Erratum: Phase i study of pm00104 (Zalypsis®) administered as a 1-hour weekly infusion resting every fourth week in patients with advanced solid tumors (Invest New Drugs, 10.1007/s10637-012-9843-5);Phase i study of PM00104 (Zalypsis®) administered as a 1-hour weekly infusion resting every fourth week in patients with advanced solid tumors

Investigational New Drugs

Volumn 31, Issue 3, 2013, Pages 623-630

  Massard, Christophe ^a   Margetts, Jane ^b   Amellal, Nadia ^a   Drew, Yvette ^b   Bahleda, Ratislav ^a   Stevens, Peter ^b   Armand, Jean Pierre ^a   Calvert, Hilary ^b   Soria, Jean Charles ^a   Coronado, Cinthya ^c   Kahatt, Carmen ^c   Alfaro, Vicente ^c   Siguero, Mariano ^c   Fernández Teruel, Carlos ^c   Plummer, Ruth ^b  

^a INSTITUT GUSTAVE ROUSSY   (France)

^b FREEMAN HOSPITAL   (United Kingdom)

^c PHARMAMAR S A   (Spain)

Author keywords

Antitumor; Cytotoxic; Dose limiting toxicities; Phase I; PM00104

Indexed keywords

CYTOTOXIC AGENT; PM 00104; UNCLASSIFIED DRUG; ZALYPSIS;

ADULT; AGED; ANEMIA; ANOREXIA; ARTICLE; BLADDER CARCINOMA; BONE MARROW SUPPRESSION; CLINICAL ARTICLE; COLORECTAL CARCINOMA; CONSTIPATION; DIARRHEA; DOSE RESPONSE; DRUG DOSE ESCALATION; DRUG RESPONSE; DRUG TOLERABILITY; FATIGUE; FEBRILE NEUTROPENIA; FEMALE; FEVER; HEADACHE; HUMAN; LACRIMAL ADENOID CARCINOMA; LACRIMAL GLAND DISEASE; LEUKOPENIA; MALE; MUCOSA INFLAMMATION; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; NAUSEA; NEUTROPENIA; PHASE 1 CLINICAL TRIAL; PHASE 2 CLINICAL TRIAL (TOPIC); PRIORITY JOURNAL; RECOMMENDED DRUG DOSE; RISK BENEFIT ANALYSIS; SIDE EFFECT; SOLID TUMOR; THROMBOCYTOPENIA; UTERINE CERVIX CARCINOMA; VOMITING;

EID: 84879100388     PISSN: 01676997     EISSN: 15730646     Source Type: Journal    
DOI: 10.1007/s10637-013-9954-7     Document Type: Erratum

References (25)

1. 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 55:4512-4515
2. 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
3. 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 66:1136-1139
4. 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
5. 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
6. R) as a strong inducer of DNA double strand breaks. AACR Meeting Abstracts 2007:5733
7. 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
8. LePage D, Sasak H, Guillen MJ, Grant W, Cuevas C, Aviles P (2007) Antitumor activity of Zalypsis® (PM00104) in experimental models of bladder, gastric and liver cancer. In: AACR-NCI-EORTC International Conference: Molecular Targets and Cancer Therapeutics; 2007 October 22-26; San Francisco, CA, p. Abstract C62
9. LePage D, Sasak H, Cheney L, Oyama S, Cuevas C, Avilés P, Maxuitenko Y, Faircloth G (2007) Antitumor activity of Zalypsis® in human pancreas tumors. In: AACR American Association for Cancer Research; Annual Meeting; 2007 April 14-18; Los Angeles, CA, p. Abstract 1519
10. 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. In: 19th AACR-NCI-EORTC International Conference on " Molecular Targets and Cancer Therapeutics: Discovery, Biology and Clinical Applications". 2007 October 22-26; San Francisco, CA, p. Abstract C60
11. Elices MJ, Grant W, Guillen MJ, Cuevas Marchante C, Aviles P, Faircloth GT (2005) The novel compound PM00104 exhibits significant in vivo activity againts breast tumors. In: AACR American Association for Cancer Research; 96th Annual Meeting; 2005 April 16-20; Anaheim, CA, p. Abstract 623
12. Elices M, LePage D, Grant W, Sasak H, Caylor T, Martin J, Guillén MJ, Cuevas Marchante C, Avilés P, Faircloth G (2005) Profile of Zalypsis™ (PM00104) against various human solid tumors. In: 17th AACR-NCI-EORTC International Conference on " Molecular Targets and Cancer Therapeutics: Discovery, Biology and Clinical Applications". Clin Cancer Res; 2005 November 14-18; Philadelphia, PA, p. 9085 s-9086s (Abstract B9216).
13. 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 2009:2018
14. Yin J, Avilés P, Guillén 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. 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 11:9072 s (Abstract B9163)
15. 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-tumor agent, Zalypsis(R) (PM00104), in dogs. AACR Meeting Abstracts 2006:728-b
16. 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
17. 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
18. 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
19. 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
20. 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: Abstract 2568
21. 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
22. Lum G, Solarz DE, Farney L (2006) False positive cardiac troponin results in patients without acute myocardial infarction. Labmedicine 37:546-550
23. Jeremias A, Gibson CM (2005) Narrative review: alternative causes for elevated cardiac troponin levels when acute coronary syndromes are excluded. Ann Intern Med 142:786-791
24. Patil H, Vaidya O, Bogart D (2011) A review of causes and systemic approach to cardiac troponin elevation. Clin Cardiol 34:723-728
25. 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