CLINICAL RESEARCH
Early Clinical Drug Development Group

ELENA GARRALDA

ELENA GARRALDA
Principal Investigator

STRATEGIC GOALS

  • Clinical early development of the best-in-class targeted therapies, determining the optimal schedule and patient population to benefit most from these drugs by participating in novel clinical trials.
  • Analyze patients’ tumors for molecular aberrations that may predict the efficacy of targeted agents, in order to select the most appropriate treatment for each individual with advanced cancer.
  • Link clinical research at the UITM facility with the various preclinical and translational research groups at VHIO and collaborate with the different partners involved in drug development and translational research (phase I units, academic centers, consortia, pharmaceutical companies).

CURRENT OBJECTIVES

  • Proof-of-concept and proof-of-mechanism trials with targeted therapies, especially targeted therapies aimed at cell signaling and cancer stem cells.
  • First-in-human studies of targeted therapies, rational combinations of targeted therapies, biomarker-driven trials and trials in molecularly selected populations.
  • Link clinical research with the different areas of research carried out by VHIO’s research groups, following a truly translational model: linking molecular biology and the best tumor models with pharmacology and innovative clinical research.
  • Molecular analysis of patients’ tumors to select the best possible treatment for our with the experimental treatments available in our portfolio of clinical trials.

TEAM

Early Clinical Drug Development Group
  • Director of Clinical Research at VHIO
    • Josep Tabernero
  • Principal Investigator, Executive Director, UITM
    • Elena Garralda
  • Associated Investigators- Senior Consultants
    • Judith Balmaña
    • Joan Carles
    • Enriqueta Felip
    • Ana Oaknin
    • Jordi Rodón
    • Cristina Saura
    • Josep Tabernero
  • Investigators
    • Maria Alsina
    • Guillem Argilés
    • Analia Azaro
    • Irene Braña
    • Cristina Cruz
    • Maria Elena Élez
    • Patricia Goméz
    • Julieta Grasseli
    • Cinta Hierro
    • Teresa Macarulla
    • Juan Martin-Liberal
    • Alex Martínez
    • Iganacio Matos
    • Alejandro Navarro
    • Maria Ochoa de Olza
    • Mafalda Oliveira
    • Cristina Saura
    • Tamara Saurí
    • Cristina Suárez
    • Claudia Valverde
    • Helena Verdaguer
    • Esther Zamora

Most relevant scientific publications

  • Almhanna K, Kalebic T, Cruz C, Faris JE, Ryan DP, Jung J, Wyant T, Fasanmade AA, Messersmith W, Rodon J. Phase I Study of the Investigational Anti-Guanylyl Cyclase Antibody-Drug Conjugate TAK-264 (MLN0264) in Adult Patients with Advanced Gastrointestinal Malignancies. Clin Cancer Res. 2016 Oct 15;22(20):5049-5057.
  • Arqués O, Chicote I, Puig I, Tenbaum SP, Argiles G, Dienstmann R, Fernández N, Caratù G, Matito J, Silberschmidt D, Rodón J, Landolfi S, Prat A, Espín E, Charco R, Nuciforo P, Vivancos A, Shao W, Tabernero J, Pálmer HG.  Tankyrase Inhibition Blocks Wnt/β-Catenin Pathway and Reverts Resistance to PI3K and AKT Inhibitors in the Treatment of Colorectal Cancer. Clin. Cancer Res. 2016 Feb; 22(3): 644-56
  • Dienstmann R, Rodón J, Tabernero J.  Optimal design of trials to demonstrate the utility of genomically-guided therapy: Putting Precision Cancer Medicine to the test. Mol Oncol 2015 May; 9(5): 940-50
  • Rodón J, Carducci M, Sepulveda-Sánchez JM, Azaro A, Calvo E, Seoane J, Braña I, Sicart E, Gueorguieva I, Cleverly A, Pillay NS, Desaiah D, Estrem ST, Paz-Ares L, Holdhoff M, Blakeley J, Lahn MM, Baselga J.  Pharmacokinetic, pharmacodynamic and biomarker evaluation of transforming growth factor-β receptor I kinase inhibitor, galunisertib, in phase 1 study in patients with advanced cancer. Invest New Drugs 2015 Apr; 33(2): 357-70
  • Hierro C, Rodón J, Tabernero J.  Fibroblast Growth Factor (FGF) Receptor/FGF Inhibitors: Novel Targets and Strategies for Optimization of Response of Solid Tumors. Semin. Oncol. 2015 Dec; 42(6): 801-19
  • Toledo M, Sarria-Estrada S, Quintana M, Maldonado X, Martínez-Ricarte F, Rodón J, Auger C, Salas-Puig J, Santamarina E, Martínez-Sáez E.  Prognostic implications of epilepsy in glioblastomas. Clin Neurol Neurosurg 2015 Dec; 139: 166-71
  • Bosch A, Li Z, Bergamaschi A, Ellis H, Toska E, Prat A, Tao JJ, Spratt DE, Viola-Villegas NT, Castel P, Minuesa G, Morse N, Rodón J, Ibrahim Y, Cortes J, Pérez-García J, Galván P, Grueso J, Guzman M, Katzenellenbogen JA, Kharas M, Lewis JS, Dickler M, Serra V, Rosen N, Chandarlapaty S, Scaltriti M, Baselga J.  PI3K inhibition results in enhanced estrogen receptor function and dependence in hormone receptor-positive breast cancer. Sci Transl Med 2015 Apr; 7(283): 283ra51
  • Shou Y, Robinson DM, Amakye DD, Rose KL, Cho YJ, Ligon KL, Sharp T, Haider AS, Bandaru R, Ando Y, Geoerger B, Doz F, Ashley DM, Hargrave DR, Casanova M, Tawbi HA, Rodón J, Thomas AL, Mita AC, MacDonald TJ, Kieran MW.  A five-gene hedgehog signature developed as a patient preselection tool for hedgehog inhibitor therapy in medulloblastoma. Clin. Cancer Res. 2015 Feb; 21(3): 585-93
  • Rodón J, Carducci MA, Sepulveda-Sánchez JM, Azaro A, Calvo E, Seoane J, Braña I, Sicart E, Gueorguieva I, Cleverly AL, Pillay NS, Desaiah D, Estrem ST, Paz-Ares L, Holdhoff M, Blakeley J, Lahn MM, Baselga J.  First-in-human dose study of the novel transforming growth factor-β receptor I kinase inhibitor LY2157299 monohydrate in patients with advanced cancer and glioma. Clin. Cancer Res. 2015 Feb; 21(3): 553-60
  • De Mattos-Arruda L, Mayor R, Ng CK, Weigelt B, Martínez-Ricarte F, Torrejón D, Oliveira M, Arias A, Raventós C, Tang J, Guerini-Rocco E, Martínez-Sáez E, Lois S, Marín O, de la Cruz X, Piscuoglio S, Towers R, Vivancos A, Peg V, Ramón y Cajal S, Carles J, Rodón J, González-Cao M, Tabernero J, Felip E, Sahuquillo J, Berger MF, Cortes J, Reis-Filho JS, Seoane J.  Cerebrospinal fluid-derived circulating tumour DNA better represents the genomic alterations of brain tumours than plasma. Nat Commun 2015; 6: 8839

All publications

  • Kristeleit R, Shapiro GI, Burris HA, Oza AM, LoRusso PM, Patel M, Domchek SM, Balmaña J, Drew Y, Chen LM, Safra T, Montes A, Giordano H, Maloney L, Goble S, Isaacson J, Xiao J, Borrow J, Rolfe L, Shapira-Frommer R. A Phase I-II Study of the Oral Poly(ADP-ribose) Polymerase Inhibitor Rucaparib in Patients with Germline BRCA1/2-mutated Ovarian Carcinoma or Other Solid Tumors. Clin Cancer Res. 2017 Mar 6. pii: clincanres.2796.2016. doi: 10.1158/1078-0432.CCR-16-2796.
  • Hui R, Garon EB, Goldman JW, Leighl NB, Hellmann MD, Patnaik A, Gandhi L, Eder
    JP, Ahn MJ, Horn L, Felip E, Carcereny E, Rangwala R, Lubiniecki GM, Zhang J,
    Emancipator K, Roach C, Rizvi NA. Pembrolizumab as first-line therapy for patients with PD-L1-positive advanced non-small cell lung cancer: a phase 1 trial. Ann Oncol. 2017 Feb 7. doi: 10.1093/annonc/mdx008. [Epub ahead of print]
  • Saura C, Roda D, Roselló S, Oliveira M, Macarulla T, Pérez-Fidalgo JA, Morales-Barrera R, Sanchis-García JM, Musib L, Budha N, Zhu J, Nannini M, Chan WY, Sanabria Bohórquez SM, Meng RD, Lin K, Yan Y, Patel P, Baselga J, Tabernero J, Cervantes A. A First-in-Human Phase I Study of the ATP-Competitive AKT Inhibitor Ipatasertib Demonstrates Robust and Safe Targeting of AKT in Patients with Solid Tumors. Cancer Discov. 2017 Jan;7(1):102-113. doi:10.1158/2159-8290.CD-16-0512.
  • Hierro C, Azaro A, Argilés G, Elez E, Gómez P, Carles J, Rodon J. Unveiling changes in the landscape of patient populations in cancer early drug development. Oncotarget. 2016 Nov 9. doi: 10.18632/oncotarget.13258. [Epub ahead of print]
    Review.
  • Kim DW, Mehra R, Tan DS, Felip E, Chow LQ, Camidge DR, Vansteenkiste J, Sharma
    S, De Pas T, Riely GJ, Solomon BJ, Wolf J, Thomas M, Schuler M, Liu G, Santoro A,
    Sutradhar S, Li S, Szczudlo T, Yovine A, Shaw AT. Activity and safety of ceritinib in patients with ALK-rearranged non-small-cell lung cancer (ASCEND-1): updated results from the multicentre, open-label, phase 1 trial. Lancet Oncol. 2016 Apr;17(4):452-63. doi: 10.1016/S1470-2045(15)00614-2.
  • Sánchez-Martín FJ, Bellosillo B, Gelabert-Baldrich M, Dalmases A, Cañadas I, Vidal J, Martinez A, Argilés G, Siravegna G, Arena S, Koefoed K, Visa L, Arpí O, Horak ID, Iglesias M, Stroh C, Kragh M, Rovira A, Albanell J, Tabernero J, Bardelli A, Montagut C. The First-in-class Anti-EGFR Antibody Mixture Sym004 Overcomes Cetuximab Resistance Mediated by EGFR Extracellular Domain Mutations in Colorectal Cancer. Clin Cancer Res. 2016 Jul 1;22(13):3260-7. doi:10.1158/1078-0432.CCR-15-2400.
  • Dienstmann R, Lassen U, Cebon J, Desai J, Brown MP, Evers S, Su F, Zhang W,
    Boisserie F, Lestini B, Schostack K, Meresse V, Tabernero J. First-in-Man Dose-Escalation Study of the Selective BRAF Inhibitor RG7256 in Patients with BRAF V600-Mutated Advanced Solid Tumors.Target Oncol. 2016 Apr;11(2):149-56. doi: 10.1007/s11523-015-0381-x.
  • Martin-Liberal J, Ochoa de Olza M, Hierro C, Gros A, Rodon J, Tabernero J. The
    expanding role of immunotherapy. Cancer Treat Rev. 2017 Mar;54:74-86. doi:
    10.1016/j.ctrv.2017.01.008. Review.
  • Perez-Gracia JL, Sanmamed MF, Bosch A, Patiño-Garcia A, Schalper KA, Segura V,
    Bellmunt J, Tabernero J, Sweeney CJ, Choueiri TK, Martín M, Fusco JP, Rodriguez-Ruiz ME, Calvo A, Prior C, Paz-Ares L, Pio R, Gonzalez-Billalabeitia E, Gonzalez Hernandez A, Páez D, Piulats JM, Gurpide A, Andueza M, de Velasco G, Pazo R, Grande E, Nicolas P, Abad-Santos F, Garcia-Donas J, Castellano D, Pajares MJ, Suarez C, Colomer R, Montuenga LM, Melero I. Strategies to design clinical studies to identify predictive biomarkers in cancer research. Cancer Treat Rev. 2017 Feb;53:79-97. doi: 10.1016/j.ctrv.2016.12.005. Review.
  • Martin-Liberal J, Hierro C, Ochoa de Olza M, Rodon J. Immuno-Oncology: The Third Paradigm in Early Drug Development. Target Oncol. 2016 Dec 20. [Epub ahead
    of print] PubMed PMID: 27995439.
  • Gueorguieva I, Cleverly A, Desaiah D, Azaro A, Seoane J, Braña I, Sicart E, Miles C, Lahn MM, Mitchell MI, Rodon J. Relative bioavailability of three formulations of galunisertib administered as monotherapy in patients with advanced or metastatic cancer. Drugs Context. 2016 Dec 2;5:212303.
  • Azaro A, Rodón J, Machiels JP, Rottey S, Damian S, Baird R, Garcia-Corbacho J, Mathijssen RH, Clot PF, Wack C, Shen L, de Jonge MJ. A phase I pharmacokinetic
    and safety study of cabazitaxel in adult cancer patients with normal and impaired
    renal function. Cancer Chemother Pharmacol. 2016 Dec;78(6):1185-1197.
  • Cassel JB, Del Fabbro E, Arkenau T, Higginson IJ, Hurst S, Jansen LA, Poklepovic A, Rid A, Rodón J, Strasser F, Miller FG. Phase I Cancer Trials and Palliative Care: Antagonism, Irrelevance, or Synergy? J Pain Symptom Manage. 2016 Sep;52(3):437-45. doi: 10.1016/j.jpainsymman.2016.02.014.
  • Almhanna K, Kalebic T, Cruz C, Faris JE, Ryan DP, Jung J, Wyant T, Fasanmade
    AA, Messersmith W, Rodon J. Phase I Study of the Investigational Anti-Guanylyl
    Cyclase Antibody-Drug Conjugate TAK-264 (MLN0264) in Adult Patients with Advanced Gastrointestinal Malignancies. Clin Cancer Res. 2016 Oct 15;22(20):5049-5057. PubMed PMID: 27178743.
  • Swanton C, Soria JC, Bardelli A, Biankin A, Caldas C, Chandarlapaty S, de Koning L, Dive C, Feunteun J, Leung SY, Marais R, Mardis ER, McGranahan N, Middleton G, Quezada SA, Rodón J, Rosenfeld N, Sotiriou C, André F. Consensus on precision medicine for metastatic cancers: a report from the MAP conference. Ann Oncol. 2016 Aug;27(8):1443-8. doi: 10.1093/annonc/mdw192
  • Turski ML, Vidwans SJ, Janku F, Garrido-Laguna I, Munoz J, Schwab R, Subbiah V, Rodon J, Kurzrock R. Genomically Driven Tumors and Actionability across Histologies: BRAF-Mutant Cancers as a Paradigm. Mol Cancer Ther. 2016 Apr;15(4):533-47. doi: 10.1158/1535-7163.MCT-15-0643. Review.
  • Batchelor T, Rodon J, Ahluwalia M. Principles of pharmacotherapy. Handb Clin
    Neurol.
     2016;134:149-62. doi: 10.1016/B978-0-12-802997-8.00009-8.
  • Ciardiello F, Adams R, Tabernero J, Seufferlein T, Taieb J, Moiseyenko V, Ma B, Lopez G, Vansteenkiste JF, Esser R, Tejpar S. Awareness, Understanding, and
    Adoption of Precision Medicine to Deliver Personalized Treatment for Patients With Cancer: A Multinational Survey Comparison of Physicians and Patients. Oncologist. 2016 Mar;21(3):292-300. doi: 10.1634/theoncologist.2015-0279.
  • Alsina M, Moehler M, Hierro C, Guardeño R, Tabernero J. Immunotherapy for Gastric Cancer: A Focus on Immune Checkpoints. Target Oncol. 2016 Aug;11(4):469-77. doi: 10.1007/s11523-016-0421-1.
  • Arqués O, Chicote I, Puig I, Tenbaum SP, Argilés G, Dienstmann R, Fernández N, Caratù G, Matito J, Silberschmidt D, Rodon J, Landolfi S, Prat A, Espín E, Charco R, Nuciforo P, Vivancos A, Shao W, Tabernero J, Palmer HG. Tankyrase Inhibition Blocks Wnt/β-Catenin Pathway and Reverts Resistance to PI3K and AKT
    Inhibitors in the Treatment of Colorectal Cancer. Clin Cancer Res. 2016 Feb 1;22(3):644-56. doi: 10.1158/1078-0432.CCR-14-3081.
  • Arqués O, Chicote I, Puig I, Tenbaum SP, Argiles G, Dienstmann R, Fernández N, Caratù G, Matito J, Silberschmidt D, Rodón J, Landolfi S, Prat A, Espín E, Charco R, Nuciforo P, Vivancos A, Shao W, Tabernero J, Pálmer HG.  Tankyrase Inhibition Blocks Wnt/β-Catenin Pathway and Reverts Resistance to PI3K and AKT Inhibitors in the Treatment of Colorectal Cancer. Clin. Cancer Res. 2016 Feb; 22(3): 644-56
  • Dienstmann R, Rodón J, Tabernero J.  Optimal design of trials to demonstrate the utility of genomically-guided therapy: Putting Precision Cancer Medicine to the test. Mol Oncol 2015 May; 9(5): 940-50
  • Rodón J, Carducci M, Sepulveda-Sánchez JM, Azaro A, Calvo E, Seoane J, Braña I, Sicart E, Gueorguieva I, Cleverly A, Pillay NS, Desaiah D, Estrem ST, Paz-Ares L, Holdhoff M, Blakeley J, Lahn MM, Baselga J.  Pharmacokinetic, pharmacodynamic and biomarker evaluation of transforming growth factor-β receptor I kinase inhibitor, galunisertib, in phase 1 study in patients with advanced cancer. Invest New Drugs 2015 Apr; 33(2): 357-70
  • Hierro C, Rodón J, Tabernero J.  Fibroblast Growth Factor (FGF) Receptor/FGF Inhibitors: Novel Targets and Strategies for Optimization of Response of Solid Tumors. Semin. Oncol. 2015 Dec; 42(6): 801-19
  • Toledo M, Sarria-Estrada S, Quintana M, Maldonado X, Martínez-Ricarte F, Rodón J, Auger C, Salas-Puig J, Santamarina E, Martínez-Sáez E.  Prognostic implications of epilepsy in glioblastomas. Clin Neurol Neurosurg 2015 Dec; 139: 166-71
  • Bosch A, Li Z, Bergamaschi A, Ellis H, Toska E, Prat A, Tao JJ, Spratt DE, Viola-Villegas NT, Castel P, Minuesa G, Morse N, Rodón J, Ibrahim Y, Cortes J, Pérez-García J, Galván P, Grueso J, Guzman M, Katzenellenbogen JA, Kharas M, Lewis JS, Dickler M, Serra V, Rosen N, Chandarlapaty S, Scaltriti M, Baselga J.  PI3K inhibition results in enhanced estrogen receptor function and dependence in hormone receptor-positive breast cancer. Sci Transl Med 2015 Apr; 7(283): 283ra51
  • Shou Y, Robinson DM, Amakye DD, Rose KL, Cho YJ, Ligon KL, Sharp T, Haider AS, Bandaru R, Ando Y, Geoerger B, Doz F, Ashley DM, Hargrave DR, Casanova M, Tawbi HA, Rodón J, Thomas AL, Mita AC, MacDonald TJ, Kieran MW.  A five-gene hedgehog signature developed as a patient preselection tool for hedgehog inhibitor therapy in medulloblastoma. Clin. Cancer Res. 2015 Feb; 21(3): 585-93
  • Rodón J, Carducci MA, Sepulveda-Sánchez JM, Azaro A, Calvo E, Seoane J, Braña I, Sicart E, Gueorguieva I, Cleverly AL, Pillay NS, Desaiah D, Estrem ST, Paz-Ares L, Holdhoff M, Blakeley J, Lahn MM, Baselga J.  First-in-human dose study of the novel transforming growth factor-β receptor I kinase inhibitor LY2157299 monohydrate in patients with advanced cancer and glioma. Clin. Cancer Res. 2015 Feb; 21(3): 553-60
  • De Mattos-Arruda L, Mayor R, Ng CK, Weigelt B, Martínez-Ricarte F, Torrejón D, Oliveira M, Arias A, Raventós C, Tang J, Guerini-Rocco E, Martínez-Sáez E, Lois S, Marín O, de la Cruz X, Piscuoglio S, Towers R, Vivancos A, Peg V, Ramón y Cajal S, Carles J, Rodón J, González-Cao M, Tabernero J, Felip E, Sahuquillo J, Berger MF, Cortes J, Reis-Filho JS, Seoane J.  Cerebrospinal fluid-derived circulating tumour DNA better represents the genomic alterations of brain tumours than plasma. Nat Commun 2015; 6: 8839
  • Prat A, Adamo B, Fan C, Peg V, Vidal M, Galván P, Vivancos A, Nuciforo P, Pálmer HG, Dawood S, Rodón J, Cajal SR, Campo JM, Felip E, Tabernero J, Cortes J.  ERRATUM: Genomic Analyses across Six Cancer Types Identify Basal-like Breast Cancer as a Unique Molecular Entity. Sci Rep 2015; 5: 8179
  • Spreafico A, Delord JP, De Mattos-Arruda L, Bergé Y, Rodón J, Cottura E, Bedard PL, Akimov M, Lu H, Pain S, Kaag A, Siu LL, Cortes J.  A first-in-human phase I, dose-escalation, multicentre study of HSP990 administered orally in adult patients with advanced solid malignancies. Br. J. Cancer 2015 Feb; 112(4): 650-9
  • Tabernero J, Bahleda R, Dienstmann R, Infante JR, Mita A, Italiano A, Calvo E, Moreno V, Adamo B, Gazzah A, Zhong B, Platero SJ, Smit JW, Stuyckens K, Chatterjee-Kishore M, Rodón J, Peddareddigari V, Luo FR, Soria JC.  Phase I Dose-Escalation Study of JNJ-42756493, an Oral Pan-Fibroblast Growth Factor Receptor Inhibitor, in Patients With Advanced Solid Tumors. J. Clin. Oncol. 2015 Oct; 33(30): 3401-8
  • De Gramont A, Watson S, Ellis LM, Rodón J, Tabernero J, Hamilton SR.  Pragmatic issues in biomarker evaluation for targeted therapies in cancer. Nat Rev Clin Oncol 2015 Apr; 12(4): 197-212
  • Elkabets M, Pazarentzos E, Juric D, Sheng Q, Pelossof RA, Brook S, Benzaken AO, Rodón J, Morse N, Yan JJ, Liu M, Das R, Chen Y, Tam A, Wang H, Liang J, Gurski JM, Kerr DA, Rosell R, Teixidó C, Huang A, Ghossein RA, Rosen N, Bivona TG, Scaltriti M, Baselga J.  AXL mediates resistance to PI3Kα inhibition by activating the EGFR/PKC/mTOR axis in head and neck and esophageal squamous cell carcinomas. Cancer Cell 2015 Apr; 27(4): 533-46
  • Zeron-Medina J, Ochoa de Olza M, Braña I, Rodón J.  The Personalization of Therapy: Molecular Profiling Technologies and Their Application. Semin. Oncol. 2015 Dec; 42(6): 775-87
  • Sepulveda-Sanchez J, Ramos A, Hilario A, DE Velasco G, Castellano D, Garcia DE LA Torre M, Rodón J, Lahn MF.  Brain perfusion and permeability in patients with advanced, refractory glioblastoma treated with lomustine and the transforming growth factor-β receptor I kinase inhibitor LY2157299 monohydrate. Oncol Lett 2015 Jun; 9(6): 2442-2448
  • Lazar V, Rubin E, Depil S, Pawitan Y, Martini JF, Gomez-Navarro J, Yver A, Kan Z, Dry JR, Kehren J, Validire P, Rodón J, Vielh P, Ducreux M, Galbraith S, Lehnert M, Onn A, Berger R, Pierotti MA, Porgador A, Pramesh CS, Ye DW, Carvalho AL, Batist G, Le Chevalier T, Morice P, Besse B, Vassal G, Mortlock A, Hansson J, Berindan-Neagoe I, Dann R, Haspel J, Irimie A, Laderman S, Nechushtan H, Al Omari AS, Haywood T, Bresson C, Soo KC, Osman I, Mata H, Lee JJ, Jhaveri K, Meurice G, Palmer G, Lacroix L, Koscielny S, Eterovic KA, Blay JY, Buller R, Eggermont A, Schilsky RL, Mendelsohn J, Soria JC, Rothenberg M, Scoazec JY, Hong WK, Kurzrock R.  A simplified interventional mapping system (SIMS) for the selection of combinations of targeted treatments in non-small cell lung cancer. Oncotarget 2015 Jun; 6(16): 14139-52
  • Rodón J, Soria JC, Berger R, Batist G, Tsimberidou A, Bresson C, Lee JJ, Rubin E, Onn A, Schilsky RL, Miller WH, Eggermont AM, Mendelsohn J, Lazar V, Kurzrock R.  Challenges in initiating and conducting personalized cancer therapy trials: perspectives from WINTHER, a Worldwide Innovative Network (WIN) Consortium trial. Ann. Oncol. 2015 Aug; 26(8): 1791-8
  • Azaro A, Rodón J, Calles A, Braña I, Hidalgo M, Lopez-Casas PP, Munoz M, Westwood P, Miller J, Moser BA, Ohnmacht U, Bumgardner W, Benhadji KA, Calvo E.  A first-in-human phase I trial of LY2780301, a dual p70 S6 kinase and Akt Inhibitor, in patients with advanced or metastatic cancer. Invest New Drugs 2015 Jun; 33(3): 710-9
  • Dienstmann R, Rodón J, Prat A, Pérez-García J, Adamo B, Felip E, Cortes J, Iafrate AJ, Nuciforo P, Tabernero J.  Genomic aberrations in the FGFR pathway: opportunities for targeted therapies in solid tumors. Ann. Oncol. 2014 Mar; 25(3): 552-63
  • Shapiro GI, Rodón J, Bedell C, Kwak EL, Baselga J, Braña I, Pandya SS, Scheffold C, Laird AD, Nguyen LT, Xu Y, Egile C, Edelman G.  Phase I safety, pharmacokinetic, and pharmacodynamic study of SAR245408 (XL147), an oral pan-class I PI3K inhibitor, in patients with advanced solid tumors. Clin. Cancer Res. 2014 Jan; 20(1): 233-45
  • Dienstmann R, Rodón J, Serra V, Tabernero J.  Picking the point of inhibition: a comparative review of PI3K/AKT/mTOR pathway inhibitors. Mol. Cancer Ther. 2014 May; 13(5): 1021-31
  • Bellmunt J, Suárez C, Gallardo E, Rodón J, Pons F, Bonfill T, Beltran M, Moya I, Galtes S, Albanell J, Carles J.  Phase I study of sunitinib in combination with gemcitabine and capecitabine for first-line treatment of metastatic or unresectable renal cell carcinoma. Oncologist 2014 Sep; 19(9): 917-8
  • Rodón J, Tawbi HA, Thomas AL, Stoller RG, Turtschi CP, Baselga J, Sarantopoulos J, Mahalingam D, Shou Y, Moles MA, Yang L, Granvil C, Hurh E, Rose KL, Amakye DD, Dummer R, Mita AC.  A phase I, multicenter, open-label, first-in-human, dose-escalation study of the oral smoothened inhibitor Sonidegib (LDE225) in patients with advanced solid tumors. Clin. Cancer Res. 2014 Apr; 20(7): 1900-9
  • Agarwal R, Liebe S, Turski ML, Vidwans SJ, Janku F, Garrido-Laguna I, Munoz J, Schwab R, Rodón J, Kurzrock R, Subbiah V.  Targeted therapy for hereditary cancer syndromes: hereditary breast and ovarian cancer syndrome, Lynch syndrome, familial adenomatous polyposis, and Li-Fraumeni syndrome. Discov Med 2014 Dec; 18(101): 331-9
  • Agarwal R, Liebe S, Turski ML, Vidwans SJ, Janku F, Garrido-Laguna I, Munoz J, Schwab R, Rodón J, Kurzrock R, Subbiah V.  Targeted therapy for hereditary cancer syndromes: neurofibromatosis type 1, neurofibromatosis type 2, and Gorlin syndrome. Discov Med 2014 Dec; 18(101): 323-30
  • Rodón J, Braña I, Siu LL, de Jonge MJ, Homji N, Mills D, Di Tomaso E, Sarr C, Trandafir L, Massacesi C, Eskens F, Bendell JC.  Phase I dose-escalation and -expansion study of buparlisib (BKM120), an oral pan-Class I PI3K inhibitor, in patients with advanced solid tumors. Invest New Drugs 2014 Aug; 32(4): 670-81
  • Mahalingam D, Malik L, Beeram M, Rodón J, Sankhala K, Mita A, Benjamin D, Ketchum N, Michalek J, Tolcher A, Wright J, Sarantopoulos J.  Phase II study evaluating the efficacy, safety, and pharmacodynamic correlative study of dual antiangiogenic inhibition using bevacizumab in combination with sorafenib in patients with advanced malignant melanoma. Cancer Chemother. Pharmacol. 2014 Jul; 74(1): 77-84
  • Prat A, Adamo B, Fan C, Peg V, Vidal M, Galván P, Vivancos A, Nuciforo P, Pálmer HG, Dawood S, Rodón J, Cajal SR, Ramón y Cajal S, del Campo JM, Ramony Cajal S, Felip E, Tabernero J, Cortes J. Genomic analyses across six cancer types identify basal-like breast cancer as a unique molecular entity. Sci Rep 2013; 3: 3544
  • Rodón J, Dienstmann R, Serra V, Tabernero J.  Development of PI3K inhibitors: lessons learned from early clinical trials. Nat Rev Clin Oncol 2013 Mar; 10(3): 143-53
  • Dienstmann R, Rodón J, Tabernero J.  Biomarker-driven patient selection for early clinical trials. Curr Opin Oncol 2013 May; 25(3): 305-12
  • Dienstmann R, Rodón J, Barretina J, Tabernero J.  Genomic medicine frontier in human solid tumors: prospects and challenges. J. Clin. Oncol. 2013 May; 31(15): 1874-84
  • De Mattos-Arruda L, Rodón J.  Pilot studies for personalized cancer medicine: focusing on the patient for treatment selection. Oncologist 2013; 18(11): 1180-8
  • Elkabets M, Vora S, Juric D, Morse N, Mino-Kenudson M, Muranen T, Tao J, Campos AB, Rodón J, Ibrahim YH, Serra V, Rodrik-Outmezguine V, Hazra S, Singh S, Kim P, Quadt C, Liu M, Huang A, Rosen N, Engelman JA, Scaltriti M, Baselga J.  mTORC1 inhibition is required for sensitivity to PI3K p110α inhibitors in PIK3CA-mutant breast cancer. Sci Transl Med 2013 Jul; 5(196): 196ra99
  • Ibrahim YH, García-García C, Serra V, He L, Torres-Lockhart K, Prat A, Anton P, Cozar P, Guzman M, Grueso J, Rodriguez O, Calvo MT, Aura C, Diez O, Rubio IT, Pérez J, Rodón J, Cortes J, Ellisen LW, Scaltriti M, Baselga J.  PI3K inhibition impairs BRCA1/2 expression and sensitizes BRCA-proficient triple-negative breast cancer to PARP inhibition. Cancer Discov 2012 Nov; 2(11): 1036-47
  • Dienstmann R, Serpico D, Rodón J, Saura C, Macarulla T, Elez E, Alsina M, Capdevila J, Pérez-García J, Sánchez-Ollé G, Aura C, Prudkin L, Landolfi S, Hernandez-Losa J, Vivancos A, Tabernero J. Molecular profiling of patients with colorectal cancer and matched targeted therapy in phase I clinical trials. Mol. Cancer Ther. 2012 Sep; 11(9): 2062-71
  • Rodón J, Saura C, Dienstmann R, Vivancos A, Ramón y Cajal S, Baselga J, Tabernero J.  Molecular prescreening to select patient population in early clinical trials. Nat Rev Clin Oncol 2012 Jun; 9(6): 359-66
  • Argiles G, Rodón J, Tabernero J.  Depicting the evolving scenario of translational-guided drug development. Clin Transl Oncol 2012 Dec; 14(12): 881-2
  • Calvo E, Vermorken JB, Hiret S, Rodón J, Cortes J, Senellart H, Van den Brande J, Dyck J, Pétain A, Ferre P, Bennouna J.  Phase I dose-escalation study of vinflunine hard capsules administered twice a day for 2 consecutive days every week in patients with advanced/metastatic solid tumors. Cancer Chemother. Pharmacol. 2012 Jun; 69(6): 1467-75
  • Rodón J, Jacobs CD, Chu Q, Rowinsky EK, Lopez-Anaya A, Takimoto CH, Wakelee HA.  A phase I pharmacokinetic study of bexarotene with paclitaxel and carboplatin in patients with advanced non-small cell lung cancer (NSCLC). Cancer Chemother. Pharmacol. 2012 Mar; 69(3): 825-34
  • Serrano C, Morales R, Suárez C, Nuñez I, Valverde C, Rodón J, Humbert J, Padrós O, Carles J. Emerging therapies for urothelial cancer. Cancer Treat. Rev. 2012 Jun; 38(4): 311-7
  • Bendell JC, Rodón J, Burris HA, de Jonge M, Verweij J, Birle D, Demanse D, De Buck SS, Ru QC, Peters M, Goldbrunner M, Baselga J.  Phase I, dose-escalation study of BKM120, an oral pan-Class I PI3K inhibitor, in patients with advanced solid tumors. J. Clin. Oncol. 2012 Jan; 30(3): 282-90
  • Atzori F, Tabernero J, Cervantes A, Prudkin L, Andreu J, Rodriguez-Braun E, Domingo A, Guijarro J, Gamez C, Rodón J, Di Cosimo S, Brown H, Clark J, Hardwick JS, Beckman RA, Hanley WD, Hsu K, Calvo E, Roselló S, Langdon RB, Baselga J.  A phase I pharmacokinetic and pharmacodynamic study of dalotuzumab (MK-0646), an anti-insulin-like growth factor-1 receptor monoclonal antibody, in patients with advanced solid tumors. Clin. Cancer Res. 2011 Oct; 17(19): 6304-12
  • Dienstmann R, Rodón J, Markman B, Tabernero J.  Recent developments in anti-cancer agents targeting PI3K, Akt and mTORC1/2. Recent Pat Anticancer Drug Discov 2011 May; 6(2): 210-36
  • Dienstmann R, Braña I, Rodón J, Tabernero J.  Toxicity as a biomarker of efficacy of molecular targeted therapies: focus on EGFR and VEGF inhibiting anticancer drugs. Oncologist 2011; 16(12): 1729-40
  • Huang HJ, Angelo LS, Rodón J, Sun M, Kuenkele KP, Parsons HA, Trent JC, Kurzrock R.  R1507, an anti-insulin-like growth factor-1 receptor (IGF-1R) antibody, and EWS/FLI-1 siRNA in Ewing’s sarcoma: convergence at the IGF/IGFR/Akt axis. PLoS ONE 2011; 6(10): e26060
  • Morales-Barrera R, Valverde C, Rodón J, Pérez J, Maldonado X, Suárez C, Trilla E, Carles J.  Bilateral testicular germ cell tumours: a single hospital experience. Clin Transl Oncol 2010 Apr; 12(4): 299-302
  • Anido J, Sáez-Borderías A, Gonzàlez-Juncà A, Rodón L, Folch G, Carmona MA, Prieto-Sánchez RM, Barba I, Martínez-Sáez E, Prudkin L, Cuartas I, Raventós C, Martínez-Ricarte F, Poca MA, García-Dorado D, Lahn MM, Yingling JM, Rodón J, Sahuquillo J, Baselga J, Seoane J.  TGF-β Receptor Inhibitors Target the CD44(high)/Id1(high) Glioma-Initiating Cell Population in Human Glioblastoma.Cancer Cell 2010 Dec; 18(6): 655-68
  • Pérez-García J, Morales R, Valverde CM, Rodón J, Suárez C, Semidey ME, Garcia-Patos V, Bartralot R, Serra M, Carles J.  Eccrine porocarcinoma presenting with scrotal lymphedema: a case report and review of systemic treatment. Ann. Oncol. 2010 Apr; 21(4): 907
  • Suárez C, Morales R, Muñoz E, Rodón J, Valverde CM, Carles J.  Molecular basis for the treatment of renal cell carcinoma. Clin Transl Oncol 2010 Jan; 12(1): 15-21
  • Carles J, Morales R, Perez JM, Suárez C, Rodón J, Valverde C.  Management and interpretation of novel toxicities of molecular targeted therapies: renal toxicities. Eur. J. Cancer 2009 Sep; 45 Suppl 1: 309-17
  • Lin CC, Calvo E, Papadopoulos KP, Patnaik A, Sarantopoulos J, Mita AC, Preston GG, Mita MM, Rodón J, Mays T, Yeh IT, O’Rourke P, Takimoto CH, Dancey JE, Chen H, Tolcher AW.  Phase I study of cetuximab, erlotinib, and bevacizumab in patients with advanced solid tumors. Cancer Chemother. Pharmacol. 2009 May; 63(6): 1065-71
  • Tolcher AW, Sarantopoulos J, Patnaik A, Papadopoulos K, Lin CC, Rodón J, Murphy B, Roth B, McCaffery I, Gorski KS, Kaiser B, Zhu M, Deng H, Friberg G, Puzanov I.  Phase I, pharmacokinetic, and pharmacodynamic study of AMG 479, a fully human monoclonal antibody to insulin-like growth factor receptor 1. J. Clin. Oncol. 2009 Dec; 27(34): 5800-7
  • Rodón J, Iniesta MD, Papadopoulos K.  Development of PARP inhibitors in oncology. Expert Opin Investig Drugs 2009 Jan; 18(1): 31-43
  • Martínez P, Valverde C, Morales R, Rodón J, Suárez C, Baselga J, Carles J.  Docetaxel activity in second line treatment for urothelial carcinoma: a retrospective analysis European Journal of Cancer Supplements 2009 September; 7(2): 448