Phase 1 dose-escalation study of IV ixazomib, an investigational proteasome inhibitor, in patients with relapsed/refractory lymphoma

Blood Cancer Journal

Volumn 4, Issue 10, 2014, Pages

  Assouline, S E ^a   Chang, J ^b   Cheson, B D ^c   Rifkin, R ^d   Hamburg, S ^e   Reyes, R ^f   Hui, A M ^g   Yu, J ^g   Gupta, N ^g   Di Bacco, A ^g   Shou, Y ^g   Martin, P ^h  

^a MCGILL UNIVERSITY   (Canada)

^b UNIVERSITY OF WISCONSIN   (United States)

^c GEORGETOWN UNIVERSITY HOSPITAL   (United States)

^d Rocky Mountain Cancer Center   (United States)

^e Tower Cancer Research Foundation ^*  (United States)

^f UNIVERSITY OF KANSAS MEDICAL CENTER   (United States)

^g TAKEDA PHARMACEUTICAL COMPANY LIMITED   (Japan)

^h WEILL CORNELL MEDICAL COLLEGE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANTIDIARRHEAL AGENT; ANTIEMETIC AGENT; GROWTH FACTOR; IXAZOMIB; PROTEASOME; PROTEASOME INHIBITOR; BORON DERIVATIVE; GLYCINE; IXAZOMIB CITRATE;

ABDOMINAL PAIN; ACNE; ACUTE KIDNEY FAILURE; ADULT; AGED; ANOREXIA; AREA UNDER THE CURVE; ARTHRALGIA; ARTICLE; ASTHENIA; CHILL; CLINICAL ASSESSMENT; CONSTIPATION; DECREASED APPETITE; DEHYDRATION; DIARRHEA; DOSE RESPONSE; DRUG ACTIVITY; DRUG DOSE ESCALATION; DRUG EFFECT; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; DYSGEUSIA; ENZYME INHIBITION; FATIGUE; FEMALE; FEVER; FOLLICULAR LYMPHOMA; HALF LIFE TIME; HEADACHE; HERPETIC STOMATITIS; HUMAN; HYPOKALEMIA; KIDNEY CLEARANCE; LARGE CELL LYMPHOMA; LIMB PAIN; LYMPHOCYTOPENIA; LYMPHOMA; MACULOPAPULAR RASH; MALE; MAXIMUM PLASMA CONCENTRATION; MAXIMUM TOLERATED DOSE; MULTIPLE CYCLE TREATMENT; NEUTROPENIA; PAPULAR RASH; PARESTHESIA; PERIPHERAL EDEMA; PERIPHERAL NEUROPATHY; PERIPHERAL T CELL LYMPHOMA; PHARMACODYNAMICS; PHASE 1 CLINICAL TRIAL; PRURITUS; RASH; REFRACTORY LYMPHOMA; RELAPSE; RESPIRATORY FAILURE; THROMBOCYTE TRANSFUSION; THROMBOCYTOPENIA; TIME TO MAXIMUM PLASMA CONCENTRATION; TREATMENT RESPONSE; VOMITING; ANALOGS AND DERIVATIVES; CHEMICALLY INDUCED; CLINICAL TRIAL; LYMPHOMA, FOLLICULAR; LYMPHOMA, T-CELL, PERIPHERAL; MIDDLE AGED; MULTICENTER STUDY; PERIPHERAL NERVOUS SYSTEM DISEASES;

ADULT; AGED; BORON COMPOUNDS; DIARRHEA; FEMALE; GLYCINE; HUMANS; LYMPHOMA, FOLLICULAR; LYMPHOMA, T-CELL, PERIPHERAL; MALE; MIDDLE AGED; NEUTROPENIA; PERIPHERAL NERVOUS SYSTEM DISEASES; PROTEASOME INHIBITORS; THROMBOCYTOPENIA;

EID: 84927752534     PISSN: None     EISSN: 20445385     Source Type: Journal    
DOI: 10.1038/bcj.2014.71     Document Type: Article

References (30)

1. Siegel R, Ma J, Zou Z, Jemal A. Cancer statistics, 2014. CA Cancer J Clin 2014; 64: 9-29
2. National Comprehensive Cancer Network NCCN Clinical Practice Guidelines in Oncology: Non-Hodgkin's Lymphoma. V. 4. 2014. https://www. nccn. org/store/ login/login. aspx?ReturnURL=http://www. nccn. org/professionals/physician-gls/ pdf/nhl. pdf
3. National Comprehensive Cancer Network NCCN Clinical Practice Guidelines in Oncology: Hodgkin Lymphoma. V. 2. 2014. https://www. nccn. org/store/login/ login. aspx?ReturnURL=http://www. nccn. org/professionals/physician-gls/pdf/ hodgkins. pdf
4. Millennium Pharmaceuticals Inc VELCADE (bortezomib) for Injection-Full Prescribing information, version 16. 2014. www. velcade. com/files/pdfs/velcade- prescribing-information. pdf
5. O'Connor OA, Portlock C, Moskowitz C, Hamlin P, Straus D, Gerecitano J et al. Time to treatment response in patients with follicular lymphoma treated with bortezomib is longer compared with other histologic subtypes. Clin Cancer Res 2010; 16: 719-726
6. Coiffier B, Osmanov EA, Hong X, Scheliga A, Mayer J, Offner F et al. Bortezomib plus rituximab versus rituximab alone in patients with relapsed, rituximab-naive or rituximab-sensitive, follicular lymphoma: A randomised phase 3 trial. Lancet Oncol 2011; 12: 773-784
7. Foss FM, Zinzani PL, Vose JM, Gascoyne RD, Rosen ST, Tobinai K. Peripheral T-cell lymphoma. Blood 2011; 117: 6756-6767
8. Zinzani PL, Musuraca G, Tani M, Stefoni V, Marchi E, Fina M et al. Phase II trial of proteasome inhibitor bortezomib in patients with relapsed or refractory cutaneous T-cell lymphoma. J Clin Oncol 2007; 25: 4293-4297
9. Ruan J, Martin P, Furman RR, Lee SM, Cheung K, Vose JM et al. Bortezomib plus CHOP-rituximab for previously untreated diffuse large B-cell lymphoma and mantle cell lymphoma. J Clin Oncol 2011; 29: 690-697
10. Dunleavy K, Pittaluga S, Czuczman MS, Dave SS, Wright G, Grant N et al. Differential efficacy of bortezomib plus chemotherapy within molecular subtypes of diffuse large B-cell lymphoma. Blood 2009; 113: 6069-6076
11. Kupperman E, Lee EC, Cao Y, Bannerman B, Fitzgerald M, Berger A et al. Evaluation of the proteasome inhibitor MLN9708 in preclinical models of human cancer. Cancer Res 2010; 70: 1970-1980
12. Lee EC, Fitzgerald M, Bannerman B, Donelan J, Bano K, Terkelsen J et al. Antitumor activity of the investigational proteasome inhibitor MLN9708 in mouse models of B-cell and plasma cell malignancies. Clin Cancer Res 2011; 17: 7313-7323
13. Kumar SK, Bensinger WI, Zimmerman TM, Reeder CB, Berenson JR, Berg D et al. Weekly dosing of the investigational oral proteasome inhibitor ixazomib in relapsed/refractory multiple myeloma: results from a phase 1 study. Blood 2014; 124: 1047-1055
14. Kumar SK, Berdeja JG, Niesvizky R, Lonial S, Hamadani M, Stewart AK et al. A phase 1/2 study of weekly mln9708, an investigational oral proteasome inhibitor, in combination with lenalidomide and dexamethasone in patients with previously untreated multiple myeloma (MM). ASH Annual Meeting Abstracts 2012; 120: 332
15. Richardson PG, Baz R, Wang M, Jakubowiak AJ, Laubach JP, Harvey RD et al. Phase study of twice-weekly dosing of investigational oral proteasome inhibitor ixazomib in patients with relapsed and/or refractory multiple myeloma. Blood 2014; 124: 1038-1046
16. Merlini G, Sanchorawala V, Zonder JA, Kukreti V, Schonland SO, Jaccard A et al. MLN9708, a novel, Investigational Oral Proteasome Inhibitor, in patients with relapsed or refractory light-chain amyloidosis (AL): results of a phase 1 study. ASH Annual Meeting Abstracts 2012; 120: 731
17. Smith PC, Infante JR, Siu LL, Sullivan D, Vlahovic G, Kauh J et al. 1210 POSTER phase 1 study of MLN9708, an Investigational Proteasome Inhibitor, in advanced nonhematologic malignancies-updated results. Eur J Cancer 2011; 47: S147 (abstract )
18. Cheson BD, Pfistner B, Juweid ME, Gascoyne RD, Specht L, Horning SJ et al. Revised response criteria for malignant lymphoma. J Clin Oncol 2007; 25: 579-586
19. Lightcap ES, McCormack TA, Pien CS, Chau V, Adams J, Elliott PJ. Proteasome inhibition measurements: Clinical application. Clin Chem 2000; 46: 673-683
20. Di Bella N, Taetle R, Kolibaba K, Boyd T, Raju R, Barrera D et al. Results of a phase 2 study of bortezomib in patients with relapsed or refractory indolent lymphoma. Blood 2010; 115: 475-480
21. Fisher RI, Bernstein SH, Kahl BS, Djulbegovic B, Robertson MJ, de Vos S et al. Multicenter phase II study of bortezomib in patients with relapsed or refractory mantle cell lymphoma. J Clin Oncol 2006; 24: 4867-4874
22. Gerecitano J, Portlock C, Moskowitz C, Hamlin P, Straus D, Zelenetz AD et al. Phase study of weekly bortezomib in mantle cell and follicular lymphoma. Br J Haematol 2009; 146: 652-655
23. Goy A, Younes A, McLaughlin P, Pro B, Romaguera JE, Hagemeister F et al. Phase II study of proteasome inhibitor bortezomib in relapsed or refractory B-cell non-Hodgkin's lymphoma. J Clin Oncol 2005; 23: 667-675
24. O'Connor OA, Wright J, Moskowitz C, Muzzy J, Gregor-Cortelli B, Stubblefield M et al. Phase II clinical experience with the novel proteasome inhibitor bortezomib in patients with indolent non-Hodgkin's lymphoma and mantle cell lymphoma. J Clin Oncol 2005; 23: 676-684
25. Strauss SJ, Maharaj L, Hoare S, Johnson PW, Radford JA, Vinnecombe S et al. Bortezomib therapy in patients with relapsed or refractory lymphoma: potential correlation of in vitro sensitivity and tumor necrosis factor alpha response with clinical activity. J Clin Oncol 2006; 24: 2105-2112
26. Moreau P, Pylypenko H, Grosicki S, Karamanesht I, Leleu X, Grishunina M et al. Subcutaneous versus intravenous administration of bortezomib in patients with relapsed multiple myeloma: A randomised, phase 3, non-inferiority study. Lancet Oncol 2011; 12: 431-440
27. Gupta N, Riordan W, Berger A, Liu G, Berg D, Kalebic T et al. Clinical pharmacokinetics (PK)/pharmacodynamics (PD) of intravenous (IV) and oral (PO) MLN9708, an investigational proteasome inhibitor, in four phase 1 monotherapy studies. Haematologica 2011; 96(suppl 1): Abstract P-197
28. Hrusovsky I, Emmerich B, von Rhee A, Voegeli J, Taverna C, Olie RA et al. Bortezomib retreatment in relapsed multiple myeloma-results from a retrospective multicentre survey in Germany and Switzerland. Oncology 2010; 79: 247-254
29. Petrucci MT, Giraldo P, Corradini P, Teixeira A, Dimopoulos MA, Blau IW et al. A prospective, international phase 2 study of bortezomib retreatment in patients with relapsed multiple myeloma. Br J Haematol 2013; 160: 649-659
30. Sood R, Carloss H, Kerr R, Lopez J, Lee M, Druck M et al. Retreatment with bortezomib alone or in combination for patients with multiple myeloma following an initial response to bortezomib. Am J Hematol 2009; 84: 657-660.