Target-specific randomized discontinuation trial design: A novel approach in molecular therapeutics

Investigational New Drugs

Volumn 28, Issue 2, 2010, Pages 194-198

  Galsky, Matthew D ^a   Zaks, Tal ^b   Hassani, Habib ^b   Vocila, Linda ^c   Sonpavde, Guru ^a   Hutson, Thomas E ^a   Von Hoff, Daniel D ^a,c  

^a Developmental Therapeutics Committee and Co Chair of the Genitourinary Committee   (United States)

^b GLAXOSMITHKLINE   (United States)

^c TRANSLATIONAL GENOMICS RESEARCH INSTITUTE   (United States)

Author keywords

Clinical trial design; Molecular therapeutics; Randomized discontinuation design; Targeted therapeutics

Indexed keywords

ANTINEOPLASTIC AGENT; EPIDERMAL GROWTH FACTOR RECEPTOR 2; LAPATINIB; PLACEBO;

ADVANCED CANCER; ANTINEOPLASTIC ACTIVITY; CANCER GROWTH; CANCER STAGING; CARCINOGENESIS; CLINICAL TRIAL; CROSSOVER PROCEDURE; CYTOSTASIS; DRUG RESPONSE; DRUG TARGETING; GENE AMPLIFICATION; HISTOPATHOLOGY; HUMAN; MAJOR CLINICAL STUDY; MOLECULAR BIOLOGY; OPEN STUDY; PATIENT SELECTION; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; REVIEW; SOLID TUMOR; STUDY DESIGN;

ANTINEOPLASTIC AGENTS; HUMANS; LIKELIHOOD FUNCTIONS; QUINAZOLINES; RANDOMIZED CONTROLLED TRIALS AS TOPIC;

EID: 77952243964     PISSN: 01676997     EISSN: None     Source Type: Journal    
DOI: 10.1007/s10637-009-9239-3     Document Type: Review

References (19)

1. AW Millar KP Lynch 2003 Rethinking clinical trials for cytostatic drugs Nat Rev 3 540 545 1:CAS:528:DC%2BD3sXltVSqtro%3D
2. MA Cobleigh CL Vogel D Tripathy, et al. 1999 Multinational study of the efficacy and safety of humanized anti-HER2 monoclonal antibody in women who have HER2-overexpressing metastatic breast cancer that has progressed after chemotherapy for metastatic disease J Clin Oncol 17 2639 2648 1:CAS:528:DyaK1MXmtlWrurk%3D 10561337
3. GL Rosner W Stadler MJ Ratain 2002 Randomized discontinuation design: application to cytostatic antineoplastic agents J Clin Oncol 20 4478 4484 10.1200/JCO.2002.11.126 1:CAS:528:DC%2BD38XosFCjs7o%3D 12431972 (Pubitemid 35334760)
4. B Escudier T Eisen WM Stadler, et al. 2007 Sorafenib in advanced clear-cell renal-cell carcinoma N Engl J Med 356 125 134 10.1056/NEJMoa060655 1:CAS:528:DC%2BD2sXksVKitg%3D%3D 17215530 (Pubitemid 46089673)
5. MJ Ratain T Eisen WM Stadler, et al. 2006 Phase II placebo-controlled randomized discontinuation trial of sorafenib in patients with metastatic renal cell carcinoma J Clin Oncol 24 2505 2512 10.1200/JCO.2005.03.6723 1:CAS:528:DC%2BD28XmtVOmtrk%3D 16636341 (Pubitemid 46630627)
6. RH Hardwick NA Shepherd M Moorghen PV Newcomb D Alderson 1995 c-erbB-2 overexpression in the dysplasia/carcinoma sequence of Barrett's oesophagus J Clin Pathol 48 129 132 10.1136/jcp.48.2.129 1:STN:280:DyaK2M3mtlyhug%3D%3D 7745111
7. DJ Hetzel TO Wilson GL Keeney PC Roche SS Cha KC Podratz 1992 HER-2/neu expression: a major prognostic factor in endometrial cancer Gynecol Oncol 47 179 185 10.1016/0090-8258(92)90103-P 1:STN:280:DyaK3s7gs1Cqtg%3D%3D 1361478 (Pubitemid 23001325)
8. H Miyamoto Y Kubota S Noguchi, et al. 2000 C-ERBB-2 gene amplification as a prognostic marker in human bladder cancer Urology 55 679 683 10.1016/S0090-4295(99)00604-4 1:STN:280:DC%2BD3c3ltlCruw%3D%3D 10792078
9. DI Park JW Yun JH Park, et al. 2006 HER-2/neu amplification is an independent prognostic factor in gastric cancer Dig Dis Sci 51 1371 1379 10.1007/s10620-005-9057-1 1:CAS:528:DC%2BD28Xosleqs7Y%3D 16868827 (Pubitemid 44315804)
10. PN Lara Jr FJ Meyers CR Gray, et al. 2002 HER-2/neu is overexpressed infrequently in patients with prostate carcinoma. Results from the California Cancer Consortium Screening Trial Cancer 94 2584 2589 10.1002/cncr.10526 12173324 (Pubitemid 34478071)
11. J Baselga N Rosen 2008 Determinants of RASistance to anti-epidermal growth factor receptor agents J Clin Oncol 26 1582 1584 10.1200/JCO.2007.15.3700 18316790
12. MD Galsky S Mironov A Iasonos J Scattergood MG Boyle DF Bajorin 2007 Phase II trial of pemetrexed as second-line therapy in patients with metastatic urothelial carcinoma Invest New Drugs 25 265 270 10.1007/s10637-006-9020-9 1:CAS:528:DC%2BD2sXltlartrY%3D 17146733 (Pubitemid 46774696)
13. MS Gordon D Matei C Aghajanian, et al. 2006 Clinical activity of pertuzumab (rhuMAb 2C4), a HER dimerization inhibitor, in advanced ovarian cancer: potential predictive relationship with tumor HER2 activation status J Clin Oncol 24 4324 4332 10.1200/JCO.2005.05.4221 1:CAS:528:DC%2BD28XhtVGju7nK 16896006 (Pubitemid 46630791)
14. MH Kulke A Muzikansky J Clark, et al. 2006 A Phase II trial of vinorelbine in patients with advanced gastroesophageal adenocarcinoma Cancer Invest 24 346 350 10.1080/07357900600705268 1:CAS:528:DC%2BD28Xns1Wnu7c%3D 16777685 (Pubitemid 43932677)
15. MH Hussain GR MacVicar DP Petrylak, et al. 2007 Trastuzumab, paclitaxel, carboplatin, and gemcitabine in advanced human epidermal growth factor receptor-2/neu-positive urothelial carcinoma: results of a multicenter phase II National Cancer Institute trial J Clin Oncol 25 2218 2224 10.1200/JCO.2006.08. 0994 1:CAS:528:DC%2BD2sXnsVShtbs%3D 17538166 (Pubitemid 46954646)
16. RG Amado M Wolf M Peeters, et al. 2008 Wild-type KRAS is required for panitumumab efficacy in patients with metastatic colorectal cancer J Clin Oncol 26 1626 1634 10.1200/JCO.2007.14.7116 1:CAS:528:DC%2BD1cXltlWhsrw%3D 18316791
17. IK Mellinghoff MY Wang I Vivanco, et al. 2005 Molecular determinants of the response of glioblastomas to EGFR kinase inhibitors N Engl J Med 353 2012 2024 10.1056/NEJMoa051918 1:CAS:528:DC%2BD2MXht1SrtrrE 16282176 (Pubitemid 41609094)
18. HI Scher MJ Morris WK Kelly LH Schwartz G Heller 2005 Prostate cancer clinical trial end points: "RECIST"ing a step backwards Clin Cancer Res 11 5223 5232 10.1158/1078-0432.CCR-05-0109 16033840 (Pubitemid 41003710)
19. A Sevinc NS Turhal 2008 'Please, desist RECIST criteria in GIST, at least in me' Onkologie 31 556 10.1159/000151688 18854657