Open-label Study of the Safety and Activity of Oprozomib in Patients With Hematologic Malignancies



Status:Active, not recruiting
Conditions:Blood Cancer, Lymphoma, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:18 - Any
Updated:2/14/2019
Start Date:September 2011
End Date:June 30, 2019

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Phase 1b/2, Multicenter, Open-label Study of the Safety and Activity of Oprozomib in Patients With Hematologic Malignancies

The purpose of this study is to determine the maximum tolerated dose (MTD), activity, and
safety of oprozomib in patients with hematologic malignancies.


INCLUSION CRITERIA:

Phase 1b

- Histologically confirmed diagnosis of a hematologic malignancy, excluding patients
with acute leukemia or MDS.

- Relapsed after standard therapy for their malignancy and considered to be an
appropriate candidate for a Phase 1 clinical study by their treating physician.

Phase 2

- Multiple myeloma with measurable disease

- Waldenström macroglobulinemia with symptomatic relapse

- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2.

Ethical/Other

- Patients must sign a written informed consent form in accordance with federal, local,
and institutional guidelines.

- Female patients of childbearing potential must have a negative serum or urine
pregnancy test and agree to use effective contraception. Male patients must use an
effective barrier method of contraception.

EXCLUSION CRITERIA:

- Chemotherapy with approved or investigational anticancer therapeutics, including
steroid therapy intended to treat underlying malignancy, within 3 weeks prior to first
dose or 6 weeks for antibody therapy.

- Radiation therapy within 3 weeks prior to first dose. Radioimmunotherapy within 8
weeks prior to first dose. Localized radiation therapy within 1 week prior to first
dose.

- Immunotherapy within 3 weeks prior to first dose (except for antibody therapy, where 6
weeks is required).

- Prior stem cell transplant (SCT) therapy (autologous SCT within the prior 8 weeks;
allogeneic SCT within the prior 16 weeks). Patients with prior allogeneic SCT should
not have evidence of moderate-to-severe graft-vs-host disease (GvHD; as defined in
Filipovich 2005).

- Evidence of central nervous system (CNS) lymphoma.

- Prior treatment with carfilzomib unless in the phase 2.

- Major surgery within 3 weeks prior to first dose.

- Symptomatic Congestive heart failure, ischemia, conduction abnormalities, or
myocardial infarction within 6 months.

- Acute active infection requiring systemic antibiotics, antivirals, or antifungals.

- Known or suspected human immunodeficiency virus (HIV) infection or patients who are
HIV seropositive.

- Active hepatitis A, B, or C infection.

- Significant neuropathy (Grade 3, Grade 4, or Grade 2 with pain) at the time of the
first dose.

- Patients with pleural effusions requiring routine thoracentesis or ascites requiring
routine paracentesis.

- History of previous clinically significant GI bleed in the last 6 months prior to
first dose.

- Female patients who are pregnant or lactating.
We found this trial at
19
sites
22 South Greene Street
Baltimore, Maryland 21201
410-328-7904
University of Maryland Greenebaum Cancer Center The University of Maryland Marlene and Stewart Greenebaum Cancer...
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Baltimore, MD
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4201 Belfort Road
Jacksonville, Florida 32216
(408) 293-2336
Mayo Clinic Mayo Clinic's campus in Arizona provides medical care for thousands of people from...
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Jacksonville, FL
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1 Gustave L Levy Pl # 271
New York, New York 10029
 (212) 241-6500
Mount Sinai Med Ctr Founded in 1852, The Mount Sinai Hospital is a 1,171-bed, tertiary-care...
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New York, NY
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Albany, New York 12206
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Albany, NY
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1365 Clifton Rd NE
Atlanta, Georgia 30322
(404) 778-1900
Winship Cancer Institute at Emory University Winship Cancer Institute of Emory University is Georgia
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Atlanta, GA
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Boston, MA
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Boston, Massachusetts 02115
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Boston, MA
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1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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Chicago, IL
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5841 S Maryland Ave
Chicago, Illinois 60637
(773) 702-1000
University of Chicago Medical Center The University of Chicago Medicine has been at the forefront...
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from
Chicago, IL
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1721 East 19th Ave., Suite #200 & #300
Denver, Colorado 80218
720-754-4800
Colorado Blood Cancer Institute When patients come to the Colorado Blood Cancer Institute, the entire...
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Denver, CO
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?
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from
Hackensack, NJ
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7360 W. Deschutes
Kennewick, Washington 99336
509-783-0144
Columbia Basin Hematology and Oncology Our collaboration with Seattle Cancer Care Alliance gives you convenient...
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Kennewick, WA
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Minneapolis, Minnesota 55408
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Minneapolis, MN
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Morristown, New Jersey 07962
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Morristown, NJ
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Nashville, TN
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Rochester, Minnesota 55905
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Rochester, MN
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Saint Louis, MO
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Salinas, California 93901
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Salinas, CA
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5777 E Mayo Blvd
Scottsdale, Arizona 85259
(480) 515-6296
Mayo Clinic Scottsdale Mayo Clinic Arizona was the second Mayo practice to be established outside...
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Scottsdale, AZ
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