Phase I study of elisidepsin (Irvalec®) in combination with carboplatin or gemcitabine in patients with advanced malignancies

Investigational New Drugs

Volumn 32, Issue 3, 2014, Pages 500-509

  Goldwasser, Francois ^a   Faivre, Sandrine ^c   Alexandre, Jerome ^a   Coronado, Cinthya ^b   Fernández García, Eva M ^b   Kahatt, Carmen M ^b   Paramio, Pilar García ^b   Dios, Jorge Luis Iglesias ^b   Miguel Lillo, Bernardo ^b   Raymond, Eric ^c  

^a AP HP Faculté de Medicine Paris Descartes Hôpital Cochin ^*  (France)

^b PHARMAMAR S A   (Spain)

^c BEAUJON HOSPITAL   (France)

Author keywords

Carboplatin; Combination; Dose limiting toxicities; Gemcitabine; Phase I; PM02734

Indexed keywords

ALANINE AMINOTRANSFERASE; ASPARTATE AMINOTRANSFERASE; BILIRUBIN; CARBOPLATIN; ELISIDEPSIN; GEMCITABINE; ANTINEOPLASTIC AGENT; DEOXYCYTIDINE; DEPSIPEPTIDE;

ABDOMINAL PAIN; ADULT; AGED; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ALOPECIA; ANEMIA; ANOREXIA; ANUS CARCINOMA; AREA UNDER THE CURVE; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; BILE DUCT CARCINOMA; BILIRUBIN BLOOD LEVEL; BODY WEIGHT DISORDER; BREAST ADENOCARCINOMA; CHILL; CLINICAL ARTICLE; COLORECTAL CARCINOMA; CONSTIPATION; DOSE LIMITING TOXICITY; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG DISTRIBUTION; DRUG DOSE ESCALATION; DRUG EFFICACY; DRUG HALF LIFE; DRUG POTENCY; DRUG PROTEIN BINDING; DRUG SAFETY; DRUG TOLERABILITY; DYSPNEA; ERYTHEMA; ESOPHAGEAL ADENOCARCINOMA; FATIGUE; FEMALE; FEVER; HEAD AND NECK CARCINOMA; HEADACHE; HERPES VIRUS INFECTION; HUMAN; HYPERKALEMIA; KIDNEY CARCINOMA; LEUKOPENIA; LUNG NON SMALL CELL CANCER; LYMPHOCYTOPENIA; MALE; MAXIMUM PLASMA CONCENTRATION; MAXIMUM TOLERATED DOSE; MIDDLE AGED; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; MYALGIA; NAUSEA; NEUTROPENIA; OPEN STUDY; PARESTHESIA; PHASE 1 CLINICAL TRIAL; PLASMA CLEARANCE; PRIORITY JOURNAL; PROSTATE ADENOCARCINOMA; PRURITUS; SOFT TISSUE SARCOMA; SOMNOLENCE; STOMATITIS; THROMBOCYTOPENIA; THYMUS CANCER; TOXICOLOGICAL PARAMETERS; VOMITING; XEROSTOMIA; ANALOGS AND DERIVATIVES; BLOOD; CLINICAL TRIAL; NEOPLASMS;

ADULT; AGED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CARBOPLATIN; DEOXYCYTIDINE; DEPSIPEPTIDES; FEMALE; HUMANS; MALE; MAXIMUM TOLERATED DOSE; MIDDLE AGED; NEOPLASMS;

EID: 84904693385     PISSN: 01676997     EISSN: 15730646     Source Type: Journal    
DOI: 10.1007/s10637-013-0060-7     Document Type: Article

References (23)

1. Hamann MT, Otto CS, Scheuer PJ, Dunbar DC (1996) Kahalalides: bioactive peptides from a marine mollusk Elysia rufescens and its algal diet bryopsis sp. (1). J Org Chem 61(19):6594-6600 (Pubitemid 26328646)
2. Sparidans RW, Stokvis E, Jimeno JM, Lopez-Lazaro L, Schellens JH, Beijnen JH (2001) Chemical and enzymatic stability of a cyclic depsipeptide, the novel, marine-derived, anti-cancer agent kahalalide F. Anti-Cancer Drugs 12(7):575-582, Epub 2001/08/07
3. Faircloth G, Cuevas C (2006) Kahalalide F and ES285: potent anticancer agents from marine molluscs. Prog Mol Subcell Biol 43:363-379, Epub 2006/12/13
4. Provencio M, Sanchez A, Gasent J, Gomez P, Rosell R (2009) Cancer treatments: can we find treasures at the bottom of the sea? Clin Lung Cancer 10(4):295-300
5. Herrero AB, Astudillo AM, Balboa MA, Cuevas C, Balsinde J, Moreno S (2008) Levels of SCS7/FA2H-mediated fatty acid 2-hydroxylation determine the sensitivity of cells to antitumor PM02734. Cancer Res 68(23):9779-9787
6. Molina-Guijarro JM, Macias A, Garcia C, Munoz E, Garcia-Fernandez LF, David M et al (2011) Irvalec inserts into the plasma membrane causing rapid loss of integrity and necrotic cell death in tumor cells. PLoS One 6(4):e19042
7. Ling YH, Aracil M, Zou Y, Yuan Z, Lu B, Jimeno J et al (2011) PM02734 (elisidepsin) induces caspase-independent cell death associated with features of autophagy, inhibition of the Akt/mTOR signaling pathway, and activation of death-associated protein kinase. Clin Cancer Res Off J Am Assoc Cancer Res 17(16):5353-5366, Epub 2011/06/22
8. Serova M, de Gramont A, Bieche I, Riveiro ME, Galmarini CM, Aracil M et al (2013) Predictive factors of sensitivity to elisidepsin, a novel kahalalide f-derived marine compound. Marine Drugs 11(3):944-959, Epub 2013/03/23
9. Coronado C, Galmarini CM, Alfaro V, Yovine A (2010) Elisidepsin. Drugs Fut 35:287-296
10. Teixido C, Arguelaguet E, Pons B, Aracil M, Jimeno J, Somoza R et al (2012) ErbB3 expression predicts sensitivity to elisidepsin treatment: in vitro synergism with cisplatin, paclitaxel and gemcitabine in lung, breast and colon cancer cell lines. Int J Oncol 41(1):317-324, Epub 2012/04/10
11. Elices M, Lepage DJ, Grant W, Alvarez E, Guillen MJ, Cuevas C, et al (2006) Activity of PM02734 against human breast and prostate tumors. AACR American Association for Cancer Research; 97th Annual Meeting; April 1-5, 2006. Washington, D.C. Abs. No 4712
12. Salazar R, Jones RJ, Oaknin A, Crawford D, Cuadra C, Hopkins C et al (2012) A phase I and pharmacokinetic study of elisidepsin (PM02734) in patients with advanced solid tumors. Cancer Chemother Pharmacol 70(5):673-681, Epub 2012/08/29
13. Bruce JY, Geary D, de las Heras B, Soto A, Garcia Paramio P, Yovine A et al (2008) Phase I study of PM02734: Association of doselimiting hepatotoxicity with plasma concentrations. ASCO American Society of Clinical Oncology, 44th Annual Meeting, May 30-Jun 3, 2008. Chicago, Illinois. Abs. N°2513
14. Salazar R, Metges JP, Anthoney DA, Laus G, Maqueda MA, Goncalves A et al (2013) IMAGE, a randomized phase Ib/II study of elisidepsin (E) as a single agent in pretreated advanced gastroesophageal (GE) cancer. 2013 Gastrointestinal Cancers Symposium, Jan 24-26, 2013. San Francisco, California. JClin Oncol vol 31(4 Supl): Abs N°92
15. Goel S, Moran T, Coronado C, Viteri Ramirez S, Chaudhary I, Haroon Ghalib M et al (2012) Phase I dose-finding and pharmacokinetic study of a combination of elisidepsin (E) and erlotinib (T) in patients (pts) with advanced solid tumors. ASCO American Society of Clinical Oncology, 48th AnnualMeeting, Jun 1-5, 2012. Chicago, Illinois. J Clin Oncol. vol 30 (Supl 1) Abs N° 3093
16. Salazar R, Cuadra C, Gil-Martin M, Vandermeeren A, Alfaro V, Coronado C (2012) Complete and sustained objective response per RECIST to Irvalec (PM02734) in undifferentiated large cell esophageal adenocarcinoma: A case report and a review of the literature. Case Rep Oncol 5(2):354-358, Epub 2012/07/19
17. National Cancer Institute Common Terminology Criteria for Adverse Events. Version 3.0. http: //ctepcancergov/forms/ CTCAEv3pdf Accessed on 10 July 2008
18. Therasse P, Arbuck SG, Eisenhauer EA, Wanders J, Kaplan RS, Rubinstein L et al (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(3):205-216, Epub 2000/02/03
19. 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(15):1138-1147, Epub 1997/08/06
20. Yin J, Aviles P, Lee W, Ly C, Guillen MJ, Munt S et al (2006) Development of a liquid chromatography/tandem mass spectrometry assay for the quantification of PM02734, a novel antineoplastic agent, in dog plasma. Rapid Commun Mass Spectrom RCM 20(18):2735-2740, Epub 2006/08/22
21. Calvert AH, Newell DR, Gumbrell LA, O'Reilly S, Burnell M, Boxall FE et al (1989) Carboplatin dosage: prospective evaluation of a simple formula based on renal function. J Clin Oncol Off J Am Soc Clin Oncol 7(11):1748-1756, Epub 1989/11/01
22. van Moorsel CJ, Kroep JR, Pinedo HM, Veerman G, Voorn DA, Postmus PE et al (1999) Pharmacokinetic schedule finding study of the combination of gemcitabine and cisplatin in patients with solid tumors. Ann Oncol Off J Eur SocMed Oncol ESMO 10(4):441-448, Epub 1999/06/17
23. Coronado C, Kahatt C, Szyldergemajn S, Iglesias JL, Florez A, Yovine A (2010) Transient isolated transaminase increases do not correlate with permanent clinical liver damage: phase I experience wih elisidepsin. 35th ESMO Congress, Milan, Italy 8-12 October 2010. Ann Oncol. Vol 21 (Supl 8) Abs. No 553 pages 180-181