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

This study is currently recruiting participants.
Verified January 2014 by Onyx Pharmaceuticals
Sponsor:
Information provided by (Responsible Party):
Onyx Pharmaceuticals ( Onyx Therapeutics, Inc. )
ClinicalTrials.gov Identifier:
NCT01832727
First received: April 10, 2013
Last updated: January 2, 2014
Last verified: January 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 Onyx Pharmaceuticals:

Primary Outcome Measures:
  • Determine the MTD (Phase 1b) [ Time Frame: 6 weeks to 18 months ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    Phase 2 - Estimate the ORR


Estimated Enrollment: 128
Study Start Date: May 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 5 consecutive days bimonthly
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
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

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
  • Patients who failed to respond to carfilzomib treatment defined as not having achieved ≥ PR during therapy
  • Carfilzomib exposure within 6 months 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01832727

Contacts
Contact: Onyx Medical Information 877-669-9121 medinfo@onyx.com

Locations
United States, Florida
H. Lee Moffitt Cancer Center & Research Institute Recruiting
Tampa, Florida, United States
United States, Maryland
Center for Cancer and Blood Disorders Recruiting
Bethesda, Maryland, United States
United States, Massachusetts
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States
United States, Michigan
Karmanos Cancer Institute Recruiting
Detroit, Michigan, United States
United States, North Carolina
Division of Hematology/ Oncology, UNC at Chapel Hill Recruiting
Chapel Hill, North Carolina, United States
United States, Ohio
Gabrail Cancer Center Research Recruiting
Canton, Ohio, United States
United States, Wisconsin
Froedtert Hospital and the Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States
Sponsors and Collaborators
Onyx Therapeutics, Inc.
  More Information

No publications provided

Responsible Party: Onyx Pharmaceuticals ( Onyx Therapeutics, Inc. )
ClinicalTrials.gov Identifier: NCT01832727     History of Changes
Other Study ID Numbers: 2012-001
Study First Received: April 10, 2013
Last Updated: January 2, 2014
Health Authority: United States: Food and Drug Administration
France: Agence Nationale de Sécurité du Médicament et des produits de santé
France: Committee for the Protection of Personnes

Keywords provided by Onyx Pharmaceuticals:
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
Dexamethasone 21-phosphate
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on April 16, 2014