Brief Title
Open-label Study of the Safety and Activity of Oprozomib in Patients With Hematologic Malignancies
Official Title
Phase 1b/2, Multicenter, Open-label Study of the Safety and Activity of Oprozomib in Patients With Hematologic Malignancies
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.
Study Phase
Phase 1/Phase 2
Study Type
Interventional
Primary Outcome
Determine the MTD (Phase 1) and ORR (Phase 2).
Secondary Outcome
Evaluate the duration of response (DOR)
Condition
Multiple Myeloma
Intervention
oprozomib
Study Arms / Comparison Groups
QDx2 Dosing Schedule
Description: 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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
210
Start Date
October 15, 2011
Completion Date
August 12, 2019
Primary Completion Date
August 8, 2016
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 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.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT01416428
Organization ID
2011-001
Responsible Party
Sponsor
Study Sponsor
Amgen
Study Sponsor
MD, Study Director, Amgen
Verification Date
November 2022