Phase I study of the novel epothilone analog ixabepilone (BMS-247550) in patients with advanced solid tumors and lymphomas

Journal of Clinical Oncology

Volumn 25, Issue 9, 2007, Pages 1082-1088

  Aghajanian, Carol ^a   Burris III, Howard A ^a   Jones, Suzanne ^a   Spriggs, David R ^a   Cohen, Marvin B ^a   Peck, Ronald ^a   Sabbatini, Paul ^a   Hensley, Martee L ^a   Greco, F Anthony ^a   Dupont, Jakob ^a   O'Connor, Owen A ^a  

^a BRISTOL MYERS SQUIBB   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANTINEOPLASTIC AGENT; BMS 249798; BMS 326412; IXABEPILONE; OXAZINE DERIVATIVE; UNCLASSIFIED DRUG; EPOTHILONE DERIVATIVE; TUBULIN MODULATOR;

ADULT; AGED; ARTHRALGIA; ARTICLE; BLEEDING; CANCER RELAPSE; CLINICAL TRIAL; CONTINUOUS INFUSION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG BLOOD LEVEL; DRUG DOSE ESCALATION; DRUG EFFICACY; DRUG RESPONSE; DRUG TOLERABILITY; FEBRILE NEUTROPENIA; HUMAN; LOADING DRUG DOSE; LYMPHOMA; MAJOR CLINICAL STUDY; MYALGIA; NEUTROPENIA; NONHODGKIN LYMPHOMA; PHARYNGITIS; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; RECOMMENDED DRUG DOSE; SOLID TUMOR; STOMATITIS; THROMBOCYTOPENIA; TREATMENT FAILURE; TREATMENT OUTCOME; CANCER STAGING; CHEMICALLY INDUCED DISORDER; COHORT ANALYSIS; DRUG ADMINISTRATION; DRUG HYPERSENSITIVITY; FEMALE; INTRAVENOUS DRUG ADMINISTRATION; MALE; MAXIMUM TOLERATED DOSE; MIDDLE AGED; MORTALITY; MULTICENTER STUDY; NEOPLASM; PATHOLOGY; PERIPHERAL NEUROPATHY; PRACTICE GUIDELINE; SURVIVAL; TIME; UNITED STATES;

ADULT; AGED; ANTINEOPLASTIC AGENTS; COHORT STUDIES; DRUG ADMINISTRATION SCHEDULE; DRUG HYPERSENSITIVITY; EPOTHILONES; FEMALE; HUMANS; INFUSIONS, INTRAVENOUS; LYMPHOMA, NON-HODGKIN; MALE; MAXIMUM TOLERATED DOSE; MIDDLE AGED; NEOPLASM STAGING; NEOPLASMS; NEUTROPENIA; PERIPHERAL NERVOUS SYSTEM DISEASES; PRACTICE GUIDELINES; SURVIVAL ANALYSIS; THROMBOCYTOPENIA; TIME FACTORS; TREATMENT FAILURE; TREATMENT OUTCOME; TUBULIN MODULATORS; UNITED STATES;

EID: 34047212584     PISSN: 0732183X     EISSN: None     Source Type: Journal    
DOI: 10.1200/JCO.2006.08.7304     Document Type: Article

References (12)

1. Bollag DM, McQueney PA, Zhu J, et al: Epothilones, a new class of microtubule-stabilizing agents with a taxol-like mechanism of action. Cancer Res 55:2325-2333, 1995
2. Wartmann M, Altmann KH: The biology and medicinal chemistry of epothilones. Curr Med Chem Anticancer Agents 2:123-148, 2002
3. Jordan MA, Miller H, Ray A, et al: The Pat-21 breast cancer model derived from a patient with primary Taxol resistance recapitulates the phenotype of its origin, has altered beta-tubulin expression and is sensitive to ixabepilone. Proc Amer Assoc Cancer Res 47, 2006 (abstr LB-280)
4. Kowalski RJ, Giannakakou P, Hamel E: Activities of the microtubule-stabilizing agents epothilones A and B with purified tubulin and in cells resistant to paclitaxel (Taxol). J Biol Chem 272:2534-2541, 1997
5. Lee FY, Borzilleri R, Fairchild CR, et al: BMS-247550: A novel epothilone analog with a mode of action similar to paclitaxel but possessing superior antitumor efficacy. Clin Cancer Res 7:1429-1437, 2001
6. Therasse P, Arbuck SG, Eisenhauer EA, et al: 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, 2000
7. Gadgeel SM, Wozniak A, Boinpally RR, et al: Phase I clinical trial of BMS-247550, a derivative of epothilone B, using accelerated titration 2B design. Clin Cancer Res 11:6233-6239, 2005
8. Roché HH, Cure H, Bunnell C, et al: A phase II study of epothilone analog BMS-247550 in patients (pts) with metastatic breast cancer (MBC) previously treated with an anthracycline. Proc Am Soc Clin Oncol 22:18, 2003 (abstr 69)
9. Thomas E, Tabernero J, Fornier M, et al: A phase II study of the epothilone B analog BMS-247550 in patients (pts) with taxane-resistant metastatic breast cancer (MBC). Proc Am Soc Clin Oncol 22:8, 2003 (abstr 30)
10. Mani S, McDaid H, Hamilton A, et al: Phase I clinical and pharmacokinetic study of BMS-247550, a novel derivative of epothilone B, in solid tumors. Clin Cancer Res 10:1289-1298, 2004
11. Hussain M, Tangen CM, Lara PN Jr, et al: Ixabepilone (epothilone B analogue BMS-247550) is active in chemotherapy-naive patients with hormone-refractory prostate cancer: A Southwest Oncology Group trial S0111. J Clin Oncol 23:8724-8729, 2005
12. Baselga J, Gianni L, Llombart A, et al: Predicting response to ixabepilone: Genomics study in patients receiving single agent ixabepilone as neoadjuvant treatment for breast cancer (BC). Breast Cancer Res Treat 94:S31, 2005 (abstr 305)