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Efficacy and Safety Study of Darolutamide (ODM-201) in Men With High-risk Nonmetastatic Castration-resistant Prostate Cancer (ARAMIS)

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ClinicalTrials.gov Identifier: NCT02200614
Recruitment Status : Active, not recruiting
First Posted : July 25, 2014
Last Update Posted : February 22, 2019
Sponsor:
Collaborator:
Orion Corporation, Orion Pharma
Information provided by (Responsible Party):
Bayer

Tracking Information
First Submitted Date  ICMJE July 22, 2014
First Posted Date  ICMJE July 25, 2014
Last Update Posted Date February 22, 2019
Actual Study Start Date  ICMJE September 12, 2014
Actual Primary Completion Date September 3, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 23, 2014)
Metastasis-Free Survival [ Time Frame: Up to 72 months ]
Time from randomisation to evidence of metastasis or death from any cause, whichever occurs first
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02200614 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 18, 2016)
  • Overall Survival [ Time Frame: Up to 72 months ]
    Date of death and primary cause of death will be recorded
  • Time to first symptomatic skeletal event (SSE) [ Time Frame: Up to 72 months ]
    Date of first SSE will be recorded
  • Time to initiation of first cytotoxic chemotherapy for prostate cancer [ Time Frame: Up to 72 months ]
    Name and start date of cytotoxic chemotherapy treatment will be recorded
  • Time to pain progression [ Time Frame: Up to 72 months ]
    Date of pain progression will be recorded
  • Safety and tolerability of ODM-201 [ Time Frame: Up to 72 months ]
    Summaries of AEs, the frequency of discontinuation of study treatment due to AEs, laboratory evaluations, vital signs, ECGs and physical examination.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 23, 2014)
  • Overall Survival [ Time Frame: Up to 72 months ]
    Date of death and primary cause of death will be recorded.
  • Time to first symptomatic skeletal event (SSE) [ Time Frame: Up to 72 months ]
    Date of first SSE will be recorded
  • Time to initiation of first cytotoxic chemotherapy [ Time Frame: Up to 72 months ]
    Name and start date of cytotoxic chemotherapy treatment will be recorded
  • Time to pain progression [ Time Frame: Up to 72 months ]
    Pain will be assessed by Brief Pain Inventory.
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety Study of Darolutamide (ODM-201) in Men With High-risk Nonmetastatic Castration-resistant Prostate Cancer
Official Title  ICMJE A Multinational, Randomised, Double-blind, Placebo-controlled, Phase III Efficacy and Safety Study of Darolutamide (ODM-201) in Men With High-risk Non-metastatic Castration-resistant Prostate Cancer
Brief Summary The purpose of this study is to assess the safety and efficacy of BAY1841788 (ODM-201) in patients with non-metastatic castration-resistant prostate cancer.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Prostate Cancer Non-Metastatic
  • Castration-Resistant
Intervention  ICMJE
  • Drug: Darolutamide (BAY1841788)
    Darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equivalent to a total daily dose of 1200 mg.
  • Drug: Placebo
    Matching placebo 2 tablets twice daily with food.
Study Arms
  • Experimental: Darolutamide (BAY1841788)
    Metastasis-free survival (MFS) in patients with high-risk non-metastatic castration-resistant prostate cancer
    Intervention: Drug: Darolutamide (BAY1841788)
  • Placebo Comparator: Placebo
    Metastasis-free survival (MFS) in patients with high-risk non-metastatic castration-resistant prostate cancer
    Intervention: Drug: Placebo
Publications * Fizazi K, Shore N, Tammela TL, Ulys A, Vjaters E, Polyakov S, Jievaltas M, Luz M, Alekseev B, Kuss I, Kappeler C, Snapir A, Sarapohja T, Smith MR; ARAMIS Investigators. Darolutamide in Nonmetastatic, Castration-Resistant Prostate Cancer. N Engl J Med. 2019 Feb 14. doi: 10.1056/NEJMoa1815671. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: November 28, 2018)
1509
Original Estimated Enrollment  ICMJE
 (submitted: July 23, 2014)
1500
Estimated Study Completion Date June 30, 2020
Actual Primary Completion Date September 3, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically or cytologically confirmed adenocarcinoma of prostate without neuroendocrine differentiation or small cell features.
  • Castration-resistant prostate cancer (CRPC) with castrate level of serum testosterone.
  • Prostate-specific antigen doubling time of ≤ 10 months and PSA > 2ng/ml.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
  • Blood counts at screening: haemoglobin ≥ 9.0 g/dl,absolute neutrophil count ≥ 1500/µl, platelet count ≥ 100,000/µl.
  • Screening values of serum alanine aminotransferase (ALT) and/or aspartate transaminase (AST) ≤ 2.5 x upper limit of normal (ULN), total bilirubin ≤ 1.5 x ULN, creatinine ≤ 2.0 x ULN.
  • Sexually active patients, unless surgically sterile, must agree to use condoms as an effective barrier method and refrain from sperm donation during the study treatment and for 3 months after the end of the study treatment.

Exclusion Criteria:

  • History of metastatic disease at any time or presence of detectable metastases.
  • Acute toxicities of prior treatments and procedures not resolved to grade ≤ 1 or baseline before randomisation.
  • Prior treatment with: second generation androgen receptor (AR) inhibitors, other investigational AR inhibitors, or CYP17 enzyme inhibitor.
  • Use of estrogens or 5-α reductase inhibitors or AR inhibitors.
  • Prior chemotherapy or immunotherapy for prostate cancer.
  • Use of systemic corticosteroid.
  • Radiation therapy within 12 weeks before randomisation.
  • Severe or uncontrolled concurrent disease, infection or co-morbidity.
  • Treatment with bisphosphonate or denosumab within 12 weeks before randomisation.
  • Known hypersensitivity to the study treatment or any of its ingredients.
  • Major surgery within 28 days before randomisation.
  • Any of the following within 6 months before randomisation: stroke, myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft; congestive heart failure New York Heart Association (NYHA) Class III or IV.
  • Uncontrolled hypertension.
  • Prior malignancy.
  • Gastrointestinal disorder or procedure which expects to interfere significantly with absorption of study treatment.
  • Active viral hepatitis, active human immunodeficiency virus (HIV) or chronic liver disease.
  • Treatment with any investigational drug within 28 days before randomisation.
  • Any condition that in the opinion of the investigator would impair the patients' ability to comply with the study procedures.
Sex/Gender
Sexes Eligible for Study: Male
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Australia,   Austria,   Belarus,   Belgium,   Brazil,   Bulgaria,   Canada,   Colombia,   Czechia,   Estonia,   Finland,   France,   Germany,   Hungary,   Israel,   Italy,   Japan,   Korea, Republic of,   Latvia,   Lithuania,   Peru,   Poland,   Portugal,   Romania,   Russian Federation,   Serbia,   Slovakia,   South Africa,   Spain,   Sweden,   Taiwan,   Turkey,   Ukraine,   United Kingdom,   United States
Removed Location Countries Czech Republic,   Greece
 
Administrative Information
NCT Number  ICMJE NCT02200614
Other Study ID Numbers  ICMJE 17712
2013-003820-36 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Bayer
Study Sponsor  ICMJE Bayer
Collaborators  ICMJE Orion Corporation, Orion Pharma
Investigators  ICMJE
Study Director: Bayer Study Director Bayer
PRS Account Bayer
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP