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Volumn 5, Issue 1, 2010, Pages 65-72

Current challenges for the early clinical development of anticancer drugs in the era of molecularly targeted agents

Author keywords

Dose escalation methods; End points; Methodology; Molecularly targeted agents; Phase I trials

Indexed keywords

6 O BENZYLGUANINE; ANTINEOPLASTIC AGENT; BEVACIZUMAB; BIOLOGICAL MARKER; CYTOTOXIC AGENT; FLUOROURACIL; HISTONE DEACETYLASE INHIBITOR; IMATINIB; OLAPARIB; TEMSIROLIMUS;

EID: 77952889757     PISSN: 17762596     EISSN: 1776260X     Source Type: Journal    
DOI: 10.1007/s11523-010-0137-6     Document Type: Review
Times cited : (52)

References (66)
  • 1
    • 33846995628 scopus 로고    scopus 로고
    • Economics of new oncology drug development
    • DOI 10.1200/JCO.2006.09.0803
    • JA DiMasi HG Grabowski 2007 Economics of new oncology drug development J Clin Oncol 25 209 216 10.1200/JCO.2006.09.0803 17210942 (Pubitemid 350003036)
    • (2007) Journal of Clinical Oncology , vol.25 , Issue.2 , pp. 209-216
    • DiMasi, J.A.1    Grabowski, H.G.2
  • 2
    • 0031896592 scopus 로고    scopus 로고
    • There are no bad anticancer agents, only bad clinical trial designs-twenty-first Richard and Hinda Rosenthal Foundation Award Lecture
    • DD Von Hoff 1998 There are no bad anticancer agents, only bad clinical trial designs-twenty-first Richard and Hinda Rosenthal Foundation Award Lecture Clin Cancer Res 4 1079 1086
    • (1998) Clin Cancer Res , vol.4 , pp. 1079-1086
    • Von Hoff, D.D.1
  • 4
    • 27544503230 scopus 로고    scopus 로고
    • 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)
    • DOI 10.1016/S0140-6736(05)67625-8, PII S0140673605676258
    • N Thatcher A Chang P Parikh, et al. 2005 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) Lancet 366 1527 1537 10.1016/S0140-6736(05)67625-8 1:CAS:528:DC%2BD2MXhtFKhsbfP 16257339 (Pubitemid 41540110)
    • (2005) Lancet , vol.366 , Issue.9496 , pp. 1527-1537
    • Thatcher, N.1    Chang, A.2    Parikh, P.3    Pereira, J.R.4    Ciuleanu, T.5    Von Pawel, J.6    Thongprasert, S.7    Tan, E.H.8    Pemberton, K.9    Archer, V.10    Carroll, K.11
  • 10
    • 0030913595 scopus 로고    scopus 로고
    • Increased intensification and total dose of cyclophosphamide in a doxorubicin-cyclophosphamide regimen for the treatment of primary breast cancer: Findings from National Surgical Adjuvant Breast and Bowel Project B-22
    • 1:CAS:528:DyaK2sXjsVClsbc%3D 9164196
    • B Fisher S Anderson DL Wickerham, et al. 1997 Increased intensification and total dose of cyclophosphamide in a doxorubicin-cyclophosphamide regimen for the treatment of primary breast cancer: findings from National Surgical Adjuvant Breast and Bowel Project B-22 J Clin Oncol 15 1858 1869 1:CAS:528:DyaK2sXjsVClsbc%3D 9164196
    • (1997) J Clin Oncol , vol.15 , pp. 1858-1869
    • Fisher, B.1    Anderson, S.2    Wickerham, D.L.3
  • 11
    • 77952890312 scopus 로고    scopus 로고
    • http://ctep.cancer.gov/protocolDevelopment/electronic-applications/docs/ ctcaev3.pdf
  • 12
    • 34548276036 scopus 로고    scopus 로고
    • Molecularly targeted oncology therapeutics and prolongation of the QT interval
    • DOI 10.1200/JCO.2006.09.6925
    • EL Strevel DJ Ing LL Siu 2007 Molecularly targeted oncology therapeutics and prolongation of the QT interval J Clin Oncol 25 3362 3371 10.1200/JCO.2006.09.6925 1:CAS:528:DC%2BD2sXhtVWqs7nI 17664484 (Pubitemid 47325624)
    • (2007) Journal of Clinical Oncology , vol.25 , Issue.22 , pp. 3362-3371
    • Strevel, E.L.1    Ing, D.J.2    Siu, L.L.3
  • 13
    • 70349116426 scopus 로고    scopus 로고
    • Cardiovascular toxicity of molecularly targeted agents
    • 10.1016/S0959-8049(09)70046-2 19775628
    • EL Strevel LL Siu 2009 Cardiovascular toxicity of molecularly targeted agents Eur J Cancer 45 Suppl 1 318 331 10.1016/S0959-8049(09)70046-2 19775628
    • (2009) Eur J Cancer , vol.45 , Issue.SUPPL. 1 , pp. 318-331
    • Strevel, E.L.1    Siu, L.L.2
  • 14
    • 70349210880 scopus 로고    scopus 로고
    • Gastrointestinal toxicities of novel agents in cancer therapy
    • 10.1016/S0959-8049(09)70047-4 19775629
    • A Asnacios S Naveau G Perlemuter 2009 Gastrointestinal toxicities of novel agents in cancer therapy Eur J Cancer 45 Suppl 1 332 342 10.1016/S0959-8049(09)70047-4 19775629
    • (2009) Eur J Cancer , vol.45 , Issue.SUPPL. 1 , pp. 332-342
    • Asnacios, A.1    Naveau, S.2    Perlemuter, G.3
  • 15
    • 70349091806 scopus 로고    scopus 로고
    • Skin toxicities of targeted therapies
    • 10.1016/S0959-8049(09)70044-9 19775626
    • S Segaert G Chiritescu L Lemmens, et al. 2009 Skin toxicities of targeted therapies Eur J Cancer 45 Suppl 1 295 308 10.1016/S0959-8049(09)70044-9 19775626
    • (2009) Eur J Cancer , vol.45 , Issue.SUPPL. 1 , pp. 295-308
    • Segaert, S.1    Chiritescu, G.2    Lemmens, L.3
  • 16
    • 70349217281 scopus 로고    scopus 로고
    • Management and interpretation of novel toxicities of molecular targeted therapies: Renal toxicities
    • 10.1016/S0959-8049(09)70045-0 19775627
    • J Carles R Morales JM Perez, et al. 2009 Management and interpretation of novel toxicities of molecular targeted therapies: renal toxicities Eur J Cancer 45 Suppl 1 309 317 10.1016/S0959-8049(09)70045-0 19775627
    • (2009) Eur J Cancer , vol.45 , Issue.SUPPL. 1 , pp. 309-317
    • Carles, J.1    Morales, R.2    Perez, J.M.3
  • 19
    • 65549149873 scopus 로고    scopus 로고
    • Clinical benefit in Phase-I trials of novel molecularly targeted agents: Does dose matter?
    • 10.1038/sj.bjc.6605030 1:CAS:528:DC%2BD1MXltFGit70%3D 19401696
    • S Postel-Vinay HT Arkenau D Olmos, et al. 2009 Clinical benefit in Phase-I trials of novel molecularly targeted agents: does dose matter? Br J Cancer 100 1373 1378 10.1038/sj.bjc.6605030 1:CAS:528:DC%2BD1MXltFGit70%3D 19401696
    • (2009) Br J Cancer , vol.100 , pp. 1373-1378
    • Postel-Vinay, S.1    Arkenau, H.T.2    Olmos, D.3
  • 20
    • 46149123415 scopus 로고    scopus 로고
    • Progress and challenges in the identification of biomarkers for EGFR and VEGFR targeting anticancer agents
    • 10.1016/j.drup.2008.04.001 18515176
    • C Le Tourneau L Vidal LL Siu 2008 Progress and challenges in the identification of biomarkers for EGFR and VEGFR targeting anticancer agents Drug Resist Updat 11 99 109 10.1016/j.drup.2008.04.001 18515176
    • (2008) Drug Resist Updat , vol.11 , pp. 99-109
    • Le Tourneau, C.1    Vidal, L.2    Siu, L.L.3
  • 21
    • 36749048184 scopus 로고    scopus 로고
    • Biomarkers in phase I oncology trials: Signal, noise, or expensive distraction?
    • DOI 10.1158/1078-0432.CCR-07-2133
    • MJ Ratain RH Glassman 2007 Biomarkers in phase I oncology trials: signal, noise, or expensive distraction? Clin Cancer Res 13 6545 6548 10.1158/1078-0432.CCR-07-2133 1:CAS:528:DC%2BD2sXhtlSmu7jP 18006752 (Pubitemid 350206786)
    • (2007) Clinical Cancer Research , vol.13 , Issue.22 , pp. 6545-6548
    • Ratain, M.J.1    Glassman, R.H.2
  • 24
    • 0037208589 scopus 로고    scopus 로고
    • Phase II, randomized trial comparing bevacizumab plus fluorouracil (FU)/leucovorin (LV) with FU/LV alone in patients with metastatic colorectal cancer
    • 10.1200/JCO.2003.10.066 1:CAS:528:DC%2BD2cXpsVWru7Y%3D 12506171
    • F Kabbinavar HI Hurwitz L Fehrenbacher, et al. 2003 Phase II, randomized trial comparing bevacizumab plus fluorouracil (FU)/leucovorin (LV) with FU/LV alone in patients with metastatic colorectal cancer J Clin Oncol 21 60 65 10.1200/JCO.2003.10.066 1:CAS:528:DC%2BD2cXpsVWru7Y%3D 12506171
    • (2003) J Clin Oncol , vol.21 , pp. 60-65
    • Kabbinavar, F.1    Hurwitz, H.I.2    Fehrenbacher, L.3
  • 25
    • 43249124980 scopus 로고    scopus 로고
    • Dose selection in phase i studies: Why we should always go for the top
    • 10.1200/JCO.2007.15.5192 18332465
    • S Sleijfer E Wiemer 2008 Dose selection in phase I studies: why we should always go for the top J Clin Oncol 26 1576 1578 10.1200/JCO.2007.15.5192 18332465
    • (2008) J Clin Oncol , vol.26 , pp. 1576-1578
    • Sleijfer, S.1    Wiemer, E.2
  • 27
    • 62449090881 scopus 로고    scopus 로고
    • Guidelines for human epidermal growth factor receptor 2 testing: Biologic and methodologic considerations
    • 10.1200/JCO.2007.14.8197 1:CAS:528:DC%2BD1MXktFKhsbs%3D 19204209
    • G Sauter J Lee JM Bartlett, et al. 2009 Guidelines for human epidermal growth factor receptor 2 testing: biologic and methodologic considerations J Clin Oncol 27 1323 1333 10.1200/JCO.2007.14.8197 1:CAS:528:DC%2BD1MXktFKhsbs%3D 19204209
    • (2009) J Clin Oncol , vol.27 , pp. 1323-1333
    • Sauter, G.1    Lee, J.2    Bartlett, J.M.3
  • 28
    • 65349189958 scopus 로고    scopus 로고
    • American Society of Clinical Oncology provisional clinical opinion: Testing for KRAS gene mutations in patients with metastatic colorectal carcinoma to predict response to anti-epidermal growth factor receptor monoclonal antibody therapy
    • 10.1200/JCO.2009.21.9170 19188670
    • CJ Allegra JM Jessup MR Somerfield, et al. 2009 American Society of Clinical Oncology provisional clinical opinion: testing for KRAS gene mutations in patients with metastatic colorectal carcinoma to predict response to anti-epidermal growth factor receptor monoclonal antibody therapy J Clin Oncol 27 2091 2096 10.1200/JCO.2009.21.9170 19188670
    • (2009) J Clin Oncol , vol.27 , pp. 2091-2096
    • Allegra, C.J.1    Jessup, J.M.2    Somerfield, M.R.3
  • 29
    • 69849108427 scopus 로고    scopus 로고
    • Clinical trial designs for predictive biomarker validation: Theoretical considerations and practical challenges
    • 10.1200/JCO.2009.22.3701 19597023
    • SJ Mandrekar DJ Sargent 2009 Clinical trial designs for predictive biomarker validation: theoretical considerations and practical challenges J Clin Oncol 27 4027 4034 10.1200/JCO.2009.22.3701 19597023
    • (2009) J Clin Oncol , vol.27 , pp. 4027-4034
    • Mandrekar, S.J.1    Sargent, D.J.2
  • 30
    • 3242679103 scopus 로고    scopus 로고
    • Phase i trial design for solid tumor studies of targeted, non-cytotoxic agents: Theory and practice
    • 1:CAS:528:DC%2BD2cXlsFyisrs%3D 15240782
    • WR Parulekar EA Eisenhauer 2004 Phase I trial design for solid tumor studies of targeted, non-cytotoxic agents: theory and practice J Natl Cancer Inst 96 990 997 1:CAS:528:DC%2BD2cXlsFyisrs%3D 15240782
    • (2004) J Natl Cancer Inst , vol.96 , pp. 990-997
    • Parulekar, W.R.1    Eisenhauer, E.A.2
  • 31
    • 66849118694 scopus 로고    scopus 로고
    • Dose escalation methods in phase i cancer clinical trials
    • 10.1093/jnci/djp079 19436029
    • C Le Tourneau JJ Lee LL Siu 2009 Dose escalation methods in phase I cancer clinical trials J Natl Cancer Inst 101 708 720 10.1093/jnci/djp079 19436029
    • (2009) J Natl Cancer Inst , vol.101 , pp. 708-720
    • Le Tourneau, C.1    Lee, J.J.2    Siu, L.L.3
  • 32
    • 0035253739 scopus 로고    scopus 로고
    • Phase i safety and pharmacokinetic study of recombinant human anti-vascular endothelial growth factor in patients with advanced cancer
    • 1:CAS:528:DC%2BD3MXhtlGrt7k%3D 11157038
    • MS Gordon K Margolin M Talpaz, et al. 2001 Phase I safety and pharmacokinetic study of recombinant human anti-vascular endothelial growth factor in patients with advanced cancer J Clin Oncol 19 843 850 1:CAS:528:DC%2BD3MXhtlGrt7k%3D 11157038
    • (2001) J Clin Oncol , vol.19 , pp. 843-850
    • Gordon, M.S.1    Margolin, K.2    Talpaz, M.3
  • 33
    • 70349115987 scopus 로고    scopus 로고
    • Pharmacokinetics and pharmacodynamic biomarkers in early oncology drug development
    • 10.1016/S0959-8049(09)70080-2 19775662
    • CH Takimoto 2009 Pharmacokinetics and pharmacodynamic biomarkers in early oncology drug development Eur J Cancer 45 Suppl 1 436 438 10.1016/S0959- 8049(09)70080-2 19775662
    • (2009) Eur J Cancer , vol.45 , Issue.SUPPL. 1 , pp. 436-438
    • Takimoto, C.H.1
  • 34
    • 33748652419 scopus 로고    scopus 로고
    • What is the right dose? The elusive optimal biologic dose in phase I clinical trials
    • DOI 10.1200/JCO.2006.07.4658
    • AA Adjei 2006 What is the right dose? The elusive optimal biologic dose in phase I clinical trials J Clin Oncol 24 4054 4055 10.1200/JCO.2006.07.4658 1:CAS:528:DC%2BD28XhtVantbzJ 16943522 (Pubitemid 46622278)
    • (2006) Journal of Clinical Oncology , vol.24 , Issue.25 , pp. 4054-4055
    • Adjei, A.A.1
  • 35
    • 37149030424 scopus 로고    scopus 로고
    • 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)
    • DOI 10.1016/j.ejca.2007.07.034, PII S0959804907005898
    • CM Booth AH Calvert G Giaccone, et al. 2008 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) Eur J Cancer 44 19 24 10.1016/j.ejca.2007. 07.034 1:CAS:528:DC%2BD2sXhsVOrurvP 17890079 (Pubitemid 350256933)
    • (2008) European Journal of Cancer , vol.44 , Issue.1 , pp. 19-24
    • Booth, C.M.1    Calvert, A.H.2    Giaccone, G.3    Lobbezoo, M.W.4    Seymour, L.K.5    Eisenhauer, E.A.6
  • 36
    • 0026572101 scopus 로고
    • The impact of pharmacokinetically guided dose escalation strategies in phase i clinical trials: Critical evaluation and recommendations for future studies
    • 1:STN:280:DyaK38zhtl2jtw%3D%3D 1616887
    • MA Graham P Workman 1992 The impact of pharmacokinetically guided dose escalation strategies in phase I clinical trials: critical evaluation and recommendations for future studies Ann Oncol 3 339 347 1:STN:280: DyaK38zhtl2jtw%3D%3D 1616887
    • (1992) Ann Oncol , vol.3 , pp. 339-347
    • Graham, M.A.1    Workman, P.2
  • 38
    • 17444423346 scopus 로고    scopus 로고
    • Patient motivations surrounding participation in phase I and phase II clinical trials of cancer chemotherapy
    • DOI 10.1038/sj.bjc.6602423
    • ZA Nurgat W Craig NC Campbell, et al. 2005 Patient motivations surrounding participation in phase I and phase II clinical trials of cancer chemotherapy Br J Cancer 92 1001 1005 10.1038/sj.bjc.6602423 1:CAS:528:DC%2BD2MXisVyisbo%3D 15770219 (Pubitemid 40546660)
    • (2005) British Journal of Cancer , vol.92 , Issue.6 , pp. 1001-1005
    • Nurgat, Z.A.1    Craig, W.2    Campbell, N.C.3    Bissett, J.D.4    Cassidy, J.5    Nicolson, M.C.6
  • 39
    • 0029002997 scopus 로고
    • Perceptions of cancer patients and their physicians involved in phase i trials
    • 1:STN:280:DyaK2M3ls12htw%3D%3D 7738612
    • C Daugherty MJ Ratain E Grochowski, et al. 1995 Perceptions of cancer patients and their physicians involved in phase I trials J Clin Oncol 13 1062 1072 1:STN:280:DyaK2M3ls12htw%3D%3D 7738612
    • (1995) J Clin Oncol , vol.13 , pp. 1062-1072
    • Daugherty, C.1    Ratain, M.J.2    Grochowski, E.3
  • 40
    • 76749086583 scopus 로고    scopus 로고
    • Phase i drug combination trial design: Walking the Ttightrope
    • 10.1200/JCO.2009.23.6703 19704054
    • P Hamberg J Verweij 2009 Phase I drug combination trial design: walking the Ttightrope J Clin Oncol 27 4441 4443 10.1200/JCO.2009.23.6703 19704054
    • (2009) J Clin Oncol , vol.27 , pp. 4441-4443
    • Hamberg, P.1    Verweij, J.2
  • 41
    • 76749121924 scopus 로고    scopus 로고
    • Phase i study of C-TPF in patients with locally advanced squamous cell carcinoma of the head and neck
    • 10.1200/JCO.2009.22.1333 1:CAS:528:DC%2BD1MXhtlCnsrfP 19704061
    • RI Haddad RB Tishler C Norris, et al. 2009 Phase I study of C-TPF in patients with locally advanced squamous cell carcinoma of the head and neck J Clin Oncol 27 4448 4453 10.1200/JCO.2009.22.1333 1:CAS:528:DC%2BD1MXhtlCnsrfP 19704061
    • (2009) J Clin Oncol , vol.27 , pp. 4448-4453
    • Haddad, R.I.1    Tishler, R.B.2    Norris, C.3
  • 42
    • 40849111655 scopus 로고    scopus 로고
    • Clinical outcome and prognostic factors for patients treated within the context of a phase I study: The Royal Marsden Hospital experience
    • DOI 10.1038/sj.bjc.6604218, PII 6604218
    • HT Arkenau D Olmos JE Ang, et al. 2008 Clinical outcome and prognostic factors for patients treated within the context of a phase I study: the Royal Marsden Hospital experience Br J Cancer 98 1029 1033 10.1038/sj.bjc.6604218 1:CAS:528:DC%2BD1cXjtlGkt7k%3D 18349817 (Pubitemid 351399798)
    • (2008) British Journal of Cancer , vol.98 , Issue.6 , pp. 1029-1033
    • Arkenau, H.-T.1    Olmos, D.2    Ang, J.E.3    De Bono, J.4    Judson, I.5    Kaye, S.6
  • 44
    • 67650471685 scopus 로고    scopus 로고
    • Inhibition of poly(ADP-ribose) polymerase in tumors from BRCA mutation carriers
    • 10.1056/NEJMoa0900212 1:CAS:528:DC%2BD1MXosVKrtrw%3D 19553641
    • PC Fong DS Boss TA Yap, et al. 2009 Inhibition of poly(ADP-ribose) polymerase in tumors from BRCA mutation carriers N Engl J Med 361 123 134 10.1056/NEJMoa0900212 1:CAS:528:DC%2BD1MXosVKrtrw%3D 19553641
    • (2009) N Engl J Med , vol.361 , pp. 123-134
    • Fong, P.C.1    Boss, D.S.2    Yap, T.A.3
  • 45
    • 70349238733 scopus 로고    scopus 로고
    • Inhibition of the hedgehog pathway in advanced basal-cell carcinoma
    • 10.1056/NEJMoa0905360
    • DD Von Hoff PM LoRusso CM Rudin, et al. 2009 Inhibition of the hedgehog pathway in advanced basal-cell carcinoma N Engl J Med 361 1164 1172 10.1056/NEJMoa0905360
    • (2009) N Engl J Med , vol.361 , pp. 1164-1172
    • Von Hoff, D.D.1    Lorusso, P.M.2    Rudin, C.M.3
  • 46
    • 63749130819 scopus 로고    scopus 로고
    • Phase i study of chidamide (CS055/HBI-8000), a novel histone deacetylase inhibitor, in patients with advanced solid tumors and lymphomas
    • 10.1200/JCO.2008.20.1111 abstract 3529
    • M Dong Z Ning MJ Newman, et al. 2009 Phase I study of chidamide (CS055/HBI-8000), a novel histone deacetylase inhibitor, in patients with advanced solid tumors and lymphomas J Clin Oncol 27 15s 10.1200/JCO.2008.20.1111 abstract 3529
    • (2009) J Clin Oncol , vol.27
    • Dong, M.1    Ning, Z.2    Newman, M.J.3
  • 47
    • 0029841357 scopus 로고    scopus 로고
    • Phase i trial design: Are new methodologies being put into practice?
    • 1:STN:280:DyaK2s%2FjtlOisg%3D%3D 8879368
    • SF Dent EA Eisenhauer 1996 Phase I trial design: are new methodologies being put into practice? Ann Oncol 7 561 566 1:STN:280:DyaK2s%2FjtlOisg%3D%3D 8879368
    • (1996) Ann Oncol , vol.7 , pp. 561-566
    • Dent, S.F.1    Eisenhauer, E.A.2
  • 48
    • 0033973070 scopus 로고    scopus 로고
    • Phase i clinical trial design in cancer drug development
    • 1:CAS:528:DC%2BD3cXht1Kmtbs%3D 10653884
    • EA Eisenhauer PJ O'Dwyer M Christian, et al. 2000 Phase I clinical trial design in cancer drug development J Clin Oncol 18 684 692 1:CAS:528: DC%2BD3cXht1Kmtbs%3D 10653884
    • (2000) J Clin Oncol , vol.18 , pp. 684-692
    • Eisenhauer, E.A.1    O'Dwyer, P.J.2    Christian, M.3
  • 50
    • 0030749549 scopus 로고    scopus 로고
    • Accelerated titration designs for phase i clinical trials in oncology
    • 10.1093/jnci/89.15.1138 1:CAS:528:DyaK2sXls1WnurY%3D 9262252
    • R Simon B Freidlin L Rubinstein, et al. 1997 Accelerated titration designs for phase I clinical trials in oncology J Natl Cancer Inst 89 1138 1147 10.1093/jnci/89.15.1138 1:CAS:528:DyaK2sXls1WnurY%3D 9262252
    • (1997) J Natl Cancer Inst , vol.89 , pp. 1138-1147
    • Simon, R.1    Freidlin, B.2    Rubinstein, L.3
  • 51
    • 0025360796 scopus 로고
    • Pharmacologically guided phase i clinical trials based upon preclinical drug development
    • 10.1093/jnci/82.16.1321 1:STN:280:DyaK3czjvFGjtw%3D%3D 2143234
    • JM Collins CK Grieshaber BA Chabner 1990 Pharmacologically guided phase I clinical trials based upon preclinical drug development J Natl Cancer Inst 82 1321 1326 10.1093/jnci/82.16.1321 1:STN:280:DyaK3czjvFGjtw%3D%3D 2143234
    • (1990) J Natl Cancer Inst , vol.82 , pp. 1321-1326
    • Collins, J.M.1    Grieshaber, C.K.2    Chabner, B.A.3
  • 52
    • 0025148278 scopus 로고
    • Continual reassessment method: A practical design for phase 1 clinical trials in cancer
    • DOI 10.2307/2531628
    • J O'Quigley M Pepe L Fisher 1990 Continual reassessment method: a practical design for phase 1 clinical trials in cancer Biometrics 46 33 48 10.2307/2531628 2350571 (Pubitemid 20245604)
    • (1990) Biometrics , vol.46 , Issue.1 , pp. 33-48
    • O'Quigley, J.1    Pepe, M.2    Fisher, L.3
  • 53
    • 0031920799 scopus 로고    scopus 로고
    • Cancer phase I clinical trials: Efficient dose escalation with overdose control
    • DOI 10.1002/(SICI)1097-0258(19980530)17:10<1103::AID-SIM793>3.0. CO;2-9
    • J Babb A Rogatko S Zacks 1998 Cancer phase I clinical trials: efficient dose escalation with overdose control Stat Med 17 1103 1120 10.1002/(SICI)1097- 0258(19980530)17:10<1103::AID-SIM793>3.0.CO;2-9 1:STN:280: DyaK1c3ot1Cqtg%3D%3D 9618772 (Pubitemid 28221028)
    • (1998) Statistics in Medicine , vol.17 , Issue.10 , pp. 1103-1120
    • Babb, J.1    Rogatko, A.2    Zacks, S.3
  • 54
    • 0031734148 scopus 로고    scopus 로고
    • Phase i trial of O6-benzylguanine for patients undergoing surgery for malignant glioma
    • 1:CAS:528:DyaK1cXnsVOgtrc%3D 9817277
    • HS Friedman DM Kokkinakis J Pluda, et al. 1998 Phase I trial of O6-benzylguanine for patients undergoing surgery for malignant glioma J Clin Oncol 16 3570 3575 1:CAS:528:DyaK1cXnsVOgtrc%3D 9817277
    • (1998) J Clin Oncol , vol.16 , pp. 3570-3575
    • Friedman, H.S.1    Kokkinakis, D.M.2    Pluda, J.3
  • 55
    • 21844458704 scopus 로고    scopus 로고
    • Dose escalation trial designs based on a molecularly targeted endpoint
    • DOI 10.1002/sim.2102
    • S Hunsberger LV Rubinstein J Dancey, et al. 2005 Dose escalation trial designs based on a molecularly targeted endpoint Stat Med 24 2171 2181 10.1002/sim.2102 15909289 (Pubitemid 40960214)
    • (2005) Statistics in Medicine , vol.24 , Issue.14 , pp. 2171-2181
    • Hunsberger, S.1    Rubinstein, L.V.2    Dancey, J.3    Korn, E.L.4
  • 56
    • 39849090451 scopus 로고    scopus 로고
    • Two-stage designs for dose-finding trials with a biologic endpoint using stepwise tests
    • DOI 10.1111/j.1541-0420.2007.00827.x
    • MY Polley YK Cheung 2008 Two-stage designs for dose-finding trials with a biologic endpoint using stepwise tests Biometrics 64 232 241 10.1111/j.1541-0420.2007.00827.x 17573866 (Pubitemid 351316860)
    • (2008) Biometrics , vol.64 , Issue.1 , pp. 232-241
    • Polley, M.-Y.1    Cheung, Y.K.2
  • 57
    • 33745956991 scopus 로고    scopus 로고
    • An adaptive dose-finding design incorporating both toxicity and efficacy
    • DOI 10.1002/sim.2325
    • W Zhang DJ Sargent S Mandrekar 2006 An adaptive dose-finding design incorporating both toxicity and efficacy Stat Med 25 2365 2383 10.1002/sim.2325 16220478 (Pubitemid 44057044)
    • (2006) Statistics in Medicine , vol.25 , Issue.14 , pp. 2365-2383
    • Zhang, W.1    Sargent, D.J.2    Mandrekar, S.3
  • 58
    • 4444272419 scopus 로고    scopus 로고
    • Dose-finding based on efficacy-toxicity trade-offs
    • DOI 10.1111/j.0006-341X.2004.00218.x
    • PF Thall JD Cook 2004 Dose-finding based on efficacy-toxicity trade-offs Biometrics 60 684 693 10.1111/j.0006-341X.2004.00218.x 15339291 (Pubitemid 39181113)
    • (2004) Biometrics , vol.60 , Issue.3 , pp. 684-693
    • Thall, P.F.1    Cook, J.D.2
  • 59
    • 34248324496 scopus 로고    scopus 로고
    • An adaptive phase I design for identifying a biologically optimal dose for dual agent drug combinations
    • DOI 10.1002/sim.2707
    • SJ Mandrekar Y Cui DJ Sargent 2007 An adaptive phase I design for identifying a biologically optimal dose for dual agent drug combinations Stat Med 26 2317 2330 10.1002/sim.2707 17016867 (Pubitemid 46730251)
    • (2007) Statistics in Medicine , vol.26 , Issue.11 , pp. 2317-2330
    • Mandrekar, S.J.1    Cui, Y.2    Sargent, D.J.3
  • 60
    • 33748795036 scopus 로고    scopus 로고
    • Bayesian dose-finding in phase I/II clinical trials using toxicity and efficacy odds ratios
    • DOI 10.1111/j.1541-0420.2006.00534.x
    • G Yin Y Li Y Ji 2006 Bayesian dose-finding in phase I/II clinical trials using toxicity and efficacy odds ratios Biometrics 62 777 787 10.1111/j.1541-0420.2006.00534.x 16984320 (Pubitemid 44410635)
    • (2006) Biometrics , vol.62 , Issue.3
    • Yin, G.1    Li, Y.2    Ji, Y.3
  • 61
    • 0041833622 scopus 로고    scopus 로고
    • Dose-finding with two agents in Phase I oncology trials
    • DOI 10.1111/1541-0420.00058
    • PF Thall RE Millikan P Mueller, et al. 2003 Dose-finding with two agents in Phase I oncology trials Biometrics 59 487 496 10.1111/1541-0420.00058 14601749 (Pubitemid 37093387)
    • (2003) Biometrics , vol.59 , Issue.3 , pp. 487-496
    • Thall, P.F.1    Millikan, R.E.2    Mueller, P.3    Lee, S.-J.4
  • 62
    • 34547659861 scopus 로고    scopus 로고
    • A parallel phase I/II clinical trial design for combination therapies
    • DOI 10.1111/j.1541-0420.2006.00685.x
    • X Huang S Biswas Y Oki, et al. 2007 A parallel phase I/II clinical trial design for combination therapies Biometrics 63 429 436 10.1111/j.1541-0420.2006. 00685.x 1:CAS:528:DC%2BD2sXhtVCqs7%2FE 17688495 (Pubitemid 47222559)
    • (2007) Biometrics , vol.63 , Issue.2
    • Huang, X.1    Biswas, S.2    Oki, Y.3    Issa, J.-P.4    Berry, D.A.5
  • 63
    • 58749104211 scopus 로고    scopus 로고
    • Sequential continual reassessment method for two-dimensional dose finding
    • 10.1002/sim.3372 18618901
    • Y Yuan G Yin 2008 Sequential continual reassessment method for two-dimensional dose finding Stat Med 27 5664 5678 10.1002/sim.3372 18618901
    • (2008) Stat Med , vol.27 , pp. 5664-5678
    • Yuan, Y.1    Yin, G.2
  • 64
    • 70349251729 scopus 로고    scopus 로고
    • Latent contingency table approach to dose finding for combinations of two agents
    • 10.1111/j.1541-0420.2008.01119.x 18759848
    • G Yin YA Yuan 2009 Latent contingency table approach to dose finding for combinations of two agents Biometrics 65 866 875 10.1111/j.1541-0420.2008.01119. x 18759848
    • (2009) Biometrics , vol.65 , pp. 866-875
    • Yin, G.1    Yuan, Y.A.2
  • 65
    • 77952967060 scopus 로고    scopus 로고
    • Utility-based optimization of combination therapy using ordinal toxicity and efficacy in phase I/II trials
    • 10.1111/j.1541-0420.2009.01302.x 19673865
    • N Houede PF Thall H Nguyen, et al. 2009 Utility-based optimization of combination therapy using ordinal toxicity and efficacy in phase I/II trials Biometrics 10.1111/j.1541-0420.2009.01302.x 19673865
    • (2009) Biometrics
    • Houede, N.1    Thall, P.F.2    Nguyen, H.3
  • 66
    • 49249113717 scopus 로고    scopus 로고
    • Challenges and pitfalls of combining targeted agents in phase i studies
    • 10.1200/JCO.2008.17.2676 1:CAS:528:DC%2BD1cXhtVGjs7zL 18669449
    • SA Cannistra 2008 Challenges and pitfalls of combining targeted agents in phase I studies J Clin Oncol 26 3665 3667 10.1200/JCO.2008.17.2676 1:CAS:528:DC%2BD1cXhtVGjs7zL 18669449
    • (2008) J Clin Oncol , vol.26 , pp. 3665-3667
    • Cannistra, S.A.1


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