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. (see Contacts and Locations)
Verified July 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: July 11, 2014
Last verified: July 2014

April 10, 2013
July 11, 2014
May 2013
July 2015   (final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT01832727 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Phase 1b/2, Multicenter, Open-label Study of Oprozomib and Dexamethasone in Patients With Relapsed and/or Refractory Multiple Myeloma
Phase 1b/2, Multicenter, Open-label Study of Oprozomib and Dexamethasone in Patients With Relapsed and/or Refractory Multiple Myeloma

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
Not Provided
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Multiple Myeloma
  • 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: 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.
    Interventions:
    • Drug: Oprozomib
    • Drug: Dexamethasone
  • 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.
    Interventions:
    • Drug: Oprozomib
    • Drug: Dexamethasone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
128
December 2015
July 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Onyx Medical Information 877-669-9121 medinfo@onyx.com
United States
 
NCT01832727
2012-001
No
Onyx Pharmaceuticals ( Onyx Therapeutics, Inc. )
Onyx Therapeutics, Inc.
Not Provided
Not Provided
Onyx Pharmaceuticals
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP