Open-label Study of the Safety and Activity of Oprozomib in Patients With Hematologic Malignancies
This trial is active, not recruiting.
|Conditions||multiple myeloma, waldenstrom macroglobulinemia|
|Phase||phase 1/phase 2|
|Sponsor||Onyx Therapeutics, Inc.|
|Start date||September 2011|
|End date||November 2016|
|Trial size||364 participants|
|Trial identifier||NCT01416428, 2011-001|
The purpose of this study is to determine the maximum tolerated dose (MTD), activity, and safety of oprozomib in patients with hematologic malignancies.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Scottsdale, AZ||Mayo Clinic Scottsdale||no longer recruiting|
|Salinas, CA||Pacific Cancer Care||no longer recruiting|
|Denver, CO||Colorado Blood Cancer Institute||no longer recruiting|
|Jacksonville, FL||Mayo Clinic||no longer recruiting|
|Atlanta, GA||Winship Cancer Institute, Emory University||no longer recruiting|
|Chicago, IL||University of Chicago Medical Center||no longer recruiting|
|Baltimore, MD||University of Maryland, Greenebaum Cancer Center||no longer recruiting|
|Boston, MA||Mass General Hospital||no longer recruiting|
|Minneapolis, MN||Virginia Piper Cancer Institute||no longer recruiting|
|Rochester, MN||Mayo Clinic||no longer recruiting|
|St. Louis, MO||Washington University School of Medicine Division of Oncology||no longer recruiting|
|Hackensack, NJ||John Theurer Cancer Center at Hackensack University||no longer recruiting|
|Morristown, NJ||Hematology Oncology of Northern New Jersey||no longer recruiting|
|Albany, NY||New York Oncology Hematology||no longer recruiting|
|New York, NY||Mount Sinai Medical Center||no longer recruiting|
|Nashville, TN||Sarah Cannon Research Institute / Tennessee Oncology, PLLC||no longer recruiting|
|Kennewick, WA||Columbia Basin Hematology and Oncology||no longer recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
Determine the MTD (Phase 1) and ORR (Phase 2).
time frame: 6 weeks to 18 months
Male or female participants at least 18 years old.
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.
|Official title||Phase 1b/2, Multicenter, Open-label Study of the Safety and Activity of Oprozomib in Patients With Hematologic Malignancies|
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