Phase i dose escalation study of KOS-1584, a novel epothilone, in patients with advanced solid tumors

Cancer Chemotherapy and Pharmacology

Volumn 69, Issue 2, 2012, Pages 523-531

  Lam, Elaine T ^a   Goel, Sanjay ^b   Schaaf, Larry J ^a   Cropp, Gillian F ^c   Hannah, Alison L ^c   Zhou, Yiqing ^c   McCracken, Barbara ^a   Haley, Brandi I ^a   Johnson, Robert G ^c   Mani, Sridhar ^b   Villalona Calero, Miguel A ^a,d  

^a OHIO STATE UNIVERSITY   (United States)

^b ALBERT EINSTEIN CANCER CENTER   (United States)

^c KOSAN BIOSCIENCES INC   (United States)

^d OHIO STATE UNIVERSITY   (United States)

Author keywords

Epothilone; KOS 1584; Phase I; Solid tumors

Indexed keywords

9,10 DIDEHYDROEPOTHILONE D; DOCETAXEL; EPOTHILONE DERIVATIVE; PACLITAXEL; TUBULIN;

ADULT; ADVANCED CANCER; AGED; ALOPECIA; ANEMIA; ANOREXIA; ANTINEOPLASTIC ACTIVITY; AREA UNDER THE CURVE; ARTHRALGIA; ARTICLE; ASTHENIA; BACKACHE; BRAIN DISEASE; BREAST CANCER; CANCER OF UNKNOWN PRIMARY SITE; COHORT ANALYSIS; COLORECTAL CANCER; CONSTIPATION; CONTINUOUS INFUSION; DEHYDRATION; DIARRHEA; DISEASE COURSE; DIZZINESS; DOSE RESPONSE; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG DISTRIBUTION; DRUG DOSE COMPARISON; DRUG DOSE ESCALATION; DRUG EFFICACY; DRUG ERUPTION; DRUG EXCRETION; DRUG HALF LIFE; DRUG HYPERSENSITIVITY; DRUG PROTEIN BINDING; DRUG SAFETY; DRUG STRUCTURE; DRUG WITHDRAWAL; DRY SKIN; DYSPNEA; EDEMA; ESOPHAGUS CANCER; FATIGUE; FEMALE; GASTROINTESTINAL HEMORRHAGE; HEADACHE; HEMATOCHEZIA; HUMAN; HYPOALBUMINEMIA; HYPOCALCEMIA; HYPOTENSION; INCIDENCE; INTESTINE NECROSIS; INTESTINE PERFORATION; KIDNEY CANCER; KIDNEY CARCINOMA; LIVER CANCER; LIVER METASTASIS; LUNG NON SMALL CELL CANCER; LUNG SMALL CELL CANCER; LYMPH NODE METASTASIS; LYMPHOCYTOPENIA; MAJOR CLINICAL STUDY; MALE; MELANOMA; MICROTUBULE ASSEMBLY; MULTIPLE CYCLE TREATMENT; MYALGIA; NAUSEA AND VOMITING; NEUROLOGIC DISEASE; NEUTROPENIA; OVARY CANCER; PAINFUL BREATHING; PANCREAS CANCER; PERIPHERAL NEUROPATHY; PHASE 1 CLINICAL TRIAL; PLEURA EFFUSION; PRIORITY JOURNAL; PROSTATE CANCER; RECOMMENDED DRUG DOSE; SARCOMA; SENSORY NEUROPATHY; SEPTICEMIA; SMALL INTESTINE OBSTRUCTION; STOMACH CANCER; STREPTOCOCCUS PNEUMONIA; THORAX PAIN; THROMBOCYTOPENIA; TREATMENT OUTCOME; TREMOR; UTERUS CANCER;

ADULT; AGED; AGED, 80 AND OVER; AREA UNDER CURVE; ARTHRALGIA; DIARRHEA; DOSE-RESPONSE RELATIONSHIP, DRUG; EPOTHILONES; FATIGUE; FEMALE; HUMANS; MALE; METABOLIC CLEARANCE RATE; MIDDLE AGED; MOLECULAR STRUCTURE; NEOPLASMS; PERIPHERAL NERVOUS SYSTEM DISEASES; TREATMENT OUTCOME; TUBULIN MODULATORS;

EID: 84856728662     PISSN: 03445704     EISSN: 14320843     Source Type: Journal    
DOI: 10.1007/s00280-011-1724-7     Document Type: Article

References (37)

1. PG Morris MN Fornier 2008 Microtubule active agents: beyond the taxane frontier Clin Cancer Res 14 7167 7172 19010832 10.1158/1078-0432.CCR-08-0169 1:CAS:528:DC%2BD1cXhtlyltbfO
2. EA Perez 2009 Microtubule inhibitors: differentiating tubulin-inhibiting agents based on mechanisms of action, clinical activity, and resistance Mol Cancer Ther 8 2086 2095 19671735 10.1158/1535-7163.MCT-09-0366 1:CAS:528:DC%2BD1MXpvFCnurw%3D
3. Villalona-Calero MA, Schaaf L, Turowski R (2008) Antimicrobule agents. In: Dai W (ed) Cancer drug discovery and development: checkpoint responses in cancer therapy. Humana Press, Tuxedo, pp 177-206
4. T Fojo M Menefee 2007 Mechanisms of multidrug resistance: the potential role of microtubule-stabilizing agents Ann Oncol 18 v3 v8 17656560 10.1093/annonc/mdm172
5. EK Rowinsky LA Cazenave RC Donehower 1990 Taxol: a novel investigational antimicrotubule agent J Natl Cancer Inst 82 1247 1259 1973737 10.1093/jnci/82.15.1247 1:STN:280:DyaK3czisFaktw%3D%3D (Pubitemid 20239995)
6. EK Rowinsky 1997 The development and clinical utility of the taxane class of antimicrotubule chemotherapy agents Annu Rev Med 48 353 374 9046968 10.1146/annurev.med.48.1.353 1:CAS:528:DyaK2sXhtFOmsLs%3D (Pubitemid 27101837)
7. KL Cheng T Bradley DR Budman 2008 Novel microtubule-targeting agents-the epothilones Biologics 2 789 811 19707459 1:CAS:528:DC%2BD1MXjvVyhurw%3D
8. S Goodin MP Kane EH Rubin 2004 Epothilones: mechanism of action and biologic activity J Clin Oncol 22 2015 2025 15143095 10.1200/JCO.2004.12.001 1:CAS:528:DC%2BD2cXptlCks7w%3D (Pubitemid 41095195)
9. S Puhalla A Brufsky 2008 Ixabepilone: a new chemotherapeutic option for refractory metastatic breast cancer Biologics 2 505 515 19707381 1:CAS:528:DC%2BD1cXhtlWrtbvI
10. S Mani HM McDaid A Grossman, et al. 2007 Peripheral blood mononuclear and tumor cell pharmacodynamics of the novel epothilone B analogue, ixabepilone Ann Oncol 18 190 195 17018704 10.1093/annonc/mdl315 1:STN:280: DC%2BD2s%2FisVWguw%3D%3D (Pubitemid 46152521)
11. P Fumoleau B Coudert N Isambert E Ferrant 2007 Novel tubulin-targeting agents: anticancer activity and pharmacologic profile of epothilones and related analogues Ann Oncol 18 Suppl 5 v9 15 17656562 10.1093/annonc/mdm173
12. EH Rubin J Rothermel F Tesfaye, et al. 2005 Phase I dose-finding study of weekly single-agent patupilone in patients with advanced solid tumors J Clin Oncol 23 9120 9129 16301595 10.1200/JCO.2005.03.0981 1:CAS:528: DC%2BD28Xnt1ygtQ%3D%3D
13. P Schmid P Kiewe K Possinger, et al. 2010 Phase I study of the novel, fully synthetic epothilone sagopilone (ZK-EPO) in patients with solid tumors Ann Oncol 21 633 639 19880436 10.1093/annonc/mdp491 1:STN:280: DC%2BC3c7isVyrug%3D%3D
14. D Arnold W Voigt P Kiewe, et al. 2009 Weekly administration of sagopilone (ZK-EPO), a fully synthetic epothilone, in patients with refractory solid tumours: results of a phase I trial Br J Cancer 101 1241 1247 19773753 10.1038/sj.bjc.6605327 1:CAS:528:DC%2BD1MXht1GntbvF
15. TC Chou OA O'Connor WP Tong, et al. 2001 The synthesis, discovery, and development of a highly promising class of microtubule stabilization agents: curative effects of desoxyepothilones B and F against human tumor xenografts in nude mice Proc Natl Acad Sci USA 98 8113 8118 11438750 10.1073/pnas.131153098 1:CAS:528:DC%2BD3MXlt1Knu78%3D (Pubitemid 32642695)
16. TM Beer CS Higano M Saleh, et al. 2007 Phase II study of KOS-862 in patients with metastatic androgen independent prostate cancer previously treated with docetaxel Invest New Drugs 25 565 570 17618407 10.1007/s10637-007-9068-1 1:CAS:528:DC%2BD2sXhtFSlsb%2FP
17. B Overmoyer S Waintraub P Kaufman 2005 Phase II trial of KOS-862 (epothilone D) in anthracycline and taxane pretreated metastatic breast cancer J Clin Oncol 2005 ASCOAnnu Meet Proc 23 778
18. Kosan Biosciences I (2004) KOS-1584 investigator's brochure
19. TC Chou X Zhang ZY Zhong, et al. 2008 Therapeutic effect against human xenograft tumors in nude mice by the third generation microtubule stabilizing epothilones Proc Natl Acad Sci USA 105 13157 13162 18755900 10.1073/pnas. 0804773105 1:CAS:528:DC%2BD1cXhtFSgs7rP
20. Zhou y, Zhong Z, Liu F et al. (2005) KOS-1584: a rationally designed epothilone D analog with improved potency and pharmacokinetic (PK) properties. Proc Amer Assoc Cancer Res 46: (Abstract #2535)
21. P Therasse SG Arbuck EA Eisenhauer, et al. 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
22. EA Eisenhauer PJ O'Dwyer M Christian JS Humphrey 2000 Phase I clinical trial design in cancer drug development J Clin Oncol 18 684 692 10653884 1:CAS:528:DC%2BD3cXht1Kmtbs%3D (Pubitemid 30078550)
23. Cancer Therapy Evaluation Program (2006) Common Terminology Criteria for Adverse Events, Version 3.0, DCTD, NCI, NIH, DHHS March 31, 2003. http://ctep.cancer.gov. Accessed 9 Aug 2006
24. H Bazette 1920 An analysis of the time-relations of electrocardiograms Heart 7 353 370
25. HM McDaid S Mani HJ Shen, et al. 2002 Validation of the pharmacodynamics of BMS-247550, an analogue of epothilone B, during a phase I clinical study Clin Cancer Res 8 2035 2043 12114401 1:CAS:528:DC%2BD38XmtVWit7s%3D (Pubitemid 34753571)
26. Gibaldi M, Perrier D (1982) Pharmacokinetics, 2nd edn. Marcel Dekker, New York
27. S Mani H McDaid A Hamilton, et al. 2004 Phase I clinical and pharmacokinetic study of BMS-247550, a novel derivative of epothilone B, in solid tumors Clin Cancer Res 10 1289 1298 14977827 10.1158/1078-0432.CCR-0919-03 1:CAS:528:DC%2BD2cXhsVCqur0%3D (Pubitemid 38365219)
28. ES Thomas HL Gomez RK Li, et al. 2007 Ixabepilone plus capecitabine for metastatic breast cancer progressing after anthracycline and taxane treatment J Clin Oncol 25 5210 5217 17968020 10.1200/JCO.2007.12.6557 1:CAS:528: DC%2BD2sXhsVKnsbzO (Pubitemid 350232252)
29. JA Sparano E Vrdoljak O Rixe, et al. 2010 Randomized phase III Trial of ixabepilone plus capecitabine versus capecitabine in patients with metastatic breast cancer previously treated with an anthracycline and a taxane J Clin Oncol 28 3256 3263 20530276 10.1200/JCO.2009.24.4244 1:CAS:528:DC%2BC3cXhtVajur3E
30. http://www.clinicaltrials.gov. In Edition Accessed 31 May 2010
31. WW Ten Bokkel Huinink J Sufliarsky WM Smit, et al. 2009 Safety and efficacy of patupilone in patients with advanced ovarian, primary fallopian, or primary peritoneal cancer: a phase I, open-label, dose-escalation study J Clin Oncol 27 3097 3103 19451434 10.1200/JCO.2008.20.4826 1:CAS:528: DC%2BD1MXhtFWitbzJ
32. RL Dixon 1976 Problems in extrapolating toxicity data for laboratory animals to man Environ Health Perspect 13 43 50 817897 10.1289/ehp.761343 1:CAS:528:DyaE28XksFKntr8%3D
33. I Mahmood MD Green JE Fisher 2003 Selection of the first-time dose in humans: comparison of different approaches based on interspecies scaling of clearance J Clin Pharmacol 43 692 697 12861964 1:CAS:528:DC%2BD3sXlvFWqs7s%3D (Pubitemid 36759146)
34. S Reagan-Shaw M Nihal N Ahmad 2008 Dose translation from animal to human studies revisited FASEB J 22 659 661 17942826 10.1096/fj.07-9574LSF 1:CAS:528:DC%2BD1cXjtVaqsrY%3D (Pubitemid 351348146)
35. Stopeck A, Moulder S, Jones S et al. (2007) Phase I trial of KOS-1584 (a novel epothilone) using two weekly dosing schedules. J Clin Oncol. 24: (Abstract 2571). ASCO Annual Meeting Proceedings Part I
36. Ixabepilone (Ixempra) (2010) Package Insert. Bristol-Myers Squibb
37. S Goel M Cohen SN Comezoglu, et al. 2008 The effect of ketoconazole on the pharmacokinetics and pharmacodynamics of ixabepilone: a first in class epothilone B analogue in late-phase clinical development Clin Cancer Res 14 2701 2709 18451235 10.1158/1078-0432.CCR-07-4151 1:CAS:528:DC%2BD1cXlsV2qtLg%3D