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Volumn 69, Issue 5, 2012, Pages 1135-1144

Exposure-response relationship of AMG 386 in combination with weekly paclitaxel in recurrent ovarian cancer and its implication for dose selection

Author keywords

AMG 386; Exposure response analysis; Ovarian cancer; Paclitaxel; Pharmacokinetics; Population pharmacokinetic pharmacodynamic modeling

Indexed keywords

PACLITAXEL; PLACEBO; TREBANANIB; ANTINEOPLASTIC AGENT; HYBRID PROTEIN;

EID: 84862275233     PISSN: 03445704     EISSN: 14320843     Source Type: Journal    
DOI: 10.1007/s00280-011-1787-5     Document Type: Article
Times cited : (39)

References (42)
  • 1
    • 78449284245 scopus 로고    scopus 로고
    • Model-based drug development: Strengths, weaknesses, opportunities, and threats for broad application of pharmacometrics in drug development
    • Wetherington JD, Pfister M, Banfield C, Stone JA, Krishna R, Allerheiligen S, Grasela DM (2010) Model-based drug development: strengths, weaknesses, opportunities, and threats for broad application of pharmacometrics in drug development. J Clin Pharmacol 50:31S-46S
    • (2010) J Clin Pharmacol , vol.50
    • Wetherington, J.D.1    Pfister, M.2    Banfield, C.3    Stone, J.A.4    Krishna, R.5    Allerheiligen, S.6    Grasela, D.M.7
  • 2
  • 3
    • 23844525541 scopus 로고    scopus 로고
    • Objective responses in patients with malignant melanoma or renal cell cancer in early clinical studies do not predict regulatory approval
    • DOI 10.1158/1078-0432.CCR-05-0130
    • Goffin J, Baral S, Tu D, Nomikos D, Seymour L (2005) Objective responses in patients with malignant melanoma or renal cell cancer in early clinical studies do not predict regulatory approval. Clin Cancer Res 11:5928-5934 (Pubitemid 41170322)
    • (2005) Clinical Cancer Research , vol.11 , Issue.16 , pp. 5928-5934
    • Goffin, J.1    Baral, S.2    Tu, D.3    Nomikos, D.4    Seymour, L.5
  • 4
    • 23844469804 scopus 로고    scopus 로고
    • Phase II oncology trials: Let's be positive
    • DOI 10.1158/1078-0432.CCR-05-1046
    • Ratain MJ (2005) Phase II oncology trials: let's be positive. Clin Cancer Res 11:5661-5662 (Pubitemid 41170285)
    • (2005) Clinical Cancer Research , vol.11 , Issue.16 , pp. 5661-5662
    • Ratain, M.J.1
  • 6
    • 35148821353 scopus 로고    scopus 로고
    • Design of phase II cancer trials using a continuous endpoint of change in tumor size: Application to a study of sorafenib and erlotinib in non small-cell lung cancer
    • Karrison TG, Maitland ML, Stadler WM, Ratain MJ (2007) Design of phase II cancer trials using a continuous endpoint of change in tumor size: application to a study of sorafenib and erlotinib in non small-cell lung cancer. J Natl Cancer Inst 99: 1455-1461
    • (2007) J Natl Cancer Inst , vol.99 , pp. 1455-1461
    • Karrison, T.G.1    Maitland, M.L.2    Stadler, W.M.3    Ratain, M.J.4
  • 7
    • 0036840774 scopus 로고    scopus 로고
    • Challenges of PK/PD measurements in modern drug development
    • DOI 10.1016/S0959-8049(02)00395-7, PII S0959804902003957
    • Workman P (2002) Challenges of PK/PD measurements in modern drug development. Eur J Cancer 38:2189-2193 (Pubitemid 35223253)
    • (2002) European Journal of Cancer , vol.38 , Issue.16 , pp. 2189-2193
    • Workman, P.1
  • 10
    • 67651171223 scopus 로고    scopus 로고
    • Elucidation of relationship between tumor size and survival in non-small-cell lung cancer patients can aid early decision making in clinical drug development
    • Wang Y, Sung C, Dartois C, Ramchandani R, Booth BP, Rock E, Gobburu J (2009) Elucidation of relationship between tumor size and survival in non-small-cell lung cancer patients can aid early decision making in clinical drug development. Clin Pharmacol Ther 86:167-174
    • (2009) Clin Pharmacol Ther , vol.86 , pp. 167-174
    • Wang, Y.1    Sung, C.2    Dartois, C.3    Ramchandani, R.4    Booth, B.P.5    Rock, E.6    Gobburu, J.7
  • 11
    • 77953033291 scopus 로고    scopus 로고
    • Relationship between exposure to sunitinib and efficacy and tolerability endpoints in patients with cancer: Results of a pharmacokinetic/pharmacodynamic meta-analysis
    • Houk BE, Bello CL, Poland B, Rosen LS, Demetri GD, Motzer RJ (2010) Relationship between exposure to sunitinib and efficacy and tolerability endpoints in patients with cancer: results of a pharmacokinetic/pharmacodynamic meta-analysis. Cancer Chemother Pharmacol 66:357-371
    • (2010) Cancer Chemother Pharmacol , vol.66 , pp. 357-371
    • Houk, B.E.1    Bello, C.L.2    Poland, B.3    Rosen, L.S.4    Demetri, G.D.5    Motzer, R.J.6
  • 13
    • 78149415046 scopus 로고    scopus 로고
    • Population pharmacokinetic/pharmacodynamic modeling for the time course of tumor shrinkage by motesanib in thyroid cancer patients
    • Lu J-F, Claret L, Sutjandra L, Kuchimanchi M, Melara R, Bruno R, Sun Y-N (2010) Population pharmacokinetic/pharmacodynamic modeling for the time course of tumor shrinkage by motesanib in thyroid cancer patients. Cancer Chemother Pharmacol 66:1151-1158
    • (2010) Cancer Chemother Pharmacol , vol.66 , pp. 1151-1158
    • Lu, J.-F.1    Claret, L.2    Sutjandra, L.3    Kuchimanchi, M.4    Melara, R.5    Bruno, R.6    Sun, Y.-N.7
  • 14
    • 77954867212 scopus 로고    scopus 로고
    • Accessed 24 Aug 2009
    • Guidance for industry end-of-phase 2A meetings (2009). United States Food and Drug Administration. Available at: http://www.fda.gov/downloads/Drugs/ GuidanceComplianceRegulatoryInformation/Guidances/ucm079690.pdf. Accessed 24 Aug 2009
    • (2009) Guidance for Industry End-of-phase 2A Meetings
  • 15
    • 33746551430 scopus 로고    scopus 로고
    • US Food and Drug Administration. US Department of Health and Human Services, Washington
    • US Food and Drug Administration (2006) Critical path opportunities report. US Department of Health and Human Services, Washington
    • (2006) Critical Path Opportunities Report
  • 20
    • 0035886979 scopus 로고    scopus 로고
    • Use of CA-125 to define progression of ovarian cancer in patients with persistently elevated levels
    • Rustin GJ, Marples M, Nelstrop AE, Mahmoudi M, Meyer T (2001) Use of CA-125 to define progression of ovarian cancer in patients with persistently elevated levels. J Clin Oncol 19: 4054-4057 (Pubitemid 32976692)
    • (2001) Journal of Clinical Oncology , vol.19 , Issue.20 , pp. 4054-4057
    • Rustin, G.J.S.1    Marples, M.2    Nelstrop, A.E.3    Mahmoudi, M.4    Meyer, T.5
  • 22
    • 0027049043 scopus 로고
    • Building population pharmacokinetic-pharmacodynamic models. I. Models for covariate effects
    • DOI 10.1007/BF01061469
    • Mandema JW, Verotta D, Sheiner LB (1992) Building population pharmacokinetic-pharmacodynamic models. I. Models for covariate effects. J Pharmacokinet Biopharm 20:511-528 (Pubitemid 23034413)
    • (1992) Journal of Pharmacokinetics and Biopharmaceutics , vol.20 , Issue.5 , pp. 511-528
    • Mandema, J.W.1    Verotta, D.2    Sheiner, L.B.3
  • 23
    • 0016916438 scopus 로고
    • Prediction of creatinine clearance from serum creatinine
    • Cockcroft DW, Gault MH (1976) Prediction of creatinine clearance from serum creatinine. Nephron 16:31-41
    • (1976) Nephron , vol.16 , pp. 31-41
    • Cockcroft, D.W.1    Gault, M.H.2
  • 27
    • 3042572930 scopus 로고    scopus 로고
    • Curtailing the high rate of late-stage attrition of investigational therapeutics against unprecedented targets in patients with lung and other malignancies
    • DOI 10.1158/1078-0432.CCR-040013
    • Rowinsky EK (2004) Curtailing the high rate of late-stage attrition of investigational therapeutics against unprecedented targets in patients with lung and other malignancies. Clin Cancer Res 10:4220s-4226s (Pubitemid 38812450)
    • (2004) Clinical Cancer Research , vol.10 , Issue.12
    • Rowinsky, E.K.1
  • 31
    • 61349174522 scopus 로고    scopus 로고
    • Use of pharmacokinetic/pharmacodynamic modelling for starting dose selection in first-in-human trials of high-risk biologics
    • Agoram BM (2009) Use of pharmacokinetic/pharmacodynamic modelling for starting dose selection in first-in-human trials of high-risk biologics. Br J Clin Pharmacol 67:153-160
    • (2009) Br J Clin Pharmacol , vol.67 , pp. 153-160
    • Agoram, B.M.1
  • 32
    • 41549136895 scopus 로고    scopus 로고
    • PK/PD modelling and simulations: Utility in drug development
    • Rajman I (2008) PK/PD modelling and simulations: utility in drug development. Drug Discov Today 13:341-346
    • (2008) Drug Discov Today , vol.13 , pp. 341-346
    • Rajman, I.1
  • 33
    • 76749161498 scopus 로고    scopus 로고
    • Phase i oncology studies: Evidence that in the era of targeted therapies patients on lower doses do not fare worse
    • Jain RK, Lee JJ, Hong D, Markman M, Gong J, Naing A, Wheler J, Kurzrock R (2010) Phase I oncology studies: evidence that in the era of targeted therapies patients on lower doses do not fare worse. Clin Cancer Res 16:1289-1297
    • (2010) Clin Cancer Res , vol.16 , pp. 1289-1297
    • Jain, R.K.1    Lee, J.J.2    Hong, D.3    Markman, M.4    Gong, J.5    Naing, A.6    Wheler, J.7    Kurzrock, R.8
  • 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
    • Adjei AA (2006) What is the right dose? The elusive optimal biologic dose in phase I clinical trials. J Clin Oncol 24:4054-4055 (Pubitemid 46622278)
    • (2006) Journal of Clinical Oncology , vol.24 , Issue.25 , pp. 4054-4055
    • Adjei, A.A.1
  • 35
    • 77649172209 scopus 로고    scopus 로고
    • Pharmacokinetic and pharmacodynamic modeling of an antiinterleukin-6 chimeric monoclonal antibody (siltuximab) in patients with metastatic renal cell carcinoma
    • Puchalski T, Prabhakar U, Jiao Q, Berns B, Davis HM (2010) Pharmacokinetic and pharmacodynamic modeling of an antiinterleukin-6 chimeric monoclonal antibody (siltuximab) in patients with metastatic renal cell carcinoma. Clin Cancer Res 16:1652-1661
    • (2010) Clin Cancer Res , vol.16 , pp. 1652-1661
    • Puchalski, T.1    Prabhakar, U.2    Jiao, Q.3    Berns, B.4    Davis, H.M.5
  • 38
    • 42249093188 scopus 로고    scopus 로고
    • Population pharmacokinetic-pharmacodynamic model of the vascular-disrupting agent 5,6-dimethylxanthenone-4-acetic acidin cancer patients
    • DOI 10.1158/1078-0432.CCR-07-1475
    • Li J, Jameson MB, Baguley BC, Pili R, Baker SD (2008) Population pharmacokinetic-pharmacodynamic model of the vascular-disrupting agent 5, 6-dimethylxanthenone-4-acetic acid in cancer patients. Clin Cancer Res 14:2102-2110 (Pubitemid 351551122)
    • (2008) Clinical Cancer Research , vol.14 , Issue.7 , pp. 2102-2110
    • Li, J.1    Jameson, M.B.2    Baguley, B.C.3    Pili, R.4    Baker, S.D.5
  • 40
    • 43249124980 scopus 로고    scopus 로고
    • Dose selection in phase i studies: Why we should always go for the top
    • Sleijfer S, Wiemer E (2008) Dose selection in phase I studies: why we should always go for the top. J Clin Oncol 26:1576-1578
    • (2008) J Clin Oncol , vol.26 , pp. 1576-1578
    • Sleijfer, S.1    Wiemer, E.2
  • 41
    • 2942558419 scopus 로고    scopus 로고
    • Maximizing the potential of bevacizumab in cancer treatment
    • DOI 10.1634/theoncologist.9-suppl-1-36
    • Bergsland E, Dickler MN (2004) Maximizing the potential of bevacizumab in cancer treatment. Oncologist 9(Suppl 1):36-42 (Pubitemid 38747846)
    • (2004) Oncologist , vol.9 , Issue.SUPPL. 1 , pp. 36-42
    • Bergsland, E.1    Dickler, M.N.2
  • 42
    • 77949873040 scopus 로고    scopus 로고
    • Applying physiological and biochemical concepts to optimize biological drug development
    • Lowe PJ (2010) Applying physiological and biochemical concepts to optimize biological drug development. Clin Pharmacol Ther 87:492-496
    • (2010) Clin Pharmacol Ther , vol.87 , pp. 492-496
    • Lowe, P.J.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.