Randomized, double-blind, placebo-controlled phase III study of tasquinimod in men with metastatic castration-resistant prostate cancer

Journal of Clinical Oncology

Volumn 34, Issue 22, 2016, Pages 2636-2643

  Sternberg, Cora ^a   Armstrong, Andrew ^b   Pili, Roberto ^c   Ng, Siobhan ^d   Huddart, Robert ^e   Agarwal, Neeraj ^h   Khvorostenko, Denis ⁱ   Lyulko, Olexiy ^j   Brize, Arija ^k   Vogelzang, Nicholas ^l   Delva, Rémy ^m   Harza, Mihai ^o   Thanos, Anastasios ^p   James, Nicholas ^f   Werbrouck, Patrick ^q   Bögemann, Martin ^r   Hutson, Thomas ^s   Milecki, Piotr ^t   Chowdhury, Simon ^g   Gallardo, Enrique ^u   Schwartsmann, Gilberto ^v   Pouget, Jean Christophe ⁿ   Baton, Frédérique ⁿ   Nederman, Thore ^w   Tuvesson, Helen ^w   Carducci, Michael ^x   more..

^a SAN CAMILLO FORLANINI HOSPITAL   (Italy)

^b DUKE CANCER INSTITUTE   (United States)

^c INDIANA UNIVERSITY SCHOOL OF MEDICINE   (United States)

^d St John of God Medical Centre   (Australia)

^e ROYAL MARSDEN HOSPITAL   (United Kingdom)

^f QUEEN ELIZABETH HOSPITAL   (United Kingdom)

^g GUY S HOSPITAL   (United Kingdom)

^h UNIVERSITY OF UTAH   (United States)

ⁱ Leningrad Regional Oncology Dispensary   (Russian Federation)

^j Zaporizhzhya Regional Clinical Hospital   (Ukraine)

^k RIGA EAST UNIVERSITY HOSPITAL   (Latvia)

^l Division of Hematology and Medical Oncology   (United States)

^m Centre Régional de Lutte Contre le Cancer   (France)

ⁿ IPSEN   (France)

^o FUNDENI CLINICAL INSTITUTE   (Romania)

^p Agios Savas Anticancer Hospital   (Greece)

^q Groeninge Ziekenhuis   (Belgium)

^r UNIVERSITY HOSPITAL MÜNSTER   (Germany)

^s TEXAS ONCOLOGY   (United States)

^t POZNAN UNIVERSITY OF MEDICAL SCIENCES   (Poland)

^u Servicio de Oncología Médica   (Spain)

^v HOSPITAL DE CLÍNICAS DE PORTO ALEGRE   (Brazil)

^w Active Biotech Research AB   (Sweden)

^x JOHNS HOPKINS UNIVERSITY   (United States)

more..

Author keywords

[No Author keywords available]

Indexed keywords

PLACEBO; TASQUINIMOD; ANTINEOPLASTIC AGENT; QUINOLONE DERIVATIVE;

AGED; ANEMIA; ANGINA PECTORIS; ARTHRALGIA; ASTHENIA; BACKACHE; BONE METASTASIS; CANCER GROWTH; CANCER PAIN; CASTRATION RESISTANT PROSTATE CANCER; CONFERENCE PAPER; CONFIDENCE INTERVAL; CONSTIPATION; CONTROLLED STUDY; CORONARY ARTERY DISEASE; DECREASED APPETITE; DEEP VEIN THROMBOSIS; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG EXPOSURE; DRUG FATALITY; DRUG SAFETY; FATIGUE; HAZARD RATIO; HEART FAILURE; HEART INFARCTION; HUMAN; HUMAN TISSUE; KARNOFSKY PERFORMANCE STATUS; MAJOR CLINICAL STUDY; MALE; METASTATIC CASTRATION RESISTANT PROSTATE CANCER; NAUSEA; PERICARDIAL EFFUSION; PERICARDITIS; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; VASCULAR DISEASE; VERY ELDERLY; VISCERAL METASTASIS; WEIGHT REDUCTION; CLINICAL TRIAL; METASTASIS; MIDDLE AGED; MORTALITY; PATHOLOGY; PROSTATIC NEOPLASMS, CASTRATION-RESISTANT;

AGED; AGED, 80 AND OVER; ANTINEOPLASTIC AGENTS; DOUBLE-BLIND METHOD; HUMANS; MALE; MIDDLE AGED; NEOPLASM METASTASIS; PROSTATIC NEOPLASMS, CASTRATION-RESISTANT; QUINOLONES;

EID: 84979642548     PISSN: 0732183X     EISSN: 15277755     Source Type: Journal    
DOI: 10.1200/JCO.2016.66.9697     Document Type: Conference Paper

References (28)

1. Beer TM, Armstrong AJ, Rathkopf DE, et al: Enzalutamide in metastatic prostate cancer before chemotherapy. N Engl J Med 371:424-433, 2014
2. de Bono JS, Oudard S, Ozguroglu M, et al: Prednisone plus cabazitaxel or mitoxantrone for metastatic castration-resistant prostate cancer progressing after docetaxel treatment: A randomised open-label trial. Lancet 376:1147-1154, 2010
3. de Bono JS, Logothetis CJ, Molina A, et al: Abiraterone and increased survival in metastatic prostate cancer. N Engl J Med 364:1995-2005, 2011
4. Kantoff PW, Higano CS, Shore ND, et al: Sipuleucel-T immunotherapy for castration-resistant prostate cancer. N Engl J Med 363:411-422, 2010
5. Parker C, Nilsson S, Heinrich D, et al: Alpha emitter radium-223 and survival in metastatic prostate cancer. N Engl J Med 369:213-223, 2013
6. Ryan CJ, Smith MR, de Bono JS, et al: Abiraterone in metastatic prostate cancer without previous chemotherapy. N Engl J Med 368:138-148, 2013
7. Scher HI, Halabi S, Tannock I, 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 26: 1148-1159, 2008
8. Sounni NE, Noel A: Targeting the tumor microenvironment for cancer therapy. Clin Chem 59: 85-93, 2013
9. Ganguly SS, Li X, Miranti CK: The host microenvironment influences prostate cancer invasion, systemic spread, bone colonization, and osteoblastic metastasis. Front Oncol 4:364, 2014
10. Clarke JM, Armstrong AJ: Novel therapies for the treatment of advanced prostate cancer. Curr Treat Options Oncol 14:109-126, 2013
11. Gupta N, Al Ustwani O, Shen L, et al: Mechanism of action and clinical activity of tasquinimod in castrate-resistant prostate cancer. Onco Targets Ther 7:223-234, 2014
12. Raymond E, Dalgleish A, Damber JE, et al: Mechanisms of action of tasquinimod on the tumour microenvironment. Cancer Chemother Pharmacol 73:1-8, 2014
13. Shen L, Sundstedt A, Ciesielski M, et al: Tasquinimod modulates suppressive myeloid cells and enhances cancer immunotherapies in murine models. Cancer Immunol Res 3:136-148, 2015
14. Isaacs JT, Antony L, Dalrymple SL, et al: Tasquinimod is an allosteric modulator of HDAC4 survival signaling within the compromised cancer microenvironment. Cancer Res 73:1386-1399, 2013
15. Pili R, Häggman M, Stadler WM, et al: Phase II randomized, double-blind, placebo-controlled study of tasquinimod in men with minimally symptomatic metastatic castrate-resistant prostate cancer. J Clin Oncol 29:4022-4028, 2011
16. Armstrong AJ, Häggman M, Stadler WM, et al: Long-term survival and biomarker correlates of tasquinimod efficacy in a multicenter randomized study of men with minimally symptomatic metastatic castration-resistant prostate cancer. Clin Cancer Res 19:6891-6901, 2013
17. Scher HI, Fizazi K, Saad F, et al: Increased survival with enzalutamide in prostate cancer after chemotherapy. N Engl J Med 367:1187-1197, 2012
18. Bratt O, Häggman M, Ahlgren G, et al: Openlabel, clinical phase I studies of tasquinimod in patients with castration-resistant prostate cancer. Br J Cancer 101:1233-1240, 2009
19. Eisenhauer EA, Therasse P, Bogaerts J, et al: New response evaluation criteria in solid tumours: Revised RECIST guideline (version 1.1). Eur J Cancer 45:228-247, 2009
20. Lan KKG, Demets DL: Discrete sequential boundaries for clinical trials. Biometrika 70:659-663, 1983
21. Brookmeyer R, Crowley J: A confidence interval for the median survival time. Biometrics 38:29-41, 1982
22. Morris MJ, Molina A, Small EJ, et al: Radiographic progression-free survival as a response biomarker in metastatic castration-resistant prostate cancer: COU-AA- 302 results. J Clin Oncol 33:1356-1363, 2015
23. Armstrong AJ, Halabi S: Making progress on progression in metastatic prostate cancer. J Clin Oncol 33:1322-1324, 2015
24. Fizazi K, Jones R, Oudard S, et al: Phase III, randomized, double-blind, multicenter trial comparing orteronel (TAK-700) plus prednisone with placebo plus prednisone in patients withmetastatic castration-resistant prostate cancer that has progressed during or after docetaxel-based therapy: ELM-PC 5. J Clin Oncol 33:723-731, 2015
25. Kelly WK, Halabi S, Carducci M, et al: Randomized, double-blind, placebo-controlled phase III trial comparing docetaxel and prednisone with or without bevacizumab in men with metastatic castration-resistant prostate cancer: CALGB 90401. J Clin Oncol 30:1534-1540, 2012
26. Michaelson MD, Oudard S, Ou YC, et al: Randomized, placebo-controlled, phase III trial of sunitinib plus prednisone versus prednisone alone in progressive, metastatic, castration-resistant prostate cancer. J Clin Oncol 32:76-82, 2014
27. Crawford ED, Higano CS, Shore ND, et al: Treating patients with metastatic castration resistant prostate cancer: A comprehensive review of available therapies. J Urol 194:1537-1547, 2015
28. Olsson A, Björk A, Vallon-Christersson J, et al: Tasquinimod (ABR-215050), a quinoline-3-carboxamide anti-angiogenic agent, modulates the expression of thrombospondin-1 in human prostate tumors. Mol Cancer 9:107, 2010