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Trial record 5 of 100 for:    mdv3100 | Recruiting, Not yet recruiting, Available Studies

Effect of Enzalutamide Dose Reduction on Fatigue, Cognition, and Drug Trough Levels in Patients With Prostate Cancer (EFFECT)

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ClinicalTrials.gov Identifier: NCT03124615
Recruitment Status : Recruiting
First Posted : April 24, 2017
Last Update Posted : April 24, 2017
Sponsor:
Information provided by (Responsible Party):
Macquarie University, Australia

Brief Summary:

The primary purpose of this trial is to determine whether dose reduction of enzalutamide in patients with grade 3 fatigue and/or cognition change will lead to an improvement in symptoms while maintaining active drug levels.

Patients within 3 months of starting enzalutamide will be assessed by their oncologist as being potentially eligible for dose reduction due to the onset of moderate to severe fatigue and/or cognition change, which is assessed as being due to enzalutamide


Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: Enzalutamide Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 47 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Patients will have commenced standard dose enzalutamide (160mg) daily and dose will be reduced if Grade 3 fatigue or cognition change has occurred and if toxicity is attributed to enzalutamide
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Enzalutamide Dose Reduction on Fatigue, Cognition, and Drug Trough Levels in Patients With Prostate Cancer
Anticipated Study Start Date : May 2017
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Enzalutamide
Patients will have commenced standard dose enzalutamide (160mg) daily and dose will be reduced if Grade 3 fatigue or cognition change has occurred and if toxicity is attributed to enzalutamide
Drug: Enzalutamide
Enzalutamide is a FDA and Therapeutic Goods Administration (TGA, Regulatory Authority of therapeutic goods in Australia) approved treatment for castration resistant prostate cancer
Other Name: Xtandi



Primary Outcome Measures :
  1. The proportion of patients who have an improvement in cognition/ fatigue symptoms [ Time Frame: 1 year post enrolment ]
    The primary endpoint is an improvement in the fatigue and cognition symptoms. Improvement will be de ned as the patient answering 'Better' in the cognition/ fatigue question at the lowest dose of enzalutamide.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   The trial involves only the male population with prostate cancer
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with prostate cancer who have commenced enzalutamide within 3 months
  2. Patient must have concomitant LHRH agonist or antagonist (no single agent enzalutamide)
  3. Receiving enzalutamide before or after docetaxel
  4. Patients may have hormone-sensitive or castrate resistant disease
  5. Patients may have metastatic (M1) or non-metastatic (M0) disease
  6. Onset of grade 3 or more cognition change and/or fatigue after commencement of enzalutamide considered to be due to enzalutamide

Exclusion Criteria:

  1. Clinical dementia
  2. Concomitant use of drugs known to impair cognition such as benzodiazepines or antihistamines.
  3. Concomitant use of strong CYP3A4 and/ or CYP2C8 inducers or inhibitors.
  4. Patient expected to have a change in opioid dose during the study period or have had a change 4 weeks before study entry.
  5. Diagnosed with sleep apnoea
  6. Brain metastases, prior seizures, drugs that significantly reduce seizure threshold.
  7. Active infection or other intercurrent illness that may contribute to fatigue or cognition change within 4 weeks of study entry.

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): NCT03124615


Contacts
Contact: Professor Gurney +61 2 9812 3526 clinicaltrials@mq.edu.au
Contact: Hung Tran +61 2 9812 3604 clinicaltrials@mq.edu.au

Locations
Australia, New South Wales
Macquarie University Recruiting
North Ryde, New South Wales, Australia, 2109
Contact: Hung Tran    +61 2 9812 3526    clinicaltrials@mq.edu.au   
Principal Investigator: Howard Gurney, MBBS         
Sponsors and Collaborators
Macquarie University, Australia
Investigators
Principal Investigator: Howard Gurney Medical Oncologist

Responsible Party: Macquarie University, Australia
ClinicalTrials.gov Identifier: NCT03124615     History of Changes
Other Study ID Numbers: HGMQ201502
First Posted: April 24, 2017    Key Record Dates
Last Update Posted: April 24, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Prostatic Neoplasms
Fatigue
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Signs and Symptoms