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| ID | Type | Description | Link |
|---|---|---|---|
| 20130408 | Other Identifier | Amgen | |
| 2013-001169-18 | EudraCT Number |
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Enrollment halted during phase 2 to reformulate the investigational product
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The primary objectives are:
Phase 1b:
Phase 2:
The purpose of the Phase 1b portion of the study was to determine the maximum tolerated dose (MTD), the recommended phase 2 dose (RP2D), safety, and pharmacokinetics (PK) of oprozomib administered orally once daily in combination with dexamethasone, in participants with relapsed and/or refractory multiple myeloma, using a 3 + 3 dose-escalation scheme with and without step-up dosing. The MTD was defined as the highest dose level at which fewer than 33% of participants had a dose-limiting toxicity (DLT).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 180 mg 5/14 Schedule (Phase 1b) | Experimental | Oprozomib 180 mg treatment once daily for 5 consecutive days bimonthly (days 1, 2, 3, 4, and 5 of a 14-day cycle) with 20 mg dexamethasone once daily on days 1, 2, 8, and 9 (referred to as the 5/14 schedule). Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason. |
|
| Cohort 210 mg 5/14 Schedule (Phase 1b) | Experimental | Oprozomib 210 mg treatment once daily for 5 consecutive days bimonthly (days 1, 2, 3, 4, and 5 of a 14-day cycle) with 20 mg dexamethasone once daily on days 1, 2, 8, and 9 (referred to as the 5/14 schedule). Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason. This was the first cohort to enroll participants into the 5/14 schedule. The Cohort Safety Review Committee (CSRC) reviewed safety data and made dose adjustments for oprozomib in 30 mg increments for all cohorts. |
|
| Cohort 150/180 mg 5/14 Schedule (Phase 1b) | Experimental | Oprozomib 150 mg once daily treatment for 5 consecutive days (days 1, 2, 3, 4, and 5 of a 14-day cycle) followed by a step-up in oprozomib once daily dose to 180 mg starting in cycle 2 and moving forward. Dexamethasone 20 mg once daily was administered on days 1, 2, 8, and 9 of each 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oprozomib | Drug | Oprozomib tablets were supplied containing 60, 90, or 120 mg of oprozomib. Oprozomib extended release tablets were supplied containing 150, 180, 210, 240, or 270 mg of oprozomib. Both formulations were administered in a single dose on dosing days. The tablet formulation required multiple tablets to reach each dose on dosing days. |
| Measure | Description | Time Frame |
|---|---|---|
| Participants With Dose-Limiting Toxicities (DLT) | Toxicities (graded per the Common Terminology Criteria for Adverse Events v 4.03) were considered DLTs if judged by the investigator to be related to oprozomib and occurred in the first 14 days of treatment, with treatment at the dose to be studied (i.e., Cycle 1 for continuous dosing or Cycle 2 for step-up dosing). A DLT was categorized as nonhematologic or hematologic. Examples include:
| Day 1 to Day 14 (Cycle 1) for continous dosing and Day 15 to Day 28 (Cycle 2) for step-up dosing |
| Participants With Treatment-Emergent Adverse Events (TEAEs) During Phase 1b and 2 | AE defined as any untoward medical occurrence in a clinical trial participant. Treatment-emergent adverse events were defined as adverse events that start on or after the first day of study treatment and within 30 days of the last day of study treatment. An adverse event that was present before the first administration of study treatment and subsequently worsens in severity during treatment was also considered to be treatment-emergent. Serious AE defined as AE that is fatal, life threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or other significant medical hazard. Severity of AEs assessed according to Common Terminology Criteria for Adverse Events (CTCAE, v4.03) based on the general guideline: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening or disabling; Grade 5: Death related to AE. IP=investigational product | Day 1 up to Week 282 |
| Participants With Treatment-Related, Treatment-Emergent Adverse Events (TEAEs) During Phase 1b and 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic (PK) Parameter for Oprozomib, Tablet and ER Formulation: Time to Maximum Serum Concentration (Tmax) on Cycle 1, Day 1 | PK samples obtained on the following schedule: Phase 1b Continuous Dosing, Cycles 1 and 2: Day 1: pre-dose, post-dose at 15 and 30 minutes, 1, 2, 4, 6, and 8 hours post-dose plus pre-dose on Day 2 Phase 1b Step-up Dosing, Day 1: pre-dose, post-dose at 15 and 30 minutes, 1, 2, 4, 6, and 7 hours post-dose plus pre-dose on Day 2 Phase 2, Day 1: pre-dose, post-dose at 15 and 30 minutes, 1, 2, 4, 6, and 7 hours post-dose plus pre-dose on Day 2 |
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Key Inclusion Criteria:
Diagnosis of multiple myeloma with measureable disease as indicated by 1 or more of the following:
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 therapy must have consisted of at least 1 regimen that included lenalidomide and/or bortezomib. Patients should be considered to be appropriate candidates for a clinical study by their treating physicians. Relapsed patients must have previously achieved ≥ minimal response (MR) on at least 1 line of therapy, as assessed by the treating physician. Refractory patients are allowed, but it is not required that patients be refractory to their last therapy. Primary refractory patients are allowed in the Phase 1b portion of the study only.
Males and females ≥ 18 years of age
Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-2
Adequate hepatic function, with bilirubin ≤ 1.5 times the upper limit of normal (ULN) in the absence of Gilbert's disease or hemolysis, aspartate aminotransferase (AST) ≤ 3 times ULN, and alanine aminotransferase (ALT) ≤ 3 times ULN
Absolute neutrophil count (ANC) ≥ 1000 cells/mcL, hemoglobin ≥ 7.0 g/dL, and platelet count ≥ 30,000 cells/mcL:
a. Patients must not have received platelet transfusions for at least 1 week prior to Screening.
b. Screening ANC must be independent of granulocyte colony-stimulating factor and granulocyte-macrophage colony-stimulating factor (G-CSF and GM-CSF) support for at least 1 week and of pegylated G-CSF for
≥ 2 weeks prior to first dose.
c. Patients may receive red blood cell (RBC) transfusions or receive supportive care with erythropoietin or darbepoetin in accordance with institutional guidelines.
Calculated or measured creatinine clearance (CrCl) of ≥ 30 mL/minute calculated using the formula of Cockcroft and Gault ([140 - Age] * Mass (kg) / [72 * creatinine mg/mL]). Multiply result by 0.85 if female.
Uric acid, if elevated, must be corrected to within laboratory normal range before dosing.
Patients must sign a written informed consent form in accordance with federal, local, and institutional guidelines.
Female patients of childbearing potential must have a negative serum or urine pregnancy test within 3 days prior to receiving the first dose of study drug and agree to use effective methods of contraception during the study and for 3 months following the last dose of study drug. Postmenopausal females (> 45 years old and without menses for > 1 year) and surgically sterilized females are exempt from these requirements. Male patients must use an effective barrier method of contraception during the study and for 3 months following the last dose if sexually active with a female of childbearing potential.
Prior carfilzomib 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/m^2, as long as the patient:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| USC/Norris Comprehensive Cancer Center | Los Angeles | California | United States | |||
| H. Lee Moffitt Cancer Center & Research Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31229804 | Result | Hari P, Paba-Prada CE, Voorhees PM, Frye J, Chang YL, Moreau P, Zonder J, Boccia R, Shain KH. Efficacy and safety results from a phase 1b/2, multicenter, open-label study of oprozomib and dexamethasone in patients with relapsed and/or refractory multiple myeloma. Leuk Res. 2019 Aug;83:106172. doi: 10.1016/j.leukres.2019.106172. Epub 2019 Jun 17. |
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Eighty-one subjects were screened; sixteen were not enrolled due to entry criteria violations.
This study was conducted at 18 centers in the United States and France.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 180 mg 5/14 Schedule (Phase 1b) | Oprozomib 180 mg treatment once daily for 5 consecutive days bimonthly (days 1, 2, 3, 4, and 5 of a 14-day cycle) with 20 mg dexamethasone once daily on days 1, 2, 8, and 9 (referred to as the 5/14 schedule). Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 8, 2018 | May 25, 2020 |
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| Cohort 210 mg 2/7 Schedule (Phase 1b) |
| Experimental |
Oprozomib 210 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason. This was the first cohort to enroll participants into the 2/7 schedule. The Cohort Safety Review Committee (CSRC) reviewed safety data and made dose adjustments for oprozomib in 30 mg increments for all cohorts. |
|
| Cohort 240 mg 2/7 Schedule (Phase 1b) | Experimental | Oprozomib 240 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason. |
|
| Cohort 270 mg 2/7 Schedule (Phase 1b) | Experimental | Oprozomib 270 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason. |
|
| Cohort 300 mg 2/7 Schedule (Phase 1b) | Experimental | Oprozomib 300 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason. |
|
| Cohort 330 mg 2/7 Schedule (Phase 1b) | Experimental | Oprozomib 330 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason. |
|
| Phase 2 300 mg 2/7 Schedule | Experimental | The Cohort Safety Review Committee (CSRC) determined this dose as the recommended phase 2 dose (RP2D). Oprozomib 300 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason. |
|
|
|
| Dexamethasone | Drug | Dexamethasone was administered as 20 mg tablets in strengths of 4 and 6 mg taken orally. If a participant could not tolerate tablets or tablets were unavailable, 20 mg administered intravenously was substituted. |
|
AE defined as any untoward medical occurrence in a clinical trial participant. TEAEs were defined as AEs that start on or after the first day of study treatment and within 30 days of the last day of study treatment. An AE that was present before the first administration of study treatment and subsequently worsens in severity during treatment was also considered a TEAE.
Investigator assessed AEs for relatedness to study drug. Serious AE defined as AE that is fatal, life threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or other significant medical hazard. Severity of AEs assessed according to Common Terminology Criteria for Adverse Events (CTCAE, v4.03) based on the general guideline: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening or disabling; Grade 5: Death related to AE.
IP=investigational product
| Day 1 up to Week 282 |
| Best Overall Response in Phase 2 as Assessed by Investigator | Disease response and progression were determined using the International Myeloma Working Group-Uniform Response Criteria (IMWG-URC), except for minimal response (MR) and near complete response (nCR) which was based on the European Group for Blood and Marrow Transplantation (EBMT) criteria. Evaluations reported were assessed by the investigator for participants in Phase 2. | Screening: Day 14 to Day -1; During study: Day 1 up to 13.16 months |
| Percentage of Participants Who Achieved an Overall Response As Assessed by Investigator During Phase 2 | The overall response rate (ORR) was defined as the percentage of participants with the best overall response of stringent complete response (sCR), complete response (CR), near complete response (nCR), very good partial response (VGPR), and partial response (PR) as defined by the International Myeloma Working Group-Uniform Response Criteria (IMWG-URC) and modified European Group for Blood and Marrow Transplantation (EBMT) criteria. | Screening: Day 14 to Day -1; During study: Day 1 up to 13.16 months |
| Day 1 |
| Pharmacokinetic (PK) Parameter for Oprozomib, Tablet and ER Formulation: Maximum Serum Concentration (Cmax) on Cycle 1, Day 1 | PK samples obtained on the following schedule: Phase 1b Continuous Dosing, Cycles 1 and 2: Day 1: pre-dose, post-dose at 15 and 30 minutes, 1, 2, 4, 6, and 8 hours post-dose plus pre-dose on Day 2 Phase 1b Step-up Dosing, Day 1: pre-dose, post-dose at 15 and 30 minutes, 1, 2, 4, 6, and 7 hours post-dose plus pre-dose on Day 2 Phase 2, Day 1: pre-dose, post-dose at 15 and 30 minutes, 1, 2, 4, 6, and 7 hours post-dose plus pre-dose on Day 2 | Day 1 |
| Pharmacokinetic (PK) Parameter for Oprozomib, Tablet and ER Formulation: Area Under the Curve at the Last Measurable Time Point (AUClast) on Cycle 1, Day 1 | The area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration (AUClast) was estimated using the linear trapezoidal method. PK samples obtained on the following schedule: Phase 1b Continuous Dosing, Cycles 1 and 2: Day 1: pre-dose, post-dose at 15 and 30 minutes, 1, 2, 4, 6, and 8 hours post-dose plus pre-dose on Day 2 Phase 1b Step-up Dosing, Day 1: pre-dose, post-dose at 15 and 30 minutes, 1, 2, 4, 6, and 7 hours post-dose plus pre-dose on Day 2 Phase 2, Day 1: pre-dose, post-dose at 15 and 30 minutes, 1, 2, 4, 6, and 7 hours post-dose plus pre-dose on Day 2 | Day 1 |
| Pharmacokinetic (PK) Parameter for Oprozomib, Tablet and ER Formulation: Area Under the Curve From Time 0 to Time Infinity (AUCinf) on Cycle 1, Day 1 | The area under the plasma concentration-curve from time 0 to time infinity (AUCinf) was estimated using the linear trapezoidal method PK samples obtained on the following schedule: Phase 1b Continuous Dosing, Cycles 1 and 2: Day 1: pre-dose, post-dose at 15 and 30 minutes, 1, 2, 4, 6, and 8 hours post-dose plus pre-dose on Day 2 Phase 1b Step-up Dosing, Day 1: pre-dose, post-dose at 15 and 30 minutes, 1, 2, 4, 6, and 7 hours post-dose plus pre-dose on Day 2 Phase 2, Day 1: pre-dose, post-dose at 15 and 30 minutes, 1, 2, 4, 6, and 7 hours post-dose plus pre-dose on Day 2 | Day 1 |
| Pharmacokinetic (PK) Parameter for Oprozomib, Tablet and ER Formulation: Terminal Half-Life (t1/2,z) on Cycle 1, Day 1 | PK samples obtained on the following schedule: Phase 1b Continuous Dosing, Cycles 1 and 2: Day 1: pre-dose, post-dose at 15 and 30 minutes, 1, 2, 4, 6, and 8 hours post-dose plus pre-dose on Day 2 Phase 1b Step-up Dosing, Day 1: pre-dose, post-dose at 15 and 30 minutes, 1, 2, 4, 6, and 7 hours post-dose plus pre-dose on Day 2 Phase 2, Day 1: pre-dose, post-dose at 15 and 30 minutes, 1, 2, 4, 6, and 7 hours post-dose plus pre-dose on Day 2 | Day 1 |
| Pharmacokinetic (PK) Parameter for Oprozomib, Tablet and ER Formulation: Apparent Drug Clearance After Oral Administration (CL/F) on Cycle 1, Day 1 | The apparent drug clearance after oral administration (CL/F) was calculated as the dose divided by AUCinf. PK samples obtained on the following schedule: Phase 1b Continuous Dosing, Cycles 1 and 2: Day 1: pre-dose, post-dose at 15 and 30 minutes, 1, 2, 4, 6, and 8 hours post-dose plus pre-dose on Day 2 Phase 1b Step-up Dosing, Day 1: pre-dose, post-dose at 15 and 30 minutes, 1, 2, 4, 6, and 7 hours post-dose plus pre-dose on Day 2 Phase 2, Day 1: pre-dose, post-dose at 15 and 30 minutes, 1, 2, 4, 6, and 7 hours post-dose plus pre-dose on Day 2 | Day 1 |
| Pharmacokinetic (PK) Parameter for Oprozomib, Tablet and ER Formulation: Apparent Volume of Distribution After Oral Administration (Vz/F) on Cycle 1, Day 1 | The apparent volume of distribution after oral administration (Vz/F) calculated as the dose divided by AUCinf times Æ’z, where Æ’z was the first-order terminal rate constant estimated via linear regression of the terminal log-linear phase. PK samples obtained on the following schedule: Phase 1b Continuous Dosing, Cycles 1 and 2: Day 1: pre-dose, post-dose at 15 and 30 minutes, 1, 2, 4, 6, and 8 hours post-dose plus pre-dose on Day 2 Phase 1b Step-up Dosing, Day 1: pre-dose, post-dose at 15 and 30 minutes, 1, 2, 4, 6, and 7 hours post-dose plus pre-dose on Day 2 Phase 2, Day 1: pre-dose, post-dose at 15 and 30 minutes, 1, 2, 4, 6, and 7 hours post-dose plus pre-dose on Day 2 | Day 1 |
| Percentage of Participants Who Achieved a Clinical Benefit Response As Assessed by Investigator During Phase 2 | The clinical benefit rate (CBR) was defined as Overall Response Rate (ORR) plus Minimal Response (MR) as defined by the European Group for Blood and Marrow Transplantation (EBMT) criteria. | Screening: Day 14 to Day -1; During study: Day 1 up to 13.16 months |
| Kaplan-Meier Estimates for Duration of Response (DOR) as Assessed by Investigator During Phase 2 | Duration of response was defined as the time from first evidence of partial response (PR) or better (i.e. best overall response) to confirmation of disease progression or death due to any cause. Durations were calculated for responders only. Medians and percentiles were estimated using the Kaplan-Meier method. 95% confidence intervals for medians and percentiles were estimated using the method by Klein and Moeschberger (1997) with log-log transformation. | Day 1 up to 13.16 months |
| Kaplan-Meier Estimates for Progression-free Survival (PFS) as Assessed by Investigator During Phase 2 | Progression-free survival (PFS) was defined as number of months between start of treatment and first evidence of documented disease progression or death (due to any cause), whichever occurs first. Disease progression was determined using IMWG-URC per investigator. The duration of PFS was right-censored for participants who met 1 of the following conditions:
| Day 1 up to 14.1 months |
| Kaplan-Meier Estimate for Time to Progression (TTP) as Assessed by Investigator During Phase 2 | Time to progression (TTP) was defined as the number of months between the start of treatment to the first documentation of disease progression. Disease progression was determined using IMWG-URC as assessed by the investigator. The same censoring rules, except for death, as in analysis of PFS were applied in the calculation of TTP. Participants who died prior to progressive disease were censored at the date of last evaluable response assessment. | Day 1 up to 14.1 months |
| Tampa |
| Florida |
| United States |
| University of Kansas Cancer Center and Medical Pavilion | Westwood | Kansas | United States |
| Center for Cancer and Blood Disorders | Bethesda | Maryland | United States |
| Dana-Farber Cancer Institute | Boston | Massachusetts | United States |
| Massachusetts General Hospital | Boston | Massachusetts | United States |
| Karmanos Cancer Institute | Detroit | Michigan | United States |
| Division of Hematology/ Oncology, UNC at Chapel Hill | Chapel Hill | North Carolina | United States |
| Gabrail Cancer Center Research | Canton | Ohio | United States |
| Froedtert Hospital and the Medical College of Wisconsin | Milwaukee | Wisconsin | United States |
| CHRU, Hopital Huriez - Department of Hematology | Lille | France |
| CHU Hotel Dieu - Service d'Hematologie Clinique | Nantes | France |
| CHU de NANCY - Hopital de BRABOlS | Vandœuvre-lès-Nancy | France |
| FG001 | Cohort 210 mg 5/14 Schedule (Phase 1b) | Oprozomib 210 mg treatment once daily for 5 consecutive days bimonthly (days 1, 2, 3, 4, and 5 of a 14-day cycle) with 20 mg dexamethasone once daily on days 1, 2, 8, and 9 (referred to as the 5/14 schedule). Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason. This was the first cohort to enroll participants into the 5/14 schedule. The Cohort Safety Review Committee (CSRC) reviewed safety data and made dose adjustments for oprozomib in 30 mg increments for all cohorts. |
| FG002 | Cohort 150/180 mg 5/14 Schedule (Phase 1b) | Oprozomib 150 mg once daily treatment for 5 consecutive days (days 1, 2, 3, 4, and 5 of a 14-day cycle) followed by a step-up in oprozomib once daily dose to 180 mg starting in cycle 2 and moving forward. Dexamethasone 20 mg once daily was administered on days 1, 2, 8, and 9 of each 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason. |
| FG003 | Cohort 210 mg 2/7 Schedule (Phase 1b) | Oprozomib 210 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason. This was the first cohort to enroll participants into the 2/7 schedule. The Cohort Safety Review Committee (CSRC) reviewed safety data and made dose adjustments for oprozomib in 30 mg increments for all cohorts. |
| FG004 | Cohort 240 mg 2/7 Schedule (Phase 1b) | Oprozomib 240 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason. |
| FG005 | Cohort 270 mg 2/7 Schedule (Phase 1b) | Oprozomib 270 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason. |
| FG006 | Cohort 300 mg 2/7 Schedule (Phase 1b) | Oprozomib 300 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason. |
| FG007 | Cohort 330 mg 2/7 Schedule (Phase 1b) | Oprozomib 330 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason. |
| FG008 | Phase 2 300 mg 2/7 Schedule | The Cohort Safety Review Committee (CSRC) determined this dose as the recommended phase 2 dose (RP2D). Oprozomib 300 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason. |
| COMPLETED |
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| NOT COMPLETED |
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Safety population: all subjects who receive at least 1 dose of study treatment
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 180 mg 5/14 Schedule (Phase 1b) | Oprozomib 180 mg treatment once daily for 5 consecutive days bimonthly (days 1, 2, 3, 4, and 5 of a 14-day cycle) with 20 mg dexamethasone once daily on days 1, 2, 8, and 9 (referred to as the 5/14 schedule). Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason. |
| BG001 | Cohort 210 mg 5/14 Schedule (Phase 1b) | Oprozomib 210 mg treatment once daily for 5 consecutive days bimonthly (days 1, 2, 3, 4, and 5 of a 14-day cycle) with 20 mg dexamethasone once daily on days 1, 2, 8, and 9 (referred to as the 5/14 schedule). Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason. This was the first cohort to enroll participants into the 5/14 schedule. The Cohort Safety Review Committee (CSRC) reviewed safety data and made dose adjustments for oprozomib in 30 mg increments for all cohorts. |
| BG002 | Cohort 150/180 mg 5/14 Schedule (Phase 1b) | Oprozomib 150 mg once daily treatment for 5 consecutive days (days 1, 2, 3, 4, and 5 of a 14-day cycle) followed by a step-up in oprozomib once daily dose to 180 mg starting in cycle 2 and moving forward. Dexamethasone 20 mg once daily was administered on days 1, 2, 8, and 9 of each 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason. |
| BG003 | Cohort 210 mg 2/7 Schedule (Phase 1b) | Oprozomib 210 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason. This was the first cohort to enroll participants into the 2/7 schedule. The Cohort Safety Review Committee (CSRC) reviewed safety data and made dose adjustments for oprozomib in 30 mg increments for all cohorts. |
| BG004 | Cohort 240 mg 2/7 Schedule (Phase 1b) | Oprozomib 240 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason. |
| BG005 | Cohort 270 mg 2/7 Schedule (Phase 1b) | Oprozomib 270 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason. |
| BG006 | Cohort 300 mg 2/7 Schedule (Phase 1b) | Oprozomib 300 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason. |
| BG007 | Cohort 330 mg 2/7 Schedule (Phase 1b) | Oprozomib 330 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason. |
| BG008 | Phase 2 300 mg 2/7 Schedule | The Cohort Safety Review Committee (CSRC) determined this dose as the recommended phase 2 dose (RP2D). Oprozomib 300 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason. |
| BG009 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Participants With Dose-Limiting Toxicities (DLT) | Toxicities (graded per the Common Terminology Criteria for Adverse Events v 4.03) were considered DLTs if judged by the investigator to be related to oprozomib and occurred in the first 14 days of treatment, with treatment at the dose to be studied (i.e., Cycle 1 for continuous dosing or Cycle 2 for step-up dosing). A DLT was categorized as nonhematologic or hematologic. Examples include:
| Safety population | Posted | Count of Participants | Participants | Day 1 to Day 14 (Cycle 1) for continous dosing and Day 15 to Day 28 (Cycle 2) for step-up dosing |
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| Primary | Participants With Treatment-Emergent Adverse Events (TEAEs) During Phase 1b and 2 | AE defined as any untoward medical occurrence in a clinical trial participant. Treatment-emergent adverse events were defined as adverse events that start on or after the first day of study treatment and within 30 days of the last day of study treatment. An adverse event that was present before the first administration of study treatment and subsequently worsens in severity during treatment was also considered to be treatment-emergent. Serious AE defined as AE that is fatal, life threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or other significant medical hazard. Severity of AEs assessed according to Common Terminology Criteria for Adverse Events (CTCAE, v4.03) based on the general guideline: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening or disabling; Grade 5: Death related to AE. IP=investigational product | Safety population | Posted | Count of Participants | Participants | Day 1 up to Week 282 |
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| Primary | Participants With Treatment-Related, Treatment-Emergent Adverse Events (TEAEs) During Phase 1b and 2 | AE defined as any untoward medical occurrence in a clinical trial participant. TEAEs were defined as AEs that start on or after the first day of study treatment and within 30 days of the last day of study treatment. An AE that was present before the first administration of study treatment and subsequently worsens in severity during treatment was also considered a TEAE. Investigator assessed AEs for relatedness to study drug. Serious AE defined as AE that is fatal, life threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or other significant medical hazard. Severity of AEs assessed according to Common Terminology Criteria for Adverse Events (CTCAE, v4.03) based on the general guideline: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening or disabling; Grade 5: Death related to AE. IP=investigational product | Safety population | Posted | Count of Participants | Participants | Day 1 up to Week 282 |
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| Primary | Best Overall Response in Phase 2 as Assessed by Investigator | Disease response and progression were determined using the International Myeloma Working Group-Uniform Response Criteria (IMWG-URC), except for minimal response (MR) and near complete response (nCR) which was based on the European Group for Blood and Marrow Transplantation (EBMT) criteria. Evaluations reported were assessed by the investigator for participants in Phase 2. | Safety Population | Posted | Count of Participants | Participants | Screening: Day 14 to Day -1; During study: Day 1 up to 13.16 months |
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| Primary | Percentage of Participants Who Achieved an Overall Response As Assessed by Investigator During Phase 2 | The overall response rate (ORR) was defined as the percentage of participants with the best overall response of stringent complete response (sCR), complete response (CR), near complete response (nCR), very good partial response (VGPR), and partial response (PR) as defined by the International Myeloma Working Group-Uniform Response Criteria (IMWG-URC) and modified European Group for Blood and Marrow Transplantation (EBMT) criteria. | Safety Population | Posted | Number | 95% Confidence Interval | percentage of participants | Screening: Day 14 to Day -1; During study: Day 1 up to 13.16 months |
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| Secondary | Pharmacokinetic (PK) Parameter for Oprozomib, Tablet and ER Formulation: Time to Maximum Serum Concentration (Tmax) on Cycle 1, Day 1 | PK samples obtained on the following schedule: Phase 1b Continuous Dosing, Cycles 1 and 2: Day 1: pre-dose, post-dose at 15 and 30 minutes, 1, 2, 4, 6, and 8 hours post-dose plus pre-dose on Day 2 Phase 1b Step-up Dosing, Day 1: pre-dose, post-dose at 15 and 30 minutes, 1, 2, 4, 6, and 7 hours post-dose plus pre-dose on Day 2 Phase 2, Day 1: pre-dose, post-dose at 15 and 30 minutes, 1, 2, 4, 6, and 7 hours post-dose plus pre-dose on Day 2 | Safety population | Posted | Median | Full Range | hours | Day 1 |
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| Secondary | Pharmacokinetic (PK) Parameter for Oprozomib, Tablet and ER Formulation: Maximum Serum Concentration (Cmax) on Cycle 1, Day 1 | PK samples obtained on the following schedule: Phase 1b Continuous Dosing, Cycles 1 and 2: Day 1: pre-dose, post-dose at 15 and 30 minutes, 1, 2, 4, 6, and 8 hours post-dose plus pre-dose on Day 2 Phase 1b Step-up Dosing, Day 1: pre-dose, post-dose at 15 and 30 minutes, 1, 2, 4, 6, and 7 hours post-dose plus pre-dose on Day 2 Phase 2, Day 1: pre-dose, post-dose at 15 and 30 minutes, 1, 2, 4, 6, and 7 hours post-dose plus pre-dose on Day 2 | Safety population | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Day 1 |
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| Secondary | Pharmacokinetic (PK) Parameter for Oprozomib, Tablet and ER Formulation: Area Under the Curve at the Last Measurable Time Point (AUClast) on Cycle 1, Day 1 | The area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration (AUClast) was estimated using the linear trapezoidal method. PK samples obtained on the following schedule: Phase 1b Continuous Dosing, Cycles 1 and 2: Day 1: pre-dose, post-dose at 15 and 30 minutes, 1, 2, 4, 6, and 8 hours post-dose plus pre-dose on Day 2 Phase 1b Step-up Dosing, Day 1: pre-dose, post-dose at 15 and 30 minutes, 1, 2, 4, 6, and 7 hours post-dose plus pre-dose on Day 2 Phase 2, Day 1: pre-dose, post-dose at 15 and 30 minutes, 1, 2, 4, 6, and 7 hours post-dose plus pre-dose on Day 2 | Safety population | Posted | Geometric Mean | Geometric Coefficient of Variation | hr*ng/mL | Day 1 |
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| Secondary | Pharmacokinetic (PK) Parameter for Oprozomib, Tablet and ER Formulation: Area Under the Curve From Time 0 to Time Infinity (AUCinf) on Cycle 1, Day 1 | The area under the plasma concentration-curve from time 0 to time infinity (AUCinf) was estimated using the linear trapezoidal method PK samples obtained on the following schedule: Phase 1b Continuous Dosing, Cycles 1 and 2: Day 1: pre-dose, post-dose at 15 and 30 minutes, 1, 2, 4, 6, and 8 hours post-dose plus pre-dose on Day 2 Phase 1b Step-up Dosing, Day 1: pre-dose, post-dose at 15 and 30 minutes, 1, 2, 4, 6, and 7 hours post-dose plus pre-dose on Day 2 Phase 2, Day 1: pre-dose, post-dose at 15 and 30 minutes, 1, 2, 4, 6, and 7 hours post-dose plus pre-dose on Day 2 | Safety population | Posted | Geometric Mean | Geometric Coefficient of Variation | hr*ng/mL | Day 1 |
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| Secondary | Pharmacokinetic (PK) Parameter for Oprozomib, Tablet and ER Formulation: Terminal Half-Life (t1/2,z) on Cycle 1, Day 1 | PK samples obtained on the following schedule: Phase 1b Continuous Dosing, Cycles 1 and 2: Day 1: pre-dose, post-dose at 15 and 30 minutes, 1, 2, 4, 6, and 8 hours post-dose plus pre-dose on Day 2 Phase 1b Step-up Dosing, Day 1: pre-dose, post-dose at 15 and 30 minutes, 1, 2, 4, 6, and 7 hours post-dose plus pre-dose on Day 2 Phase 2, Day 1: pre-dose, post-dose at 15 and 30 minutes, 1, 2, 4, 6, and 7 hours post-dose plus pre-dose on Day 2 | Safety population | Posted | Geometric Mean | Geometric Coefficient of Variation | hr | Day 1 |
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| Secondary | Pharmacokinetic (PK) Parameter for Oprozomib, Tablet and ER Formulation: Apparent Drug Clearance After Oral Administration (CL/F) on Cycle 1, Day 1 | The apparent drug clearance after oral administration (CL/F) was calculated as the dose divided by AUCinf. PK samples obtained on the following schedule: Phase 1b Continuous Dosing, Cycles 1 and 2: Day 1: pre-dose, post-dose at 15 and 30 minutes, 1, 2, 4, 6, and 8 hours post-dose plus pre-dose on Day 2 Phase 1b Step-up Dosing, Day 1: pre-dose, post-dose at 15 and 30 minutes, 1, 2, 4, 6, and 7 hours post-dose plus pre-dose on Day 2 Phase 2, Day 1: pre-dose, post-dose at 15 and 30 minutes, 1, 2, 4, 6, and 7 hours post-dose plus pre-dose on Day 2 | Safety population | Posted | Geometric Mean | Geometric Coefficient of Variation | mL/hr | Day 1 |
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| Secondary | Pharmacokinetic (PK) Parameter for Oprozomib, Tablet and ER Formulation: Apparent Volume of Distribution After Oral Administration (Vz/F) on Cycle 1, Day 1 | The apparent volume of distribution after oral administration (Vz/F) calculated as the dose divided by AUCinf times Æ’z, where Æ’z was the first-order terminal rate constant estimated via linear regression of the terminal log-linear phase. PK samples obtained on the following schedule: Phase 1b Continuous Dosing, Cycles 1 and 2: Day 1: pre-dose, post-dose at 15 and 30 minutes, 1, 2, 4, 6, and 8 hours post-dose plus pre-dose on Day 2 Phase 1b Step-up Dosing, Day 1: pre-dose, post-dose at 15 and 30 minutes, 1, 2, 4, 6, and 7 hours post-dose plus pre-dose on Day 2 Phase 2, Day 1: pre-dose, post-dose at 15 and 30 minutes, 1, 2, 4, 6, and 7 hours post-dose plus pre-dose on Day 2 | Safety population | Posted | Geometric Mean | Geometric Coefficient of Variation | mL | Day 1 |
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| Secondary | Percentage of Participants Who Achieved a Clinical Benefit Response As Assessed by Investigator During Phase 2 | The clinical benefit rate (CBR) was defined as Overall Response Rate (ORR) plus Minimal Response (MR) as defined by the European Group for Blood and Marrow Transplantation (EBMT) criteria. | Safety Population | Posted | Number | 95% Confidence Interval | percentage of participants | Screening: Day 14 to Day -1; During study: Day 1 up to 13.16 months |
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| Secondary | Kaplan-Meier Estimates for Duration of Response (DOR) as Assessed by Investigator During Phase 2 | Duration of response was defined as the time from first evidence of partial response (PR) or better (i.e. best overall response) to confirmation of disease progression or death due to any cause. Durations were calculated for responders only. Medians and percentiles were estimated using the Kaplan-Meier method. 95% confidence intervals for medians and percentiles were estimated using the method by Klein and Moeschberger (1997) with log-log transformation. | Safety population | Posted | Median | 95% Confidence Interval | months | Day 1 up to 13.16 months |
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| Secondary | Kaplan-Meier Estimates for Progression-free Survival (PFS) as Assessed by Investigator During Phase 2 | Progression-free survival (PFS) was defined as number of months between start of treatment and first evidence of documented disease progression or death (due to any cause), whichever occurs first. Disease progression was determined using IMWG-URC per investigator. The duration of PFS was right-censored for participants who met 1 of the following conditions:
| Safety population | Posted | Median | 95% Confidence Interval | months | Day 1 up to 14.1 months |
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| Secondary | Kaplan-Meier Estimate for Time to Progression (TTP) as Assessed by Investigator During Phase 2 | Time to progression (TTP) was defined as the number of months between the start of treatment to the first documentation of disease progression. Disease progression was determined using IMWG-URC as assessed by the investigator. The same censoring rules, except for death, as in analysis of PFS were applied in the calculation of TTP. Participants who died prior to progressive disease were censored at the date of last evaluable response assessment. | Safety population | Posted | Median | 95% Confidence Interval | months | Day 1 up to 14.1 months |
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All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort 180 mg 5/14 Schedule (Phase 1b) | Oprozomib 180 mg treatment once daily for 5 consecutive days bimonthly (days 1, 2, 3, 4, and 5 of a 14-day cycle) with 20 mg dexamethasone once daily on days 1, 2, 8, and 9 (referred to as the 5/14 schedule). Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason. | 0 | 9 | 4 | 9 | 9 | 9 |
| EG001 | Cohort 210 mg 5/14 Schedule (Phase 1b) | Oprozomib 210 mg treatment once daily for 5 consecutive days bimonthly (days 1, 2, 3, 4, and 5 of a 14-day cycle) with 20 mg dexamethasone once daily on days 1, 2, 8, and 9 (referred to as the 5/14 schedule). Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason. This was the first cohort to enroll participants into the 5/14 schedule. The Cohort Safety Review Committee (CSRC) reviewed safety data and made dose adjustments for oprozomib in 30 mg increments for all cohorts. | 1 | 7 | 2 | 7 | 7 | 7 |
| EG002 | Cohort 150/180 mg 5/14 Schedule (Phase 1b) | Oprozomib 150 mg once daily treatment for 5 consecutive days (days 1, 2, 3, 4, and 5 of a 14-day cycle) followed by a step-up in oprozomib once daily dose to 180 mg starting in cycle 2 and moving forward. Dexamethasone 20 mg once daily was administered on days 1, 2, 8, and 9 of each 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason. | 0 | 3 | 2 | 3 | 3 | 3 |
| EG003 | Cohort 210 mg 2/7 Schedule (Phase 1b) | Oprozomib 210 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason. This was the first cohort to enroll participants into the 2/7 schedule. The Cohort Safety Review Committee (CSRC) reviewed safety data and made dose adjustments for oprozomib in 30 mg increments for all cohorts. | 0 | 4 | 2 | 4 | 4 | 4 |
| EG004 | Cohort 240 mg 2/7 Schedule (Phase 1b) | Oprozomib 240 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason. | 1 | 4 | 1 | 4 | 4 | 4 |
| EG005 | Cohort 270 mg 2/7 Schedule (Phase 1b) | Oprozomib 270 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason. | 0 | 6 | 1 | 6 | 6 | 6 |
| EG006 | Cohort 300 mg 2/7 Schedule (Phase 1b) | Oprozomib 300 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason. | 0 | 8 | 3 | 8 | 8 | 8 |
| EG007 | Cohort 330 mg 2/7 Schedule (Phase 1b) | Oprozomib 330 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason. | 0 | 6 | 0 | 6 | 6 | 6 |
| EG008 | Phase 2 300 mg 2/7 Schedule | The Cohort Safety Review Committee (CSRC) determined this dose as the recommended phase 2 dose (RP2D). Oprozomib 300 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14- day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason. | 0 | 18 | 9 | 18 | 18 | 18 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Clostridium difficile infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Meningitis aseptic | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Spinal cord infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Subarachnoid haemorrhage | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Tumour lysis syndrome | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Bone lesion | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 20.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Microcytic anaemia | Blood and lymphatic system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Bundle branch block right | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
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| Diastolic dysfunction | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
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| Palpitations | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Ventricular extrasystoles | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Cerumen impaction | Ear and labyrinth disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Ear congestion | Ear and labyrinth disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Ear discomfort | Ear and labyrinth disorders | MedDRA 20.1 | Systematic Assessment |
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| Middle ear effusion | Ear and labyrinth disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Otorrhoea | Ear and labyrinth disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA 20.1 | Systematic Assessment |
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| Vision blurred | Eye disorders | MedDRA 20.1 | Systematic Assessment |
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| Visual impairment | Eye disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Vitreous floaters | Eye disorders | MedDRA 20.1 | Systematic Assessment |
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| Abdominal discomfort | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Abdominal distension | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Abdominal rigidity | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Anal incontinence | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Dental caries | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Diverticulum | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Eructation | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Faeces soft | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Functional gastrointestinal disorder | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Gastrointestinal motility disorder | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Gastrointestinal sounds abnormal | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Gingival bleeding | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Glossodynia | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Haematochezia | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Haemorrhoids | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Hypoaesthesia oral | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Large intestine polyp | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Lip haematoma | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Oral disorder | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Periodontal disease | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Retching | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Salivary hypersecretion | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 20.1 | Systematic Assessment |
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| Discomfort | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Facial pain | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Feeling abnormal | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Feeling jittery | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Gait disturbance | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Nodule | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hepatitis cholestatic | Hepatobiliary disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Seasonal allergy | Immune system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Candida infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Clostridium difficile infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Fungal skin infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Genital herpes | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Haemophilus infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Herpes virus infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Hordeolum | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Tinea cruris | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Tooth abscess | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Tooth infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Urinary tract infection enterococcal | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Animal bite | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
| |
| Animal scratch | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
| |
| Concussion | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
| |
| Laceration | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
| |
| Muscle strain | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
| |
| Skin abrasion | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
| |
| Thermal burn | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
| |
| Wound | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Aspartate aminotransferase decreased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Blood alkaline phosphatase decreased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Blood creatinine decreased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Blood phosphorus increased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Blood pressure abnormal | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Blood urea decreased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Blood uric acid decreased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Cardiac murmur | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Ejection fraction decreased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| International normalised ratio increased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Protein total increased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| White blood cell count increased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Cell death | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Fluid overload | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hypermagnesaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hyperphosphataemia | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hypovolaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Iron deficiency | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Lactic acidosis | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Malnutrition | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Exostosis | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Joint stiffness | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Limb discomfort | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Osteonecrosis of jaw | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Plasma cell myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
| |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
| |
| Cognitive disorder | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Head discomfort | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Memory impairment | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Bruxism | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Disorientation | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Irritability | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Mental disorder | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Thinking abnormal | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Nocturia | Renal and urinary disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Urinary hesitation | Renal and urinary disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Balanoposthitis | Reproductive system and breast disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Breast disorder | Reproductive system and breast disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Erectile dysfunction | Reproductive system and breast disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Uterine prolapse | Reproductive system and breast disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Vaginal prolapse | Reproductive system and breast disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Orthopnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Rhonchi | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Actinic keratosis | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Angioedema | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Blister | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Chronic papillomatous dermatitis | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hair texture abnormal | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Miliaria | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Nail ridging | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Onychomadesis | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Rash macular | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Joint surgery | Surgical and medical procedures | MedDRA 20.1 | Systematic Assessment |
| |
| Medical device implantation | Surgical and medical procedures | MedDRA 20.1 | Systematic Assessment |
| |
| Aortic aneurysm | Vascular disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Phlebitis | Vascular disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Post thrombotic syndrome | Vascular disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Venous thrombosis | Vascular disorders | MedDRA 20.1 | Systematic Assessment |
|
The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Amgen, Inc | 866-572-6436 | medinfo@amgen.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 20, 2016 | May 25, 2020 | SAP_001.pdf |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C554738 | ONX 0912 |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
Not provided
Not provided
| 65 - <75 years |
|
| >=75 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Cohort 240 mg 2/7 Schedule (Phase 1b) |
Oprozomib 240 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason. |
| OG005 | Cohort 270 mg 2/7 Schedule (Phase 1b) | Oprozomib 270 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason. |
| OG006 | Cohort 300 mg 2/7 Schedule (Phase 1b) | Oprozomib 300 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason. |
| OG007 | Cohort 330 mg 2/7 Schedule (Phase 1b) | Oprozomib 330 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason. |
| OG008 | Phase 2 300 mg 2/7 Schedule | The Cohort Safety Review Committee (CSRC) determined this dose as the recommended phase 2 dose (RP2D). Oprozomib 300 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason. |
| Mental status changes |
|
| Alanine aminotransferase increased |
|
| Aspartate aminotransferase increased |
|
| Hypertension |
|
| Subarachnoid haemorrhage |
|
| Thrombocytopenia |
|
| Anemia |
|
| Nausea |
|
| Upper respiratory tract infection |
|
| Vomiting |
|
| Pain in jaw |
|
| Cohort 210 mg 5/14 Schedule (Phase 1b) |
Oprozomib 210 mg treatment once daily for 5 consecutive days bimonthly (days 1, 2, 3, 4, and 5 of a 14-day cycle) with 20 mg dexamethasone once daily on days 1, 2, 8, and 9 (referred to as the 5/14 schedule). Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason. This was the first cohort to enroll participants into the 5/14 schedule. The Cohort Safety Review Committee (CSRC) reviewed safety data and made dose adjustments for oprozomib in 30 mg increments for all cohorts. |
| OG002 | Cohort 150/180 mg 5/14 Schedule (Phase 1b) | Oprozomib 150 mg once daily treatment for 5 consecutive days (days 1, 2, 3, 4, and 5 of a 14-day cycle) followed by a step-up in oprozomib once daily dose to 180 mg starting in cycle 2 and moving forward. Dexamethasone 20 mg once daily was administered on days 1, 2, 8, and 9 of each 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason. |
| OG003 | Cohort 210 mg 2/7 Schedule (Phase 1b) | Oprozomib 210 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason. This was the first cohort to enroll participants into the 2/7 schedule. The Cohort Safety Review Committee (CSRC) reviewed safety data and made dose adjustments for oprozomib in 30 mg increments for all cohorts. |
| OG004 | Cohort 240 mg 2/7 Schedule (Phase 1b) | Oprozomib 240 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason. |
| OG005 | Cohort 270 mg 2/7 Schedule (Phase 1b) | Oprozomib 270 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason. |
| OG006 | Cohort 300 mg 2/7 Schedule (Phase 1b) | Oprozomib 300 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason. |
| OG007 | Cohort 330 mg 2/7 Schedule (Phase 1b) | Oprozomib 330 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason. |
| OG008 | Phase 2 300 mg 2/7 Schedule | The Cohort Safety Review Committee (CSRC) determined this dose as the recommended phase 2 dose (RP2D). Oprozomib 300 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason. |
|
|
| Cohort 210 mg 5/14 Schedule (Phase 1b) |
Oprozomib 210 mg treatment once daily for 5 consecutive days bimonthly (days 1, 2, 3, 4, and 5 of a 14-day cycle) with 20 mg dexamethasone once daily on days 1, 2, 8, and 9 (referred to as the 5/14 schedule). Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason. This was the first cohort to enroll participants into the 5/14 schedule. The Cohort Safety Review Committee (CSRC) reviewed safety data and made dose adjustments for oprozomib in 30 mg increments for all cohorts. |
| OG002 | Cohort 150/180 mg 5/14 Schedule (Phase 1b) | Oprozomib 150 mg once daily treatment for 5 consecutive days (days 1, 2, 3, 4, and 5 of a 14-day cycle) followed by a step-up in oprozomib once daily dose to 180 mg starting in cycle 2 and moving forward. Dexamethasone 20 mg once daily was administered on days 1, 2, 8, and 9 of each 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason. |
| OG003 | Cohort 210 mg 2/7 Schedule (Phase 1b) | Oprozomib 210 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason. This was the first cohort to enroll participants into the 2/7 schedule. The Cohort Safety Review Committee (CSRC) reviewed safety data and made dose adjustments for oprozomib in 30 mg increments for all cohorts. |
| OG004 | Cohort 240 mg 2/7 Schedule (Phase 1b) | Oprozomib 240 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason. |
| OG005 | Cohort 270 mg 2/7 Schedule (Phase 1b) | Oprozomib 270 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason. |
| OG006 | Cohort 300 mg 2/7 Schedule (Phase 1b) | Oprozomib 300 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason. |
| OG007 | Cohort 330 mg 2/7 Schedule (Phase 1b) | Oprozomib 330 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason. |
| OG008 | Phase 2 300 mg 2/7 Schedule | The Cohort Safety Review Committee (CSRC) determined this dose as the recommended phase 2 dose (RP2D). Oprozomib 300 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason. |
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Participants who were administered 270 mg oprozomib tablets.
| OG004 | 300 mg Oprozomib Tablet | Participants who were administered 300 mg oprozomib tablets. |
| OG005 | 150 mg Oprozomib ER Tablet | Participants who were administered 150 mg extended release oprozomib tablets. |
| OG006 | 300 mg Oprozomib ER Tablet | Participants who were administered 300 mg extended release oprozomib tablets. |
| OG007 | 330 mg Oprozomib ER Tablet | Participants who were administered 330 mg extended release oprozomib tablets. |
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Participants who were administered 270 mg oprozomib tablets. |
| OG004 | 300 mg Oprozomib Tablet | Participants who were administered 300 mg oprozomib tablets. |
| OG005 | 150 mg Oprozomib ER Tablet | Participants who were administered 150 mg extended release oprozomib tablets. |
| OG006 | 300 mg Oprozomib ER Tablet | Participants who were administered 300 mg extended release oprozomib tablets. |
| OG007 | 330 mg Oprozomib ER Tablet | Participants who were administered 330 mg extended release oprozomib tablets. |
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| OG003 | 270 mg Oprozomib Tablet | Participants who were administered 270 mg oprozomib tablets. |
| OG004 | 300 mg Oprozomib Tablet | Participants who were administered 300 mg oprozomib tablets. |
| OG005 | 150 mg Oprozomib ER Tablet | Participants who were administered 150 mg extended release oprozomib tablets. |
| OG006 | 300 mg Oprozomib ER Tablet | Participants who were administered 300 mg extended release oprozomib tablets. |
| OG007 | 330 mg Oprozomib ER Tablet | Participants who were administered 330 mg extended release oprozomib tablets. |
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| OG003 |
| 270 mg Oprozomib Tablet |
Participants who were administered 270 mg oprozomib tablets. |
| OG004 | 300 mg Oprozomib Tablet | Participants who were administered 300 mg oprozomib tablets. |
| OG005 | 150 mg Oprozomib ER Tablet | Participants who were administered 150 mg extended release oprozomib tablets. |
| OG006 | 300 mg Oprozomib ER Tablet | Participants who were administered 300 mg extended release oprozomib tablets. |
| OG007 | 330 mg Oprozomib ER Tablet | Participants who were administered 330 mg extended release oprozomib tablets. |
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Participants who were administered 270 mg oprozomib tablets.
| OG004 | 300 mg Oprozomib Tablet | Participants who were administered 300 mg oprozomib tablets. |
| OG005 | 150 mg Oprozomib ER Tablet | Participants who were administered 150 mg extended release oprozomib tablets. |
| OG006 | 300 mg Oprozomib ER Tablet | Participants who were administered 300 mg extended release oprozomib tablets. |
| OG007 | 330 mg Oprozomib ER Tablet | Participants who were administered 330 mg extended release oprozomib tablets. |
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|
| 270 mg Oprozomib Tablet |
Participants who were administered 270 mg oprozomib tablets. |
| OG004 | 300 mg Oprozomib Tablet | Participants who were administered 300 mg oprozomib tablets. |
| OG005 | 150 mg Oprozomib ER Tablet | Participants who were administered 150 mg extended release oprozomib tablets. |
| OG006 | 300 mg Oprozomib ER Tablet | Participants who were administered 300 mg extended release oprozomib tablets. |
| OG007 | 330 mg Oprozomib ER Tablet | Participants who were administered 330 mg extended release oprozomib tablets. |
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| OG003 | 270 mg Oprozomib Tablet | Participants who were administered 270 mg oprozomib tablets. |
| OG004 | 300 mg Oprozomib Tablet | Participants who were administered 300 mg oprozomib tablets. |
| OG005 | 150 mg Oprozomib ER Tablet | Participants who were administered 150 mg extended release oprozomib tablets. |
| OG006 | 300 mg Oprozomib ER Tablet | Participants who were administered 300 mg extended release oprozomib tablets. |
| OG007 | 330 mg Oprozomib ER Tablet | Participants who were administered 330 mg extended release oprozomib tablets. |
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| Participants |
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