Overview

This trial is active, not recruiting.

Condition multiple myeloma
Treatments oprozomib, dexamethasone
Phase phase 1/phase 2
Target proteasome
Sponsor Onyx Therapeutics, Inc.
Start date May 2013
End date January 2017
Trial size 128 participants
Trial identifier NCT01832727, 2012-001

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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.
oprozomib OPZ
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.
dexamethasone
Dexamethasone 20 mg will be taken on Days 1, 2, 8, and 9
(Experimental)
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.
oprozomib OPZ
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.
dexamethasone
Dexamethasone 20 mg will be taken on Days 1, 2, 8, and 9

Primary Outcomes

Measure
Determine the MTD (Phase 1b)
time frame: 6 weeks to 18 months
Determine the ORR (Phase 2)
time frame: 6 weeks - 18 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Phase 1b/2, Multicenter, Open-label Study of Oprozomib and Dexamethasone in Patients With Relapsed and/or Refractory Multiple Myeloma
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Onyx Pharmaceuticals.