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Phase 1b/2, Multicenter, Open-label Study of the Safety and Activity of Oprozomib in Patients With Hematologic Malignancies


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Multiple Myeloma, Waldenstrom Macroglobulinemia

Thank you

Trial Information

Phase 1b/2, Multicenter, Open-label Study of the Safety and Activity of Oprozomib in Patients With Hematologic Malignancies

Inclusion 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.

- 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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determine the MTD (Phase 1) and ORR (Phase 2).

Outcome Description:

Phase 1- Determine Maximum Tolerated Dose (MTD) with 3 + 3 Dose Escalation Cohorts in patients hematologic malignancies. Phase 2- The Phase 2 portion of this trial will enroll patients with Multiple Myeloma (MM) and Waldenstrom Macroglobulinemia (WM) into separate arms to assess activity of oprozomib in these patient groups. The purpose of the Phase 2 portion of the study is to estimate the best ORR (for each group separately).

Outcome Time Frame:

6 weeks to 18 months

Safety Issue:

Yes

Principal Investigator

Study Director, MD

Investigator Role:

Study Director

Investigator Affiliation:

Onyx Therapeutics, Inc.

Authority:

United States: Food and Drug Administration

Study ID:

2011-001

NCT ID:

NCT01416428

Start Date:

September 2011

Completion Date:

December 2014

Related Keywords:

  • Multiple Myeloma
  • Waldenström Macroglobulinemia
  • multiple myeloma
  • waldenstrom macroglobulinemia
  • Waldenstrom Macroglobulinemia
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Hematologic Neoplasms

Name

Location

Mount Sinai Medical CenterNew York, New York  10029
Dana Farber Cancer InstituteBoston, Massachusetts  02115
University of Maryland, Greenebaum Cancer CenterBaltimore, Maryland  21201
Winship Cancer Institute, Emory UniversityAtlanta, Georgia  30322
Tennessee Oncology, PLLCClarksville, Tennessee  37043
South Texas Accelerated Research TherapeuticsSan Antonio, Texas  78229
Oncology Research AssociatesScottsdale, Arizona  85258
John Theurer Cancer Center at Hackensack UniversityHackensack, New Jersey  07601
Washington University School of Medicine Division of OncologySt. Louis, Missouri  63110