A Dose Escalation Study of OMP-52M51 in Subjects With Lymphoid Malignancies

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by OncoMed Pharmaceuticals, Inc.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
OncoMed Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01703572
First received: September 27, 2012
Last updated: July 1, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Relapsed or Refractory Lymphoid Malignancies
Drug: OMP-52M51
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1 Dose Escalation Study of OMP-52M51 in Subjects With Lymphoid Malignancies

Resource links provided by NLM:


Further study details as provided by OncoMed Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Apparent half life, AUC, clearance, volume of distribution

  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]

Estimated Enrollment: 53
Study Start Date: October 2012
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: OMP-52M51 Drug: OMP-52M51

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Lymphoid malignancy that has relapsed or is refractory after two or more treatments that are FDA approved or are commonly used clinically.
  2. Subjects must have progressive disease requiring therapy. Subjects who are candidates for observation only are not eligible.
  3. Subjects are either not currently considered to be candidates or refuse potentially curative therapies including peripheral stem cell or bone marrow transplant
  4. Subjects must have measurable disease as per disease specific criteria
  5. 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.
  6. Age >18 years
  7. ECOG performance status <2
  8. Normal Ejection Fraction on ECHO scan
  9. 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

  10. 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.
  11. Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

Subjects who meet any of the following criteria will not be eligible for participation in the study:

  1. Currently receiving any therapeutic treatment for lymphoid malignancies including other investigational agents
  2. Prior treatment with gamma secretase inhibitors or other Notch 1 inhibitors
  3. Active CNS involvement, uncontrolled seizure disorder, or active neurologic disease
  4. History of a Grade 4 allergic reaction attributed to humanized or human monoclonal antibody therapy
  5. 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
  6. Pregnant women or nursing women
  7. 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.
  8. Subjects with known HIV infection
  9. Known bleeding disorder or coagulopathy
  10. 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.
  11. New York Heart Association Classification II, III, or IV
  12. 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.
  13. 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.
  14. Subjects with known clinically significant gastrointestinal disease including, but not limited to, inflammatory bowel disease
  15. Subjects with diarrhea at time of enrollment or have an ongoing requirement for anti diarrheal therapy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01703572

Locations
United States, Colorado
University of Colorado Hospital, Anschutz Cancer Pavilion Recruiting
Aurora, Colorado, United States, 80045
Contact: Lia Gore, MD    303-724-4011    lia.gore@ucdenver.edu   
Principal Investigator: Lia Gore, MD         
United States, Nebraska
University of Nebraska Medical Center Recruiting
Omaha, Nebraska, United States, 68198
Contact: Julie M Vose, MD    402-559-3848    jmvose@unmc.edu   
Principal Investigator: Julie M Vose, MD         
United States, New York
Cornell University Division of Hematology and Medical Oncology Recruiting
New York, New York, United States, 10065
Contact: Jia Ruan, MD    646-962-2064    jruan@med.cornell.edu   
Principal Investigator: Jia Ruan, MD         
University of Rochester Medical Center Recruiting
Rochester, New York, United States, 14642
Contact: Carla Casulo, MD    585-273-5573    carla_casulo@URMC.Rochester.edu   
Principal Investigator: Carla Casulo, MD         
United States, Ohio
The Ohio State University Wexner Medical Center, James Cancer Hospital Recruiting
Columbus, Ohio, United States, 43210
Contact: Pierluigi Porcu, MD    614-293-2268    pierluigi.porcu@osumc.edu   
Principal Investigator: Pierluigi Porcu, MD         
United States, Tennessee
Sara Cannon Research Institute Recruiting
Nashville, Tennessee, United States, 37203
Contact: Ian Flinn, MD    615-329-7274    iflinn@tnonc.com   
Principal Investigator: Ian Flinn, MD         
Sponsors and Collaborators
OncoMed Pharmaceuticals, Inc.
GlaxoSmithKline
  More Information

No publications provided

Responsible Party: OncoMed Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01703572     History of Changes
Other Study ID Numbers: 52M51-001
Study First Received: September 27, 2012
Last Updated: July 1, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by OncoMed Pharmaceuticals, Inc.:
Phase 1
Dose escalation
relapsed or refractory
lymphoid malignancies

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on August 28, 2014