Phase II study of single-agent orteronel (TAK-700) in patients with nonmetastatic castration-resistant prostate cancer and rising prostate-specific antigen

Clinical Cancer Research

Volumn 20, Issue 16, 2014, Pages 4218-4227

  Hussain, Maha ^a   Corn, Paul G ^b   Michaelson, M Dror ^c   Hammers, Hans J ^f   Alumkal, Joshi J ^g   Ryan, Charles J ^h   Bruce, Justine Y ⁱ   Moran, Susan ^d   Lee, Shih Yuan ^d   Lin, H Mark ^e   George, Daniel J ^j  

^a UNIVERSITY OF MICHIGAN COMPREHENSIVE CANCER CENTER   (United States)

^b UNIVERSITY OF TEXAS MD ANDERSON CANCER CENTER   (United States)

^c MASSACHUSETTS GENERAL HOSPITAL CANCER CENTER   (United States)

^d Takeda Pharmaceuticals International Co   (Japan)

^e MILLENNIUM PHARMACEUTICALS INC   (United States)

^f JOHNS HOPKINS UNIVERSITY   (United States)

^g OREGON HEALTH AND SCIENCE UNIVERSITY   (United States)

^h UNIVERSITY OF CALIFORNIA   (United States)

ⁱ UNIVERSITY OF WISCONSIN   (United States)

^j DUKE UNIVERSITY MEDICAL CENTER   (United States)

more..

Author keywords

[No Author keywords available]

Indexed keywords

ASPARTATE AMINOTRANSFERASE; CORTICOSTERONE; CORTICOTROPIN; ORTERONEL; PROSTATE SPECIFIC ANTIGEN; TESTOSTERONE; IMIDAZOLE DERIVATIVE; NAPHTHALENE DERIVATIVE; STEROID 17ALPHA MONOOXYGENASE; TUMOR MARKER;

ADRENAL INSUFFICIENCY; ADULT; AGED; ARTHRALGIA; ARTICLE; BONE DENSITY; BONE TURNOVER; CANCER CHEMOTHERAPY; CANCER GROWTH; CASTRATION RESISTANT PROSTATE CANCER; CHRONIC DRUG ADMINISTRATION; CIRCULATING TUMOR CELL; CLINICAL ARTICLE; CONSTIPATION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; COUGHING; DECREASED APPETITE; DIARRHEA; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG SAFETY; DRUG WITHDRAWAL; DYSGEUSIA; DYSPEPSIA; DYSPNEA; FAINTNESS; FATIGUE; FEASIBILITY STUDY; GASTROINTESTINAL SYMPTOM; HUMAN; HYPERTENSION; HYPERTRANSAMINASEMIA; HYPOKALEMIA; MALE; METASTASIS; MONOTHERAPY; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; NAUSEA; NONMETASTATIC CASTRATION RESISTANT PROSTATE CANCER; PHASE 2 CLINICAL TRIAL; PNEUMONIA; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; QUALITY OF LIFE; TREATMENT OUTCOME; UNSPECIFIED SIDE EFFECT; VOMITING; ANTAGONISTS AND INHIBITORS; BLOOD; CANCER GRADING; CANCER STAGING; CLINICAL TRIAL; DISEASE COURSE; DRUG EFFECTS; FOLLOW UP; MIDDLE AGED; PROGNOSIS; PROSTATIC NEOPLASMS, CASTRATION-RESISTANT; SURVIVAL RATE; TIME; VERY ELDERLY;

AGED; AGED, 80 AND OVER; BONE DENSITY; DISEASE PROGRESSION; FOLLOW-UP STUDIES; HUMANS; IMIDAZOLES; MALE; MIDDLE AGED; NAPHTHALENES; NEOPLASM GRADING; NEOPLASM STAGING; PROGNOSIS; PROSTATE-SPECIFIC ANTIGEN; PROSTATIC NEOPLASMS, CASTRATION-RESISTANT; STEROID 17-ALPHA-HYDROXYLASE; SURVIVAL RATE; TIME FACTORS; TUMOR MARKERS, BIOLOGICAL;

EID: 84905989210     PISSN: 10780432     EISSN: 15573265     Source Type: Journal    
DOI: 10.1158/1078-0432.CCR-14-0356     Document Type: Article

References (32)

1. Attard G, Sarker D, Reid A, Molife R, Parker C, de Bono JS. Improving the outcome of patients with castration-resistant prostate cancer through rational drug development. Br J Cancer 2006;95:767-74. (Pubitemid 44498089)
2. Diaz M, Patterson SG. Management of androgen-independent prostate cancer. Cancer Control 2004;11:364-73. (Pubitemid 39602210)
3. Harris WP, Mostaghel EA, Nelson PS, Montgomery B. Androgen deprivation therapy: progress in understanding mechanisms of resistance and optimizing androgen depletion. Nat Clin Pract Urol 2009;6:76-85.
4. Mellado B, Codony J, Ribal MJ, Visa L, Gascon P. Molecular biology of androgen-independent prostate cancer: the role of the androgen receptor pathway. Clin Transl Oncol 2009;11:5-10.
5. Smith MR, Kabbinavar F, Saad F, Hussain A, Gittelman MC, Bilhartz DL, et al. Natural history of rising serum prostate-specific antigen in men with castrate nonmetastatic prostate cancer. J Clin Oncol 2005;23:2918-25. (Pubitemid 46224110)
6. Smith MR, Cook R, Lee KA, Nelson JB. Disease and host characteristics as predictors of time to first bone metastasis and death in men with progressive castration-resistant nonmetastatic prostate cancer. Cancer 2011;117:2077-85.
7. Smith MR, Saad F, Oudard S, Shore N, Fizazi K, Sieber P, et al. Denosumab and bone metastasis-free survival in men with nonmetastatic castration-resistant prostate cancer: exploratory analyses by baseline prostate-specific antigen doubling time. J Clin Oncol 2013;31:3800-6.
8. Mason MD, Sydes MR, Glaholm J, Langley RE, Huddart RA, Sokal M, et al. Oral sodium clodronate for nonmetastatic prostate cancer-results of a randomized double-blind placebo-controlled trial: Medical Research Council PR04 (ISRCTN61384873). J Natl Cancer Inst 2007;99:765-76. (Pubitemid 47073523)
9. Nelson JB, Love W, Chin JL, Saad F, Schulman CC, Sleep DJ, et al. Phase 3, randomized, controlled trial of atrasentan in patients with nonmetastatic, hormone-refractory prostate cancer. Cancer 2008;113:2478-87.
10. Smith MR, Saad F, Coleman R, Shore N, Fizazi K, Tombal B, et al. Denosumab and bone-metastasis-free survival in men with castration-resistant prostate cancer: results of a phase 3, randomised, placebo-controlled trial. Lancet 2012;379:39-46.
11. Wirth M, Tammela T, Cicalese V, Gomez VF, Delaere K, Miller K, et al. Prevention of bone metastases in patients with high-risk nonmetastatic prostate cancer treated with Zoledronic Acid: efficacy and safety results of the Zometa European Study (ZEUS). Eur Urol. 2014 Feb 20. [Epub ahead of print].
12. Auclerc G, Antoine EC, Caj finger F, Brunet-Pommeyrol A, Agazia C, Khayat D. Management of advanced prostate cancer. Oncologist 2000;5:36-44.
13. Gregory CW, He B, Johnson RT, Ford OH, Mohler JL, French FS, et al. A mechanism for androgen receptor-mediated prostate cancer recurrence after androgen deprivation therapy. Cancer Res 2001;61:4315-9. (Pubitemid 32685750)
14. Miller M. PSA as a treatment marker for prostate cancer? J Natl Cancer Inst 1999;91:1108-10.
15. Potter GA, Barrie SE, Jarman M, Rowlands MG. Novel steroidal inhibitors of human cytochrome P45017 alpha (17 alpha-hydroxylase-C17,20-lyase): potential agents for the treatment of prostatic cancer. J Med Chem 1995;38:2463-71.
16. Yamaoka M, Hara T, Hitaka T, Kaku T, Takeuchi T, Takahashi J, et al. Orteronel (TAK-700), a novel non-steroidal 17,20-lyase inhibitor: effects on steroid synthesis in human and monkey adrenal cells and serum steroid levels in cynomolgus monkeys. J Steroid Biochem Mol Biol 2012;129:115-28.
17. de Bono JS, Logothetis CJ, Molina A, Fizazi K, North S, Chu L, et al. Abiraterone and increased survival in metastatic prostate cancer. N Engl J Med 2011;364:1995-2005.
18. Ryan CJ, Smith MR, de Bono JS, Molina A, Logothetis CJ, de SP, et al. Abiraterone in metastatic prostate cancer without previous chemotherapy. N Engl J Med 2013;368:138-48.
19. Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R, et al. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer 2009;45:228-47.
20. Scher HI, Halabi S, Tannock I, Morris M, Sternberg CN, Carducci MA, et al. Design and end points of clinical trials for patients with progressive prostate cancer and castrate levels of testosterone: recommendations of the Prostate Cancer Clinical Trials Working Group. J Clin Oncol 2008;26:1148-59.
21. Daig I, Heinemann LA, Kim S, Leungwattanakij S, Badia X, Myon E, et al. The Aging Males' Symptoms (AMS) scale: review of its methodological characteristics. Health Qual Life Outcomes 2003;1:77.
22. Heinemann LA, Moore C, Dinger JC, Stoehr D. Sensitivity as outcome measure of androgen replacement: the AMS scale. Health Qual Life Outcomes 2006;4:23.
23. Sharifi N, Gulley JL, Dahut WL. Androgen deprivation therapy for prostate cancer. JAMA 2005;294:238-44. (Pubitemid 41043794)
24. Paller CJ, Carducci MA, Philips GK. Management of bone metastases in refractory prostate cancer-role of denosumab. Clin Interv Aging 2012;7:363-72.
25. Agus D, Stadler W, Shevrin D. Safety, efficacy, and pharmacodynamics of the investigational agent orteronel (TAK-700) in metastatic castration-resistant prostate cancer (mCRPC): Updated data from a phase 1/2 study. J Clin Oncol 31, 2012 (suppl 5; abstr 98).
26. Petrylak D, Gandhi JG, Clark WR, Heath EI, Lin J, Oh WK, et al. A phase I/II study of safety and efficacy of orteronel (TAK-700), an oral, investigational, nonsteroidal 17,20-lyase inhibitor, with docetaxel and prednisone (DP) in metastatic castration-resistant prostate cancer (mCRPC): Updated phase II results. J Clin Oncol 31, 2013 (suppl 6; abstr 59).
27. Dreicer R, MacLean D, Suri A, Stadler WM, Shevrin D, Hart L, et al. Phase I/II trial of orteronel (TAK-700)-an investigational 17,20-lyase inhibitor-in patients with metastatic castration-resistant prostate cancer. Clin Cancer Res 2014;20:1335-44.
28. Dreicer R, Jones R, Oudard S, Efstathiou E, Saad F, De Wit R, et al. Results from a phase 3, randomized, double-blind, multicenter, placebo-controlled trial of orteronel (TAK-700) plus prednisone in patients with metastatic castration-resistant prostate cancer (mCRPC) that has progressed during or following docetaxel-based therapy (ELM-PC 5 trial). J Clin Oncol 32, 2014 (suppl 4; abstr 7).
29. Lu C, Suri A, Prakash S. Application of physiologically based pharmacokinetic modeling and simulation for waiver of orteronel drug-drug interaction trials. International Society for the Study of Xenobiotics (ISSX) Meeting Abstracts 2012 (abstr P90).
30. Banu E, Banu A, Medioni J, Levy E, Thiounn N, Mejean A, et al. Serum PSA half-life as a predictor of survival for hormone-refractory prostate cancer patients: modelization using a standardized set of response criteria. Prostate 2007;67:1543-9. (Pubitemid 47536153)
31. Petrylak DP, Ankerst DP, Jiang CS, Tangen CM, Hussain MH, Lara PN Jr, et al. Evaluation of prostate-specific antigen declines for surrogacy in patients treated on SWOG 99-16. J Natl Cancer Inst 2006;98:516-21. (Pubitemid 43898814)
32. Hussain M, Tangen CM, Higano C, Schelhammer PF, Faulkner J, Crawford ED, et al. Absolute prostate-specific antigen value after androgen deprivation is a strong independent predictor of survival in new metastatic prostate cancer: data from Southwest Oncology Group Trial 9346 (INT-0162). J Clin Oncol 2006;24:3984-90. (Pubitemid 46630748)