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

• Status: Terminated
• Trial end date: 2019-08-12
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen; Onyx Therapeutics, Inc.

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 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.