Open-label Study of the Safety and Activity of Oprozomib in Patients With Hematologic Malignancies
NCT ID: NCT01416428
Last Updated: 2022-11-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1/PHASE2
210 participants
INTERVENTIONAL
2011-10-15
2019-08-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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QDx2 Dosing Schedule
QDx2 is defined as patients receiving Oprozomib Tablets once daily on Days 1, 2, 8, and 9 of the 14-day cycle.
The schedule will be evaluated in Phase 1 for MTD in patients with hematologic malignancies, and will also be evaluated in Phase 2 for ORR in patients with MM and WM.
oprozomib
Patients enrolled will receive Oprozomib Tablets once daily either on Days 1-5 (QDx5 schedule) or on Days 1, 2, 8, and 9 (QDx2 weekly schedule) of the 14-day treatment cycle.
QDx5 Dosing Schedule
QDx5 is defined as patients receiving Oprozomib Tablets once daily on Days 1 to 5 of the 14-day cycle.
The schedule will be evaluated in Phase 1 for MTD in patients with hematologic malignancies, and will also be evaluated in Phase 2 for ORR in patients with MM and WM.
oprozomib
Patients enrolled will receive Oprozomib Tablets once daily either on Days 1-5 (QDx5 schedule) or on Days 1, 2, 8, and 9 (QDx2 weekly schedule) of the 14-day treatment cycle.
Interventions
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oprozomib
Patients enrolled will receive Oprozomib Tablets once daily either on Days 1-5 (QDx5 schedule) or on Days 1, 2, 8, and 9 (QDx2 weekly schedule) of the 14-day treatment cycle.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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Mayo Clinic Scottsdale
Scottsdale, Arizona, United States
Pacific Cancer Care
Salinas, California, United States
Colorado Blood Cancer Institute
Denver, Colorado, United States
Mayo Clinic
Jacksonville, Florida, United States
Winship Cancer Institute, Emory University
Atlanta, Georgia, United States
Rush University Medical Center
Chicago, Illinois, United States
University of Chicago Medical Center
Chicago, Illinois, United States
University of Maryland, Greenebaum Cancer Center
Baltimore, Maryland, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Mass General Hospital
Boston, Massachusetts, United States
Virginia Piper Cancer Institute
Minneapolis, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
Washington University School of Medicine Division of Oncology
St Louis, Missouri, United States
John Theurer Cancer Center at Hackensack University
Hackensack, New Jersey, United States
Hematology Oncology of Northern New Jersey
Morristown, New Jersey, United States
New York Oncology Hematology
Albany, New York, United States
Mount Sinai Medical Center
New York, New York, United States
Sarah Cannon Research Institute / Tennessee Oncology, PLLC
Nashville, Tennessee, United States
Columbia Basin Hematology and Oncology
Kennewick, Washington, United States
Countries
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Related Links
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AmgenTrials clinical trials website
Other Identifiers
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2011-001
Identifier Type: -
Identifier Source: org_study_id
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