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`_:|'_e|ephor_ie
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`Applicanblpatent Owner. Cougar Biotechnology. Inc.
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`STATEMENT UNDER 37 CFR 3.73jb[
`
`Application No..~‘Patent No.2 113344.440
`Titled:
`
`METHODS AND COMOSITIONS FOR TREATING CANCER
`
`__
`
`Filedllssue Date: AU9'-|3t 24. 2007
`
`Cougar Biotechnology, Inc.
`(Name of Assignoe)
`
`states that it is:
`
`_a
`
`Corporation
`{Type of Assignee, e.g.. corporation. partn%hip. university. government agency. etc.
`
`1.
`
`the assignee of the entire right. title, and interest in;
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`:.
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`'i_]
`
`An assignment from the inventorls) of the patent applicationfpatent identified above. The assignment was recorded in
`the United States Patent and Trademark Office at Reel
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`. or for which a
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`1_ From; Alan H. Auerbach and Arie S. Belldegmn
`
`To; Cougar Biotechnology, Inc-
`
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`
`Reel 018839
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`Frame 0027
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`2. From: Alan H. Auerbach
`
`To: Cougar Biotechnology, Inc.
`
`The document was recorded in the United States Patent and Trademark Office at
`
`Reel 020040
`
`Frame 0635
`
`.
`
`or for which a copy thereof is attached.
`
`3_ From; Arie S. Belldegrun
`
`To: Cougar Biotechnology, Inc.
`
`The document was recorded in the United States Patent and Trademark Ulfice at
`
`Root 020040
`
`,
`
`Frame D690_
`
`,
`
`or for which a copy thereof is attached.
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`Additional documents in the chain of title are listed on a supplemental sheet(s].
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`The urersigned [whosetitle issupplied below) is authorized to act on he-harfofthe assignee.
`L
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`_
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`Assistant Secretary
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`Electronic Patent Application Fee Transmittal
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`Application Number:
`
`Filing Date:
`
`Title of Invention:
`
`Methods and Compositions forTreating Cancer
`
`First Named lnventormpplicant Name:
`
`Alan H. Auerbach
`
`Attorney Docket Number:
`
`CGFI5001USCNT1
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`Filed as Large Entity
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`Utility under 35 USC 1 1 1 (a) Filing Fees
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`Description
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`Su b-Tota I in
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`1201
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`‘I
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`‘I
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`540
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`540
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`220
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`Total in USD (5)
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`2142
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`Electronic Acknowledgement Receipt
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`Application Number:
`
`13034340
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`International Application Number:
`
`Confirmation N um ber:
`
`Title of Invention:
`
`Methods and Compositions forTreating Cancer
`
`First Named |nventor!Applicant Name:
`
`Alan H. Auerbach
`
`Customer Number:
`
`27777
`
`Filer:
`
`Andrea J. KamageILaurie Phillips
`
`Filer Authorized By:
`
`Andrea J. Kamage
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`Attorney Docket Number:
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`CGR5001USCNT1
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`Receipt Date:
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`24—F EB—201 1
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`Time Stamp:
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`16:49:59
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`Application Type:
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`Charge any Additional Fees required under 37 C.F.Fl. Section 1.16 [National application filing. search, and examination fees]
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`
`
`Charge any Additional Fees required under 37 C.F.R. Section 1.19 (Document supply fees)
`
`Charge any Additional Fees required under 37 CFR. Section 1.20 [Post Issuance fees]
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`Charge any Additional Fees required under 37 C.F.R. Section 1.21 (Miscellaneous fees and charges]
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`File Listing:
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`Document Descnpmm
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`Info rmation:
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`Warnings:
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`Info rmation:
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`Warnings:
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`CGR5001USNPAPPLNASOR|G|N
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`ALLYF|LED.pdf
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`1649829
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`
`I
`
`YES
`
`Multipart Descriptiom‘PDF files in .zip description
`
`Specification
`
`Claims
`
`1
`
`24
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`30
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`23
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`29
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`1292?8
`
`(L1-1tl[6“)l'lh-Illb-'1TIIIJE-I¢lJ9aa(d-I0tlflCE59l
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`Change of Address
`
`11844-'-l40POA.pdf
`
`511 aa33fa(c8h?h9(.0dr-I1l3d[| lotklrilrhtk I5
`.IH'l
`
`Assignee showing of ownership per 37
`CFR 173(b)_
`
`1 1844440STATEMENT373B.pdf hifhlrlrlbr Jh hIhba«Ihl1I193 R-el‘J‘11co1e0rfil)l
`llJJ[I.i'
`
`Fee Worksheet [PTO-875]
`
`fee-info.pdf
`
`ha 3e.1il'eS Iarflh ! 3.10filhl7lree I‘-'J|wlo‘1[-Id?
`SEFJC
`
`
`
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`2936584
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`This Acknowledgement Receipt evidences receipt on the noted date by the USPTO of the indicated documents,
`characterized by the applicant, and including page counts, where applicable. It serves as evidence of receipt similar to a
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`
`New Applications Under 35 U.S.C. 111
`Ifa new application is being filed and the application includes the necessary components for a filing date {see 37 CFR
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`National Stage of an International Application under 35 U.S.C. 371
`Ifa timely submission to enter the national stage ofan international application is compliant with the conditions of 35
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`national stage submission under 35 U.S.C. 371 will be issued in addition to the Filing Receipt, in due course.
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`New International Application Filed with the USPTO asa Receiving Office
`Ifa new international application is being filed and the international application includes the necessary components for
`an international filing date (see PCT Article 11 and MPEP1810}, a Notification of the International Application Number
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`
`Electronic Acknowledgement Receipt
`
`Application Number:
`
`13034340
`
`International Application Number:
`
`Confirmation N um ber:
`
`Title of Invention:
`
`Methods and Compositions forTreating Cancer
`
`First Named |nventor!Applicant Name:
`
`Alan H. Auerbach
`
`Customer Number:
`
`27777
`
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`
`Andrea J. KamageILaurie Phillips
`
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`
`Andrea J. Kamage
`
`Attorney Docket Number:
`
`CGR5001USCNT1
`
`Receipt Date:
`
`24—F EB—201 1
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`
`Time Stamp:
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`16:49:59
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`Utility under 35 USC 111(a]
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`Payment information:
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`
`yes
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`Payment Type
`
`Deposit Accou nt
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`3721 Deposit Accou nt
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`Payment was successfully received in RAM
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`$2142
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`100750
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`Authorized User
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`The Director of the USPTO is hereby authorized to charge indicated fees and credit any overpayment as follows:
`
`Charge any Additional Fees required under 37 C.F.Fl. Section 1.16 [National application filing. search, and examination fees]
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`Charge any Additional Fees required under 37 C.F.R. Section 1.19 (Document supply fees)
`
`Charge any Additional Fees required under 37 CFR. Section 1.20 [Post Issuance fees]
`
`Charge any Additional Fees required under 37 C.F.R. Section 1.21 (Miscellaneous fees and charges]
`
`File Listing:
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`Document
`Number
`
`.
`.
`Document Descnpmm
`
`.
`Flle Name
`
`CGR5001 USCNTAPPLICATIOND
`
`File Size(Byteslr'
`Message Digest
`1031200
`
`Part Lzip (ifappI.)
`
`Application Data Sheet
`
`ATA SH EET.pdf
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`lJ‘J‘).i'1:lI.n_-0:lmlflla9bB‘J.i'[t|-|c.i'55I21r_-0‘.?c9l
`7¥ai"h
`
`Warnings:
`
`Info rmation:
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`Warnings:
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`Info rmation:
`
`Warnings:
`
`Info rmation:
`
`Warnings:
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`Info rmation:
`
`Warnings:
`
`Info rmation:
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`Warnings:
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`CGR5001USNPAPPLNASOR|G|N
`
`ALLYF|LED.pdf
`
`1649829
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`‘)I.il.ll‘JJ!.2'.’.t.6l.JUJ J15 ';::I.k(E|4a l ITJLD6 9'92
`rlr.5r.'u¥
`
`I
`
`YES
`
`Multipart Descriptiom‘PDF files in .zip description
`
`Specification
`
`Claims
`
`1
`
`24
`
`30
`
`23
`
`29
`
`30
`
`Oath or Declaration filed
`
`CGR5001DECLARAT|ON.pdf
`
`1292?8
`
`(L1-1tl[6“)l'lh-Illb-'1TIIIJE-I¢lJ9aa(d-I0tlflCE59l
`incl
`
`Change of Address
`
`11844-'-l40POA.pdf
`
`511 aa33fa(c8h?h9(.0dr-I1l3d[| lotklrilrhtk I5
`.IH'l
`
`Assignee showing of ownership per 37
`CFR 173(b)_
`
`1 1844440STATEMENT373B.pdf hifhlrlrlbr Jh hIhba«Ihl1I193 R-el‘J‘11co1e0rfil)l
`llJJ[I.i'
`
`Fee Worksheet [PTO-875]
`
`fee-info.pdf
`
`ha 3e.1il'eS Iarflh ! 3.10filhl7lree I‘-'J|wlo‘1[-Id?
`SEFJC
`
`
`
`Info rmation:
`
`2936584
`
`Total Files Size {in bytes]
`
`This Acknowledgement Receipt evidences receipt on the noted date by the USPTO of the indicated documents,
`characterized by the applicant, and including page counts, where applicable. It serves as evidence of receipt similar to a
`Post Card, as described in MPEP 503.
`
`New Applications Under 35 U.S.C. 111
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`national stage submission under 35 U.S.C. 371 will be issued in addition to the Filing Receipt, in due course.
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`Ifa new international application is being filed and the international application includes the necessary components for
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`PTOJSBI14 (11-O8)
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`.
`-
`Application Data Sheet 37 CFR 1.76
`
`Attotttev Docket Nttmttet
`_
`_
`Attttttcatttttt Ntttttttet B
`
`document may be printed and included in a paper filed application.
`
`Title of Invention
`
`Methods and Compositions for Treating Cancer
`
`The application data sheet is part of the provisional or nonprovisional application for which it is being submitted. The following form contains the
`bibliographic data arranged in a format specified by the United States Patent and Trademark Office as outlined in 37 CFR 1.76.
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`Secrecy Order 37 CFR 5.2
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`Prefix Given Name
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`Residence Information (Select One) @ US Residency 0 Non US Residency 0 Active US Military Service
`
`City
`
`Hermosa Beach
`
`State.lProvince
`
`CA
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`Country of Residencei
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`US
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`Mailing Address of Applicant:
`Address 1
`One Johnson 8. Johnson Plaza
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`Addtttts 2
`city
`~°ttttte'Pt°Vt"°°
`"°sta'°°dtt
`Applicant 2
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`OPar1y of Interest under 35 U.S.C. 118
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`State! Province
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`us
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`
`PTOJSBI14 (11-O8)
`Approved for use through 0913012010. OMB 0651-0032
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`Under the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it contains a valid OMB control number.
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`.
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`Application Data Sheet 37 CFR 1.76
`
`
`
`rttterrreu beetet Number
`_
`_
`rtbbteetrert Number —
`
`Title of Invention
`
`Methods and Compositions for Treating Cancer
`
`Customer Number
`
`27777
`
`Email Address
`
`jnjuspatent@corus.jnj.com
`
`
`
`Application Information:
`
`Title of the Invention
` Methods and Compositions for Treating Cancer
`
`
`CGR5001USCNT1
`| Small Entity Status Claimed
`|:|
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`Nonprovisional
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`Utility
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`|:| Request Early Publication (Fee required at time of Request 37 CFR 1.219)
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`Attorney Docket No. ll5l5-004-999
`
`METHODS AND COMPOSITIONS FOR TREATING CANCER
`
`FIELD OF THE INVENTION
`
`[0001]
`
`Methods and compositions for treating cancer are described herein. More
`
`particularly, the methods for treating cancer comprise administering a 17a-hydroxylascft‘ :1
`
`2;)-ly£lS€
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`inhibitor, such as abiraterone acetate (:'.e.. 3]i~acetoxy~l 7—(3~pyridyl) androsta-5,
`
`I6-diene). in combination with at least one additional therapeutic agent, such as an anti-
`
`cancer agent or a steroid. Furthermore, disclosed are compositions comprising a 17(1-
`
`hydroxylase;’C.120-lyase inhibitor. and at least one additional therapeutic agent such as an
`
`anti—cancer agent or a steroid. e.g._. a corticosteroid or, more specifically, a glucocorticoid.
`
`BACKGROUND
`
`[0002]
`
`The number of people diagnosed with cancer has significantly increased. Of
`
`special interest are individuals diagnosed with androgen-dependent disorders, such as
`
`prostate cancer, and estrogen-dependent disorders, such as breast cancer since such
`
`diagnoses are increasing in number at an alarming rate.
`
`[0003]
`
`Prostate cancer is currently the most common non-skin cancer and the
`
`second leading cause ofcancenrelated death in men after lung cancer. The primary course
`
`of treatment for patients diagnosed with organ-confined prostate cancer is usually
`
`prostatectomy or radiotherapy. Not only are these treatments highly invasive and have
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`undesirable side effects, such localized treatments are not effective on prostate cancer after
`
`it has rnetastasized. Moreover, a large percent of individuals who receive localized
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`treatments will stiffer from recurring cancer.
`
`[0004]
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`Additionally, breast cancer incidence in women has increased from one out
`
`of every 20 women in 1960 to one out of every eight women in 2005. Moreover, it is the
`
`most common cancer among white and African-American women. Similar to treating
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`prostate cancer. most options for women diagnosed with breast cancer are highly invasive
`
`and have significant side—et'fects_ Such treatments include surgery. radiation and
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`chemotherapy.
`
`[0005]
`
`Hormone therapy is another treatment option for individuals diagnosed with
`
`prostate or breast cancer. Hormone therapy is a form of systemic treatment for prostate or
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`breast cancer wherein hormone ablation agents are used to suppress the production or block
`
`-1-
`
`
`
`the effects of ho1'mones. such as estrogen and progesterone in the body, which are believed
`
`to promote the growth of breast cancer, as well as testosterone and dihydrotestosterone,
`
`which are believed to promote the growth of prostate cancer. Moreover, hormone therapy is
`
`less invasive than surgery and does not have many of the side effects associated with
`
`chemotherapy or radiation. Hormone therapy can also be used by itself or in addition to
`
`localized therapy and has shown to be effective in individuals whose cancer has
`
`metastasized.
`
`[0006]
`
`Even though hormone therapy is less invasive and can be used on more
`
`advanced stages of cancer, some individuals administered current hormone therapy
`
`treatments may not show a significant response or may 11ot show any response at all to such
`
`treatments. Additionally, some patients treated with current hormone therapy treatments
`
`may also suffer from relapsing or recurring cancer. Currently. such refractory cancer
`
`patients are left with very few treatment options.
`
`[0007]
`
`Despite the progress made in the treatment of cancer. there remains a need
`
`for more effective ways to treat cancer such as, but not limited to. prostate cancer and breast
`
`cancer. Additionally, there is a need for effective anti-cancer treatment options for patients
`
`who are not responding to current anti-cancer treatments- Also, there is a need for effective
`
`anti-cancer treatment options for patients whose cancer has recurred.
`
`SUMMARY OF THE INVENTION
`
`[0008]
`
`Described herein are methods for treating a cancer in which a therapeutically
`
`effective amount ofa 170.-hydroxylaseXCn_gmlyase inhibitor. such as abiraterone acetate
`
`(11 e. 3[3-acetoxy-17—(3-pyridyl)androsta-S,16-diene). is administered to a patient, e. a
`
`patient in need thereof, in combination with a therapeutically effective amount of at least
`
`one additional therapeutic agent including, but not limited to, an anti-cancer agent or
`
`steroid. Such methods can also provide an effective treatment for individuals with a
`
`refractory cancer, including individuals who are currently undergoing a cancer treatment.
`
`Therefore, in certain embodiments, the method is directed to treating a refractory cancer in 3
`
`patient, in which a therapeutically effective amount o