A Dose Escalation Study of OMP-52M51 in Subjects With Lymphoid Malignancies
This study is currently recruiting participants.
Verified September 2013 by OncoMed Pharmaceuticals, Inc.
Information provided by (Responsible Party):
OncoMed Pharmaceuticals, Inc.
First received: September 27, 2012
Last updated: September 20, 2013
Last verified: September 2013
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.
Relapsed or Refractory Lymphoid Malignancies
||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||A Phase 1 Dose Escalation Study of OMP-52M51 in Subjects With Lymphoid Malignancies
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:
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||May 2014 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||18 Years to 90 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
- 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
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
- 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01703572
|University of Nebraska Medical Center
|Omaha, Nebraska, United States, 68198 |
|Contact: Julie M Vose, MD 402-559-3848 firstname.lastname@example.org |
|Principal Investigator: Julie M Vose, MD |
|Cornell University Division of Hematology and Medical Oncology
|New York, New York, United States, 10065 |
|Contact: Jia Ruan, MD 646-962-2064 email@example.com |
|Principal Investigator: Jia Ruan, MD |
|University of Rochester Medical Center
|Rochester, New York, United States, 14642 |
|Contact: Carla Casulo, MD 585-273-5573 carla_casulo@URMC.Rochester.edu |
|Principal Investigator: Carla Casulo, MD |
|The Ohio State University Wexner Medical Center, James Cancer Hospital
|Columbus, Ohio, United States, 43210 |
|Contact: Pierluigi Porcu, MD 614-293-2268 firstname.lastname@example.org |
|Principal Investigator: Pierluigi Porcu, MD |
|Sara Cannon Research Institute
|Nashville, Tennessee, United States, 37203 |
|Contact: Ian Flinn, MD 615-329-7274 email@example.com |
|Principal Investigator: Ian Flinn, MD |
OncoMed Pharmaceuticals, Inc.
No publications provided
||OncoMed Pharmaceuticals, Inc.
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 27, 2012
||September 20, 2013
||United States: Food and Drug Administration
Keywords provided by OncoMed Pharmaceuticals, Inc.:
relapsed or refractory
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 11, 2014