A phase I trial of ispinesib, a kinesin spindle protein inhibitor, with docetaxel in patients with advanced solid tumours

British Journal of Cancer

Volumn 98, Issue 5, 2008, Pages 894-899

  Blagden, S P ^a,d   Molife, L R ^a   Seebaran, A ^b   Payne, M ^b   Reid, A H M ^a   Protheroe, A S ^b   Vasist, L S ^c   Williams, D D ^c   Bowen, C ^c   Kathman, S J ^c   Hodge, J P ^c   Dar, M M ^c   De Bono, J S ^a   Middleton, M R ^b  

^a ROYAL MARSDEN HOSPITAL   (United Kingdom)

^b CHURCHILL HOSPITAL   (United Kingdom)

^c GLAXOSMITHKLINE   (United States)

^d HAMMERSMITH HOSPITAL   (United Kingdom)

Author keywords

Docetaxel; Kinesin spindle protein; Mitotic kinesin; Phase I; SB 715992

Indexed keywords

DOCETAXEL; ISPINESIB; KINESIN; PROSTATE SPECIFIC ANTIGEN;

ADULT; ADVANCED CANCER; AGED; ALOPECIA; ANEMIA; ARTICLE; BLOOD SAMPLING; BONE MARROW SUPPRESSION; CANCER PATIENT; CLINICAL ARTICLE; CLINICAL TRIAL; CONSTIPATION; CONTINUOUS INFUSION; DEATH; DIARRHEA; DRUG DOSE ESCALATION; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG SAFETY; DRUG WITHDRAWAL; DYSGEUSIA; FATIGUE; FEBRILE NEUTROPENIA; FEMALE; HEADACHE; HUMAN; KIDNEY CANCER; LETHARGY; LEUKOPENIA; MALE; MAXIMUM TOLERATED DOSE; MUCOSA INFLAMMATION; MULTIPLE CYCLE TREATMENT; NAUSEA; NEUROPATHY; NEUTROPENIA; PERIPHERAL NEUROPATHY; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; PROSTATE CANCER; SIDE EFFECT; SOLID TUMOR; THROMBOCYTOPENIA; TREATMENT OUTCOME; TREATMENT RESPONSE; VOMITING;

ADULT; AGED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BENZAMIDES; FEMALE; HUMANS; KINESIN; MALE; MIDDLE AGED; NEOPLASMS; QUINAZOLINES; TAXOIDS;

EID: 40349096404     PISSN: 00070920     EISSN: 15321827     Source Type: Journal    
DOI: 10.1038/sj.bjc.6604264     Document Type: Article

References (31)

1. Baker SD, Zhao M, Lee CKK, Verweij J, Zabelina Y, Brahmer JR, Wolff AC, Sparreboom A, Carducci MA (2003) Comparative Pharmacokinetics of weekly and every three weeks docetaxel. Clin Cancer Res 10: 1976-1983
2. Blagden S, de Bono J (2005) Drugging cell cycle kinases in cancer therapy. Curr Drug Targets 6: 325-335
3. Blangy A, Lane HA, d'Herin P, Harper M, Kress M, Nigg EA (1995) Phosphorylation by p34cdc2 regulates spindle association of human Eg5, a kinesin-related motor essential for bipolar spindle formation in vivo. Cell 83: 1159-1169
4. Bubley GJ, Carducci M, Dahut W, Dawson N, Daliani D, Eisenberger M, Figg WD, Freidlin B, Halabi S, Hudes G, Hussain M, Kaplan R, Myers C, Oh W, Petrylak DP, Reed E, Roth B, Sartor O, Scher H, Simons J, Sinibaldi V, Small EJ, Smith MR, Trump DL, Vollmer R, Wilding G (1999) Eligibility and response guidelines for phase II clinical trials in androgen-independent prostate cancer: recommendations from the Prostate-Specific Antigen Working Group. J Clin Oncol 17: 3461-3467
5. Burris HA, Lorusso P, Jones S, Guthrie TM, Orr JB, Williams DD, Hodge JP, Bush M, Sabry J (2004) Phase I trial of novel kinesin spindle protein (KSP) inhibitor SB-715992 IV days 1, 8 15 q 28 days. Proc Am Soc Clin Oncol 22: 14S
6. Chan S, Friedrichs K, Noel D, Pintér T, Van Belle S, Vorobiof D, Duarte R, Gil MG, Bodrogi I, Murray E, Yelle L, von Minckwitz G, Korec S, Simmonds P, Buzz Fi, González-Mancha R, Richardson G, Walpole E, Ronzoni M, Murawsky M, Alakl M, Riva A, Crown J (1999) Prospective randomized trial of docetaxel versus doxorubicin in patients with metastatic breast cancer. J Clin Oncol 17: 2341-2354
7. Chu Q, Holen KD, Rowinsky EK, Wilding G, Volkman JL, Orr JB, Williams DD, Hodge JP, Sabry J (2004) A Phase I trial of novel kinesin spindle protein (KSP) inhibitor SB-715992 IV q 21 days. Proc Amer Soc Clin Oncol 22: 2078
8. Chu QS, Holen KD, Rowinsky EK, Alberti DB, Monroe P, Volkman JL, Hodge JP, Sabry J, Ho PTC, Wilding G (2003) A phase I study to determine the safety and pharmacokinetics of IV administered SB-715992, a novel kinesin spindle protein (KSP) inhibitor in patients with solid tumors. Proc Am Soc Clin Oncol 22: 525
9. Cochran JC, Gatial III JE, Kapoor TM, Gilbert SP (2005) Monastrol inhibition of the mitotic kinesin Eg5. J Biol Chem 280: 12658-12667
10. Drinka PJ, Langer E (1989) The Cockroft-Gault formula. J Am Geriatr Soc 37: 820
11. Eisenhauer EA, Vermorken JB (1998) The taxoids: comparative clinical pharmacology and therapeutic potential. Drugs 55: 5-30
12. Fossella F, Pereira JR, von Pawel J, Pluzanska A, Gorbounova V, Kaukel E, Mattson KV, Ramlau R, Szczesna A, Fidias P, Millward M, Belani CP (2003) Randomized, multinational, phase III study of docetaxel plus platinum combinations versus vinorelbine plus cisplatin for advanced non-small-cell lung cancer: the TAX 326 Study Group. J Clin Oncol 21: 3016-3024
13. Fossella FV, DeVore R, Kerr RN, Crawford J, Natale RR, Dunphy F, Kalman L, Miller V, Lee JS, Moore M, Gandara D, Karp D, Vokes E, Kris M, Kim Y, Gamza F, Hammershaimb L (2000) Randomized phase III trial of docetaxel versus vinorelbine or ifosfamide in patients with advanced non-small-cell lung cancer previously treated with platinum-containing chemotherapy regimens. J Clin Oncol 18: 2354-2362
14. Hegde PS, Cogswell J, Carrick K, Jackson J, Wood KW, Eng WK, Brawner M, Huang PS, Bergsma D (2003) Differential gene expression analysis of kinesin spindle protein in human solid tumors. Proc Am Soc Clin Oncol 22: 535
15. Holen KD, Belani CP, Wilding G, Ramalingam S, Heideman JL, Ramanathan RK, Bowen CJ, Williams DD, Hodge JP, Dar MM (2006) Phase I study to determine tolerability and pharmacokinetics (PK) of SB-743921, a novel kinesin spindle protein (KSP) inhibitor. Proc Am Soc Clin Oncol 24: 2000
16. Jackson JR, Gilmartin A, Dhanak D, Gilmartin A, Dhanak D, Knight S, Parrish C, Luo L, Sutton D, Caulder E, Diamond M, Giardiniere M, Zhang SY, Huang P, Bergnes G, McDonald A, Lee Y, Sakowicz R, Wood KW (2006) A second generation KSP inhibitor, SB-743921, is a highly potent and active therapeutic in preclinical models of cancer. Proc Am Assoc Cancer Res 2006: B11
17. Jackson JR, Patrick DR, Dar MM, Huang PS (2007) Targeted anti-mitotic therapies: can we improve on tubulin agents? Nat Rev Canc 7: 107-117
18. Johnson RK, McCabe FL, Cauder E, Inlow-Porter L, Whitacre M, Winkler JD, Bergnes G, Feng B, Morgans D, Wood KW, Jackson JR (2002) SB-715992, a potent and selective inhibitor of KSP mitotic kinesin, demonstrates broad-spectrum activity in advanced murine tumors and human tumor xenografts. Proc Am Assoc Cancer Res 43: 269
19. Jones SF, Plummer ER, Burris HA, Razak AR, Meluch AA, Bowen CJ, Williams DH, Hodge JP, Dar MM, Calvert AH (2006) Phase I study of ispinesib in combination with carboplatin in patients with advanced solid tumors. Proc Am Soc Clin Oncol 24: 2027; 18S
20. Mayer TU, Kapoor TM, Haggarty SJ, King RW, Schreiber SL, Mitchison T (1999) Small molecule inhibitor of mitotic spindle bipolarity identified in a phenotype-based screen. Science 286: 971-974
21. Miller K, Ng C, Ang P, Brufsky AM, Lee SC, Dees EC, Piccart M, Verrill M, Wardley A, Loftiss J, Bal J, Yeoh S, Hodge J, Williams D, Dar M, Ho PTC (2005) Phase II, Open Label Study of Ispinesib in Patients with Locally Advanced or Metastatic Breast Cancer. San Antonio Breast Cancer Symposium 2005: 1089
22. Nabholtz J-M, Senn HJ, Bezwoda WR, Melnychuk D, Deschênes L, Douma J, Vandenberg TA, Rapoport B, Rosso R, Trillet-Lenoir V, Drbal J, Molino A, Nortier JWR, Richel DJ, Nagykalnai T, Siedlecki P, Wilking N, Genot JY, Hupperets PSGJ, Pannuti F, Skarlos D, Tomiak EM, Murawsky A, Alakl M, Riva A, Aapro M (1999) Prospective randomized trial of docetaxel versus mitomycin plus vinblastine in patients with metastatic breast cancer progressing despite previous anthracycline-containing chemotherapy. J Clin Oncol 17: 1413-1424
23. Rodon J, Till E, Patnaik A, Takimoto C, Beeram M, Williams D, Bowen C, Hodge J, Dar M, Tolcher A (2006) Phase I study of ispinesib (SB-715992), a kinesin spindle protein inhibitor, in combination with capecitabine in patients with advanced solid tumors. Eur J Canc Suppl 4: 193
24. Sakowicz R, Finer JT, Beraud C, Crompton A, Lewis E, Fritsch A, Lee Y, Mak J, Moody R, Turincio R, Chabala JC, Gonzales P, Roth S, Weitman S, Wood KW (2004) Antitumor activity of a kinesin inhibitor. Cancer Res 64: 3276-3280
25. Shahin M, Braly P, Rose P, Malpass T, Bailey H, Alvarez RD, Hodge J, Bowen C, Buller R (2007) A phase II, open-label study of ispinesib (SB-715992) in patients with platinum/taxane refractory or resistant relapsed ovarian cancer. Proc Am Soc Clin Oncol 21: 5562
26. Shepherd FA, Dancey J, Ramlau R, Mattson K, Gralla R, O'Rourke M, Levitan N, Gressot L, Vincent M, Burkes R, Coughlin S, Kim Y, Berille J (2000) Prospective randomized trial of docetaxel versus best supportive care in patients with non-small-cell lung cancer previously treated with platinum-based chemotherapy. J Clin Oncol 18: 2095-2103
27. Stein MN, Rubin EH, Scott PD, Fernandez R, Agrawal NG, Hsu K, Walker A, Holen K, Wilding G (2006) Phase I clinical and pharmacokinetic (PK) trial of the kinesin spindle protein (KSP) inhibitor MK-0731 in cancer patients. Proc Am Soc Clin Oncol 24: 2001
28. Tannock IF, de Wit R, Berry WR, Horti J, Pluzanska A, Chi KN, Oudard S, Théodore C, James ND, Turesson I, Rosenthal MA, Eisenberger MA (2004) Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer. N Engl J Med 351: 1502-1512
29. Taxotere® Prescribing Information (2005). Bridgewater, NJ: Aventis Pharmaceuticals Inc.
30. Therasse P, Arbuck SG, Eisenhauer EA, Wanders J, Kaplan RS, Rubinstein L, Verweij J, van Glabbeke M, van Oosterom AT, Christian MC, Gwyther SG (2000) New guidelines to evaluate the response to treatment in solid tumors. J Natl Cancer Inst 92: 205-216
31. Wood KW, Cornwell WD, Jackson JR (2001) Past and future of the mitotic spindle as an oncology target. Curr Opin Pharmacol 1: 370-377