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

Stopped early · Phase 1/Phase 2

Conditions studied: Multiple Myeloma, Waldenstrom Macroglobulinemia

In brief

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

Key facts

Study ID

NCT01416428

Run by

Amgen

People needed

210

Starts

2011-10-15

Expected to finish

2019-08-12

Last updated by the study team

2022-11-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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