Tanespimycin pharmacokinetics: A randomized dose-escalation crossover phase 1 study of two formulations

Cancer Chemotherapy and Pharmacology

Volumn 67, Issue 5, 2011, Pages 1045-1054

  Burris III, Howard A ^a   Berman, David ^b   Murthy, Bindu ^b   Jones, Suzanne ^a  

^a SARAH CANNON RESEARCH INSTITUTE   (United States)

^b BRISTOL MYERS SQUIBB   (United States)

Author keywords

HSP90; Pharmacokinetics; Safety; Suspension; Tanespimycin

Indexed keywords

ALCOHOL; CREMOPHOR; DIMETHYL SULFOXIDE; DRUG METABOLITE; HEAT SHOCK PROTEIN 90 INHIBITOR; PHOSPHATIDYLCHOLINE; POLYSORBATE 80; SUCROSE; TANESPIMYCIN;

ABDOMINAL DISTENSION; ADULT; AGED; ANEMIA; ANOREXIA; AREA UNDER THE CURVE; ARTICLE; BACTEREMIA; BLOOD SAMPLING; BONE MARROW SUPPRESSION; BREAST CANCER; CLINICAL ARTICLE; CONTROLLED STUDY; CROSSOVER PROCEDURE; DIARRHEA; DISTRIBUTION VOLUME; DIZZINESS; DRUG CLEARANCE; DRUG DOSE COMPARISON; DRUG DOSE ESCALATION; DRUG FORMULATION; DRUG HALF LIFE; DRUG RESPONSE; DRUG SAFETY; DRUG TOLERABILITY; FATIGUE; FEMALE; HEADACHE; HUMAN; LUNG NON SMALL CELL CANCER; MALE; MAXIMUM PLASMA CONCENTRATION; NAUSEA; OPEN STUDY; PHASE 1 CLINICAL TRIAL; PNEUMONIA; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RHINOPHARYNGITIS; SEPSIS; SIDE EFFECT; SUSPENSION; TIME TO MAXIMUM PLASMA CONCENTRATION; VOMITING;

ADULT; AGED; AGED, 80 AND OVER; ANTINEOPLASTIC AGENTS; BENZOQUINONES; CROSS-OVER STUDIES; EXCIPIENTS; FEMALE; GLYCEROL; HSP90 HEAT-SHOCK PROTEINS; HUMANS; LACTAMS, MACROCYCLIC; MALE; MIDDLE AGED; SUSPENSIONS;

EID: 79955551254     PISSN: 03445704     EISSN: None     Source Type: Journal    
DOI: 10.1007/s00280-010-1398-6     Document Type: Article

References (31)

1. WG An RC Schnur L Neckers MV Blagosklonny 1997 Depletion of p185erbB2, Raf-1 and mutant p53 proteins by geldanamycin derivatives correlates with antiproliferative activity Cancer Chemother Pharmacol 40 60 64 9137531 10.1007/s002800050626 1:CAS:528:DyaK2sXivVWnt7g%3D (Pubitemid 27160962)
2. R Bagatell L Whitesell 2004 Altered Hsp90 function in cancer: a unique therapeutic opportunity Mol Cancer Ther 3 1021 1030 15299085 10.4161/cbt.3.10.1142 1:CAS:528:DC%2BD2cXmtleksL4%3D (Pubitemid 39199597)
3. U Banerji A O'Donnell M Scurr S Pacey S Stapleton Y Asad L Simmons A Maloney F Raynaud M Campbell M Walton S Lakhani S Kaye P Workman I Judson 2005 Phase I pharmacokinetic and pharmacodynamic study of 17-allylamino, 17-demethoxygeldanamycin in patients with advanced malignancies J Clin Oncol 23 4152 4161 15961763 10.1200/JCO.2005.00.612 1:CAS:528:DC%2BD2MXmt1elsrY%3D (Pubitemid 46211321)
4. AD Basso DB Solit PN Munster N Rosen 2002 Ansamycin antibiotics inhibit Akt activation and cyclin D expression in breast cancer cells that overexpress HER2 Oncogene 21 1159 1166 11850835 10.1038/sj.onc.1205184 1:CAS:528: DC%2BD38XitFSjtr0%3D (Pubitemid 34185232)
5. D Dye J Watkins 1980 Suspected anaphylactic reaction to Cremophor EL Br Med J 280 1353 7388538 10.1136/bmj.280.6228.1353 1:STN:280:DyaL3c3it1SitQ%3D%3D (Pubitemid 10124276)
6. MJ Egorin DM Rosen JH Wolff PS Callery SM Musser JL Eiseman 1998 Metabolism of 17-(allylamino)-17-demethoxygeldanamycin (NSC 330507) by murine and human hepatic preparations Cancer Res 58 2385 2396 9622079 1:CAS:528:DyaK1cXjs12qsrg%3D (Pubitemid 28252699)
7. MJ Egorin EG Zuhowski DM Rosen DL Sentz JM Covey JL Eiseman 2001 Plasma pharmacokinetics and tissue distribution of 17-(allylamino)-17- demethoxygeldanamycin (NSC 330507) in CD2F1 mice1 Cancer Chemother Pharmacol 47 291 302 11345645 10.1007/s002800000242 1:CAS:528:DC%2BD3MXjt1Chsbw%3D (Pubitemid 32640768)
8. MP Goetz D Toft J Reid M Ames B Stensgard S Safgren AA Adjei J Sloan P Atherton V Vasile S Salazaar A Adjei G Croghan C Erlichman 2005 Phase I trial of 17-allylamino-17-demethoxygeldanamycin in patients with advanced cancer J Clin Oncol 23 1078 1087 15718306 10.1200/JCO.2005.09.119 1:CAS:528: DC%2BD2MXitl2gtbw%3D (Pubitemid 46202262)
9. JL Grem G Morrison XD Guo E Agnew CH Takimoto R Thomas E Szabo L Grochow F Grollman JM Hamilton L Neckers RH Wilson 2005 Phase I and pharmacologic study of 17-(allylamino)-17-demethoxygeldanamycin in adult patients with solid tumors J Clin Oncol 23 1885 1893 15774780 10.1200/JCO.2005.12.085 1:CAS:528: DC%2BD2MXjt1Cku78%3D (Pubitemid 46211366)
10. JP Grenert WP Sullivan P Fadden TA Haystead J Clark E Mimnaugh H Krutzsch HJ Ochel TW Schulte E Sausville LM Neckers DO Toft 1997 The amino-terminal domain of heat shock protein 90 (hsp90) that binds geldanamycin is an ATP/ADP switch domain that regulates hsp90 conformation J Biol Chem 272 23843 23850 9295332 10.1074/jbc.272.38.23843 1:CAS:528:DyaK2sXmtlOhs7w%3D (Pubitemid 27410964)
11. RA Mesa D Loegering HL Powell K Flatten SJ Arlander NT Dai MP Heldebrant BT Vroman BD Smith JE Karp CJ Eyck C Erlichman SH Kaufmann LM Karnitz 2005 Heat shock protein 90 inhibition sensitizes acute myelogenous leukemia cells to cytarabine Blood 106 318 327 15784732 10.1182/blood-2004-09-3523 1:CAS:528:DC%2BD2MXlvVWjtrY%3D (Pubitemid 40967208)
12. CS Mitsiades NS Mitsiades CJ McMullan V Poulaki AL Kung FE Davies G Morgan M Akiyama R Shringarpure NC Munshi PG Richardson T Hideshima D Chauhan X Gu C Bailey M Joseph TA Libermann NS Rosen KC Anderson 2006 Antimyeloma activity of heat shock protein-90 inhibition Blood 107 1092 1100 16234364 10.1182/blood-2005-03-1158 1:CAS:528:DC%2BD28Xht1Ont7k%3D (Pubitemid 43156310)
13. S Modi AT Stopeck MS Gordon D Mendelson DB Solit R Bagatell W Ma J Wheler N Rosen L Norton GF Cropp RG Johnson AL Hannah CA Hudis 2007 Combination of trastuzumab and tanespimycin (17-AAG, KOS-953) is safe and active in trastuzumab-refractory HER-2 overexpressing breast cancer: a phase I dose-escalation study J Clin Oncol 25 5410 5417 18048823 10.1200/JCO.2007.11. 7960 1:CAS:528:DC%2BD1cXnvVCisQ%3D%3D (Pubitemid 350232217)
14. L Neckers 2007 Heat shock protein 90: the cancer chaperone J Biosci 32 517 530 17536171 10.1007/s12038-007-0051-y 1:CAS:528:DC%2BD2sXmsFamu7k%3D (Pubitemid 46708702)
15. DM Nguyen S Desai A Chen TS Weiser DS Schrump 2000 Modulation of metastasis phenotypes of non-small cell lung cancer cells by 17-allylamino 17-demethoxy geldanamycin Ann Thorac Surg 70 1853 1860 11156083 10.1016/S0003-4975(00)01810-5 1:STN:280:DC%2BD3M%2FpvFertQ%3D%3D (Pubitemid 32015273)
16. GS Nowakowski AK McCollum MM Ames SJ Mandrekar JM Reid AA Adjei DO Toft SL Safgren C Erlichman 2006 A phase I trial of twice-weekly 17-allylamino- demethoxy-geldanamycin in patients with advanced cancer Clin Cancer Res 12 6087 6093 17062684 10.1158/1078-0432.CCR-06-1015 1:CAS:528:DC%2BD28XhtFWhsbnI (Pubitemid 44703773)
17. RK Ramanathan MJ Egorin JL Eiseman S Ramalingam D Friedland SS Agarwala SP Ivy DM Potter G Chatta EG Zuhowski RG Stoller C Naret J Guo CP Belani 2007 Phase I and pharmacodynamic study of 17-(allylamino)-17-demethoxygeldanamycin in adult patients with refractory advanced cancers Clin Cancer Res 13 1769 1774 17363531 10.1158/1078-0432.CCR-06-2233 1:CAS:528:DC%2BD2sXivV2gt7c%3D (Pubitemid 46952944)
18. RK Ramanathan DL Trump JL Eiseman CP Belani SS Agarwala EG Zuhowski J Lan DM Potter SP Ivy S Ramalingam AM Brufsky MK Wong S Tutchko MJ Egorin 2005 Phase I pharmacokinetic-pharmacodynamic study of 17-(allylamino)-17- demethoxygeldanamycin (17AAG, NSC 330507), a novel inhibitor of heat shock protein 90, in patients with refractory advanced cancers Clin Cancer Res 11 3385 3391 15867239 10.1158/1078-0432.CCR-04-2322 1:CAS:528:DC%2BD2MXjslOqt70%3D (Pubitemid 40627891)
19. P Richardson AA Chanan-Khan S Lonial A Krishnan M Alsina M Carroll K Adler G Cropp C Mitsiades R Johnson A Hannah KC Anderson 2006 A Multicenter Phase 1 Clinical Trial of Tanespimycin (KOS-953) + Bortezomib (BZ): Encouraging Activity and Manageable Toxicity in Heavily Pre-Treated Patients with Relapsed Refractory Multiple Myeloma (MM) ASH Ann Meet Abstr 108 406
20. Richardson PG, Chanan-Khan A, Lonial S, Krishnan A, Carroll M, Alsina M, Albitar M, Berman D, Kaplita S, Anderson KC (2009) Tanespimycin + bortezomib in patients with relapsed and refractory multiple myeloma: final results of a phase 1/2 study. American Society of Clinical Oncology (ASCO), Orlando, FL
21. PG Richardson AA Chanan-Khan M Alsina D Doss B Landrigan D Kettner M Albitar C Mitsiades GF Cropp RG Johnson AL Hannah KC Anderson 2005 Safety and Activity of KOS-953 in Patients with Relapsed Refractory Multiple Myeloma (MM): Interim Results of a Phase 1 Trial ASH Annu Meet Abstr 106 361
22. NC Santos J Figueira-Coelho J Martins-Silva C Saldanha 2003 Multidisciplinary utilization of dimethyl sulfoxide: pharmacological, cellular, and molecular aspects Biochem Pharmacol 65 1035 1041 12663039 10.1016/S0006-2952(03)00002-9 1:CAS:528:DC%2BD3sXit12gur0%3D (Pubitemid 36349743)
23. C Schneider L Sepp-Lorenzino E Nimmesgern O Ouerfelli S Danishefsky N Rosen FU Hartl 1996 Pharmacologic shifting of a balance between protein refolding and degradation mediated by Hsp90 Proc Natl Acad Sci USA 93 14536 14541 8962087 10.1073/pnas.93.25.14536 1:CAS:528:DyaK28XnsVKrsbs%3D (Pubitemid 26419002)
24. TW Schulte MV Blagosklonny C Ingui L Neckers 1995 Disruption of the Raf-1-Hsp90 molecular complex results in destabilization of Raf-1 and loss of Raf-1-Ras association J Biol Chem 270 24585 24588 7592678 10.1074/jbc.270.41. 24585 1:CAS:528:DyaK2MXovVSnsLw%3D
25. TW Schulte LM Neckers 1998 The benzoquinone ansamycin 17-allylamino-17-demethoxygeldanamycin binds to HSP90 and shares important biologic activities with geldanamycin Cancer Chemother Pharmacol 42 273 279 9744771 10.1007/s002800050817 1:CAS:528:DyaK1cXls1Wlt7Y%3D (Pubitemid 28393843)
26. DB Solit SP Ivy C Kopil R Sikorski MJ Morris SF Slovin WK Kelly A DeLaCruz T Curley G Heller S Larson L Schwartz MJ Egorin N Rosen HI Scher 2007 Phase I trial of 17-allylamino-17-demethoxygeldanamycin in patients with advanced cancer Clin Cancer Res 13 1775 1782 17363532 10.1158/1078-0432.CCR-06- 1863 1:CAS:528:DC%2BD2sXivV2gtL4%3D (Pubitemid 46952945)
27. DB Solit FF Zheng M Drobnjak PN Munster B Higgins D Verbel G Heller W Tong C Cordon-Cardo DB Agus HI Scher N Rosen 2002 17-Allylamino-17- demethoxygeldanamycin induces the degradation of androgen receptor and HER-2/neu and inhibits the growth of prostate cancer xenografts Clin Cancer Res 8 986 993 12006510 1:CAS:528:DC%2BD38XksVSqur4%3D (Pubitemid 34517631)
28. T Taldone A Gozman R Maharaj G Chiosis 2008 Targeting Hsp90: small-molecule inhibitors and their clinical development Curr Opin Pharmacol 8 370 374 18644253 10.1016/j.coph.2008.06.015 1:CAS:528:DC%2BD1cXhtFCktL7J
29. P Therasse SG Arbuck EA Eisenhauer J Wanders RS Kaplan L Rubinstein J Verweij M Van Glabbeke AT van Oosterom MC Christian SG Gwyther 2000 New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada J Natl Cancer Inst 92 205 216 10655437 10.1093/jnci/92.3.205 1:STN:280:DC%2BD3c7it1Gitg%3D%3D
30. SZ Usmani R Bona Z Li 2009 17 AAG for HSP90 inhibition in cancer-from bench to bedside Curr Mol Med 9 654 664 19601813 10.2174/156652409788488757 1:CAS:528:DC%2BD1MXntVCju78%3D
31. L Whitesell EG Mimnaugh B De Costa CE Myers LM Neckers 1994 Inhibition of heat shock protein HSP90-pp60v-src heteroprotein complex formation by benzoquinone ansamycins: essential role for stress proteins in oncogenic transformation Proc Natl Acad Sci USA 91 8324 8328 8078881 10.1073/pnas.91.18. 8324 1:CAS:528:DyaK2cXlslKnsLw%3D