Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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:
Information provided by (Responsible Party):
Onyx Pharmaceuticals ( Onyx Therapeutics, Inc. )
ClinicalTrials.gov Identifier:
NCT01832727
First received: April 10, 2013
Last updated: September 26, 2016
Last verified: September 2016

April 10, 2013
September 26, 2016
May 2013
January 2017   (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
  • 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: Yes ]
    Phase 2 - Estimate the ORR
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 (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.
    Interventions:
    • Drug: Oprozomib
    • Drug: Dexamethasone
  • 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.
    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.
 
Active, not recruiting
128
April 2017
January 2017   (final data collection date for primary outcome measure)

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
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States,   France
 
NCT01832727
2012-001
No
Not Provided
Not Provided
Onyx Therapeutics, Inc.
Onyx Therapeutics, Inc.
Not Provided
Not Provided
Onyx Pharmaceuticals
September 2016

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