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Generated: December 19, 2018

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CLINICAL TRIALS PROFILE FOR KYPROLIS

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Clinical Trials for Kyprolis

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.
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.
NCT01137747 Carfilzomib in Patients With Relapsed Acute Myeloid or Acute Lymphoblastic Leukemia Completed Washington University School of Medicine Phase 1 This study is to test escalating doses of carfilzomib in patients with relapsed acute myeloid and acute lymphoblastic leukemia.
NCT01204164 Phase 1 Study of TG02 Citrate in Patients With Advanced Hematological Malignancies Completed Tragara Pharmaceuticals, Inc. Phase 1 This is a multicenter, open-label, dose escalation Phase 1 study.
NCT01246063 Carfilzomib, Pegylated Liposomal Doxorubicin Hydrochloride, and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma Recruiting Washington University School of Medicine Phase 1/Phase 2 The aim of this phase I/II trial is to determine the maximal tolerated dose (MTD) of carfilzomib together with pegylated liposomal doxorubicin hydrochloride (PLD) with or without dexamethasone, and then to establish the efficacy and safety of this novel combination in patients with relapsed or refractory multiple myeloma
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Kyprolis

Condition Name

Condition Name for Kyprolis
Intervention Trials
Multiple Myeloma 24
Recurrent Plasma Cell Myeloma 5
Refractory Plasma Cell Myeloma 5
Stage I Multiple Myeloma 3
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Condition MeSH

Condition MeSH for Kyprolis
Intervention Trials
Multiple Myeloma 39
Neoplasms, Plasma Cell 38
Lymphoma 9
Lymphoma, Non-Hodgkin 6
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Clinical Trial Locations for Kyprolis

Trials by Country

Trials by Country for Kyprolis
Location Trials
United States 209
United Kingdom 13
Canada 2
Lithuania 1
Austria 1
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Trials by US State

Trials by US State for Kyprolis
Location Trials
Illinois 16
California 16
Missouri 10
New York 10
Florida 9
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Clinical Trial Progress for Kyprolis

Clinical Trial Phase

Clinical Trial Phase for Kyprolis
Clinical Trial Phase Trials
Phase 3 4
Phase 2 21
Phase 1/Phase 2 15
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Clinical Trial Status

Clinical Trial Status for Kyprolis
Clinical Trial Phase Trials
Recruiting 24
Not yet recruiting 15
Active, not recruiting 8
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Clinical Trial Sponsors for Kyprolis

Sponsor Name

Sponsor Name for Kyprolis
Sponsor Trials
National Cancer Institute (NCI) 16
Onyx Pharmaceuticals 8
University of Chicago 7
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Sponsor Type

Sponsor Type for Kyprolis
Sponsor Trials
Other 50
Industry 42
NIH 16
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