Specifications of a continual reassessment method design for phase i trials of combined drugs

Pharmaceutical Statistics

Volumn 12, Issue 4, 2013, Pages 217-224

  Wages, Nolan A ^a   Conaway, Mark R ^a  

^a UNIVERSITY OF VIRGINIA   (United States)

Author keywords

continual reassessment method; dose finding; drug combination; maximum tolerated dose; partial ordering; phase I trials

Indexed keywords

CARBOPLATIN; PACLITAXEL;

AREA UNDER THE CURVE; ARTICLE; CLINICAL TRIAL (TOPIC); CONTINUAL REASSESSMENT METHOD; DOSE RESPONSE; DRUG DOSE ESCALATION; DRUG FORMULATION; DRUG SAFETY; DRUG TOLERABILITY; HUMAN; MAXIMUM TOLERATED DOSE; SIMULATION; STATISTICAL ANALYSIS; STUDY DESIGN;

CONTINUAL REASSESSMENT METHOD; DOSE FINDING; DRUG COMBINATION; MAXIMUM TOLERATED DOSE; PARTIAL ORDERING; PHASE I TRIALS;

ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CLINICAL TRIALS, PHASE I AS TOPIC; DOSE-RESPONSE RELATIONSHIP, DRUG; HUMANS; MAXIMUM TOLERATED DOSE; MODELS, THEORETICAL; RESEARCH DESIGN;

EID: 84880038586     PISSN: 15391604     EISSN: 15391612     Source Type: Journal    
DOI: 10.1002/pst.1575     Document Type: Article

References (17)

1. Wages NA, Conaway MR, O'Quigley J,. Continual reassessment method for partial ordering. Biometrics 2011a; 67: 1555-1563.
2. O'Quigley J, Pepe M, Fisher L,. Continual reassessment method: a practical design for phase I clinical trials in cancer. Biometrics 1990; 46: 33-48.
3. Conaway MR, Dunbar S, Peddada S,. Designs for single-or multiple-agent phase I trials. Biometrics 2004; 60: 661-69.
4. Yin G, Yuan Y,. Bayesian dose finding for drug combinations by copula regression. Journal of the Royal Statistical Society 2009a; 58 (2): 211-224.
5. Yin G, Yuan Y,. A latent contingency table approach to dose-finding for combinations of two agents. Biometrics 2009b; 65: 866-875.
6. Wages NA, Conaway MR, O'Quigley J,. Dose-finding design for multi-drug combinations. Clinical Trials 2011; 8 (4): 380-389.
7. Patnaik A, Warner E, Michael M, Egorin M, Moore M, Siu L, Fracasso P, Rivkin S, Kerr I, Litchman M, Oza A,. Phase I dose-finding and pharmacokinetic study of paclitaxel and carboplatin with oral valspodar in patients with advanced solid tumors. Journal of the National Cancer Institute 2000; 18: 3677-3689.
8. Berenson JR, Yellin O, Patel R, Duvivier H, Nassir Y, Mapes R, Abaya CD, Swift RA,. A phase I study of Samarium Lexidronam/Bortezomib combination therapy for the treatment of relapsed or refractory multiple myeloma. Clinical Cancer Research 2009; 15 (3): 1069-75.
9. Ranson M, Middleton MR, Bridgewater J, Lee SM, Dawson M, Jowle D, Halbert G, Waller S, McGrath H, Gumbrell L, McElhinney RS, Donnelly D, McMurry TBH, Margison GP,. Lomeguatrib, a potent inhibitor of -Alkylguanine- DNAAlkyltransferase: phase I safety, pharmacodynamic, and pharmacokinetic trial and evaluation in combination with Temozolomide in patients with advanced solid tumors. Clinical Cancer Research 2006; 12: 1577-1584.
10. Wages NA, Conaway MR, O'Quigley J,. Using the time-to-event continual reassessment method in the presence of partial orders. Statistics in Medicine 2013; 32: 131-141.
11. O'Quigley J, Zohar S,. Retrospective robustness of the continual reassessment method. Journal of Biopharmaceutical Statistics 2010; 5: 1013-1025.
12. Lee SM, Cheung YK,. Model calibration in the continual reassessment method. Clinical Trials 2009; 6: 227-238.
13. Shen LZ, O'Quigley J,. Consistency of continual reassessment method under model misspecification. Biometrika 1996; 83: 395-405.
14. Heyd J, Carlin B,. Adaptive design improvements in the continual reassessment method for phase I studies. Statistics in Medicine 1999; 18: 1307-21.
15. O'Quigley J, Reiner E,. A stopping rule for the continual reassessment method. Biometrika 1998; 85: 741-748.
16. Korn EL, Midthune D, Chen TT, Rubinstien VR, Christian MC, Simon R,. A comparison of two phase I trial designs. Statistics in Medicine 1995; 15: 1799-1806.
17. O'Quigley J, Paoletti X, Maccario J,. Non-parametric optimal design in dose finding studies. Biostatistics 2002; 3 (1): 51-56.