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

  • Study type:

    Interventional What is this?

    Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Study phase:

    I/II What is this?

    During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

Study IDs

  • Site IRB:

    • Scottsdale/Phoenix, Arizona: 12-009498
    • Jacksonville, Florida: 12-009498
    • Rochester, Minnesota: 12-009498
  • NCT ID:

    NCT01416428
  • Sponsor Protocol Number:

    2011-001

About this study

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

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See 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.
  • Female patients who are pregnant or lactating.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Joseph Mikhael, M.D.

Open for enrollment

Cancer Center Clinical Trials Referral Office

855-776-0015

Jacksonville, Fla.

Mayo Clinic principal investigator

Joseph Mikhael, M.D.

Open for enrollment

Cancer Center Clinical Trials Referral Office

855-776-0015

Rochester, Minn.

Mayo Clinic principal investigator

Joseph Mikhael, M.D.

Open for enrollment

Cancer Center Clinical Trials Referral Office

855-776-0015