Phase I safety, pharmacokinetic and pharmacodynamic evaluation of the vascular disrupting agent ombrabulin (AVE8062) in patients with advanced solid tumors

Clinical Cancer Research

Volumn 19, Issue 17, 2013, Pages 4832-4842

  Sessa, Cristiana ^a   Lorusso, Patricia ^b   Tolcher, Anthony ^c   Farace, Françoise ^d   Lassau, Nathalie ^e   Delmonte, Angelo ^a   Braghetti, Antonio ^a   Bahleda, Rastislav ^d   Cohen, Patrick ^f   Hospitel, Marie ^f   Veyrat Follet, Christine ^f   Soria, Jean Charles ^d  

^a SAN GIOVANNI HOSPITAL   (Switzerland)

^b KARMANOS CANCER INSTITUTE   (United States)

^c University of Texas Health Science Center at San Antonio   (United States)

^d INSTITUT GUSTAVE ROUSSY   (France)

^e In vivo Molecular Imaging Laboratory   (France)

^f SANOFI   (France)

Author keywords

[No Author keywords available]

Indexed keywords

CAFFEINE; CYTOCHROME P450 1A2; CYTOCHROME P450 2C19; CYTOCHROME P450 3A4; GELATINASE B; MIDAZOLAM; OMBRABULIN; OMEPRAZOLE; VASCULOTROPIN;

ABDOMINAL PAIN; ACUTE HEART INFARCTION; ADRENAL CANCER; ADULT; AGED; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ANEMIA; AREA UNDER THE CURVE; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; ASTHENIA; CANCER PAIN; COHORT ANALYSIS; COLORECTAL CANCER; CONTINUOUS INFUSION; CREATININE BLOOD LEVEL; DIARRHEA; DRUG CLEARANCE; DRUG DISTRIBUTION; DRUG DOSE ESCALATION; DRUG HALF LIFE; DRUG METABOLISM; DRUG SAFETY; DRUG WITHDRAWAL; ENDOTHELIUM CELL; ENZYME INHIBITION; FEMALE; HEADACHE; HEART LEFT VENTRICLE EJECTION FRACTION; HUMAN; HYPERBILIRUBINEMIA; HYPERKALEMIA; HYPERTENSION; KIDNEY CANCER; LEUKOPENIA; LIMIT OF QUANTITATION; LYMPHOCYTOPENIA; MAJOR CLINICAL STUDY; MALE; MALIGNANT NEOPLASTIC DISEASE; MAXIMUM PLASMA CONCENTRATION; MELENA; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; NAUSEA; NAUSEA AND VOMITING; NEUTROPENIA; OVARY CANCER; PARESTHESIA; PHASE 1 CLINICAL TRIAL; PRESYNCOPE; PRIORITY JOURNAL; QT PROLONGATION; RECOMMENDED DRUG DOSE; RECTUM CANCER; RETROPERITONEAL CANCER; SCIATICA; SIDE EFFECT; SOMNOLENCE; THORAX PAIN; THROMBOCYTOPENIA; THROMBOSIS; TREATMENT OUTCOME; TREATMENT RESPONSE; TUMOR BLOOD FLOW; TUMOR NECROSIS; UTERUS CANCER;

ADULT; AGED; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG ADMINISTRATION SCHEDULE; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; FEMALE; HUMANS; MALE; MAXIMUM TOLERATED DOSE; MIDDLE AGED; NEOPLASM STAGING; NEOPLASMS; SERINE; TREATMENT OUTCOME; TUMOR MARKERS, BIOLOGICAL;

EID: 84883486172     PISSN: 10780432     EISSN: 15573265     Source Type: Journal    
DOI: 10.1158/1078-0432.CCR-13-0427     Document Type: Article

References (35)

1. Kanthou C, Tozer GM. The tumor vascular targeting agent combretastatin A-4-phosphate induces reorganization of the actin cytoskeleton and early membrane blebbing in human endothelial cells. Blood 2002;99:2060-9. (Pubitemid 34525489)
2. Hori K, Saito S. Microvascular mechanisms by which the combretastatin A-4 derivative AC7700 (AVE8062) induces tumour blood flow stasis. Br J Cancer 2003;89:1334-44. (Pubitemid 37363426)
3. Nihei Y, Suzuki M, Okano A, Tsuji T, Akiyama Y, Tsuruo T, et al. Evaluation of antivascular and antimitotic effects of tubulin binding agents in solid tumor therapy. Jpn J Cancer Res 1999;90:1387-95. (Pubitemid 30032079)
4. Nihei Y, Suga Y, Morinaga Y, Ohishi K, Okano A, Ohsumi K, et al. A novel combretastatin A-4 derivative, AC-7700, shows marked antitumor activity against advanced solid tumors and orthotopically transplanted tumors. Jpn J Cancer Res 1999;90:1016-25. (Pubitemid 29500443)
5. Lavisse S, Lejeune P, Rouffiac V, Elie N, Bribes E, Demers B, et al. Early quantitative evaluation of a tumor vasculature disruptive agent AVE8062 using dynamic contrast-enhanced ultrasonography. Invest Radiol 2008;43:100-11.
6. TozerGM, Prise VE, Wilson J, Locke RJ, Vojnovic B, Stratford MR, et al. Combretastatin A-4 phosphate as a tumor vascular-targeting agent: early effects in tumors and normal tissues. Cancer Res 1999;59:1626-34. (Pubitemid 29160136)
7. Hori K, Saito S, Nihei Y, Suzuki M, Sato Y. Antitumor effects due to irreversible stoppage of tumor tissue blood flow: evaluation of a novel combretastatin A-4 derivative, AC7700. Jpn J Cancer Res 1999;90:1026-38. (Pubitemid 29500444)
8. Delmonte A, Sessa C. AVE8062: a new combretastatin derivative vascular disrupting agent. Expert Opin Investig Drugs 2009;18:1541-8.
9. Subbiah IM, Lenihan DJ, Tsimberidou AM. Cardiovascular toxicity profiles of vascular-disrupting agents. Oncologist 2011;16:1120-30.
10. Sessa C, Lorusso P, Tolcher AW, Braghetti A, Besenval M, Terrot T, et al. A pharmacokinetic and DCE-MRI-dynamic phase I study of the antivascular combretastatin analogue AVE8062A administered every 3 weeks [abstract]. In: Proceedings of the 96th Annual Meeting of the American Association for Cancer Research; 2005 Apr 16- 20; Anaheim, CA. Philadelphia (PA): AACR; 2005. Abstract nr 5827.
11. Therasse P, Arbuck SG, Eisenhauer EA, Wanders J, Kaplan RS, Rubinstein L, 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 2000;92:205-16.
12. Jacques N, Vimond N, Conforti R, Griscelli F, Lecluse Y, Laplanche A, et al. Quantification of circulating mature endothelial cells using a whole blood four-color flow cytometric assay. J Immunol Methods 2008;337:132-43.
13. + bone marrow-derived progenitor cells correlate with metastatic disease in patientswith pediatric solid malignancies. Clin Cancer Res 2009;15:4561-71.
14. Stevenson JP, Rosen M, Sun W, Gallagher M, Haller DG, Vaughn D, et al. Phase I trial of the antivascular agent combretastatin A4 phosphate on a 5-day schedule to patients with cancer: magnetic resonance imaging evidence for altered tumor blood flow. J Clin Oncol 2003;21:4428-38. (Pubitemid 46621821)
15. Rustin GJ, Galbraith SM, Anderson H, Stratford M, Folkes LK, Sena L, et al. Phase I clinical trial of weekly combretastatin A4 phosphate: clinical and pharmacokinetic results. J Clin Oncol 2003;21:2815-22. (Pubitemid 46621828)
16. Dowlati A, Robertson K, Cooney M, Petros WP, Stratford M, Jesberger J, et al. A phase I pharmacokinetic and translational study of the novel vascular targeting agent combretastatin A-4 phosphate on a single-dose intravenous schedule in patients with advanced cancer. Cancer Res 2002;62:3408-16. (Pubitemid 34651387)
17. Mita MM, Spear MA, Yee LK, Mita AC, Heath EI, Papadopoulos KP, et al. Phase 1 first-in-human trial of the vascular disrupting agent plinabulin (NPI-2358) in patients with solid tumors or lymphomas. Clin Cancer Res 2010;16:5892-9.
18. Kurata T, Murakami H, Fujisaka Y, Kiyota H, Nakagawa K, Onozawa Y, et al. Phase I study of ombrabulin, a vascular disrupting agent (VDA), administered every 3 weeks to Japanese patients with advanced solid tumors [abstract]. In: Proceedings of the AACR-NCI-EORTC International Conference: Molecular Targets and Cancer Therapeutics; 2011 Nov 12-16; San Francisco, CA. Philadelphia (PA): AACR;
19. Mol Cancer Ther 2011;10(11 Suppl):Abstract nr C20.
20. Cooney MM, Radivoyevitch T, Dowlati A, Overmoyer B, Levitan N, Robertson K, et al. Cardiovascular safety profile of combretastatin A4 phosphate in a single-dose phase I study in patients with advanced cancer. Clin Cancer Res 2004;10:96-100. (Pubitemid 38114167)
21. McKeage MJ, Fong P, Jeffery M, Baguley BC, Kestell P, Ravic M, et al. 5,6-Dimethylxanthenone-4-acetic acid in the treatment of refractory tumors: a phase I safety study of a vascular disrupting agent. Clin Cancer Res 2006;12:1776-84.
22. Kim TJ, Ravoori M, Landen CN, Kamat AA, Han LY, Lu C, et al. Antitumor and antivascular effects of AVE8062 in ovarian carcinoma. Cancer Res 2007;67:9337-45. (Pubitemid 47535923)
23. Gao D, Nolan DJ, Mellick AS, Bambino K, McDonnell K, Mittal V. Endothelial progenitor cells control the angiogenic switch in mouse lung metastasis. Science 2008;319:195-8.
24. Shaked Y, Ciarrocchi A, Franco M, Lee CR, Man S, Cheung AM, et al. Therapy-induced acute recruitment of circulating endothelial progenitor cells to tumors. Science 2006;313:1785-7. (Pubitemid 44454154)
25. Taylor M, Billiot F, Marty V, Rouffiac V, Cohen P, Tournay E, et al. Reversing resistance to vascular-disrupting agents by blocking late mobilization of circulating endothelial progenitor cells. Cancer Discov 2012;2:434-49.
26. Bertolini F, Shaked Y, Mancuso P, Kerbel RS. The multifaceted circulating endothelial cell in cancer: towards marker and target identification. Nat Rev Cancer 2006;6:835-45. (Pubitemid 44629895)
27. Massard C, Borget I, Le Deley MC, Taylor M, Gomez-Roca C, Soria JC, et al. Prognostic value of circulating VEGFR2+ bone marrow-derived progenitor cells in patients with advanced cancer. Eur J Cancer 2012; 48:1354-62.
28. Farace F, Massard C, Borghi E, Bidart JM, Soria JC. Vascular disrupting therapy-induced mobilization of circulating endothelial progenitor cells. Ann Oncol 2007;18:1421-2. (Pubitemid 47305018)
29. Seandel M, Butler J, Lyden D, Rafii S. A catalytic role for proangiogenic marrow-derived cells in tumor neovascularization. Cancer Cell 2008; 13:181-3. (Pubitemid 351318378)
30. Ahn GO, Brown JM. Matrix metalloproteinase-9 is required for tumor vasculogenesis but not for angiogenesis: role of bone marrow-derived myelomonocytic cells. Cancer Cell 2008;13:193-205. (Pubitemid 351318369)
31. Shaked Y, Tang T, Woloszynek J, Daenen LG, Man S, Xu P, et al. Contribution of granulocyte colony-stimulating factor to the acute mobilization of endothelial precursor cells by vascular disrupting agents. Cancer Res 2009;69:7524-8.
32. Tozer GM, Kanthou C, Baguley BC. Disrupting tumour blood vessels. Nat Rev Cancer 2005;5:423-35. (Pubitemid 40791485)
33. Nathan P, Zweifel M, Padhani AR, Koh DM, Ng M, Collins DJ, et al. Phase I trial of combretastatin A4 phosphate (CA4P) in combination with bevacizumab in patients with advanced cancer. Clin Cancer Res 2012;18:3428-39.
34. Soria J, Sessa C, Massard C, Perotti A, et al. A comprehensive study of translational research and safety exploration of the vascular disrupting agent (VDA) AVE8062 in combination with cisplatin administered every 3 weeks to patients with advanced solid tumors. Proceedings of the American Association for Cancer Research Annual Meeting, 49 Abstract LB-302, 2008.
35. Del Conte G, Bahleda R, Moreno V, Damian S, Perotti A, Lassau N, et al. A phase I study of ombrabulin (O) combined with bevacizumab (B) in patients with advanced solid tumors (NCT01193595) [abstract]. J Clin Oncol 30, 2012 (suppl; abstr 3080).