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CLINICAL TRIALS PROFILE FOR KYPROLIS
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. |
| Trial ID | Title | Status | Sponsor | Phase | Summary |
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Clinical Trial Sponsors for KYPROLIS
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