Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
drksid header

  DRKS00006457

Trial Description

start of 1:1-Block title

Title

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase III Study of ARN-509 in Men With Non-Metastatic (M0) Castration-Resistant Prostate Cancer

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

SPARTAN

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

The purpose of this study is to evaluate the efficacy and safety of ARN-509 in adult men
with high-risk non-metastatic castration-resistant prostate cancer.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

This Phase 3 clinical trial is an essential step in the evaluation of an investigational
medication to see if it may be useful in treating prostate cancer. The purpose of the
SPARTAN study is to compare the safety and effectiveness of the investigational medication
to placebo in delaying prostate cancer from spreading to other parts of the body. A placebo
is a pill that looks like the investigational medication but does not contain any active
medication, a dummy pill.

Phase 3 studies are performed after preliminary evidence suggesting effectiveness of the
drug has been obtained in previous Phase 2 studies. These studies are intended to gather the
additional information about effectiveness and safety that is needed to evaluate the overall
benefit-risk relationship of the drug.

Study participants will take the oral investigational medication daily. One cycle of study
treatment lasts 4 weeks or 28 days. The number of cycles will depend on how you and your
cancer respond to the study medication.

In order for the researchers to evaluate and compare the study results, there are two
different study groups. Study participants will be randomly (like flipping a coin) assigned
to one of these groups:

- One group will receive their current treatment along with the investigational
medication

- One group will receive their current medications along with a placebo

The investigational medication will be given to 2 out of every 3 study participants. Neither
you nor the study staff will know which group you are in. However, in case of a medical
emergency, your study doctor can quickly find out which treatment group you are in.

All participants will continue to receive their current treatment along with either the
investigational medication or a placebo. The selections will be random, and you may remain
on investigational treatment until your disease worsens, or until significant side effects
occur or you can no longer tolerate treatment.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00006457
  •   2015/04/29
  •   2013/09/17
  •   no
  •   [---]*
  •   [---]*
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  •   2012-004322-24 
  •   NCT01946204  (ClinicalTrials.gov)
  •   CR102931  (Aragon Pharmaceuticals, Inc.)
  •   ARN-509-003 
  •   2012-004322-24 
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   Prostatic Neoplasms
  •   C61 -  Malignant neoplasm of prostate
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Drug: ARN-509
  •   Drug: Placebo
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, caregiver, investigator/therapist
  •   Placebo
  •   Treatment
  •   Single (group)
  •   III
  •   [---]*
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

- Metastasis-free survival; time frame: Up to death, loss to follow-up, or withdrawal of consent, whichever comes first (up to Month 59)

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

- Overall survival; time frame: Up to death, loss to follow-up, or withdrawal of consent, whichever comes first (up to Month 59)
- Time to symptomatic progression; time frame: Up to documented progression or the development of unacceptable toxicity (up to Month 59)
- Time to initiation of cytotoxic chemotherapy; time frame: Up to documented progression or the development of unacceptable toxicity (up to Month 59)
- Progression Free Survival; time frame: Up to Month 59
- Time to metastasis; time frame: Up to documented progression or the development of unacceptable toxicity (up to Month 59)
- Participants with change in FACT-P and EQ-5D questionnaire scores; time frame: Up to documented progression or the development of unacceptable toxicity (up to Month 59)
- Number of participants affected by adverse events; time frame: Up to 30 days after the last dose of study medication
- Plasma concentrations of ARN-509 and metabolites ARN000308 and ARN000066; time frame: Day 1 of Cycles 1, 2, 3, 6, 12, 18, 24, 36, yearly thereafter, and at the end-of-treatment visit (up to Month 59)

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Australia
  •   Austria
  •   Belgium
  •   Canada
  •   Czech Republic
  •   Denmark
  •   Finland
  •   France
  •   Germany
  •   Hungary
  •   Israel
  •   Japan
  •   Korea, Republic of
  •   Netherlands
  •   New Zealand
  •   Norway
  •   Poland
  •   Romania
  •   Russian Federation
  •   Slovakia
  •   Spain
  •   Sweden
  •   Taiwan, Province of China
  •   United Kingdom
  •   United States
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   [---]*
  •   2013/10/31
  •   1200
  •   Multicenter trial
  •   International
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Male
  •   18   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

- Histologically or cytologically confirmed adenocarcinoma of the prostate without
neuroendocrine differentiation or small cell features with high risk for development
of metastases, defined as prostate-specific antigen doubling time (PSADT) less than
or equal to (<=) 10 months. PSADT is calculated using at least 3 prostate-specific
antigen (PSA) values obtained during continuous ADT (androgen deprivation therapy)

- Castration-resistant prostate cancer demonstrated during continuous ADT, defined as 3
PSA rises, at least 1 week apart, with the last PSA greater than (>) 2 nanogram per
milliliter (ng/mL)

- Maintain castrate levels of testosterone within 4 weeks prior to randomization and
throughout the study

- Patients currently receiving bone loss prevention treatment with bone-sparing agents
must be on stable doses for at least 4 weeks prior to randomization

- Patients who received a first generation anti-androgen (for example, bicalutamide,
flutamide, nilutamide) must have at least a 4-week washout prior to randomization AND
must show continuing disease (PSA) progression (an increase in PSA) after washout

- At least 4 weeks must have elapsed from the use of 5-alpha reductase inhibitors,
estrogens, and any other anti-cancer therapy prior to randomization

- At least 4 weeks must have elapsed from major surgery or radiation therapy prior to
randomization

- Eastern Cooperative Oncology Group Performance Status 0 or 1

- Resolution of all acute toxic effects of prior therapy or surgical procedure to Grade
<= 1 or baseline prior to randomization

- Adequate organ function according to protocol-defined criteria

- Administration of growth factors or blood transfusions will not be allowed within 4
weeks of the hematology labs required to confirm eligibility

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

- Presence of confirmed distant metastases, including central nervous system and
vertebral or meningeal involvement

- Symptomatic local or regional disease requiring medical intervention

- Prior treatment with second generation anti-androgens

- Prior treatment with CYP17 inhibitors

- Prior treatment with radiopharmaceutical agents, or any other investigational agent
for non-metastatic castration-resistant prostate cancer

- Prior chemotherapy for prostate cancer except if administered in the
adjuvant/neoadjuvant setting

- History of seizure or condition that may pre-dispose to seizure

- Concurrent therapy with protocol-defined excluded medications

- History or evidence of any of the following conditions: any prior malignancy (other
than adequately treated basal cell or squamous cell skin cancer, superficial bladder
cancer, or any other cancer in situ currently in complete remission) within 5 years
prior to randomization; severe/unstable angina, myocardial infarction, symptomatic
congestive heart failure, arterial or venous thromboembolic events, or clinically
significant ventricular arrhythmias within 6 months prior to randomization;
uncontrolled hypertension; gastrointestinal disorder affecting absorption; active
infection; and, any other condition that, in the opinion of the investigator, would
impair the patient's ability to comply with study procedures

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Aragon Pharmaceuticals, Inc.
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Aragon Pharmaceuticals, Inc.
    • Aragon Pharmaceuticals, Inc. Clinical Trial 
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions: 
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting ongoing
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

end of 1:n-Block publications
The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   3
  •   2016/01/14


* This entry means the parameter is not applicable or has not been set.