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

Status: Recruiting
Phase: Phase 1/Phase 2
Diagnosis: Multiple Myeloma
NCT ID: NCT01416428 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 12-008

 

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

 

Conducting Institutions:
Dana-Farber Cancer Institute, Brigham and Women's Hospital, Massachusetts General Hospital

Overall PI:
Irene Ghobrial, MD, Dana-Farber Cancer Institute

Site-responsible Investigators:
Noopur Raje, MD, Massachusetts General Hospital

Contacts:
Dana-Farber Cancer Institute: Stacey Chuma, 617-632-4863, schuma@partners.org
Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100

Eligibility Criteria

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. - 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. - Female patients who are pregnant or lactating.
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