Envisioning the future of early anticancer drug development
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Paul Workman | Timothy A. Yap | P. Workman | T. Yap | J. Bono | S. Sandhu | Johann S. de Bono | Shahneen K. Sandhu
[1] D. Dearnaley,et al. Characterization of ERG, AR and PTEN gene status in circulating tumor cells from patients with castration-resistant prostate cancer. , 2009, Cancer research.
[2] J. Llovet,et al. Preclinical overview of sorafenib, a multikinase inhibitor that targets both Raf and VEGF and PDGF receptor tyrosine kinase signaling , 2008, Molecular Cancer Therapeutics.
[3] E. Crivellato,et al. Mast cells and tumour angiogenesis: new insight from experimental carcinogenesis. , 2008, Cancer letters.
[4] Mitch Dowsett,et al. Phase I clinical trial of a selective inhibitor of CYP17, abiraterone acetate, confirms that castration-resistant prostate cancer commonly remains hormone driven. , 2008, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.
[5] G. Evan,et al. Tumor angiogenesis: cause or consequence of cancer? , 2007, Cancer research.
[6] R. Kalluri,et al. Endogenous inhibitors of angiogenesis. , 2005, Cancer research.
[7] L. Tanoue,et al. Detection of Mutations in EGFR in Circulating Lung-Cancer Cells , 2010 .
[8] W. McGuire,et al. Human breast cancer: correlation of relapse and survival with amplification of the HER-2/neu oncogene. , 1987, Science.
[9] C. Köhne,et al. Randomized phase III study of irinotecan and 5-FU/FA with or without cetuximab in the first-line treatment of patients with metastatic colorectal cancer (mCRC): The CRYSTAL trial , 2007 .
[10] R. Pearson,et al. Cetuximab and Chemotherapy as Initial Treatment for Metastatic Colorectal Cancer , 2010 .
[11] Nicholas R. English,et al. Increased Production of Immature Myeloid Cells in Cancer Patients: A Mechanism of Immunosuppression in Cancer1 , 2001, The Journal of Immunology.
[12] L. Forthun,et al. Final Results , 2009 .
[13] J. DiMasi,et al. Trends in Risks Associated With New Drug Development: Success Rates for Investigational Drugs , 2010, Clinical pharmacology and therapeutics.
[14] S. Friend,et al. A network view of disease and compound screening , 2009, Nature Reviews Drug Discovery.
[15] M. Ratain,et al. Biomarkers in Phase I Oncology Trials: Signal, Noise, or Expensive Distraction? , 2007, Clinical Cancer Research.
[16] G. Szakács,et al. Relevance of multidrug resistance in the age of targeted therapy. , 2009, Current opinion in drug discovery & development.
[17] L. Trusolino,et al. Drug development of MET inhibitors: targeting oncogene addiction and expedience , 2008, Nature Reviews Drug Discovery.
[18] Joseph A DiMasi,et al. Economics of new oncology drug development. , 2007, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.
[19] David Warde-Farley,et al. Dynamic modularity in protein interaction networks predicts breast cancer outcome , 2009, Nature Biotechnology.
[20] A. Tutt,et al. Phase II trial of the oral PARP inhibitor olaparib in BRCA-deficient advanced breast cancer. , 2009, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.
[21] P. Workman. Auditing the pharmacological accounts for Hsp90 molecular chaperone inhibitors: unfolding the relationship between pharmacokinetics and pharmacodynamics. , 2003, Molecular cancer therapeutics.
[22] Daniel J Sargent,et al. Clinical trial designs for predictive biomarker validation: theoretical considerations and practical challenges. , 2009, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.
[23] Paul Workman,et al. Molecular pharmacology of phosphatidylinositol 3-kinase inhibition in human glioma , 2009, Cell cycle.
[24] H. McLeod,et al. Pharmacogenomic progress in individualized dosing of key drugs for cancer patients , 2009, Nature Clinical Practice Oncology.
[25] P. Workman. How much gets there and what does it do?: The need for better pharmacokinetic and pharmacodynamic endpoints in contemporary drug discovery and development. , 2003, Current pharmaceutical design.
[26] G. Ahn,et al. Matrix metalloproteinase-9 is required for tumor vasculogenesis but not for angiogenesis: role of bone marrow-derived myelomonocytic cells. , 2008, Cancer cell.
[27] J. Lee,et al. Dose Escalation Methods in Phase I Cancer Clinical Trials , 2009, Journal of the National Cancer Institute.
[28] Jan Lubinski,et al. Poly(ADP)-ribose polymerase inhibition: frequent durable responses in BRCA carrier ovarian cancer correlating with platinum-free interval. , 2010, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.
[29] C. Sawyers. The cancer biomarker problem , 2008, Nature.
[30] P. Workman,et al. Biomarker-Driven Early Clinical Trials in Oncology: A Paradigm Shift in Drug Development , 2009, Cancer journal.
[31] J. Ware,et al. A phase I study evaluating the pharmacokinetics (PK) and pharmacodynamics (PD) of the oral pan-phosphoinositide-3 kinase (PI3K) inhibitor GDC-0941. , 2009, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.
[32] David A. Tuveson,et al. Maximizing mouse cancer models , 2007, Nature Reviews Cancer.
[33] Ultan McDermott,et al. Personalized cancer therapy with selective kinase inhibitors: an emerging paradigm in medical oncology. , 2009, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.
[34] R. Bast,et al. Project Zero Delay: a process for accelerating the activation of cancer clinical trials. , 2009, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.
[35] D. Hanahan,et al. Inflammatory mast cells up-regulate angiogenesis during squamous epithelial carcinogenesis. , 1999, Genes & development.
[36] K. Gelmon,et al. Objective response rate in a phase II multicenter trial of pertuzumab (P), a HER2 dimerization inhibiting monoclonal antibody, in combination with trastuzumab (T) in patients (pts) with HER2-positive metastatic breast cancer (MBC) which has progressed during treatment with T , 2007 .
[37] A. Ashworth,et al. Inhibition of poly(ADP-ribose) polymerase in tumors from BRCA mutation carriers. , 2009, The New England journal of medicine.
[38] Susan Groshen,et al. The Design of Phase II Clinical Trials Testing Cancer Therapeutics: Consensus Recommendations from the Clinical Trial Design Task Force of the National Cancer Institute Investigational Drug Steering Committee , 2010, Clinical Cancer Research.
[39] C. Takimoto. Maximum tolerated dose: clinical endpoint for a bygone era? , 2009, Targeted Oncology.
[40] T. Fleming,et al. Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2. , 2001, The New England journal of medicine.
[41] P. Workman,et al. Biological properties of potent inhibitors of class I phosphatidylinositide 3-kinases: from PI-103 through PI-540, PI-620 to the oral agent GDC-0941 , 2009, Molecular Cancer Therapeutics.
[42] A. Tutt,et al. Phase II trial of the oral PARP inhibitor olaparib (AZD2281) in BRCA-deficient advanced ovarian cancer. , 2016, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.
[43] Y. Meng,et al. G-CSF-initiated myeloid cell mobilization and angiogenesis mediate tumor refractoriness to anti-VEGF therapy in mouse models , 2009, Proceedings of the National Academy of Sciences.
[44] J. Clark,et al. Utility and costs of surrogate endpoints (SEs) and biomarkers in phase I oncology trials. , 2004, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.
[45] T. Yap,et al. Targeting the HGF/c-Met Axis: State of Play , 2010, Molecular Cancer Therapeutics.
[46] M. Ratain,et al. Pharmacogenetics and pharmacogenomics of anticancer agents , 2009, CA: a cancer journal for clinicians.
[47] L. Elmore,et al. Telomerase as a Target for Cancer Immunotherapy , 2003, Cancer biology & therapy.
[48] S. Gabriel,et al. High-throughput oncogene mutation profiling in human cancer , 2007, Nature Genetics.
[49] J O'Quigley,et al. Continual reassessment method: a practical design for phase 1 clinical trials in cancer. , 1990, Biometrics.
[50] G. Giaccone,et al. Endpoints and other considerations in phase I studies of targeted anticancer therapy: recommendations from the task force on Methodology for the Development of Innovative Cancer Therapies (MDICT). , 2008, European journal of cancer.
[51] K. Gelmon,et al. Ki67 in breast cancer: prognostic and predictive potential. , 2010, The Lancet. Oncology.
[52] M. Birkner,et al. A phase II study of trastuzumab-DM1 (T-DM1), a HER2 antibody-drug conjugate (ADC), in patients (pts) with HER2+ metastatic breast cancer (MBC): Final results. , 2009, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.
[53] Kevin Carroll,et al. Gefitinib plus best supportive care in previously treated patients with refractory advanced non-small-cell lung cancer: results from a randomised, placebo-controlled, multicentre study (Iressa Survival Evaluation in Lung Cancer) , 2005, The Lancet.
[54] J. Doroshow,et al. Drug development in oncology: classical cytotoxics and molecularly targeted agents. , 2006, British journal of clinical pharmacology.
[55] P. Allavena,et al. Tumor-Associated Macrophages (TAM) as Major Players of the Cancer-Related Inflammation , 2010 .
[56] R. Plummer,et al. Phase I trial of the irreversible EGFR and HER2 kinase inhibitor BIBW 2992 in patients with advanced solid tumors. , 2010, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.
[57] Ian Collins,et al. New approaches to molecular cancer therapeutics , 2006, Nature chemical biology.
[58] Craig Murdoch,et al. The role of myeloid cells in the promotion of tumour angiogenesis , 2008, Nature Reviews Cancer.
[59] P. Workman,et al. Use of pharmacokinetic/pharmacodynamic biomarkers to support rational cancer drug development. , 2007, Biomarkers in medicine.
[60] Srinivas Nagaraj,et al. Myeloid-derived suppressor cells as regulators of the immune system , 2009, Nature Reviews Immunology.
[61] Larry Rubinstein,et al. Randomized Phase II Designs , 2009, Clinical Cancer Research.
[62] M. Lai,et al. Neutrophils and macrophages promote angiogenesis in the early stage of endometriosis in a mouse model. , 2006, Endocrinology.
[63] J. Dancey,et al. A Perspective on Challenges and Issues in Biomarker Development and Drug and Biomarker Codevelopment , 2009, Journal of the National Cancer Institute.
[64] Paul Workman,et al. Targeting the PI3K-AKT-mTOR pathway: progress, pitfalls, and promises. , 2008, Current opinion in pharmacology.
[65] D. Hodgson,et al. Circulating tumour-derived predictive biomarkers in oncology. , 2010, Drug discovery today.
[66] Suzanne F. Jones,et al. Phase I study of trastuzumab-DM1, an HER2 antibody-drug conjugate, given every 3 weeks to patients with HER2-positive metastatic breast cancer. , 2010, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.
[67] M. Ratain,et al. Clinical activity observed in a phase I dose escalation trial of an oral c-met and ALK inhibitor, PF-02341066. , 2009, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.
[68] Marc Buyse,et al. Surrogate threshold effect: an alternative measure for meta‐analytic surrogate endpoint validation , 2006, Pharmaceutical statistics.
[69] F. Peale,et al. The endocrine-gland-derived VEGF homologue Bv8 promotes angiogenesis in the testis: Localization of Bv8 receptors to endothelial cells , 2003, Proceedings of the National Academy of Sciences of the United States of America.
[70] F. Peale,et al. Bv8 and endocrine gland-derived vascular endothelial growth factor stimulate hematopoiesis and hematopoietic cell mobilization. , 2004, Proceedings of the National Academy of Sciences of the United States of America.
[71] M. Cristofanilli. Circulating tumor cells, disease progression, and survival in metastatic breast cancer. , 2006, Seminars in oncology.
[72] Paul Workman,et al. Drugging the PI3 kinome: from chemical tools to drugs in the clinic. , 2010, Cancer research.
[73] C. Sigman,et al. New science-based endpoints to accelerate oncology drug development. , 2005, European journal of cancer.
[74] M. Baccarani,et al. Imatinib induces durable hematologic and cytogenetic responses in patients with accelerated phase chronic myeloid leukemia: results of a phase 2 study. , 2002, Blood.
[75] P. Workman,et al. Biomarkers In Early Clinical Trials: the Committed and the Skeptics , 2008, Clinical Cancer Research.
[76] T. Yap,et al. Targeting CYP17: established and novel approaches in prostate cancer. , 2008, Current opinion in pharmacology.
[77] N. Ferrara. Pathways mediating VEGF-independent tumor angiogenesis. , 2010, Cytokine & growth factor reviews.
[78] Janice M. Reichert,et al. Development trends for new cancer therapeutics and vaccines. , 2008, Drug discovery today.
[79] P. Workman,et al. Cancer: Drug-tolerant insurgents , 2010, Nature.
[80] C. Lewis,et al. Mechanisms regulating the recruitment of macrophages into hypoxic areas of tumors and other ischemic tissues. , 2004, Blood.
[81] C. Divino,et al. Reversion of immune tolerance in advanced malignancy: modulation of myeloid-derived suppressor cell development by blockade of stem-cell factor function. , 2008, Blood.
[82] S. Lakhani,et al. Phase I pharmacokinetic and pharmacodynamic study of 17-allylamino, 17-demethoxygeldanamycin in patients with advanced malignancies. , 2005, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.
[83] A. Harris,et al. Use of positron emission tomography in pharmacokinetic studies to investigate therapeutic advantage in a phase I study of 120-hour intravenous infusion XR5000. , 2003, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.
[84] M. Christian,et al. Phase I clinical trial design in cancer drug development. , 2000, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.
[85] A. Adjei,et al. Phase I Dose Escalation Study of the Anti–Insulin-Like Growth Factor-I Receptor Monoclonal Antibody CP-751,871 in Patients with Refractory Solid Tumors , 2007, Clinical Cancer Research.
[86] Timothy A. Yap,et al. Beyond chemotherapy: targeted therapies in ovarian cancer , 2009, Nature Reviews Cancer.
[87] Richard Simon,et al. The Use of Genomics in Clinical Trial Design , 2008, Clinical Cancer Research.
[88] Paul Workman,et al. Minimally invasive pharmacokinetic and pharmacodynamic technologies in hypothesis-testing clinical trials of innovative therapies. , 2006, Journal of the National Cancer Institute.
[89] P. Workman,et al. Gene expression profiling of human colon cancer cells following inhibition of signal transduction by 17-allylamino-17-demethoxygeldanamycin, an inhibitor of the hsp90 molecular chaperone , 2000, Oncogene.
[90] P. Fu,et al. Multi-institutional phase I trials of anticancer agents. , 2008, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.
[91] Noam Brown,et al. The role of tumour‐associated macrophages in tumour progression: implications for new anticancer therapies , 2002, The Journal of pathology.
[92] S. Cannistra. Challenges and pitfalls of combining targeted agents in phase I studies. , 2008, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.
[93] K. Kinzler,et al. Cancer genes and the pathways they control , 2004, Nature Medicine.
[94] D. Auclair,et al. BAY 43-9006 Exhibits Broad Spectrum Oral Antitumor Activity and Targets the RAF/MEK/ERK Pathway and Receptor Tyrosine Kinases Involved in Tumor Progression and Angiogenesis , 2004, Cancer Research.
[95] K. Pienta,et al. Circulating Tumor Cells Predict Survival Benefit from Treatment in Metastatic Castration-Resistant Prostate Cancer , 2008, Clinical Cancer Research.
[96] P. Workman,et al. Targeted therapeutics for cancer treatment: major progress towards personalised molecular medicine. , 2008, Current opinion in pharmacology.
[97] P. Workman. Challenges of PK/PD measurements in modern drug development. , 2002, European journal of cancer.
[98] E. Eisenhauer,et al. Phase I trial design for solid tumor studies of targeted, non-cytotoxic agents: theory and practice. , 2004, Journal of the National Cancer Institute.
[99] D. Olmos,et al. Antitumor activity with CYP17 blockade indicates that castration-resistant prostate cancer frequently remains hormone driven. , 2009, Cancer research.
[100] P. Workman,et al. Cytostasis and Apoptosis 17-Allylamino-17-demethoxygeldanamycin Results in Inhibition of Signal Transduction by the Hsp 90 Inhibitor Updated Version , 2001 .
[101] G. Demetri,et al. A first-in-human phase I study to evaluate the pan-PI3K inhibitor GDC-0941 administered QD or BID in patients with advanced solid tumors. , 2009, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.
[102] Alan Ashworth,et al. Targeting the DNA repair defect in BRCA mutant cells as a therapeutic strategy , 2005, Nature.
[103] R. Kerbel,et al. Rationale for Biomarkers and Surrogate End Points in Mechanism-Driven Oncology Drug Development , 2004, Clinical Cancer Research.
[104] Alexia Iasonos,et al. A Comprehensive Comparison of the Continual Reassessment Method to the Standard 3 + 3 Dose Escalation Scheme in Phase I Dose-Finding Studies , 2008, Clinical trials.
[105] N. Spector,et al. EGF103009, a phase II trial of lapatinib monotherapy in patients with relapsed/refractory inflammatory breast cancer (IBC): Clinical activity and biologic predictors of response. , 2006, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.
[106] L. Coussens,et al. The contribution of bone marrow-derived cells to the tumor vasculature in neuroblastoma is matrix metalloproteinase-9 dependent. , 2005, Cancer research.
[107] Jeffrey W. Clark,et al. Trends in the Use and Role of Biomarkers in Phase I Oncology Trials , 2007, Clinical Cancer Research.
[108] Steven Gutman,et al. Opinion: The US Food and Drug Administration perspective on cancer biomarker development , 2006, Nature Reviews Cancer.
[109] A. Adjei. What is the right dose? The elusive optimal biologic dose in phase I clinical trials. , 2006, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.
[110] K. Flaherty,et al. Phase I study of PLX4032: Proof of concept for V600E BRAF mutation as a therapeutic target in human cancer. , 2016, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.
[111] Daniel J Sargent,et al. Optimising the design of phase II oncology trials: the importance of randomisation. , 2009, European journal of cancer.
[112] F.A.M. Bordonaba,et al. Wild-Type KRAS Is Required for Panitumumab Efficacy in Patients With Metastatic Colorectal Cancer , 2009 .
[113] Antje Hoering,et al. Randomized Phase III Clinical Trial Designs for Targeted Agents , 2008, Clinical Cancer Research.
[114] Masahiro Inoue,et al. An amino-bisphosphonate targets MMP-9-expressing macrophages and angiogenesis to impair cervical carcinogenesis. , 2004, The Journal of clinical investigation.
[115] Caroline Dive,et al. Tumorigenesis and Neoplastic Progression Evaluation of Circulating Tumor Cells and Serological Cell Death Biomarkers in Small Cell Lung Cancer Patients Undergoing Chemotherapy , 2010 .
[116] P. Workman,et al. Pharmacokinetic-Pharmacodynamic Relationships for the Heat Shock Protein 90 Molecular Chaperone Inhibitor 17-Allylamino , 17-Demethoxygeldanamycin in Human Ovarian Cancer , 2005 .
[117] B. Fingleton,et al. Matrix Metalloproteinase Inhibitors and Cancer—Trials and Tribulations , 2002, Science.
[118] Paul Workman,et al. Pharmacodynamic biomarkers for molecular cancer therapeutics. , 2007, Advances in cancer research.
[119] Nathanael Gray,et al. Factors underlying sensitivity of cancers to small-molecule kinase inhibitors , 2009, Nature Reviews Drug Discovery.
[120] M. Stratton,et al. The cancer genome , 2009, Nature.
[121] Alan Ashworth,et al. A synthetic lethal therapeutic approach: poly(ADP) ribose polymerase inhibitors for the treatment of cancers deficient in DNA double-strand break repair. , 2008, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.
[122] S. Sleijfer,et al. Dose selection in phase I studies: why we should always go for the top. , 2008, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.
[123] Michael Morse,et al. Relationship of circulating tumor cells to tumor response, progression-free survival, and overall survival in patients with metastatic colorectal cancer. , 2008, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.
[124] Y. Ohe,et al. EGFR mutations predict survival benefit from gefitinib in patients with advanced lung adenocarcinoma: a historical comparison of patients treated before and after gefitinib approval in Japan. , 2008, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.
[125] A. Ashworth,et al. Utilizing RNA interference to enhance cancer drug discovery , 2007, Nature Reviews Drug Discovery.
[126] M. Nishimura,et al. Increased circulating myeloid-derived suppressor cells correlate with clinical cancer stage, metastatic tumor burden, and doxorubicin–cyclophosphamide chemotherapy , 2008, Cancer Immunology, Immunotherapy.
[127] D. Sargent,et al. Comparison of error rates in single-arm versus randomized phase II cancer clinical trials. , 2010, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.