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Generated: February 23, 2019

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CLINICAL TRIALS PROFILE FOR CARFILZOMIB

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Clinical Trials for Carfilzomib

Trial ID Title Status Sponsor Phase Summary
NCT00150462 Safety Study of the Proteasome Inhibitor PR-171 (Carfilzomib for Injection) in Patients With Hematological Malignancies Completed Onyx Pharmaceuticals Phase 1 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.
NCT00461045 Phase 1/2 Clinical Trial of NPI-0052 in Patients With Relapsed or Relapsed/Refractory Multiple Myeloma Unknown status Triphase Research and Development I Corporation Phase 1/Phase 2 This is a Phase 1/2, open-label, multicenter study examining the safety, pharmacokinetics and pharmacodynamics, and best overall response to escalating doses of the proteasome inhibitor NPI-0052 in patients with relapsed or relapsed/refractory multiple myeloma. NPI-0052 is a novel, second generation proteasome inhibitor that prevents the breakdown of proteins involved in signal transduction which blocks growth and survival in cancer cells. The study is divided into 2 parts: Part 1 is Phase 1 and explores 2 different schedules of NPI-0052 to determine the maximum tolerated dose and/or recommended phase 2 dose (Schedules A [once weekly dosing] and B [twice-weekly dosing]). Part 2 is Phase 2 and is a 2-stage efficacy design in a selected subgroup of patients treated with Schedule B at the recommended phase 2 dose, as determined in Part 1. Amendment 13 to the protocol is currently recruiting to evaluate the safety and any preliminary evidence of efficacy of NPI-0052 in multiple myeloma patients who have previously received carfilzomib (PR-171, Kyprolis™) and subsequently had disease progression. Patients in Part 2 will be followed for survival for up to 5 years from date of first dose.
NCT00511238 Phase 2 Study of Carfilzomib in Relapsed and Refractory Multiple Myeloma Completed Onyx Therapeutics, Inc. Phase 2 To evaluate the overall response rate and safety and tolerability of carfilzomib in subjects with relapsed and refractory multiple myeloma. Patients must have received prior treatment with bortezomib and either thalidomide or lenalidomide and be refractory to their last treatment.
NCT00530816 Phase 2 Study of Carfilzomib in Relapsed Multiple Myeloma Completed Onyx Therapeutics, Inc. Phase 2 To evaluate the best overall response rate, safety and tolerability of carfilzomib in patients with relapsed or refractory multiple myeloma.
NCT00531284 Phase 1b/2 Study of Carfilzomib in Relapsed Solid Tumors, Multiple Myeloma, or Lymphoma Active, not recruiting Onyx Therapeutics, Inc. Phase 1/Phase 2 The primary objectives of this Phase 1b/2 study were as follows: - Phase 1b (Bolus and Infusion): To evaluate the safety and tolerability of carfilzomib in patients with relapsed solid tumors and in patients with relapsed and/or refractory multiple myeloma and in patients with refractory lymphoma. - Phase 2 (Bolus): To evaluate the overall response rate (ORR) after 4 cycles of carfilzomib in patients with relapsed solid tumors.
NCT00603447 Phase 1b Multicenter Study of Carfilzomib With Lenalidomide and Dexamethasone in Relapsed Multiple Myeloma Completed Onyx Therapeutics, Inc. Phase 1 To evaluate the safety and maximum tolerated dose (MTD) of carfilzomib in combination with lenalidomide and dexamethasone in patients with relapsed multiple myeloma
NCT00721734 Study of the Safety and Pharmacokinetics of Carfilzomib in Patients With Relapsed and Refractory Multiple Myeloma and Varying Degrees of Renal Function Completed Onyx Therapeutics, Inc. Phase 2 The purpose of this study is to assess the influence of renal impairment on carfilzomib in patients with Multiple Myeloma (MM).
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Carfilzomib

Condition Name

Condition Name for Carfilzomib
Intervention Trials
Multiple Myeloma 81
Lymphoma 7
Myeloma 7
Refractory Multiple Myeloma 6
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Condition MeSH

Condition MeSH for Carfilzomib
Intervention Trials
Multiple Myeloma 120
Neoplasms, Plasma Cell 119
Lymphoma 19
Lymphoma, Non-Hodgkin 8
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Clinical Trial Locations for Carfilzomib

Trials by Country

Trials by Country for Carfilzomib
Location Trials
United States 565
Canada 39
Japan 36
United Kingdom 28
Germany 21
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Trials by US State

Trials by US State for Carfilzomib
Location Trials
New York 41
California 39
Texas 37
Illinois 30
New Jersey 28
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Clinical Trial Progress for Carfilzomib

Clinical Trial Phase

Clinical Trial Phase for Carfilzomib
Clinical Trial Phase Trials
Phase 4 1
Phase 3 13
Phase 2 62
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Clinical Trial Status

Clinical Trial Status for Carfilzomib
Clinical Trial Phase Trials
Recruiting 64
Active, not recruiting 36
Not yet recruiting 27
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Clinical Trial Sponsors for Carfilzomib

Sponsor Name

Sponsor Name for Carfilzomib
Sponsor Trials
Onyx Therapeutics, Inc. 35
Onyx Pharmaceuticals 27
National Cancer Institute (NCI) 20
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Sponsor Type

Sponsor Type for Carfilzomib
Sponsor Trials
Other 144
Industry 134
NIH 20
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Serving hundreds of leading biopharmaceutical companies globally:

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Chinese Patent Office
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