Overview

This trial is active, not recruiting.

Conditions multiple myeloma, waldenstrom macroglobulinemia
Treatment oprozomib
Phase phase 1/phase 2
Target proteasome
Sponsor Onyx Therapeutics, Inc.
Start date September 2011
End date November 2016
Trial size 364 participants
Trial identifier NCT01416428, 2011-001

Summary

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

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
QDx2 is defined as patients receiving Oprozomib Tablets once daily on Days 1, 2, 8, and 9 of the 14-day cycle. The schedule will be evaluated in Phase 1 for MTD in patients with hematologic malignancies, and will also be evaluated in Phase 2 for ORR in patients with MM and WM.
oprozomib
Patients enrolled will receive Oprozomib Tablets once daily either on Days 1-5 (QDx5 schedule) or on Days 1, 2, 8, and 9 (QDx2 weekly schedule) of the 14-day treatment cycle.
(Experimental)
QDx5 is defined as patients receiving Oprozomib Tablets once daily on Days 1 to 5 of the 14-day cycle. The schedule will be evaluated in Phase 1 for MTD in patients with hematologic malignancies, and will also be evaluated in Phase 2 for ORR in patients with MM and WM.
oprozomib
Patients enrolled will receive Oprozomib Tablets once daily either on Days 1-5 (QDx5 schedule) or on Days 1, 2, 8, and 9 (QDx2 weekly schedule) of the 14-day treatment cycle.

Primary Outcomes

Measure
Determine the MTD (Phase 1) and ORR (Phase 2).
time frame: 6 weeks to 18 months

Eligibility Criteria

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.

Additional Information

Official title Phase 1b/2, Multicenter, Open-label Study of the Safety and Activity of Oprozomib in Patients With Hematologic Malignancies
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Onyx Pharmaceuticals.