First-in-man phase I trial of two schedules of the novel synthetic tetrahydroisoquinoline alkaloid PM00104 (Zalypsis) in patients with advanced solid tumours

British Journal of Cancer

Volumn 106, Issue 8, 2012, Pages 1379-1385

  Yap, T A ^a,b   Cortes Funes, H ^c   Shaw, H ^a   Rodriguez, R ^c   Olmos, D ^a,b   Lal, R ^a   Fong, P C ^a   Tan, D S ^a   Harris, D ^a   Capdevila, J ^d   Coronado, C ^e   Alfaro, V ^e   Soto Matos, A ^e   Fernandez Teruel C ^e   Siguero, M ^e   Tabernero, J M ^d   Paz Ares, L ^c   De Bono, J S ^a,b   Lopez Martin J A ^c  

^a INSTITUTE OF CANCER RESEARCH   (United Kingdom)

^b INSTITUTE OF CANCER RESEARCH   (United Kingdom)

^c HOSPITAL UNIVERSITARIO 12 DE OCTUBRE   (Spain)

^d HOSPITAL UNIVERSITARI VALL D HEBRON   (Spain)

^e PHARMAMAR S A   (Spain)

Author keywords

cytotoxic; novel marine derived compound; phase I; PM00104

Indexed keywords

PM00104; TETRAHYDROISOQUINOLINE DERIVATIVE; UNCLASSIFIED DRUG; ZALYPSIS;

ABDOMINAL PAIN; ADULT; ADVANCED CANCER; AGED; ANEMIA; ANOREXIA; ANTINEOPLASTIC ACTIVITY; ARTICLE; BONE MARROW SUPPRESSION; CANCER PATIENT; CONSTIPATION; DIZZINESS; DRUG DOSE ESCALATION; DRUG DOSE INCREASE; DRUG SAFETY; DRUG TOLERANCE; DYSPEPSIA; FATIGUE; FEMALE; FEVER; HUMAN; HYPOTENSION; MALE; MAXIMUM PLASMA CONCENTRATION; NAUSEA; NEUTROPENIA; PERIPHERAL NEUROPATHY; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; SIDE EFFECT; SOLID TUMOR; THROMBOCYTOPENIA; THRUSH; VOMITING; WEIGHT REDUCTION;

ADULT; AGED; ANTINEOPLASTIC AGENTS; DISEASE PROGRESSION; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG ADMINISTRATION SCHEDULE; FEMALE; HUMANS; MALE; MAXIMUM TOLERATED DOSE; MIDDLE AGED; NEOPLASMS; TETRAHYDROISOQUINOLINES; YOUNG ADULT;

EID: 84859651995     PISSN: 00070920     EISSN: 15321827     Source Type: Journal    
DOI: 10.1038/bjc.2012.99     Document Type: Article

References (23)

1. Capdevila J, Clive S, Tabernero J, Lardelli P, Soto-Matos A, Baselga J, Piera A, Pardos I, Rye R, Smyth JF (2009) Phase I study of the novel anticancer drug PM00104 as a 24-hour IV infusion every 3 weeks (q3w) in patients (pts) with advanced solid tumors or lymphoma. J Clin Oncol 27(15 (suppl)): Abstract 2568
2. Elices M, LePage D, Grant W, Sasak H, Caylor T, Martin J, Guillén MJ, Cuevas Marchante C, Avilés P, Faircloth G (2005a) Profile of Zalypsis™ (PM00104) against various human solid tumors. 17th AACR-NCI-EORTC International Conference on 'Molecular Targets and Cancer Therapeutics: Discovery, Biology and Clinical Applications' Clin Cancer Res 11(24 Part 2): 9085s-9086s (Abstract B216)
3. Elices MJ, Grant W, Guillen MJ, Cuevas Marchante C, Aviles P, Faircloth GT (2005b) The novel compound PM00104 exhibits significant in vivo activity againts breast tumors. AACR American Association for Cancer Research; 96th Annual Meeting. Abstract 623
4. Fontana A, Cavaliere P, Wahidulla S, Naik CG, Cimino G (2000) A new antitumor isoquinoline alkaloid from the marine nudibranch Jorunna funebris. Tetrahedron 56: 7305-7308
5. Greiner T, Maier A, Bausch N, Fiebig HH, LePage D, Guillén MJ, Cuevas C, Avilés P (2007) Preclinical evaluation of PM00104 to support the selection of tumor indications for clinical studies. 19th AACR-NCI-EORTC International Conference on 'Molecular Targets and Cancer Therapeutics: Discovery, Biology and Clinical Applications': Abstract C60
6. Guillen MJ, Lepage D, Grant W, Cuevas C, Aviles P (2009) Abstract #2018: Antitumor activity of PM00104 in hepatocellular carcinoma (HCC) experimental models. AACR Meeting Abstracts 2009 (2-Annual-Meeting): 2018
7. 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. Molecular Cancer Therapeutics 8(7): 2007-2014
8. R) as a strong inducer of DNA double strand breaks. AACR Meeting Abstracts 2007 (1-Annual-Meeting): 5733
9. 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(18): 2932-2947 (Pubitemid 46630595)
10. 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(2): 162-170
11. LePage D, Sasak H, Cheney L, Oyama S, Cuevas C, Avilés P, Maxuitenko Y, Faircloth G (2007a) Antitumor activity of Zalypsis™ in human pancreas tumors. AACR American Association for Cancer Research; Annual Meeting: Abstract 1519
12. LePage D, Sasak H, Guillen MJ, Grant W, Cuevas C, Aviles P (2007b) Antitumor activity of Zalypsis™ (PM00104) in experimental models of bladder, gastric and liver cancer. AACR-NCI-EORTC International Conference: Molecular Targets and Cancer Therapeutics: Abstract C62
13. Magro P, Alvarez E, Kolb E. Mandola M, Scotto K (2007) Characterization of tumor cell response to the novel anti-tumor agent Zalypsis (R). AACR Meeting Abstracts 2007 (1-Annual-Meeting): 1529
14. National Cancer Institute (2006) Common Terminology Criteria for Adverse Events (CTCAE) v.3.0. http://ctep.cancer.gov/protocolDevelopment/electronic- applications/docs/ctcaev3.pdf, 1-72
15. 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(16): 3781-3791
16. Oku N, Matsunaga S, van Soest RW, Fusetani N (2003) Renieramycin J, a highly cytotoxic tetrahydroisoquinoline alkaloid, from a marine sponge Neopetrosia sp. J Nat Prod 66(8): 1136-1139 (Pubitemid 37034057)
17. 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(1): 15-24
18. Rinehart KL, Holt TG, Fregeau NL, Stroh JG, Keifer PA, Sun F, Li LH, Martin DG (1990) Ecteinascidins 729, 743, 745, 759A, 759B, and 770: potent antitumor agents from the Caribbean tunicate Ecteinascidia turbinata. J Org Chem 55(15): 4512-4515 (Pubitemid 20274262)
19. Soria JC, Plummer R, Soto A, Massard C, Calvert H, Prados R, Angevin E, Jones C, de las Heras B (2008) Phase I study of the novel anti-cancer drug PM00104 as a 1-hour weekly infusion resting every fourth week in patients with advanced solid tumors or lymphoma. Eur J Cancer 6(Suppl 12): 57 (abstract no.179)
20. 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 Nat Cancer Inst 92(3): 205-216
21. Yin J, Avilés P, Guillén MJ, Ly C, Lee W, Munt S, Cuevas C, Faircloth GT (2005a) Pharmacokinetic evaluation of a novel anti-tumor agent, zalypsis (PM00104), in mice and dogs. 17th AACR-NCI-EORTC International Conference on 'Molecular Targets and Cancer Therapeutics: Discovery, Biology and Clinical Applications' Filadelfia, EEUU, 14-18 Noviembre, 2005 Clin Cancer Res 11(24 Part 2): 9072s (Abstract B163)
22. Yin J, Aviles P, Lee W, Ly C, Guillen MJ, Munt S, Cuevas C, Faircloth G (2005b) 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(5): 689-695 (Pubitemid 40332765)
23. Yin J, Aviles P, Wright T, Guillen MJ, Ly C, Lee W, Munt S, Cuevas C, Faircloth GT (2006) Toxicokinetic evaluation of a novel anti-tumour agent, Zalypsis(R) (PM00104), in dogs. AACR Meeting Abstracts 2006(1): 728-72