A Study of ARN-509 in Men With Non-Metastatic Castration-Resistant Prostate Cancer (SPARTAN)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Aragon Pharmaceuticals, Inc.
Sponsor:
Information provided by (Responsible Party):
Aragon Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01946204
First received: September 17, 2013
Last updated: August 19, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Prostatic Neoplasms
Drug: ARN-509
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase III Study of ARN-509 in Men With Non-Metastatic (M0) Castration-Resistant Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Aragon Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Metastasis-free survival [ Time Frame: Up to death, loss to follow-up, or withdrawal of consent, whichever comes first (up to Month 59) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: Up to death, loss to follow-up, or withdrawal of consent, whichever comes first (up to Month 59) ] [ Designated as safety issue: No ]
  • Time to symptomatic progression [ Time Frame: Up to documented progression or the development of unacceptable toxicity (up to Month 59) ] [ Designated as safety issue: No ]
  • Time to initiation of cytotoxic chemotherapy [ Time Frame: Up to documented progression or the development of unacceptable toxicity (up to Month 59) ] [ Designated as safety issue: No ]
  • Progression Free Survival [ Time Frame: Up to Month 59 ] [ Designated as safety issue: No ]
  • Time to metastasis [ Time Frame: Up to documented progression or the development of unacceptable toxicity (up to Month 59) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • Number of participants affected by adverse events [ Time Frame: Up to 30 days after the last dose of study medication ] [ Designated as safety issue: Yes ]
  • 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) ] [ Designated as safety issue: No ]

Estimated Enrollment: 1200
Study Start Date: September 2013
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment Arm A: ARN-509 Drug: ARN-509
240 mg capsules administered by mouth on a continuous once daily dosing regimen
Placebo Comparator: Treatment Arm B: Placebo Drug: Placebo
Matched placebo capsules administered by mouth on a continuous once daily dosing regimen

Detailed Description:

This is a randomized (individuals will be assigned by chance to study treatments), double-blind (individuals and study personnel will not know the identity of study treatments), placebo (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial)-controlled study to evaluate the efficacy and safety of ARN-509 versus placebo in adult men with high-risk non-metastatic castration-resistant prostate cancer. Approximately 1200 participants will be randomly assigned in a 2:1 ratio to receive either ARN-509 (treatment arm A) or placebo (treatment arm B). Serial pharmacokinetic blood samples will be collected. Participants will be followed for safety and efficacy and will remain on study treatment until documented disease progression, development of unacceptable toxicity, or withdrawal of consent. Participants discontinuing study treatment will enter the survival follow-up period where they will be followed for the development of symptomatic progression and initiation of subsequent anti-cancer therapies, until death, loss of follow-up, or withdrawal of consent, whichever comes first. The total study duration will be approximately up to Month 59.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01946204

Contacts
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: JNJ.CT@sylogent.com

  Show 271 Study Locations
Sponsors and Collaborators
Aragon Pharmaceuticals, Inc.
Investigators
Study Director: Aragon Pharmaceuticals, Inc. Clinical Trial Aragon Pharmaceuticals, Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: Aragon Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01946204     History of Changes
Other Study ID Numbers: CR102931, ARN-509-003, 2012-004322-24
Study First Received: September 17, 2013
Last Updated: August 19, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Aragon Pharmaceuticals, Inc.:
Prostate neoplasms
Prostate cancer
Castration-resistant prostate cancer
Non-metastatic castration-resistant prostate cancer
ARN-509

Additional relevant MeSH terms:
Neoplasms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on August 28, 2014