Status:
TERMINATED
Open-label Study of the Safety and Activity of Oprozomib in Patients With Hematologic Malignancies
Lead Sponsor:
Amgen
Conditions:
Multiple Myeloma
Waldenstrom Macroglobulinemia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to determine the maximum tolerated dose (MTD), activity, and safety of oprozomib in patients with hematologic malignancies.
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
October 15 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 12 2019
Estimated Enrollment :
210 Patients enrolled
Trial Details
Trial ID
NCT01416428
Start Date
October 15 2011
End Date
August 12 2019
Last Update
November 8 2022
Active Locations (19)
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1
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States
2
Pacific Cancer Care
Salinas, California, United States
3
Colorado Blood Cancer Institute
Denver, Colorado, United States
4
Mayo Clinic
Jacksonville, Florida, United States