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Phase 1b/2, Multicenter, Open-label Study of Oprozomib and Dexamethasone in Patients With Relapsed and/or Refractory Multiple Myeloma

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01832727
First Posted: April 16, 2013
Last Update Posted: July 18, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Amgen
  Purpose

The primary objectives are as follows:

Phase 1b:

  • To determine the maximum tolerated dose (MTD) of oprozomib given orally, once daily, on 2 different schedules.
  • To evaluate safety and tolerability

Phase 2:

  • To estimate the overall response rate (ORR).
  • To evaluate safety and tolerability

Condition Intervention Phase
Multiple Myeloma Drug: Oprozomib Drug: Dexamethasone Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1b/2, Multicenter, Open-label Study of Oprozomib and Dexamethasone in Patients With Relapsed and/or Refractory Multiple Myeloma

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Determine the MTD (Phase 1b) [ Time Frame: 6 weeks to 18 months ]
    Phase 1b- Determine the Maximum Tolerated Dose (MTD) of oprozomib given orally, once daily, on 2 different schedules: 5 consecutive days every 14 days (bimonthly) or 2 consecutive days every 7 days (weekly) for a 14-day treatment cycle, both schedules given in combination with dexamethasone

  • Determine the ORR (Phase 2) [ Time Frame: 6 weeks - 18 months ]
    Phase 2 - Estimate the ORR


Estimated Enrollment: 128
Study Start Date: May 2013
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 5 consecutive days bimonthly (Phase 1b)
Subjects will receive oprozomib administered orally, once daily, on Days 1-5 of a 14-day cycle in combination with 20 mg of dexamethasone on Days 1, 2, 8, and 9. Treatment will be administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.
Drug: Oprozomib
Patients enrolled will receive Oprozomib Tablets once daily either on Days 1-5 or on Days 1, 2, 8, and 9 of the 14-day treatment cycle.
Other Names:
  • OPZ
  • ONX 0912
  • oprozomib tablets
Drug: Dexamethasone
Dexamethasone 20 mg will be taken on Days 1, 2, 8, and 9
Experimental: 2 consecutive days weekly (Phase 1b/2)
Subjects will receive oprozomib administered orally, once daily, on Days 1, 2, 8, and 9 of a 14-day cycle in combination with 20 mg of dexamethasone on Days 1, 2, 8, and 9. Treatment will be administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.
Drug: Oprozomib
Patients enrolled will receive Oprozomib Tablets once daily either on Days 1-5 or on Days 1, 2, 8, and 9 of the 14-day treatment cycle.
Other Names:
  • OPZ
  • ONX 0912
  • oprozomib tablets
Drug: Dexamethasone
Dexamethasone 20 mg will be taken on Days 1, 2, 8, and 9

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Diagnosis of multiple myeloma with measureable disease
  • Patients requiring therapy who have relapsed and/or are refractory to their last therapy and have been treated with at least 1, but not more than 5 lines of multiple myeloma therapy.
  • Prior carfizolmib is not required but is allowed if a patient had at least 2 cycles of carfilzomib alone or in combination with a dose of at least 20/27 mg/m2, as long as the patient :

    1. Had at least a partial response to prior carfilzomib therapy
    2. Was not removed from carfilzomib therapy due to toxicity, unless approved by the medical monitor
    3. Was not removed from carfilzomib therapy for progressive disease nor experienced progressive disease within 6 months after any prior carfizolmib therapy
  • Calculated or measured creatinine clearance (CrCl) rate of ≥ 30 mL/min calculated using the formula of Cockcroft and Gault [(140 − age) × mass (kg) / (72 × serum creatinine mg/dL)]. Multiply result by 0.85 if female.

Key Exclusion Criteria:

  • Radiation therapy within 2 weeks prior to first dose. Localized radiation therapy within 1 week prior to first dose.
  • Immunotherapy/standard myeloma therapy within 2 weeks; prior stem cell transplant (SCT) therapy (autologous SCT within the prior 8 weeks; allogeneic SCT within the prior 16 weeks)
  • Participation in an investigational therapeutic study within 3 weeks prior to first dose
  • Prior oprozomib exposure
  • Significant neuropathy (Grade 3, Grade 4, or Grade 2 with pain) at the time of the first dose
  • Other malignancy within the past 3 years with the exception of adequately treated basal cell carcinoma of the skin, squamous cell skin cancer, thyroid cancer, carcinoma in situ of the cervix, carcinoma in situ of the breast, prostate cancer of Gleason Score 6 or less with stable prostate specific antigen levels, or cancer considered cured by surgical resection.
  • Plasma cell leukemia
  • History of previous clinically significant GI bleed in the last 6 months prior to first dose
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01832727


Locations
United States, California
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States
United States, Florida
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, United States
United States, Kansas
University of Kansas Cancer Center and Medical Pavilion
Westwood, Kansas, United States
United States, Maryland
Center for Cancer and Blood Disorders
Bethesda, Maryland, United States
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
United States, Michigan
Karmanos Cancer Institute
Detroit, Michigan, United States
United States, North Carolina
Division of Hematology/ Oncology, UNC at Chapel Hill
Chapel Hill, North Carolina, United States
United States, Ohio
Gabrail Cancer Center Research
Canton, Ohio, United States
United States, Wisconsin
Froedtert Hospital and the Medical College of Wisconsin
Milwaukee, Wisconsin, United States
France
CHRU, Hopital Huriez - Department of Hematology
Lille CEDEX, France
CHU Hotel Dieu - Service d'Hematologie Clinique
NANTES Cedex, France
CHU de NANCY - Hopital de BRABOlS
Vandoeuvre Les Nancy, France
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01832727     History of Changes
Other Study ID Numbers: 2012-001
First Submitted: April 10, 2013
First Posted: April 16, 2013
Last Update Posted: July 18, 2017
Last Verified: July 2017

Keywords provided by Amgen:
multiple myeloma
oprozomib
OPZ
ONX 0912
Onyx
proteasome inhibitor
oprozomib tablets

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone acetate
Dexamethasone
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors