Relapsed or Refractory Lymphoid MalignanciesPhase 1NCT01703572
A Dose Escalation Study of OMP-52M51 in Subjects With Lymphoid Malignancies
A Phase 1 study testing OMP-52M51 in people with Relapsed or Refractory Lymphoid Malignancies, run by OncoMed Pharmaceuticals, Inc. at 10 sites in United States.
Trial summary
This is an open-label Phase 1a dose escalation study of single-agent OMP-52M51 in subjects with relapsed or refractory lymphoid malignancies. Study includes a dose escalation phase and expansion phase. Subjects will be assessed for safety, immunogenicity, pharmacokinetics, biomarkers, and efficacy. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Relapsed or Refractory Lymphoid Malignancies
- What is being tested?
- OMP-52M51
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 10 sitesUnited States
- Study dates
- Oct 2012to Jan 2016
- 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
- Lymphoid malignancy that has relapsed or is refractory after two or more treatments that are FDA approved or are commonly used clinically.
- Subjects must have progressive disease requiring therapy. Subjects who are candidates for observation only are not eligible.
- Subjects are either not currently considered to be candidates or refuse potentially curative therapies including peripheral stem cell or bone marrow transplant
- Subjects must have measurable disease as per disease specific criteria
- Must have received their last chemotherapy, biologic, radiotherapy, or investigational therapy at least 4 weeks prior to enrollment; 12 weeks from their last radioimmunotherapy; 3 months if the last therapy was bone marrow/ peripheral stem cell transplant.
- Age >18 years
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- ECOG performance status <2
- Normal Ejection Fraction on ECHO scan
- Subjects must have normal organ and marrow function as defined below:
- Absolute neutrophil count >1000/mL Platelets >75,000/mL For subjects with known marrow infiltration, ANC ≥500 and platelets ≥30,000 Total bilirubin <1.5 X institutional upper limit of normal (ULN) (<2X ULN for subjects with Gilbert's syndrome) AST (SGOT) and ALT (SGPT) <3 X institutional ULN (for subjects with hepatic involvement <5 X institutional ULN) PT/INR and aPTT within 1.5 X institutional ULN Creatinine <1.5 X institutional ULN OR Creatinine clearance >60 mL/min/1.73 m2 for subjects with creatinine levels above institutional normal
- 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 (hormonal or 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:
- Currently receiving any therapeutic treatment for lymphoid malignancies including other investigational agents
- Prior treatment with gamma secretase inhibitors or other Notch 1 inhibitors
- Active CNS involvement, uncontrolled seizure disorder, or active neurologic disease
- History of a Grade 4 allergic reaction attributed to humanized or human monoclonal antibody therapy
- 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
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- Pregnant women or nursing women
- Ongoing malignancies or malignancies in remission <3 years other than the lymphoid malignancies included in this trial. Patients with history of known skin cancers including non-melanotic skin cancers within the past 3 years will not be included in this trial. The following prior malignancies are allowable irrespective of when they occurred: in situ carcinoma of the cervix, in situ ductal breast cancer, and low-grade local bladder cancer.
- Subjects with known HIV 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 II, III, or IV
- Subjects with a blood pressure of >140/90 mmHg that is not responsive to medical therapy. Subjects taking antihypertensive medications must be taking ≤2 medications to obtain this level of blood pressure control.
- Subjects with EKG evidence of ischemia or ≥Grade 2 ventricular arrhythmia, subjects who have a history of acute myocardial infarction within 6 months, or subjects with unstable angina.
- Subjects with known clinically significant gastrointestinal disease including, but not limited to, inflammatory bowel disease
- Subjects with diarrhea at time of enrollment or have an ongoing requirement for anti diarrheal therapy
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
University of Colorado Hospital, Anschutz Cancer Pavilion
Aurora, Colorado, 80045
Duke Cancer Institute
Durham, North Carolina, 27710
UF Health Davis Cancer Pavilion and Shands Med Plaza
Gainesville, Florida, 32608
UC San Diego Moores Cancer Center
La Jolla, California, 92093
Sara Cannon Research Institute
Nashville, Tennessee, 37203
Cornell University Division of Hematology and Medical Oncology
New York, New York, 10065
NYU Clinical Cancer Center
New York, New York, 97219
University of Nebraska Medical Center
Omaha, Nebraska, 68198-7680
University of Nebraska Medical Center
Omaha, Nebraska, 68198
University of Rochester Medical Center
Rochester, New York, 14642
About this study
Official title: A Phase 1 Dose Escalation Study of OMP-52M51 in Subjects With Lymphoid Malignancies
This is an open-label Phase 1a dose escalation study of single-agent OMP-52M51 in subjects with relapsed or refractory lymphoid malignancies. Study includes a dose escalation phase and expansion phase. Subjects will be assessed for safety, immunogenicity, pharmacokinetics, biomarkers, and efficacy.
- Being tested
- OMP-52M51
- Keywords
- Phase 1, Dose escalation, relapsed or refractory, lymphoid malignancies
- Medical subject headings
- Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OMP-52M51Drug
| Study group | Role | What they receive |
|---|---|---|
| OMP-52M51 | Experimental | Not described Receives: Drug: OMP-52M51 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety profile of OMP-52M51 in subjects with relapsed or refractory lymphoid malignancies
Measured: Subjects will be assessed for DLTs from Days 0-29. Adverse events will be reported through 30 days after the last dose
Secondary outcomes (3)
Pharmacokinetics (PK) of OMP-52M51 in subjects with relapsed or refractory lymphoid malignancies
Apparent half life, AUC, clearance, volume of distribution
Measured: PK analyses at various time points following the 1st and 2nd doses, immediately pre and post-dose for all subsequent doses at treatment term, every 4 weeks after discontinuation of study drug or 12 weeks
Immunogenicity of OMP-52M51 in subjects with relapsed or refractory lymphoid malignancies
Measured: At baseline, every 4 weeks, at treatment termination and every 4 weeks after the discontinuation of the study drug for 12 weeks.
Preliminary efficacy of OMP-52M51 in subjects with relapsed or refractory lymphoid malignancies
Measured: Evaluation for response will be assessed every 56 days and will be based on disease specific criteria.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed or Refractory Lymphoid MalignanciesStudies 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
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- OncoMed Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01703572
- Sponsor's protocol ID
- 52M51-001
- Status last verified
- Sep 2020
- First submitted
- 27 Sep 2012
- Last updated
- 9 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Dose Escalation Study of OMP-52M51 in Subjects With Lymphoid Malignancies
- ClinicalTrials.gov ID
- NCT01703572
- Acronym / sponsor ID
- 52M51-001
- Keywords
- Phase 1, Dose escalation, relapsed or refractory, lymphoid malignancies
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- OncoMed Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2012
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 10 Oct 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 1a dose escalation study of single-agent OMP-52M51 in subjects with relapsed or refractory lymphoid malignancies. Study includes a dose escalation phase and expansion phase. Subjects will be assessed for safety, immunogenicity, pharmacokinetics, biomarkers, and efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OMP-52M51 | Experimental | Drug: OMP-52M51 |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Lymphoid malignancy that has relapsed or is refractory after two or more treatments that are FDA approved or are commonly used clinically.
- Subjects must have progressive disease requiring therapy. Subjects who are candidates for observation only are not eligible.
- Subjects are either not currently considered to be candidates or refuse potentially curative therapies including peripheral stem cell or bone marrow transplant
- Subjects must have measurable disease as per disease specific criteria
- Must have received their last chemotherapy, biologic, radiotherapy, or investigational therapy at least 4 weeks prior to enrollment; 12 weeks from their last radioimmunotherapy; 3 months if the last therapy was bone marrow/ peripheral stem cell transplant.
Key exclusion criteria (16 listed)
- Subjects who meet any of the following criteria will not be eligible for participation in the study:
- Currently receiving any therapeutic treatment for lymphoid malignancies including other investigational agents
- Prior treatment with gamma secretase inhibitors or other Notch 1 inhibitors
- Active CNS involvement, uncontrolled seizure disorder, or active neurologic disease
- History of a Grade 4 allergic reaction attributed to humanized or human monoclonal antibody therapy
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-52M51 | Drug | OMP-52M51 |
Primary outcome
Safety profile of OMP-52M51 in subjects with relapsed or refractory lymphoid malignancies
Time frame: Subjects will be assessed for DLTs from Days 0-29. Adverse events will be reported through 30 days after the last dose
3 secondary outcomes
Pharmacokinetics (PK) of OMP-52M51 in subjects with relapsed or refractory lymphoid malignancies
Time frame: PK analyses at various time points following the 1st and 2nd doses, immediately pre and post-dose for all subsequent doses at treatment term, every 4 weeks after discontinuation of study drug or 12 weeks
Immunogenicity of OMP-52M51 in subjects with relapsed or refractory lymphoid malignancies
Time frame: At baseline, every 4 weeks, at treatment termination and every 4 weeks after the discontinuation of the study drug for 12 weeks.
Preliminary efficacy of OMP-52M51 in subjects with relapsed or refractory lymphoid malignancies
Time frame: Evaluation for response will be assessed every 56 days and will be based on disease specific criteria.
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 9 Sep 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.
10 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-52M51 in people with Relapsed or Refractory Lymphoid Malignancies, run by OncoMed Pharmaceuticals, Inc. at 10 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 16 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 9 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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 profile of OMP-52M51 in subjects with relapsed or refractory lymphoid malignancies (time frame: Subjects will be assessed for DLTs from Days 0-29. 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 9 Sep 2020.