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Safety Study of the Proteasome Inhibitor PR-171 (Carfilzomib for Injection) in Patients With Hematological Malignancies

Primary Purpose

Waldenstrom's Macroglobulinemia, Non-Hodgkin's Lymphoma, Hodgkin's Disease

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Carfilzomib
Dexamethasone
Sponsored by
Amgen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Waldenstrom's Macroglobulinemia focused on measuring Hematological, Proteasome, Myeloma, Lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Written informed consent in accordance with federal, local, and institutional guidelines Males and females ≥18 years of age Histologically confirmed diagnosis of one of the hematologic malignancies below: Multiple myeloma (MM) Non-Hodgkin's lymphoma (NHL) Waldenström's Macroglobulinemia (WM) Hodgkin's disease (HD) Subjects who are refractory or relapsed following at least two prior therapies Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2 Adequate cardiovascular function without symptomatic ischemia, conduction abnormalities uncontrolled by conventional intervention, or myocardial infarction in the previous six months Adequate hepatic function, with bilirubin < 2.0 times the upper limit of normal, and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) of < 3.0 times the upper limit of normal Total white blood cell (WBC) count ≥ 2,000/mm³, absolute neutrophil count (ANC) ≥ 1000/mm³, hemoglobin ≥ 8.0 g/dL, and platelet count ≥ 50,000/mm³ Screening ANC should be independent of granulocyte colony stimulating factor (G-CSF) or granulocyte-macrophage colony-stimulating factor (GM-CSF) support for ≥ 1 week and of pegylated G-CSF for ≥ 2 weeks) Subjects receiving supportive care including erythropoietin, darbepoetin and/or bisphosphonates can continue to do so, but must be transfusion independent; subjects receiving erythropoietic support must remain on the same dose for the first 28 days of study participation An estimated creatinine clearance of ≥ 30 mL/min, calculated using the formula of Cockroft and Gault Serum creatinine ≤ 2.0 mg/dL Uric acid, if elevated, must be corrected to within laboratory normal range prior to dosing Female subjects of child-bearing potential must agree to use dual methods of contraception and have a negative serum pregnancy test. Male subjects must use an effective barrier method of contraception throughout the study and for three months following the last dose if sexually active with a female of child-bearing potential. Exclusion Criteria: Female subjects who are pregnant or lactating Subjects who are transfusion dependent Subjects with NHL or HL who have received steroid therapy in the previous seven days Subjects with MM or Waldenström's Macroglobulinemia who have received steroid therapy in the previous three weeks, except for MM subjects in the Carfilzomib + DEX Expansion Cohort, where previous treatment with dexamethasone will be allowed. The dose and schedule of administration of dexamethasone will be adjusted to that used in the protocol Radiation, chemotherapy, or immunotherapy in the previous four weeks, or subjects who, in the judgment of the Investigator, have not recovered from the effects of previous therapy For the Dose Escalation period, subjects who have received prior radioimmunotherapy with anti-cluster of differentiation (CD)20 monoclonal antibodies such as Bexxar® or Zevalin®; subjects treated with these products will be allowed in the Dose Expansion period Subjects who have received allogeneic stem cell transplant therapy Subjects with NHL or HL who have received autologous stem cell transplant therapy and have relapsed within 100 days of therapy Rituxan therapy within three months before Day 1 unless there is evidence of disease progression Major surgery within three weeks before Day 1 Congestive heart failure (CHF) (New York Heart Association class III to IV) Acute active infection requiring systemic antibiotics, antivirals, or antifungals within two weeks prior to first dose Subjects who are known or suspected of having human immunodeficiency virus (HIV) infection or who are HIV seropositive Active hepatitis A, B, or C infection; or positive for Hepatitis C ribonucleic acid (RNA) or hepatitis B antigen Non-hematologic malignancy within the past three years except a) adequately treated basal cell or squamous cell skin cancer, b) carcinoma in situ of the cervix, or c) prostate cancer with stable prostate specific antigen (PSA) levels for three years Subjects with treatment-related myelodysplastic disorder Subjects with known brain metastasis (active central nervous system [CNS] disease only) Serious psychiatric or medical conditions that could interfere with treatment Participation in an investigational therapeutic study within one month prior to Day 1 Significant neurotoxicity (Grade 2 or higher with pain) at the time of study initiation Concurrent therapy with approved or investigative anticancer therapeutics Subjects with previous hypersensitivity to bortezomib injection Subjects with contraindications to receiving allopurinol Subjects in whom the required program of oral and intravenous fluid hydration is contraindicated, e.g., due to pre-existing pulmonary, cardiac, or renal impairment Subjects with known or suspected amyloidosis Subjects with pleural effusions requiring thoracentesis or ascites requiring paracentesis

Sites / Locations

  • Tower Cancer Research Foundation
  • H. Lee Moffitt Cancer Center and Research Institute
  • Memorial Sloan Kettering Cancer Center
  • Weil Medical College of Cornell University
  • Herbert Irving Comprehensive Cancer Center, Columbia University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

CFZ 1.2 mg/m²

CFZ 2.4 mg/m²

CFZ 4.0 mg/m²

CFZ 6.0 mg/m²

CFZ 8.4 mg/m²

CFZ 11.0 mg/m²

CFZ 15.0 mg/m²

CFZ 20.0 mg/m²

CFZ 27.0 mg/m²

CFZ 20/27 mg/m²

CFZ 20/27 mg/m² + DEX

Arm Description

Participants received carfilzomib (CFZ) 1.2 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.

Participants received carfilzomib 2.4 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.

Participants received carfilzomib 4.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.

Participants received carfilzomib 6.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.

Participants received carfilzomib 8.4 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.

Participants received carfilzomib 11.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.

Participants received carfilzomib 115.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.

Participants received carfilzomib 20.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.

Participants received carfilzomib 27.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.

Participants received carfilzomib 20 mg/m² administered by intravenous bolus on Cycle 1 Days 1, 2, 8, 9, 15 and 16, then 27 mg/m² in all subsequent cycles, for up to 12 cycles.

Participants received carfilzomib 20 mg/m² administered by intravenous bolus on Cycle 1 Days 1, 2, 8, 9, 15 and 16, then 27 mg/m² in all subsequent cycles, for up to 12 cycles. Participants also received 20 mg dexamethasone (DEX) administered before each dose of carfilzomib (i.e. 40 mg weekly).

Outcomes

Primary Outcome Measures

Number of Participants With Dose-limiting Toxicities (DLTs)
A DLT was defined as any of the following occurring in the first 28 days of study participation: Nonhematologic: > Grade 2 neuropathy with pain ≥ Grade 3 nonhematologic toxicity (excluding nausea, vomiting, or diarrhea) ≥ Grade 3 nausea, vomiting, or diarrhea uncontrolled by maximal antiemetic/antidiarrheal therapy Hematologic: Grade 4 neutropenia (absolute neutrophil count [ANC] < 0.5 × 10ˆ9/L) lasting ≥ 14 days without hematopoietic growth factor support Febrile neutropenia (ANC < 1.0 × 10ˆ9/L with a fever ≥ 38.3°C) Grade 4 thrombocytopenia (platelets < 25.0 × 10ˆ9/L) or thrombocytopenia associated with bleeding. Toxicities were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) of the National Cancer Institute (NCI) version 3.0.
Maximum Observed Plasma Concentration of Carfilzomib (Cmax)
Time to Maximum Observed Plasma Concentration of Carfilzomib (Tmax)
Area Under the Concentration-time Curve to Last Measureable Timepoint (AUClast) for Carfilzomib
Area Under the Concentration-time Curve Extrapolated to Infinity (AUCinf) for Carfilzomib

Secondary Outcome Measures

Best Clinical Response to Treatment
Disease response criteria for NHL were according to the International Working Group Criteria for Non-Hodgkin's Lymphoma. Disease response criteria for Multiple Myeloma were according to the European Group for Blood and Marrow Transplantation (EBMT). Disease response criteria for WM were according to the consensus panel recommendations from the Second International Workshop on Waldenström's Macroglobulinemia. The disease response criteria for Hodgkin's Lymphoma are defined as follows: Complete response: total resolution of measurable disease parameters. Partial response: a ≥ 50% resolution without the appearance of new disease. Stable disease: between < 50% resolution and ≤ 25% increases in measurable disease parameters without appearance of new disease. Progressive disease: an increase of > 25% in measurable disease parameters. Best clinical response is the best response observed from the start of study treatment until disease progression or death.
Duration of Response
Duration of objective response is defined as the time from the date of first documented assessment of clinical response (confirmed or unconfirmed complete response, partial response, or minimal response) to the date of documented assessment of progressive disease or death, whichever comes first, plus one day. Participants without tumor progression or death were censored at the date of their last valid clinical response assessment. Median duration of response was calculated using the Kaplan-Meier method.
Time to Progression
Time to progressive disease is defined as the time from the date of Cycle 1, Day 1 of treatment to the date of documented assessment of progressive disease, plus one day. Participants without tumor progression were censored at the date of their last clinical response assessment. Median time to progression was calculated using the Kaplan-Meier method.
Progression-free Survival
Progression-free survival is defined as the time from the date of Cycle 1, Day 1 of treatment to the date of documented assessment of progressive disease or death, whichever comes first, plus one day. Participants without tumor progression or death were censored at the date of their last valid clinical response assessment. Median progression-free survival was calculated using the Kaplan-Meier method.

Full Information

First Posted
September 6, 2005
Last Updated
April 28, 2017
Sponsor
Amgen
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1. Study Identification

Unique Protocol Identification Number
NCT00150462
Brief Title
Safety Study of the Proteasome Inhibitor PR-171 (Carfilzomib for Injection) in Patients With Hematological Malignancies
Official Title
A Phase I Study of the Safety and Pharmacokinetics of Escalating Intravenous Doses of the Proteasome Inhibitor PR-171 in Patients With Hematological Malignancies
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
October 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amgen

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to test the safety and tolerability of carfilzomib at different dose levels on hematological cancers such as multiple myeloma, non-Hodgkin's lymphoma, Hodgkin's disease, or Waldenstrom's macroglobulinemia. Carfilzomib is a proteasome inhibitor, an enzyme responsible for degrading a wide variety of cellular proteins.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Waldenstrom's Macroglobulinemia, Non-Hodgkin's Lymphoma, Hodgkin's Disease, Multiple Myeloma
Keywords
Hematological, Proteasome, Myeloma, Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CFZ 1.2 mg/m²
Arm Type
Experimental
Arm Description
Participants received carfilzomib (CFZ) 1.2 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
Arm Title
CFZ 2.4 mg/m²
Arm Type
Experimental
Arm Description
Participants received carfilzomib 2.4 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
Arm Title
CFZ 4.0 mg/m²
Arm Type
Experimental
Arm Description
Participants received carfilzomib 4.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
Arm Title
CFZ 6.0 mg/m²
Arm Type
Experimental
Arm Description
Participants received carfilzomib 6.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
Arm Title
CFZ 8.4 mg/m²
Arm Type
Experimental
Arm Description
Participants received carfilzomib 8.4 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
Arm Title
CFZ 11.0 mg/m²
Arm Type
Experimental
Arm Description
Participants received carfilzomib 11.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
Arm Title
CFZ 15.0 mg/m²
Arm Type
Experimental
Arm Description
Participants received carfilzomib 115.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
Arm Title
CFZ 20.0 mg/m²
Arm Type
Experimental
Arm Description
Participants received carfilzomib 20.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
Arm Title
CFZ 27.0 mg/m²
Arm Type
Experimental
Arm Description
Participants received carfilzomib 27.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
Arm Title
CFZ 20/27 mg/m²
Arm Type
Experimental
Arm Description
Participants received carfilzomib 20 mg/m² administered by intravenous bolus on Cycle 1 Days 1, 2, 8, 9, 15 and 16, then 27 mg/m² in all subsequent cycles, for up to 12 cycles.
Arm Title
CFZ 20/27 mg/m² + DEX
Arm Type
Experimental
Arm Description
Participants received carfilzomib 20 mg/m² administered by intravenous bolus on Cycle 1 Days 1, 2, 8, 9, 15 and 16, then 27 mg/m² in all subsequent cycles, for up to 12 cycles. Participants also received 20 mg dexamethasone (DEX) administered before each dose of carfilzomib (i.e. 40 mg weekly).
Intervention Type
Drug
Intervention Name(s)
Carfilzomib
Other Intervention Name(s)
PR-171, Kyprolis
Intervention Description
Administered as an IV bolus dose
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
Administered orally prior to carfilzomib
Primary Outcome Measure Information:
Title
Number of Participants With Dose-limiting Toxicities (DLTs)
Description
A DLT was defined as any of the following occurring in the first 28 days of study participation: Nonhematologic: > Grade 2 neuropathy with pain ≥ Grade 3 nonhematologic toxicity (excluding nausea, vomiting, or diarrhea) ≥ Grade 3 nausea, vomiting, or diarrhea uncontrolled by maximal antiemetic/antidiarrheal therapy Hematologic: Grade 4 neutropenia (absolute neutrophil count [ANC] < 0.5 × 10ˆ9/L) lasting ≥ 14 days without hematopoietic growth factor support Febrile neutropenia (ANC < 1.0 × 10ˆ9/L with a fever ≥ 38.3°C) Grade 4 thrombocytopenia (platelets < 25.0 × 10ˆ9/L) or thrombocytopenia associated with bleeding. Toxicities were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) of the National Cancer Institute (NCI) version 3.0.
Time Frame
28 days
Title
Maximum Observed Plasma Concentration of Carfilzomib (Cmax)
Time Frame
Cycle 1, Day 1 at predose, 5, 15, and 30 minutes, and 1, 2, 4, and 24 hours post dose.
Title
Time to Maximum Observed Plasma Concentration of Carfilzomib (Tmax)
Time Frame
Cycle 1, Day 1 at predose, 5, 15, and 30 minutes, and 1, 2, 4, and 24 hours post dose.
Title
Area Under the Concentration-time Curve to Last Measureable Timepoint (AUClast) for Carfilzomib
Time Frame
Cycle 1, Day 1 at predose, 5, 15, and 30 minutes, and 1, 2, 4, and 24 hours post dose.
Title
Area Under the Concentration-time Curve Extrapolated to Infinity (AUCinf) for Carfilzomib
Time Frame
Cycle 1, Day 1 at predose, 5, 15, and 30 minutes, and 1, 2, 4, and 24 hours post dose.
Secondary Outcome Measure Information:
Title
Best Clinical Response to Treatment
Description
Disease response criteria for NHL were according to the International Working Group Criteria for Non-Hodgkin's Lymphoma. Disease response criteria for Multiple Myeloma were according to the European Group for Blood and Marrow Transplantation (EBMT). Disease response criteria for WM were according to the consensus panel recommendations from the Second International Workshop on Waldenström's Macroglobulinemia. The disease response criteria for Hodgkin's Lymphoma are defined as follows: Complete response: total resolution of measurable disease parameters. Partial response: a ≥ 50% resolution without the appearance of new disease. Stable disease: between < 50% resolution and ≤ 25% increases in measurable disease parameters without appearance of new disease. Progressive disease: an increase of > 25% in measurable disease parameters. Best clinical response is the best response observed from the start of study treatment until disease progression or death.
Time Frame
From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 6.3 weeks in the dose escalation phase and 6.4 weeks in the dose expansion phase.
Title
Duration of Response
Description
Duration of objective response is defined as the time from the date of first documented assessment of clinical response (confirmed or unconfirmed complete response, partial response, or minimal response) to the date of documented assessment of progressive disease or death, whichever comes first, plus one day. Participants without tumor progression or death were censored at the date of their last valid clinical response assessment. Median duration of response was calculated using the Kaplan-Meier method.
Time Frame
From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 6.3 weeks in the dose escalation phase and 6.4 weeks in the dose expansion phase.
Title
Time to Progression
Description
Time to progressive disease is defined as the time from the date of Cycle 1, Day 1 of treatment to the date of documented assessment of progressive disease, plus one day. Participants without tumor progression were censored at the date of their last clinical response assessment. Median time to progression was calculated using the Kaplan-Meier method.
Time Frame
From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 6.3 weeks in the dose escalation phase and 6.4 weeks in the dose expansion phase.
Title
Progression-free Survival
Description
Progression-free survival is defined as the time from the date of Cycle 1, Day 1 of treatment to the date of documented assessment of progressive disease or death, whichever comes first, plus one day. Participants without tumor progression or death were censored at the date of their last valid clinical response assessment. Median progression-free survival was calculated using the Kaplan-Meier method.
Time Frame
From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 6.3 weeks in the dose escalation phase and 6.4 weeks in the dose expansion phase.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Written informed consent in accordance with federal, local, and institutional guidelines Males and females ≥18 years of age Histologically confirmed diagnosis of one of the hematologic malignancies below: Multiple myeloma (MM) Non-Hodgkin's lymphoma (NHL) Waldenström's Macroglobulinemia (WM) Hodgkin's disease (HD) Subjects who are refractory or relapsed following at least two prior therapies Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2 Adequate cardiovascular function without symptomatic ischemia, conduction abnormalities uncontrolled by conventional intervention, or myocardial infarction in the previous six months Adequate hepatic function, with bilirubin < 2.0 times the upper limit of normal, and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) of < 3.0 times the upper limit of normal Total white blood cell (WBC) count ≥ 2,000/mm³, absolute neutrophil count (ANC) ≥ 1000/mm³, hemoglobin ≥ 8.0 g/dL, and platelet count ≥ 50,000/mm³ Screening ANC should be independent of granulocyte colony stimulating factor (G-CSF) or granulocyte-macrophage colony-stimulating factor (GM-CSF) support for ≥ 1 week and of pegylated G-CSF for ≥ 2 weeks) Subjects receiving supportive care including erythropoietin, darbepoetin and/or bisphosphonates can continue to do so, but must be transfusion independent; subjects receiving erythropoietic support must remain on the same dose for the first 28 days of study participation An estimated creatinine clearance of ≥ 30 mL/min, calculated using the formula of Cockroft and Gault Serum creatinine ≤ 2.0 mg/dL Uric acid, if elevated, must be corrected to within laboratory normal range prior to dosing Female subjects of child-bearing potential must agree to use dual methods of contraception and have a negative serum pregnancy test. Male subjects must use an effective barrier method of contraception throughout the study and for three months following the last dose if sexually active with a female of child-bearing potential. Exclusion Criteria: Female subjects who are pregnant or lactating Subjects who are transfusion dependent Subjects with NHL or HL who have received steroid therapy in the previous seven days Subjects with MM or Waldenström's Macroglobulinemia who have received steroid therapy in the previous three weeks, except for MM subjects in the Carfilzomib + DEX Expansion Cohort, where previous treatment with dexamethasone will be allowed. The dose and schedule of administration of dexamethasone will be adjusted to that used in the protocol Radiation, chemotherapy, or immunotherapy in the previous four weeks, or subjects who, in the judgment of the Investigator, have not recovered from the effects of previous therapy For the Dose Escalation period, subjects who have received prior radioimmunotherapy with anti-cluster of differentiation (CD)20 monoclonal antibodies such as Bexxar® or Zevalin®; subjects treated with these products will be allowed in the Dose Expansion period Subjects who have received allogeneic stem cell transplant therapy Subjects with NHL or HL who have received autologous stem cell transplant therapy and have relapsed within 100 days of therapy Rituxan therapy within three months before Day 1 unless there is evidence of disease progression Major surgery within three weeks before Day 1 Congestive heart failure (CHF) (New York Heart Association class III to IV) Acute active infection requiring systemic antibiotics, antivirals, or antifungals within two weeks prior to first dose Subjects who are known or suspected of having human immunodeficiency virus (HIV) infection or who are HIV seropositive Active hepatitis A, B, or C infection; or positive for Hepatitis C ribonucleic acid (RNA) or hepatitis B antigen Non-hematologic malignancy within the past three years except a) adequately treated basal cell or squamous cell skin cancer, b) carcinoma in situ of the cervix, or c) prostate cancer with stable prostate specific antigen (PSA) levels for three years Subjects with treatment-related myelodysplastic disorder Subjects with known brain metastasis (active central nervous system [CNS] disease only) Serious psychiatric or medical conditions that could interfere with treatment Participation in an investigational therapeutic study within one month prior to Day 1 Significant neurotoxicity (Grade 2 or higher with pain) at the time of study initiation Concurrent therapy with approved or investigative anticancer therapeutics Subjects with previous hypersensitivity to bortezomib injection Subjects with contraindications to receiving allopurinol Subjects in whom the required program of oral and intravenous fluid hydration is contraindicated, e.g., due to pre-existing pulmonary, cardiac, or renal impairment Subjects with known or suspected amyloidosis Subjects with pleural effusions requiring thoracentesis or ascites requiring paracentesis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
Facility Information:
Facility Name
Tower Cancer Research Foundation
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211-1850
Country
United States
Facility Name
H. Lee Moffitt Cancer Center and Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Weil Medical College of Cornell University
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Herbert Irving Comprehensive Cancer Center, Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Safety Study of the Proteasome Inhibitor PR-171 (Carfilzomib for Injection) in Patients With Hematological Malignancies

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