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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01578655




Registration number
NCT01578655
Ethics application status
Date submitted
9/04/2012
Date registered
17/04/2012
Date last updated
12/10/2016

Titles & IDs
Public title
Comparison of Cabazitaxel/Prednisone Alone or in Combination With Custirsen for 2nd Line Chemotherapy in Prostate Cancer
Scientific title
A Randomized Phase 3 Study Comparing Cabazitaxel/Prednisone in Combination With Custirsen (OGX-011) to Cabazitaxel/Prednisone for Second-Line Chemotherapy in Men With Metastatic Castrate Resistant Prostate Cancer (AFFINITY)
Secondary ID [1] 0 0
OGX-011-12
Universal Trial Number (UTN)
Trial acronym
AFFINITY
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - cabazitaxel
Treatment: Drugs - prednisone
Treatment: Drugs - custirsen sodium

Experimental: Cabazitaxel plus Custirsen - cabazitaxel, prednisone, and custirsen sodium

Active Comparator: Cabazitaxel - cabazitaxel and prednisone


Treatment: Drugs: cabazitaxel
Cabazitaxel (25mg/m² IV) is administered on day 1 of each 21-day cycle until disease progression, unacceptable toxicity, or completion of 10 cycles

Treatment: Drugs: prednisone
Prednisone (10 mg PO) is administered daily until disease progression, unacceptable toxicity, or completion of 10 cycles

Treatment: Drugs: custirsen sodium
Custirsen is administered as 3 loading doses (640 mg IV each) within 9 days, followed by weekly custirsen (640 mg IV) during each 21-day cycle until disease progression, unacceptable toxicity, or completion of 10 cycles

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Survival in the intent-to-treat population - To determine whether the survival for patients randomized to the investigational arm (cabazitaxel/prednisone plus custirsen) is consistent with longer survival as compared to patients randomized to the control arm (cabazitaxel/prednisone).
Timepoint [1] 0 0
3.4 years
Primary outcome [2] 0 0
Survival in the poor-prognosis patient population - To determine whether the survival for patients randomized to the investigational arm (cabazitaxel/prednisone plus custirsen) and identified as having poor prognosis is consistent with longer survival as compared to patients randomized to the control arm (cabazitaxel/prednisone) and identified as having poor prognosis.
Timepoint [2] 0 0
2.7 years
Secondary outcome [1] 0 0
Progression-free survival at Day 140 - To compare the arms with respect to the proportion of patients having a milestone Day 140 status of Alive Without Event (within the window of Day 125-155 post-randomization). An event is defined as disease progression or death on or before Day 140.
Timepoint [1] 0 0
From randomization to Day 125 to Day 155

Eligibility
Key inclusion criteria
- Histological or cytological diagnosis of adenocarcinoma of the prostate

- Metastatic disease on chest, abdominal, or pelvic CT scan and/or bone scan

- Previous first-line treatment for CRPC with a docetaxel-containing regimen

- Current progressive disease

- Increasing serum PSA level (for patients who progress based only on increasing serum
PSA level, a minimum starting value of 5.0 ng/mL is required)

- Baseline laboratory values as defined

- Willing to continue primary androgen suppression with gonadotropin-releasing hormone
(GnRH) analogues (unless treated with bilateral orchiectomy)

- Karnofsky score =70%

- At least 21 days have passed since completing radiotherapy

- At least 21 days have passed since receiving any investigational agent at the time of
randomization

- At least 21 days have passed since major surgery

- Recovered from any docetaxel therapy-related neuropathy to =grade 1 at the time of
randomization

- Recovered from all therapy related toxicity to =grade 2 (except alopecia, anemia, and
any signs or symptoms of androgen deprivation therapy) at the time of randomization

- Able to tolerate a starting dose of 25 mg/m² cabazitaxel

- Willing to not add, delete, or change current bisphosphonate or denosumab usage

- Able to tolerate oral prednisone at 10 mg per day

- Competent to provide written informed consent
Minimum age
No limit
Maximum age
No limit
Gender
Males
Can healthy volunteers participate?
No
Key exclusion criteria
- Received any other cytotoxic chemotherapy beyond the first-line docetaxel-containing
regimen as treatment for prostate cancer

- Received prior radioisotope with strontium 89 or samarium 153

- Received any cycling, intermittent, or continuous hormonal treatment within 21 days
prior to randomization with the exception of the continuous GnRH analogues (prior
treatment with abiraterone or MDV3100 is allowed as long as 21 days have passed since
last dose)

- Participated in a prior Phase 3 clinical study evaluating custirsen regardless of
study arm assignment

- Requiring ongoing treatment during the study with medications known to be either
strong CYP3A inhibitors or strong CYP3A inducers

- History of or current documented brain metastasis or carcinomatous meningitis, treated
or untreated

- Current symptomatic cord compression requiring surgery or radiation therapy

- Active second malignancy (except non melanomatous skin or superficial bladder cancer)
defined in general as requiring anticancer therapy or at high risk of recurrence
during the study

- Uncontrolled medical condition or significant concurrent illness that in the opinion
of the Investigator would preclude protocol therapy

- Known severe hypersensitivity to taxanes or polysorbate 80-containing drugs

- Planned concomitant participation in another clinical trial of an experimental agent,
vaccine, or device

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,TAS,VIC
Recruitment hospital [1] 0 0
The Canberra Hospital - Garran
Recruitment hospital [2] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [3] 0 0
St George Public Hospital - Kogarah
Recruitment hospital [4] 0 0
Royal North Shore Hospital - Saint Leonards
Recruitment hospital [5] 0 0
Westmead Hospital - Westmead
Recruitment hospital [6] 0 0
Haematology and Oncology Clinics of Australia - Brisbane
Recruitment hospital [7] 0 0
The Queen Elizabeth Hospital - Woodville South
Recruitment hospital [8] 0 0
Royal Hobart Hospital - Hobart
Recruitment hospital [9] 0 0
Box Hill Hospital - Box Hill
Recruitment hospital [10] 0 0
Austin Health - Heidelberg
Recruitment hospital [11] 0 0
Epworth Healthcare - Richmond
Recruitment postcode(s) [1] 0 0
- Garran
Recruitment postcode(s) [2] 0 0
- Camperdown
Recruitment postcode(s) [3] 0 0
- Kogarah
Recruitment postcode(s) [4] 0 0
- Saint Leonards
Recruitment postcode(s) [5] 0 0
- Westmead
Recruitment postcode(s) [6] 0 0
- Brisbane
Recruitment postcode(s) [7] 0 0
- Woodville South
Recruitment postcode(s) [8] 0 0
- Hobart
Recruitment postcode(s) [9] 0 0
- Box Hill
Recruitment postcode(s) [10] 0 0
- Heidelberg
Recruitment postcode(s) [11] 0 0
- Richmond
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
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Colorado
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Connecticut
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Florida
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Georgia
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Kansas
Country [7] 0 0
United States of America
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Massachusetts
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Michigan
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Missouri
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Nebraska
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New York
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North Carolina
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Ohio
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Oregon
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South Carolina
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United States of America
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Tennessee
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United States of America
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Texas
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United States of America
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Utah
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United States of America
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Virginia
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Canada
State/province [20] 0 0
Alberta
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Canada
State/province [21] 0 0
British Columbia
Country [22] 0 0
Canada
State/province [22] 0 0
Ontario
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Canada
State/province [23] 0 0
Quebec
Country [24] 0 0
Czech Republic
State/province [24] 0 0
Severomoravsky Kraj
Country [25] 0 0
Czech Republic
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Hradec Králové
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Czech Republic
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Liberec
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Czech Republic
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Olomouc
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France
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Basse-Normandie
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France
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Champagne-Ardenne
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France
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Ile de France
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France
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Ile-de-France
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France
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Pays de la Loire
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France
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Poitou-Charentes
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France
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Provence Alpes Cote d'Azur
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France
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Rhone-Alpes
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France
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Marseille
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Hungary
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Bekes
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Hungary
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Borsod-Abauj-Zemplen
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Hungary
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Csongrad
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Hungary
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Budapest
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Russian Federation
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Ural
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Russian Federation
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Volgograd
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Russian Federation
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Barnaul
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Russian Federation
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Ivanovo
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Russian Federation
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Moscow
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Russian Federation
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Omsk
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Russian Federation
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Saint Petersburg
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Russian Federation
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Stavropol
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United Kingdom
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England
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United Kingdom
State/province [50] 0 0
Scotland

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Achieve Life Sciences
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This Phase 3 study has been designed to confirm that adding custirsen to
cabazitaxel/prednisone treatment can slow tumor progression and enhance survival outcomes
compared to standard cabazitaxel/prednisone treatment in men with metastatic castrate
resistant prostate cancer (CRPC). This will be a randomized, open-label, multicenter,
international trial. Treatment will consist of cabazitaxel/prednisone/custirsen vs.
cabazitaxel/prednisone. A total of approximately 630 patients will be randomized with equal
probability to the two arms.
Trial website
https://clinicaltrials.gov/show/NCT01578655
Trial related presentations / publications
Saad F, Hotte S, North S, Eigl B, Chi K, Czaykowski P, Wood L, Pollak M, Berry S, Lattouf JB, Mukherjee SD, Gleave M, Winquist E; Canadian Uro-Oncology Group. 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-06c. Clin Cancer Res. 2011 Sep 1;17(17):5765-73. doi: 10.1158/1078-0432.CCR-11-0859. Epub 2011 Jul 25.
Chi KN, Hotte SJ, Yu EY, Tu D, Eigl BJ, Tannock I, Saad F, North S, Powers J, Gleave ME, Eisenhauer EA. Randomized phase II study of docetaxel and prednisone with or without OGX-011 in patients with metastatic castration-resistant prostate cancer. J Clin Oncol. 2010 Sep 20;28(27):4247-54. doi: 10.1200/JCO.2009.26.8771. Epub 2010 Aug 23.
Public notes

Contacts
Principal investigator
Name 0 0
Thomasz Beer, MD
Address 0 0
Oregon Health & Science University, Portland, Oregon
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications