`Date Served: May 19, 2017
`
`
`Filed on behalf of: Aventis Pharma S.A.
`
`By:
`
`Dominick A. Conde
`dconde@fchs.com
`(212) 218-2100
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`________________
`
`MYLAN LABORATORIES LIMITED
`Petitioner,
`v.
`AVENTIS PHARMA S.A.
`Patent Owner.
`________________
`
`Case IPR2016-00712
`U.S. Patent No. 8,927,592
`________________
`
`
`
`PATENT OWNER’S EXHIBIT LIST 12
`
`
`
`
`
`
`
`
`
`EXHIBIT LIST 12
`
`Description
`
`
`
`Aventis
`Exhibit No.
`
`2001
`
`June 23, 2016 Declaration of Dr. Oliver Sartor.
`
`2002
`
`Curriculum Vitae of Dr. Oliver Sartor.
`
`2003
`
`A Randomized, Open Label, Phase 3 Study of Larotaxel IV every 3
`
`Weeks Versus Capecitabine (Xeloda) Tablets Twice Daily for 2
`
`Weeks in 3-Week Cycles in Patients with Metastatic Cancer (MBC)
`
`Progressing After Taxanes and Anthracycline Therapy (EFC6089),
`
`available at EFC6089_summary.pdf.
`
`2004
`
`Antonarakis & Eisenberger, Phase III Trials with Docetaxel-Based
`
`Combinations for Metastatic Castration-Resistant Prostate Cancer:
`
`Time to Learn From Past Experiences, 31(14) J. Clin. Oncol. 1709-
`
`12 (2013).
`
`2005
`
`Armstrong & George, New Drug Development in Metastatic
`
`Prostate Cancer, 26(4) Urologic Oncol.: Seminars & Original
`
`Investigations 430-37 (2008).
`
`2006
`
`Beer et al., Double-Blinded Randomized Study of High-Dose
`
`Calcitriol plus Docetaxel Compared with Placebo plus Docetaxel
`
`
`
`1
`
`
`
`
`
`in Androgen-Independent Prostate Cancer: A Report from the
`
`ASCENT Investigators, 25(6) J. Clin. Oncol. 669-74 (2007).
`
`2007
`
`Berry et al., Phase III Study of Mitoxantrone plus Low Dose
`
`Prednisone Versus Low Dose Prednisone Alone in Patients with
`
`Asymptomatic Hormone Refractory Prostate Cancer, 168(6) J.
`
`Urol. 2439-43 (2002).
`
`2008
`
`Bristol-Myers Squibb Reports Results for Phase 3 Trial of Yervoy®
`
`(Ipilimumab) in Previously-Treated Castration Resistant Prostate
`
`Cancer, Business Wire News HQ Press Release (September 12,
`
`2013), available at http://news.bms.com/press-release/rd-
`
`news/Bristol-myers-squibb-reports-results-Phase-3- trial-yervoy-
`
`ipilimumab-previousl.
`
`2009
`
`Cabral, Factors Determining Cellular Mechanisms of Resistance to
`
`Antimitotic Drugs, 4(1) Drug Resistance Updates 3-8 (2001).
`
`2010
`
`Carducci et al., A Phase 3 Randomized Controlled Trial of the
`
`Efficacy and Safety of Atrasentan in Men with Metastatic Hormone-
`
`Refractory Prostate Cancer, 110(9) Cancer 1959-66 (2007).
`
`2011
`
`D'Amico, US Food and Drug Administration Approval of Drugs for
`
`the Treatment of Prostate Cancer: A New Era Has Begun, 32(4) J.
`
`Clin. Oncol. 362-64 (2014).
`
`
`
`2
`
`
`
`December 2013 Yervoy® Label.
`
`Didier, US Patent Application Publication No. 2005/0065138.
`
`Di Lorenzo et al., Combination of Bevacizumab and Docetaxel in
`
`Docetaxel-Pretreated Hormone-Refractory Prostate Cancer: A
`
`Phase 2 Study, 54(5) Eur. Urol. 1089-96 (2008).
`
`
`
`2012
`
`2013
`
`2014
`
`2015
`
`Dieras et al., Phase II Multicenter Study of Larotaxel (XRP9881), a
`
`Novel Taxoid, in Patients with Metastatic Breast Cancer Who
`
`Previously Received Taxane-Based Therapy, 19(7) Annals of
`
`Oncol. 1255-60 (2008).
`
`2016
`
`Dumontet & Sikic, Mechanisms of Action of and Resistance to
`
`Antitubulin Agents: Microtubule Dynamics, Drug Transport, and
`
`Cell Death, 17(3) J. Clin. Oncol. 1061-70 (1999).
`
`2017
`
`Halabi et al., Prostate-Specific Antigen Changes as Surrogate for
`
`Overall Survival in Men with Metastatic Castration-Resistant
`
`Prostate Cancer Treated with Second-Line Chemotherapy, 31(31)
`
`J. Clin. Oncol. 1-9 (2013).
`
`2018
`
`Higano et al., Phase 1/2 Dose-Escalation Study of a GM-CSF-
`
`Secreting, Allogeneic, Cellular Immunotherapy for Metastatic
`
`Hormone-Refractory Prostate Cancer, 113(5) Cancer 975-84
`
`(2008).
`
`
`
`3
`
`
`
`July 2009 Avastin® Label.
`
`Kaur et al., Suramin 's Development: What Did We Learn?, 20(2)
`
`Investigational New Drugs 209-19 (2002).
`
`
`
`2019
`
`2020
`
`2021
`
`Kola & Landis, Can the Pharmaceutical Industry Reduce Attrition
`
`Rates?, 3(8) Nature Revs. Drug Discovery 711-15 (2004).
`
`2022
`
`Larotaxel Every 3 Weeks vs. Capecitabine in Patients with
`
`Metastatic Breast Cancer Progressing After Taxanes and
`
`Anthracycline Therapy, available at
`
`https://clinicaltrials.gov/ct2/show/NCT00081796?term
`
`=larotaxel&rank=7.
`
`2023
`
`Larotaxel plus Cisplatin vs. Gemcitabine plus Cisplatin in First
`
`Line Treatment of Patients with Locally Advanced/Metastatic
`
`Bladder Cancer, available at
`
`https://clinicaltrials.gov/ct2/show/NCT00625664?term=larotaxel&r
`
`ank=4.
`
`2024
`
`Larotaxel vs. 5-FU in Patients with Pancreatic Cancer Previously
`
`Treated with Gemcitabine, available at
`
`https://clinicaltrials.gov/ct2/show/NCT00417209?term=larotaxel&r
`
`ank=2
`
`2025
`
`Mackinnon et al., Molecular Biology Underlying the Clinical
`
`
`
`4
`
`
`
`
`
`Heterogeneity of Prostate Cancer: An Update, 133(7) Arch. Pathol.
`
`Lab. Med. 1033-40 (2009).
`
`2026
`
`Michaelson et al., Randomized, Placebo-Controlled, Phase III Trial
`
`of Sunitinib plus Prednisone Versus Prednisone Alone in
`
`Progressive Metastatic, Castration-Resistant Prostate Cancer,
`
`32(2) J. Clin. Oncol. 76-83 (2014).
`
`2027
`
`Mulcahy, Phase 3 Trial of Immunotherapy for Metastatic Prostate
`
`Cancer Terminated, Medscape (October 17, 2008), available at
`
`http://www.medscape.com/viewarticle/582220_print.
`
`2028
`
`Novacea, Inc. SEC Form 8-K at 1.02 (April 4, 2008), available at
`
`http://www.sec. gov/Archives/edgar/data/1178711/
`
`000119312508077953/d8k.htm.
`
`2029
`
`OncoGenex Announces Top-Line Survival Results of Phase 3
`
`SYNERGY Trial Evaluating Custirsen for Metastatic Castrate-
`
`Resistant Prostate Cancer, Acquire Media Press Release (April 28,
`
`2014), available at http://ir.oncogenex.com/releasedetail.cfm
`
`?ReleaseID=842949.
`
`2030
`
`Ramiah et al., Clinical Endpoints for Drug Development in
`
`Prostate Cancer, 18(3) Curr. Opin. Urol. 303-08 (2008).
`
`2031
`
`Roche Provides Update on Phase III study of Avastin in Men with
`
`
`
`5
`
`
`
`
`
`Late Stage Prostate Cancer, Media Release (March 12, 2010),
`
`http://www.roche.com/media/media_releases/med-cor-2010-03-
`
`12.htm.
`
`2032
`
`Satraplatin in Hormone Refractory Prostate Cancer Patients
`
`Previously Treated with One Cytotoxic Chemotherapy Regimen,
`
`available at https://clinicaltrials.gov/ct2/show/NCT00069745
`
`?term=SPARC&cond=prostate&rank=3.
`
`2033
`
`Slovin et al., Ipilimumab Alone or in Combination with
`
`Radiotherapy in Metastatic Castration-Resistant Prostate Cancer:
`
`Results from an Open-Label, Multicenter Phase I/II Study, 24(7)
`
`Annals of Oncol. 1813-21 (2013).
`
`2034
`
`Small et al., Granulocyte Macrophage Colony-Stimulating Factor
`
`Secreting Allogeneic Cellular Immunotherapy for Hormone-
`
`Refractory Prostate Cancer, 13(13) Clin. Cancer Res. 3883-91
`
`(2007).
`
`2035
`
`Small et al., Randomized Phase II Study Comparing 4 Monthly
`
`Doses of Ipilimumab (MDX-010) as a Single Agent or in
`
`Combination with a Single Dose of Docetaxel in Patients with
`
`Hormone-Refractory Prostate Cancer, 24(18S) J. Clin. Oncol.
`
`(Meeting Abstracts) S4609 (June 2006).
`
`
`
`6
`
`
`
`
`
`2036
`
`Sternberg et al., Larotaxel with Cisplatin in the First-Line
`
`Treatment of Locally Advanced/Metastatic Urothelial Tract or
`
`Bladder Cancer: A Randomized, Active-Controlled, Phase III Trial
`
`(CILAB), 85(4) Oncology 208-15 (2013).
`
`2037
`
`Susman, ASCO: Calcitriol Fails in ASCENT-2 Prostate CA Trial,
`
`MedPage Today (June 9, 2010), available at
`
`http://www.medpagetoday.com/MeetingCoverage/ASCO/20575.
`
`2038
`
`Takeda Announces Termination of Orteronel (TAK-700)
`
`2039
`
`2040
`
`Development for Prostate Cancer in Japan, U.S.A. and Europe,
`
`Takeda Latest News Release (June 19, 2014), available at
`
`http://www.takeda.com/news/2014/20140619_6615.html.
`
`Gupta, US Patent Application Publication No. 2012/0301425.
`
`Van Cutsem et al., A Phase III Study Comparing Larotaxel to 5-FU
`
`(Continuous Intravenous 5-FU or Capecitabine) in Patients with
`
`Advanced Pancreatic Cancer (APC) Previously Treated with a
`
`Gemcitabine Containing Regimen, 21(6S) Annals of Oncol. Oral
`
`Presentations 0-007 (July 2010).
`
`2041
`
`Van Hook et al., Orteronel for the Treatment of Prostate Cancer,
`
`10(5) Future Oncol. 803-11 (2014).
`
`2042
`
`Wiechec & Hansen, The Effect of Genetic Variability on Drug
`
`
`
`7
`
`
`
`
`
`Response in Conventional Breast Cancer Treatment, 625 Eur. J.
`
`Pharmacol. 122-30 (2009).
`
`2043
`
`Williams, Discontinued Drugs in 2008: Oncology Drugs, 18(11)
`
`Expert Opin. Investig. Drugs 1581-94 (2009).
`
`2044
`
`Wirth & Froschermaier, The Antiandrogen Withdrawal Syndrome,
`
`25 (Suppl. 2) Urol. Res. S67-71(1997).
`
`2045
`
`Zatloukal et al., Randomized Multicenter Phase II Study of
`
`Larotaxel (XRP9881) in Combination with Cisplatin or
`
`Gemcitabine as First-Line Chemotherapy in Nonirradiable Stage
`
`IIIB or Stage IV Non-Small Cell Lung Cancer, 3(8) J. Thorac.
`
`Oncol. 894-901 (2008).
`
`2046
`
`Zielinski & Chi, Custirsen (OGX-01 I): A Second-Generation
`
`Antisense Inhibitor of Clusterin in Development for the Treatment
`
`of Prostate Cancer, 8(10) Future Oncol. 1239-51 (2012).
`
`American Cancer Society, Cancer Facts & Figures 2009.
`
`Baselga et al., Phase II Study of Efficacy, Safety, and
`
`2047
`
`2048
`
`Pharmacokinetics of Trastuzumab Monotherapy Administered on a
`
`3-Weekly Schedule, 23(10) J. Clin. Oncol. 2162-71 (2005).
`
`2049
`
`Baselga et al., Phase II Study of Weekly Intravenous Trastuzumab
`
`
`
`8
`
`
`
`
`
`(Herceptin) in Patients with HER2/neu-Overexpressing Metastatic
`
`Breast Cancer, 26 (4 Suppl. 12) Semin. Oncol. 78-83 (1999).
`
`2050
`
`Bissery et al., Experimental Antitumor Activity of Taxotere (RP
`
`56976, NSC 628503), a Taxol Analogue, 51(18) Cancer Res. 4845-
`
`52 (1991).
`
`2051
`
`Chen et al., Gefitinib Treatment is Highly Effective in Non-Small-
`
`Cell Lung Cancer Patients Failing Previous Chemotherapy in
`
`Taiwan: A Prospective Phase II Study, 17(6) J. Chemother. 679-84
`
`(2005).
`
`2052
`
`Cisternino et al., Nonlinear Accumulation in the Brain of the New
`
`Taxoid TXD258 Following Saturation of P-glycoprotein at the
`
`Blood-Brain Barrier in Mice and Rats, 138(7) Br. J. Pharmacol.
`
`1367-75 (2003).
`
`2053
`
`Cobleigh et al., 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, 17(9) J.
`
`Clin. Oncol. 2639-48 (1999).
`
`2054
`
`De Bono et al., Open-Label Phase II Study Evaluating the Efficacy
`
`
`
`9
`
`
`
`
`
`and Safety of Two Doses of Pertuzumab in Castrate Chemotherapy-
`
`Naive Patients with Hormone-Refractory Prostate Cancer, 25(3) J.
`
`Clin. Oncol. 257-62 (2007).
`
`2055
`
`De Bono et al., Prednisone plus Cabazitaxel or Mitoxantrone for
`
`Metastatic Castration-Resistant Prostate Cancer Progressing after
`
`Docetaxel Treatment: a Randomized Open-Label Trial, 376(9747)
`
`Lancet 1147-54 (2010).
`
`2056
`
`European Medicine Agency, ICH Topic E8 General Considerations
`
`for Clinical Trials (March 1998).
`
`2057
`
`62(247) Federal Register 67377-388 (December 24, 1997), FDA
`
`Notice International Conference on Harmonisation; Guidance on
`
`Impurities: Residual Solvents.
`
`2058
`
`FDA News Release, FDA Approves New Indication for Taxotere -
`
`Prostate Cancer (May 19, 2004).
`
`2059
`
`FDA News Release, FDA Approves New Treatment for Advanced
`
`Prostate Cancer (June 17, 2010).
`
`2060
`
`Fukuoka et al., Multi Institutional Randomized Phase II Trial of
`
`Gefitinib for Previously Treated Patients with Advanced Non–
`
`Small-Cell Lung Cancer, 21(12) J. Clin. Oncol. 2237-46 (2003).
`
`
`
`10
`
`
`
`
`
`2061
`
`Gianni et al., Nonlinear Pharmacokinetics and Metabolism of
`
`Paclitaxel and Its Pharmacokinetic/Pharmacodynamic
`
`Relationships in Humans, 13(1) J. Clin. Oncol. 180-90 (1995).
`
`2062
`
`Hande, The Importance of Drug Scheduling in Cancer
`
`Chemotherapy: Etoposide as an Example, 1(4) The Oncologist
`
`234-29 (1996).
`
`January 2008 Herceptin® Label.
`
`Hope, ‘Last Hope’ Drug for Prostate Cancer Patients Is Axed from
`
`the NHS, in a Move Doctors Call a Travesty, DailMail.com
`
`(January 9, 2015), available at
`
`http://www.dailymail.co.uk/health/article-2903235/Last-hope-drug-
`
`prostate-cancer-patients-axed-NHS-dcotors-call-travesty.html.
`
`July 2004 Iressa® Label.
`
`October 2007 Ixempra® Label.
`
`June 2015 Jevtana® Label.
`
`Sanofi-Aventis Press Release, Phase III Data Showing Improved
`
`Survival with Jevtana® (cabazitaxel) Injection in Second-Line
`
`Advanced Prostate Cancer Published in the Lancet (October 1,
`
`2010).
`
`11
`
`2063
`
`2064
`
`2065
`
`2066
`
`2067
`
`2068
`
`
`
`
`
`
`
`2069
`
`Water Insoluble Drug Formulation 213, 267-68, 355, 393-94, 427,
`
`436, 645, 650 (First Edition, Liu ed. 2000).
`
`2070
`
`Lokich & Anderson, Dose Intensity for Bolus Versus Infusion
`
`Chemotherapy Administration: Review of the Literature for 27
`
`Anti-Neoplastic Agents, 8(1) Ann Oncol. 15-25 (1997).
`
`2071
`
`Malhotra et al., Cabazitaxel: a Novel Drug for Hormone-
`
`Refractory Prostate Cancer, 13(2) Mini Revs. Med. Chem. 1-6
`
`(2013).
`
`2072
`
`Excerpt of Claim Construction Hearing Transcript from Sanofi-
`
`Aventis U.S., LLC et al. v. Mylan Laboratories Ltd., et al., 3:15-cv-
`
`03392(MAS)(LHG).
`
`2073
`
`Mokbel, Concise Notes in Oncology for MRCP and MRCS, 6-7
`
`(2005).
`
`2074
`
`Morant et al., Capecitabine in Hormone-Resistant Metastatic
`
`Prostatic Carcinoma – a Phase II Trial, 90(7) Br. J. Cancer 1312–
`
`17 (2004).
`
`2075
`
`Motzer et al., Activity of SU11248, a Multitargeted Inhibitor of
`
`Vascular Endothelial Growth Factor Receptor and Platelet-
`
`Derived Growth Factor Receptor, in Patients with Metastatic Renal
`
`Cell Carcinoma, 24(1) J. Clin. Oncol. 16-24 (2006).
`
`
`
`12
`
`
`
`
`
`2076
`
`NCCN Clinical Practice Guidelines in Oncology: Breast Cancer
`
`V.1.2009.
`
`2077
`
`NCCN Clinical Practice Guidelines in Oncology: Prostate Cancer
`
`V.2.2009.
`
`2078
`
`National Horizon Scanning Centre, Cabazitaxel (XRP-6258) for
`
`Hormone Refractory, Metastatic Prostate Cancer – Second Line
`
`After Docetaxel (April 2009).
`
`2079
`
`Niho et al., First-Line Single Agent Treatment with Gefitinib in
`
`Patients with Advanced Non–Small-Cell Lung Cancer: A Phase II
`
`Study, 24(1) J. Clin. Oncol. 64-69 (2006).
`
`2080
`
`Pazdur, Endpoints for Assessing Drug Activity in Clinical Trials,
`
`13(suppl 2) The Oncologist 19-21 (2008).
`
`2081
`
`Perez-Soler et al., Determinants of Tumor Response and Survival
`
`with Erlotinib in Patients with Non–Small-Cell Lung Cancer,
`
`2082
`
`2083
`
`22(16) J. Clin. Oncol. 3238-47 (2004).
`
`June 2012 Perjeta® Label.
`
`Pienta & Smith, Advances in Prostate Cancer Chemotherapy: A
`
`New Era Begins, 55(5) CA Cancer J. Clin. 300-18 (2005).
`
`2084
`
`Ramanathan et al., A Phase II Study of Milataxel: a Novel Taxane
`
`
`
`13
`
`
`
`
`
`Analogue in Previously Treated Patients with Advanced Colorectal
`
`Cancer, 61(3) Cancer Chemother. Pharmacol. 453-58 (2008).
`
`2085
`
`Reck et al., An Open-Label, Multi Centre, Phase II, Non-
`
`Comparative Trial of ZD1839 Monotherapy in Chemotherapy-
`
`Naive Patients with Stage IV or Stage III Non-Operable Non-Small
`
`Cell Lung Cancer (NSCLC), 23(16S) J. Clin. Oncol. 7098 (2005).
`
`2086
`
`Sanofi-Aventis U.S., LLC et al. v. Mylan Laboratories Ltd., et al.,
`
`3:15-cv-03392(MAS)(LHG), Excerpts of Defendants’ Joint
`
`Responsive Claim Construction Brief.
`
`2087
`
`Compilation of excerpts of SEC 20-F filings showing Jevtana®
`
`sales.
`
`2088
`
`Spigel et al., Single-Agent Gefitinib in Patients with Untreated
`
`Advanced Non-Small-Cell Lung Cancer and Poor Performance
`
`Status: A Minnie Pearl Cancer Research Network Phase II Trial,
`
`7(2) Clin. Lung Cancer 127-32 (2005).
`
`2089
`
`Straub et al., Intravenous Hydrophobic Drug Delivery: A Porous
`
`Particle Formulation of Paclitaxel (AI-850), 22(3) Pharm Res. 347-
`
`55 (2005).
`
`2090
`
`April 2008 Sutent® Label.
`
`
`
`14
`
`
`
`
`
`2091
`
`Takeda et al., The Establishment of Two Paclitaxel-Resistant
`
`Prostate Cancer Cell Lines and the Mechanisms of Paclitaxel
`
`Resistance with Two Cell Lines, 67(9) The Prostate 955-67 (2007).
`
`2092
`
`2093
`
`2094
`
`April 2009 Tarceva® Label.
`
`February 2000 Taxol® Label.
`
`Ten Tije et al., Pharmacological Effects of Formulation Vehicles:
`
`Implications for Cancer Chemotherapy, 42(7) Clin. Pharmacokinet.
`
`665-85 (2003).
`
`2095
`
`Vogel et al., Efficacy and Safety of Trastuzumab as a Single Agent
`
`in First-Line Treatment of HER2-Overexpressing Metastatic Breast
`
`Cancer, 20(3) J. Clin. Oncol. 719-26 (2002).
`
`2096
`
`Vrignaud et al., Preclinical Antitumor Activity of Cabazitaxel, a
`
`Semisynthetic Taxane Active in Taxane-Resistant Tumors, 19(11)
`
`Clin. Cancer Res. 2973-83 (2013).
`
`Reserved.
`
`February 2003 Xeloda® Label.
`
`Ziada et al., The Use of Trastuzumab in the Treatment of Hormone
`
`Refractory Prostate Cancer; Phase II Trial, 60(4) The Prostate
`
`332-37 (2004).
`
`15
`
`2097
`
`2098
`
`2099
`
`
`
`
`
`
`
`2100
`
`2006 clinicaltrials.gov listing for TROPIC: View of NCT00417079
`
`on 2006_12_28, available at http://clinicaltrials.gov/archive?
`
`NCT00417079/2006_12_28.
`
`2101
`
`Dieras et al., Larotaxel (L) in Combination with Trastuzumab in
`
`Patients with Her2+ Metastatic Breast Cancer (MBC): Interim
`
`Analysis of an Open Phase II Label Study, 26(15S) J. Clin. Oncol.
`
`1070 (2008).
`
`2102
`
`Excerpts of Sanofi-Aventis SEC Form 20-F (December 31, 2006),
`
`available at https://www.sec.gov/Archives/edgar/data/1121404/
`
`000119312507072848/d20f.htm.
`
`2103
`
`Butler, Natural Products to Drugs: Natural Product-Derived
`
`Compounds in Clinical Trials, 25(3) Nat. Prod. Rep. 475-516
`
`(2008).
`
`2104
`
`Canil et al., Randomized Phase II Study of Two Doses of Gefitinib
`
`in Hormone-Refractory Prostate Cancer: A Trial of the National
`
`Cancer Institute of Canada –Clinical Trials Group, 23(3) J. Clin.
`
`Oncol. 455-60 (2005).
`
`2105
`
`Mononen et al., Two Percent of Finnish Prostate Cancer Patients
`
`Have a Germ-Line Mutation in the Hormone-Binding Domain of
`
`the Androgen Receptor Gene, 60(22) Cancer Research 6471-81
`
`
`
`16
`
`
`
`(2000).
`
`
`
`2106
`
`Saad et al., Randomized Phase II Trial of Custirsen (OGX-011) in
`
`Combination with Docetaxel or Mitoxantrone as Second-Line
`
`Therapy in Patients with Metastatic Castrate-Resistant Prostate
`
`Cancer Progressing After First-Line Docetaxel: CUOG Trial P-
`
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