listed)
- Subjects who meet any of the following criteria will not be eligible for participation in the study:
- Subjects receiving any other investigational agents
- Subjects with brain metastases (subjects must have a CT scan or MRI of the head within 28 days prior to enrollment to rule out brain metastases), uncontrolled seizure disorder, or active neurologic disease
- History of a significant allergic reaction attributed to humanized or human monoclonal antibody therapy or Fc fusion protein
- Significant intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OMP-54F28dose escalation of 0.5, 1, 2.5, 5, and 10 mg/kg administered IV once every 3 weeks | Biological | – |
Primary outcome
• To determine the safety of OMP-54F28 in subjects with previously treated solid tumors
Time frame: Subjects will be assessed for dose limiting toxicities from Days 0-28. Adverse events will be reported through 30 days after the last dose.
3 secondary outcomes
To determine the pharmacokinetics of OMP-54F28 in subjects with previously treated solid tumors
Time frame: Baseline,end of infusion,0.5,1,3,6,24, and 72 hours post-infusion (1st infusion) 0.5, 1, 3, 6, 24, 72, and 168 hours (3rd infusion),before/end 2nd infusion,Days 7, 14, 28, and 35. After termination: Weekly for the first 4 weeks, then at Week 8 and 12
To determine the immunogenicity of OMP-54F28 in subjects with previously treated solid tumors
Time frame: Subjects will be assessed during screening ,every 4 weeks while on study drug, at the time of treatment termination, then weekly for the first 4 weeks, then at Week 8 and 12 following discontinuation of study drug
To assess the preliminary efficacy of OMP-54F28 in subjects with previously treated solid tumors
Time frame: Every 56 days until disease progression
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing OMP-54F28 in people with Solid Tumors, run by OncoMed Pharmaceuticals, Inc. at 3 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 10 inclusion and 21 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 3 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?
• To determine the safety of OMP-54F28 in subjects with previously treated solid tumors (time frame: Subjects will be assessed for dose limiting toxicities from Days 0-28. Adverse events will be reported through 30 days after the last dose.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.