Efficiency of New Dose Escalation Designs in Dose-Finding Phase I Trials of Molecularly Targeted Agents

PLoS ONE

Volumn 7, Issue 12, 2012, Pages

  Le Tourneau, Christophe ^a   Gan, Hui K ^b   Razak, Albiruni R A ^c   Paoletti, Xavier ^a  

^a INSTITUT CURIE   (France)

^b AUSTIN HOSPITAL   (Australia)

^c PRINCESS MARGARET HOSPITAL   (Canada)

Author keywords

[No Author keywords available]

Indexed keywords

ANTINEOPLASTIC AGENT; VACCINE;

ACCELERATED TITRATION DESIGN; ACCURACY; ALGORITHM; ARTICLE; CANCER GENE THERAPY; CANCER HORMONE THERAPY; CANCER IMMUNOTHERAPY; CLINICAL TRIAL (TOPIC); CONTROLLED STUDY; DOSE ESCALATION METHOD; DRUG DOSE; DRUG RESEARCH; HUMAN; INTERMETHOD COMPARISON; MAXIMUM TOLERATED DOSE; MODIFIED CONTINUAL REASSESSMENT METHOD; PHARMACOLOGICALLY GUIDED DOSE ESCALATION; PHASE 1 CLINICAL TRIAL (TOPIC);

ALGORITHMS; CLINICAL TRIALS, PHASE I AS TOPIC; DOSE-RESPONSE RELATIONSHIP, DRUG; HUMANS; MAXIMUM TOLERATED DOSE; MODELS, STATISTICAL; NEOPLASMS; RESEARCH DESIGN;

EID: 84871218944     PISSN: None     EISSN: 19326203     Source Type: Journal    
DOI: 10.1371/journal.pone.0051039     Document Type: Article

References (14)

1. Le Tourneau C, Lee JJ, Siu LL, (2009) Dose escalation methods in phase I cancer clinical trials. J Natl Cancer Inst 101: 708-720.
2. Rogatko A, Schoeneck D, Jonas W, Tighiouart M, Khuri FR, et al. (2007) Translation of innovative designs into phase I trials. J Clin Oncol 25: 4982-4986.
3. Iasonos A, Wilton AS, Riedel ER, Seshan VE, Spriggs DR, (2008) A comprehensive comparison of the continual reassessment method to the standard 3+3 dose escalation scheme in phase I dose-finding studies. Clin Trials 5: 465-477.
4. Walling J, Zervos PH, McCarthy S, Rinaldi DA, McDonald A, et al. (1997) Dose escalation methodology in phase I clinical trials: a comparison of the modified continual reassessment method (MCRM) and a traditional method. Experience with the multitargeted antifolate (MTA). Proc Am Soc Clin Oncol (abstract #733).
5. Eckhardt SG, Siu LL, Clark G, DeMoor C, Von Hoff DD, et al. (1999) The continual reassessment method (CRM) for dose escalation in phase I trials in San Antonio does not result in more rapid study completion. Proc Am Soc Clin Oncol (abstract #627).
6. Le Tourneau C, Razak AR, Gan HK, Pop S, Diéras V, et al. (2011) Heterogeneity in the definition of dose-limiting toxicity in phase I cancer clinical trials of molecularly targeted agents. Eur J Cancer 47: 1468-1475.
7. Le Tourneau C, Stathis A, Vidal L, Moore MJ, Siu LL, (2010) Choice of starting dose for molecularly targeted agents evaluated in first-in-human phase I cancer clinical trials. J Clin Oncol 28: 1401-1407.
8. Thall PF, Cook JD, (2004) Dose-finding based on efficacy-toxicity trade-offs. Biometrics 60: 684-693.
9. Zhang W, Sargent DJ, Mandrekar S, (2006) An adaptative dose-finding design incorporating both toxicity and efficacy. Stat Med 25: 2365-2383.
10. Yin G, Li Y, Ji Y, (2006) Bayesian dose-finding in phase I/II clinical trials using toxicity and efficacy odds ratios. Biometrics 62: 777-787.
11. Hunsberger S, Rubinstein LV, Dancey J, Korn EL, (2005) Dose escalation trial designs based on a molecularly targeted endpoint. Stat Med 24: 2171-2181.
12. Cheung YK, Chappell R, (2000) Sequential designs for phase I clinical trials with late-onset toxicities. Biometrics 56: 1177-1182.
13. Postel-Vinay S, Gomez-Roca C, Molife LR, Anghan B, Levy A, et al. (2011) Phase I Trials of Molecularly Targeted Agents: Should We Pay More Attention to Late Toxicities? J Clin Oncol 29: 1728-1735.
14. O'Quigley J, Paoletti X, (2003) Continual reassessment method for ordered groups. Biometrics 59: 430-440.