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Trial record 1 of 1 for:    NCT02200614
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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
Results First Posted : October 29, 2019
Last Update Posted : October 29, 2019
Sponsor:
Collaborator:
Orion Corporation, Orion Pharma
Information provided by (Responsible Party):
Bayer

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Non-Metastatic Castration-Resistant Drug: Darolutamide (BAY1841788) Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1509 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : September 12, 2014
Actual Primary Completion Date : September 3, 2018
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: Darolutamide (BAY1841788)
Participants received Darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equal to a total daily dose of 1200 mg.
Drug: Darolutamide (BAY1841788)
Darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equivalent to a total daily dose of 1200 mg.

Placebo Comparator: Placebo
Participants received matching placebo 2 tablets twice daily with food.
Drug: Placebo
Matching placebo 2 tablets twice daily with food.




Primary Outcome Measures :
  1. Metastasis-Free Survival [ Time Frame: From randomization to the time approximately 385 MFS events were observed (approximately 48 months) ]
    Metastasis-Free Survival (MFS) is defined as the time from randomisation to evidence of metastasis or death from any cause, whichever occurs first


Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: From randomization of the first subject to the time approximatively 140 death events were observed (approximately 48 months) ]
    Overall Survival (OS) was defined as the time from randomization to death due to any cause.

  2. Time to Pain Progression [ Time Frame: From randomization until last study treatment (assessed every 4 months) (approximately 48 months) ]
    Time to pain progression (PP) is defined as time from randomization to pain progression, where progression is defined as an increase of 2 or more points from baseline in question 3 of the Brief Pain Inventory-Short Form questionnaire (BPI-SF) related to the worst pain in the last 24 hours taken as a 7-day average for post-baseline scores, or initiation of short or long-acting opioids for pain, whichever comes first. Initiation or change in the use of other non-opioid analgesics is not used in the analysis of pain progression.

  3. Time to Initiation of First Cytotoxic Chemotherapy for Prostate Cancer [ Time Frame: From randomization until last study treatment (assessed every 4 months) (approximately 48 months) ]
    The time to cytotoxic chemotherapy was defined as the time from randomization to the start of the first cytotoxic chemotherapy cycle.

  4. Time to First Symptomatic Skeletal Event (SSE) [ Time Frame: From randomization until last study treatment (assessed every 4 months) (approximately 48 months) ]
    The time to the first SSE was defined as the time from randomization to the occurrence of the first SSE.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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 (PSA) 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02200614


  Show 405 Study Locations
Sponsors and Collaborators
Bayer
Orion Corporation, Orion Pharma
Investigators
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Study Director: Bayer Study Director Bayer
  Study Documents (Full-Text)

Documents provided by Bayer:
Study Protocol  [PDF] February 26, 2018
Statistical Analysis Plan  [PDF] September 20, 2018


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02200614     History of Changes
Other Study ID Numbers: 17712
2013-003820-36 ( EudraCT Number )
First Posted: July 25, 2014    Key Record Dates
Results First Posted: October 29, 2019
Last Update Posted: October 29, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases