A phase i pharmacokinetic study of PM00104 (Zalypsis®) administered as a 24-h intravenous infusion every 3 weeks in patients with advanced solid tumors

Cancer Chemotherapy and Pharmacology

Volumn 71, Issue 5, 2013, Pages 1247-1254

  Capdevila, J ^a   Clive, S ^b   Casado, E ^a   Michie, C ^b   Piera, A ^a   Sicart, E ^a   Carreras, M J ^a   Coronado, C ^c   Kahatt, C ^c   Soto Matos Pita, A ^c   Fernandez Teruel, C ^c   Siguero, M ^c   Cullell Young, M ^c   Tabernero, J ^a  

^a VALL D HEBRON UNIVERSITY HOSPITAL   (Spain)

^b WESTERN GENERAL HOSPITAL   (United Kingdom)

^c PHARMAMAR S A   (Spain)

Author keywords

Pharmacokinetics; Phase I study; PM00104; Tetrahydroisoquinoline

Indexed keywords

PM 00104; TETRAHYDROISOQUINOLINE DERIVATIVE; UNCLASSIFIED DRUG; ZALYPSIS;

ADULT; ADVANCED CANCER; AGED; ANTINEOPLASTIC ACTIVITY; AREA UNDER THE CURVE; ARTICLE; BONE MARROW SUPPRESSION; CANCER PAIN; CHEMOTHERAPY INDUCED EMESIS; CLINICAL ARTICLE; COLORECTAL CARCINOMA; DISEASE SEVERITY; DISTRIBUTION VOLUME; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG HALF LIFE; DRUG SAFETY; ESOPHAGEAL ADENOCARCINOMA; FATIGUE; FEMALE; HUMAN; LEUKOCYTE; LIVER CELL CARCINOMA; MALE; MAXIMUM PLASMA CONCENTRATION; MELANOMA; MORBIDITY; MULTIPLE CYCLE TREATMENT; MUSCLE RIGIDITY; MYALGIA; NAUSEA; NEUTROPENIA; NEUTROPHIL; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; PROSTATE ADENOCARCINOMA; RECOMMENDED DRUG DOSE; SIDE EFFECT; SOLID TUMOR; THROMBOCYTE; THROMBOCYTOPENIA;

ADULT; AGED; ANTINEOPLASTIC AGENTS; AREA UNDER CURVE; DOSE-RESPONSE RELATIONSHIP, DRUG; FEMALE; HUMANS; INFUSIONS, INTRAVENOUS; MALE; MIDDLE AGED; NEOPLASMS; SEVERITY OF ILLNESS INDEX; TETRAHYDROISOQUINOLINES; TREATMENT OUTCOME;

EID: 84877923100     PISSN: 03445704     EISSN: 14320843     Source Type: Journal    
DOI: 10.1007/s00280-013-2119-8     Document Type: Article

References (19)

1. Ocio EM, Maiso P, Chen X, Garayoa M, Alvarez-Fernandez S, San-Segundo L, Vilanova D, Lopez-Corral L, Montero JC, Hernandez-Iglesias T, de Alava E, Galmarini C, Aviles P, Cuevas C, San-Miguel JF, Pandiella A (2009) Zalypsis: a novel marine-derived compound with potent antimyeloma activity that reveals high sensitivity of malignant plasma cells to DNA double-strand breaks. Blood 113:3781-3791
2. Leal JF, Garcia-Hernandez V, Moneo V, Domingo A, Bueren-Calabuig JA, Negri A, Gago F, Guillen-Navarro MJ, Aviles P, Cuevas C, Garcia-Fernandez LF, Galmarini CM (2009) Molecular pharmacology and antitumor activity of Zalypsis in several human cancer cell lines. Biochem Pharmacol 78:162-170
3. Elices M, LePage DJ, Grant WL, Sasak HT, Caylor T, Guillen MJ, Martin J, Cuevas C, Aviles P, Faircloth G (2005) Profile of Zalypsis (PM00104) against various human solid tumors. Clin Cancer Res 11:9085s-9086s
4. Elices M, Sasak H, Caylor T, Grant W, Guillen MJ, Martin J, Cuevas C, Aviles P, Faircloth G (2005) Antitumor activity of the novel investigational compound PM00104 (Zalypsis). AACR American Association for Cancer Research; 96th Annual Meeting: Abstract #5882
5. Elices M, Grant W, Harper C, Guillen MJ, Cuevas C, Faircloth G, Aviles P (2005) The novel compound PM00104 exhibits significant in vivo activity against breast tumors. AACR American Association for Cancer Research; 96th Annual Meeting: Abstract #623
6. Guirouilh-Barbat J, Antony S, Pommier Y (2009) Zalypsis (PM00104) is a potent inducer of gamma-H2AX foci and reveals the importance of the C ring of trabectedin for transcription-coupled repair inhibition. Mol Cancer Ther 8:2007-2014
7. Magro PG, Kolb A, Alvarez E, Mandola MV, Scotto KW (2007) Characterization of tumor cell response to the novel anti-tumor agent Zalypsis. American Association for Cancer Research (AACR) Meeting Abstracts: Abstract #1529
8. Yin J, Aviles P, Guillen MJ, Ly C, Lee W, Munt S, Cuevas C, Faircloth GT (2005) Pharmacokinetic evaluation of a novel anti-tumor agent, Zalypsis (PM00104), in mice and dogs. Clin Cancer Res 11:9072 s (Abstract B9163)
9. Yin J, Aviles P, McCarroll L, Wright T, Guillen MJ, Ly C, Lee W, Munt S, Cuevas C, Faircloth GT (2006) Toxicokinetic evaluation of a novel anti-tumor agent, Zalypsis(R) (PM00104), in dogs. AACR American Association for Cancer Research; 97th Annual Meeting: Abstract 3095
10. Simon R, Freidlin B, Rubinstein L, Arbuck SG, Collins J, Christian MC (1997) Accelerated titration designs for phase I clinical trials in oncology. J Natl Cancer Inst 89:1138-1147
11. National Cancer Institute (2006) Common terminology criteria for adverse events v3.0 (CTCAE). http://www.eortc.be/services/doc/ctc/ctcaev3.pdf
12. 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. 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
13. Yin J, Aviles P, Lee W, Ly C, Guillen MJ, Munt S, Cuevas C, Faircloth G (2005) Development of a liquid chromatography/tandem mass spectrometry assay for the quantification of PM00104, a novel antineoplastic agent, in mouse, rat, dog, and human plasma. Rapid Commun Mass Spectrom 19:689-695
14. Beal S, Sheiner L, Boeckmann A, Bauer R (2009) NONMEM User's Guides. (1989-2009). Icon Development Solutions, Ellicott City, MD, USA
15. Yap TA, Cortes-Funes H, Shaw H, Rodriguez R, Olmos D, Lal R, Fong PC, Tan DS, Harris D, Capdevila J, Coronado C, Alfaro V, Soto-Matos A, Fernandez-Teruel C, Siguero M, Tabernero JM, Paz-Ares L, de Bono JS, Lopez-Martin JA (2012) First-in-man phase I trial of two schedules of the novel synthetic tetrahydroisoquinoline alkaloid PM00104 (Zalypsis) in patients with advanced solid tumours. Br J Cancer 106:1379-1385. doi: 10.1038/bjc.2012.99
16. Massard C, Margetts J, Amellal N, Drew Y, Bahleda R, Stevens P, Armand JP, Calvert H, Soria JC, Coronado C, Kahatt C, Alfaro V, Siguero M, Fernandez-Teruel C, Plummer R (2012) Phase I study of PM00104 (Zalypsis(R)) administered as a 1-hour weekly infusion resting every fourth week in patients with advanced solid tumors. Investigational new drugs: Jun 12 (Epub ahead of print). doi: 10.1007/s10637-012-9843-5
17. Kris MG, Hesketh PJ, Somerfield MR, Feyer P, Clark-Snow R, Koeller JM, Morrow GR, Chinnery LW, Chesney MJ, Gralla RJ, Grunberg SM (2006) American Society of Clinical Oncology guideline for antiemetics in oncology: update 2006. J Clin Oncol 24:2932-2947
18. Gonzalez-Sales M, Valenzuela B, Perez-Ruixo C, Fernandez Teruel C, Miguel-Lillo B, Soto-Matos A, Perez-Ruixo JJ (2012) Population pharmacokinetic-pharmacodynamic analysis of neutropenia in cancer patients receiving PM00104 (Zalypsis((R))). Clin Pharmacokinet 51:751-764. doi: 10.1007/s40262-012-0011-z
19. Perez-Ruixo C, Valenzuela B, Fernandez Teruel C, Gonzalez-Sales M, Miguel-Lillo B, Soto-Matos A, Perez-Ruixo JJ (2012) Population pharmacokinetics of PM00104 (Zalypsis((R))) in cancer patients. Cancer Chemother Pharmacol 69:15-24