A Phase I Study of Oral BMS-275291, a Novel Nonhydroxamate Sheddase-Sparing Matrix Metalloproteinase Inhibitor, in Patients with Advanced or Metastatic Cancer

Clinical Cancer Research

Volumn 10, Issue 6, 2004, Pages 1963-1970

  Rizvi, Naiyer A ^a,d   Humphrey, Jeffrey S ^c   Ness, Elizabeth A ^a   Johnson, Michael D ^a   Gupta, Elora ^c   Williams, Kathleen ^c   Daly, Diana J ^c   Sonnichsen, Daryl ^c   Conway, Delina ^b   Marshall, John ^a   Hurwitz, Herbert ^b  

^a GEORGETOWN UNIVERSITY   (United States)

^b DUKE UNIVERSITY MEDICAL CENTER   (United States)

^c BRISTOL MYERS SQUIBB PHARMACEUTICAL RESEARCH INSTITUTE   (United States)

^d MEMORIAL SLOAN KETTERING CANCER CENTER   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BIOLOGICAL MARKER; GELATINASE A; GELATINASE B; HYDROXAMIC ACID; MARIMASTAT; MATRIX METALLOPROTEINASE INHIBITOR; METALLOPROTEINASE; NEW DRUG; REBIMASTAT; SHEDDASE; TUMOR NECROSIS FACTOR ALPHA; TUMOR NECROSIS FACTOR RECEPTOR 2; UNCLASSIFIED DRUG;

ABDOMINAL PAIN; ADULT; ADVANCED CANCER; AGED; ANOREXIA; AREA UNDER THE CURVE; ARTHROPATHY; ARTICLE; CATARACT; CLINICAL ARTICLE; CLINICAL TRIAL; COLORECTAL CANCER; CONSTIPATION; DIARRHEA; DOSE CALCULATION; DRUG BLOOD LEVEL; DRUG RESPONSE; DRUG SAFETY; DRUG STRUCTURE; DYSPNEA; ENZYME ACTIVITY; ENZYME INHIBITION; FATIGUE; FEMALE; FLUSHING; HEADACHE; HUMAN; IC 50; LIVER TOXICITY; LUNG NON SMALL CELL CANCER; MALE; METASTASIS; MYALGIA; NAUSEA; OPEN STUDY; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; RASH; SIDE EFFECT; TASTE CHANGE; TASTE DISORDER; XEROSTOMIA;

ADULT; AGED; ANTINEOPLASTIC AGENTS; FEMALE; HUMANS; IMIDAZOLES; MALE; MATRIX METALLOPROTEINASES; MIDDLE AGED; NEOPLASM METASTASIS; NEOPLASM STAGING; NEOPLASMS; ORGANIC CHEMICALS; SAFETY;

EID: 12144286743     PISSN: 10780432     EISSN: None     Source Type: Journal    
DOI: 10.1158/1078-0432.CCR-1183-02     Document Type: Article

References (33)

1. Chambers AF, Matrisian LM. Changing views of the role of matrix metalloproteinases in metastasis (Review). J Natl Cancer Inst (Bethesda) 1997;89:1260-70.
2. Nelson AR, Fingleton B, Rothenberg ML, Matrisian LM. Matrix metalloproteinases: biologic activity and clinical implications. J Clin Oncol 2000;18:1135-49.
3. Macaulay VM, O'Byme KJ, Saunders MP, et al. Phase I study of matrix metalloproteinase inhibitor batimastat (BB94) in patients with malignant pleural effusions (Abstract). Proc Am Soc Clin Oncol 1995;14:A1580.
4. Saarinen A, Jekunen A, Halme M, et al. A phase II trial of docetaxel in advanced non-small cell lung cancer. Anticancer Drugs 1996;7:890-2.
5. Kleiner DE, Stetler-Stevenson WG. Matrix metalloproteinases and metastasis. Cancer Chemother Pharmacol 1999;43(Suppl):S42-51.
6. Brown PD, Bloxidge RE, Stuart NS, Gatter KC, Carmichael J. Association between expression of activated 72-kilodalton gelatinase and tumor spread in non-small-cell lung carcinoma. JNCI 1993;85:574-8.
7. Garbisa S, Scagliotti G, Masiero L, et al. Correlation of serum metalloproteinase levels with lung cancer metastasis and response to therapy. Cancer Res 1992;52:4548-9.
8. Thomas P, Khokha R, Shepherd FA, Feld R, Tsao MS. Differential expression of matrix metalloproteinases and their inhibitors in non-small cell lung cancer. J Pathol 2000;190:150-6.
9. Michael M, Babic B, Khokha R, et al. Expression and prognostic significance of metalloproteinases and their tissue inhibitors in patients with small-cell lung cancer. J Clin Oncol 1999;17:1802-8.
10. Zeng ZS, Huang Y, Cohen AM, Guillem JG. Prediction of colorectal cancer relapse and survival via tissue RNA levels of matrix metalloproteinase-9. J Clin Oncol 1996;14:3133-40.
11. Murray GI, Duncan ME, O'Neil P, McKay JA, Melvin WT, Fothergill JE. Matrix metalloproteinase-1 is associated with poor prognosis in oesophageal cancer. J Pathol 1998;185:256-61.
12. Walther MM, Kleiner DE, Lubensky IA, et al. Progelatinase A mRNA expression in cell lines derived from tumors in patients with metastatic renal cell carcinoma correlates inversely with survival. Urology 1997;50:295-301.
13. Nomura H, Fujimoto N, Seiki M, Mai M, Okada Y. Enhanced production of matrix metalloproteinases and activation of matrix metalloproteinase 2 (gelatinase A) in human gastric carcinomas. Int J Cancer 1996;69:9-16.
14. Muller D, Wolf C, Abecassis J, et al. Increased stromelysin 3 gene expression is associated with increased local invasiveness in head and neck squamous cell carcinomas. Cancer Res 1993;53:165-9.
15. Hamdy FC, Fadlon EJ, Cottam D, et al. Matrix metalloproteinase 9 expression in primary human prostatic adenocarcinoma and benign prostatic hyperplasia. Br J Cancer 1994;69:177-82.
16. Martin FM, Beckett RP, Bellamy CL, et al. The synthesis and biological evaluation of non-peptidic matrix metalloproteinase inhibitors. Bioorg Med Chem Lett 1999;9:2887-92.
17. Wojtowicz-Praga S, Torri J, Johnson M, et al. Phase I trial of marimastat, a novel matrix metalloproteinase inhibitor, administered orally to patients with advanced lung cancer. J Clin Oncol 1998;16:2150-6.
18. Newton RC, Solomon KA, Covington MB, et al. Biology of TACE inhibition. Ann Rheum Dis 2001;60 (Suppl 3):iii25-32.
19. Vincenti MP, Brinckerhoff CE. Transcriptional regulation of collagenase (MMP-1, MMP-13) genes in arthritis: integration of complex signaling pathways for the recruitment of gene-specific transcription factors. Arthritis Res 2002;4:157-64.
20. Scatena R. Prinomastat, a hydroxamate-based matrix metalloproteinase inhibitor. A novel pharmacological approach for tissue remodelling-related diseases. Expert Opin Investig Drugs 2000;9:2159-65.
21. Lombard MA, Wallace TL, Kubicek MF, et al. Synthetic matrix metalloproteinase inhibitors and tissue inhibitor of metalloproteinase (TIMP)-2, but not TIMP-1, inhibit shedding of tumor necrosis factor-α receptors in a human colon adenocarcinoma (Colo 205) cell line. Cancer Res 1998;58:4001-7.
22. Naglich JG, Jure-Kunkel M, Gupta E, et al. Inhibition of angiogenesis and metastasis in two murine models by the matrix metalloproteinase inhibitor, BMS-275291. Cancer Res 2001;61:8480-5.
23. Investigator Brochure, Matrix metalloproteinase inhibitor (MMPI), BMS-275291;1999.
24. Daniels R, Gupta E, Kollias G, et al. Safety and pharmacokinetics of BMS-275291, a novel matrix metalloproteinase inhibitor in healthy subjects. 37th Annual Meeting of the American Society of Clinical Oncology; 2001 May 12-15; San Francisco, CA. Alexandria, VA: ASCO Publications; 2001. p. 100a.
25. Lockhart AC, Braun RD, Yu D, et al. Reduction of wound angiogenesis in patients treated with BMS-275291, a broad spectrum matrix metalloproteinase inhibitor. Clin Cancer Res 2003;9:586-93.
26. Naglich JG, Jure-Kunkel M, Gao J, Smith D, Talbott R, Henderson AJ. Activities of a synthetic matrix metalloproteinase inhibitor (MMPI), BMS-275291, in models of angiogenesis and tumor metastasis. American Association for Cancer Research 91st Annual Meeting; 2000 April 1-5; San Francisco, CA, Philidelphia, PA: AACR; 2000.
27. Nemunaitis J, Poole C, Primrose J, Rosemurgy A, Malfetano J, Brown P. Combined analysis of studies of the effects of the matrix metalloproteinase inhibitor marimastat on serum tumor markers in advanced cancer: selection of a biologically active and tolerable dose for longer-term studies. Clin Cancer Res 1998;4:1101-9.
28. Bramhall SR, Rosemurgy A, Brown PD, Bowry C, Buckels JA. Marimastat as first-line therapy for patients with unresectable pancreatic cancer: a randomized trial. J Clin Oncol 2001;19:3447-55.
29. Nemunaitis J, Sterman D, Jablons J, Smith J, Fox EA. Phase I/II study of autologous GM-CSF gene-modified cancer vaccines in subjects with non-small cell lung cancer (NSCLC). 10th International Conference on Gene Therapy of Cancer; 2001 Dec. 13-15. San Diego, CA. London, United Kingdom: International Society for Cancer Gene Therapy; 2001.
30. Bramhall SR, Schulz J, Nemunaitis J, Brown PD, Baillet M, Buckels JA. A double-blind placebo-controlled, randomised study comparing gemcitabine and marimastat with gemcitabine and placebo as first line therapy in patients with advanced pancreatic cancer. Br J Cancer 2002;87:161-7.
31. Bramhall SR, Hallissey MT, Whiting J, et al. Marimastat as maintenance therapy for patients with advanced gastric cancer: a randomised trial. Br J Cancer 2002;86:1864-70.
32. Gupta E, Huang M, Mao Y, et al. Pharmacokinetic (PK) evaluation of BMS-275291, a matrix metalloproteinase (MMP) inhibitor, in cancer patients. Proceedings of the American Society of Clinical Oncology 37th Annual Meeting; 2001 May 12-15; San Francisco, CA. Alexandria, VA: ASCO Publications; 2001.
33. Pithvala Y, Shalinsky D, Wilding G, Hande K, Dixon M, Collier M. Comparison of preclinical efficacy and associated plasma concentrations of AG3340, a matrix metalloprotease (MMP) inhibitor, with plasma concentrations achieved clinically. Proceeding of the American Society of Clinical Oncology 35th Annual Meeting; 1999 May 15-18; Atlanta, GA. Alexandria, VA: ASCO Publications; 1999.