Phase 0 clinical chemoprevention trial of the Akt inhibitor SR13668

Cancer Prevention Research

Volumn 4, Issue 3, 2011, Pages 347-353

  Reid, Joel M ^a   Walden, Chad A ^a   Qin, Rui ^a   Allen Ziegler, Katie L ^a   Haslam, John L ^b   Rajewski, Roger A ^b   Warndahl, Roger ^a   Fitting, Cindy L ^a   Boring, Daniel ^c   Szabo, Eva ^c   Crowell, James ^c   Perloff, Marjorie ^c   Jong, Ling ^d   Bauer, Brent A ^a   Mandrekar, Sumithra J ^a   Ames, Matthew M ^a   Limburg, Paul J ^a  

^a MAYO CLINIC CANCER CENTER   (United States)

^b UNIVERSITY OF KANSAS   (United States)

^c NATIONAL CANCER INSTITUTE   (United States)

^d SRI INTERNATIONAL   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANTINEOPLASTIC AGENT; PROTEIN KINASE B INHIBITOR; SR 13668; UNCLASSIFIED DRUG;

ADULT; ALANINE AMINOTRANSFERASE BLOOD LEVEL; AREA UNDER THE CURVE; ARTICLE; CANCER PREVENTION; CONTROLLED STUDY; DRUG BIOAVAILABILITY; DRUG FORMULATION; DRUG HALF LIFE; DRUG SAFETY; DRUG SOLUBILITY; FEMALE; HUMAN; HUMAN EXPERIMENT; HYPERGLYCEMIA; LYMPHOCYTE; MALE; MAXIMUM PLASMA CONCENTRATION; NAUSEA; NORMAL HUMAN; OUTCOME ASSESSMENT; PLASMA CONCENTRATION-TIME CURVE; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; STUDY DESIGN;

ADULT; ANTICARCINOGENIC AGENTS; AREA UNDER CURVE; CARBAZOLES; CHEMOPREVENTION; DOSE-RESPONSE RELATIONSHIP, DRUG; FEMALE; FOLLOW-UP STUDIES; HUMANS; MALE; MEDICAL ONCOLOGY; MIDDLE AGED; NEOPLASMS; PROTO-ONCOGENE PROTEINS C-AKT; TREATMENT OUTCOME;

EID: 79955876707     PISSN: 19406207     EISSN: 19406215     Source Type: Journal    
DOI: 10.1158/1940-6207.CAPR-10-0313     Document Type: Article

References (19)

1. Grabowski HG, Moe JL. Impact of economic, regulatory, and patent policies on innovation in cancer chemoprevention. Cancer Prev Res. 2008;1:84-90.
2. Guidance for industry, investigators and reviewers: Exploratory IND studies. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER); 2006.
3. Chinni SR, Sarkar FH. Akt inactivation is a key event in indole-3-carbinol-induced apoptosis in PC-3 cells. Clin Cancer Res 2002;8:1228-36. (Pubitemid 35177379)
4. Balsara BR, Pei J, Mitsuuchi Y, Page R, Klein-Szanto A, Wang H, et al. Frequent activation of AKT in non-small cell lung carcinomas and preneoplastic bronchial lesions. Carcinogenesis 2004;25:2053-9. (Pubitemid 39534841)
5. Roy HK, Olusola BF, Clemens DL, Karolski WJ, Ratashak A, Lynch HT, et al. AKT proto-oncogene overexpression is an early event during sporadic colon carcinogenesis. Carcinogenesis 2002;23:201-5. (Pubitemid 34213570)
6. Rahman KW, Sarkar FH. Inhibition of nuclear translocation of nuclear factor-κB contributes to 3,3′-diindolylmethane-induced apoptosis in breast cancer cells. Cancer Res 2005;65:364-71. (Pubitemid 40070830)
7. Chao WR, Yean D, Amin K, Green C, Jong L. Computer-aided rational drug design: a novel agent (SR13668) designed to mimic the unique anticancer mechanisms of dietary indole-3-carbinol to block Akt signaling. J Med Chem 2007;50:3412-5. (Pubitemid 47195447)
8. Doppalapudi RS, Riccio ES, Rausch LL, Shimon JA, Lee PS, Mortelmans KE, et al. Evaluation of chemopreventive agents for genotoxic activity. Mutat Res 2007;629:148-60. (Pubitemid 46603083)
9. Green CE, Swezey R, Bakke J, Shinn W, Furimsky A, Bejugam N, et al. Improved oral bioavailability in rats of Sr13668, a novel anti-cancer agent. Cancer Chemother Pharmacol 2010.
10. Kapetanovic IM, Muzzio M, Hu SC, Crowell JA, Rajewski RA, Haslam JL, et al. Pharmacokinetics and enhanced bioavailability of candidate cancer preventive agent, SR13668 in dogs and monkeys. Cancer Chemother Pharmacol 2010;65:1109-16.
11. Amidon GL, Lennernäs H, Shah VP, Crison JR. A theoretical basis for biopharmaceutic drug classificaiton: the correlation of in vitro drug product dissolution and in vivo bioavailability. Pharm Res 1995;12:413-20.
12. Guidance for industry: Food-effect bioavailability and fed bioequivalence studies. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER); 2002.
13. Chen Y, Reid JM, Nelson AD, Ames MM, Limburg PJ. Quantification of a chemoprevention agent SR16668 in human plasma by high-performance liquid chromotography with fluorescence detection. 100th AACR Annual Meeting. Denver, CO, 2009.
14. Porter CJ, Pouton CW, Cuine JF, Charman WN. Enhancing intestinal drug solubilisation using lipid-based delivery systems. Adv Drug Deliv Rev 2008;60:673-91.
15. Kummar S, Kinders R, Gutierrez MZ, Rubinstein L, Parchment RE, Phillips LR, et al. Phase 0 clinical trial of poly (ADP-ribos) polymerase inhibitor ABT-888 in patients with advanced malignancies. J Clin Oncol 2009;27:2705-11.
16. Kummar S, Kinders R, Rubinstein L, Parchment RE, Murgo AJ, Collins J, et al. Compressing drug development timelines in oncology using phase '0' trials. Nat Rev Cancer 2007;7:131-9.
17. Rubinstein LV, Steinberg SM, Kummar S, Kinders R, Parchment RE, Murgo AJ, et al. The statistics of phase 0 trials. Stat Med 2010;29:1072-6.
18. West KA, Brognard J, Clark AS, Linnoila IR, Yang X, Swain SM, et al. Rapid Akt activation by nicotine and a tobacco carcinogen modulates the phenotype of normal human airway epithelial cells. J Clin Invest 2003;111:81-90. (Pubitemid 36134851)
19. Murgo AJ, Kummar S, Rubinstein L, Gutierrez M, Collins J, Kinders R, et al. Designing phase 0 cancer clinical trials. Clin Cancer Res 2008;14:3675-82.