Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study of Patient Preference Between ODM-201 and Enzalutamide in Men With Metastatic Castrate-resistant Prostate Cancer (ODENZA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03314324
Recruitment Status : Recruiting
First Posted : October 19, 2017
Last Update Posted : February 19, 2018
Sponsor:
Information provided by (Responsible Party):
Gustave Roussy, Cancer Campus, Grand Paris

Brief Summary:
To assess patient preference between ODM-201 and enzalutamide by patient preference questionnaire

Condition or disease Intervention/treatment Phase
Metastatic Castrate-resistant Prostate (CRPC) Cancer Drug: ODM-201 Drug: Enzalutamide Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Prospective, randomized, open-label, multicenter, cross-over phase II trial
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Study of Patient Preference Between ODM-201 and Enzalutamide in Men With Metastatic Castrate-resistant Prostate Cancer
Actual Study Start Date : November 29, 2017
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ODM-201 Drug: ODM-201
ODM-201: 600 mg (2 x 300 mg tablets) twice daily with food equivalent to a total daily dose of 1200 mg. ODM-201 should be taken at similar times day, approximately 12 hours between doses.

Active Comparator: Enzalutamide Drug: Enzalutamide
Enzalutamide: 160 mg/day (4 x 40 mg tablets) taken once a day preferably with food, preferably in the evening (Enzalutamide can generally be given with or without food, but in the present trial, it is preferable that it is given with food, to be consistent with ODM-201 intake).




Primary Outcome Measures :
  1. Patient preference [ Time Frame: up to 24 months ]
    Patient preference (assessed by a single question) between ODM-201 and enzalutamide after completion of the second period of treatment.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male patients older than 18 years
  • Histologically confirmed adenocarcinoma of the prostate
  • Evidence of metastatic disease (imaging can include bon scan, CT scan, PET choline, PET PSMA and MRI)
  • Continued androgen deprivation therapy (ADT) either with LHRH agonists/antagonists or bilateral orchiectomy
  • Serum testosterone <0.50 ng/ml (1.7 nmol/L)
  • Progressive disease (PSA progression or radiological progression or clinical progression) as per PCWG3 criteria
  • ECOG 0-1 (2 is accepted if the impairement is not due to prostate cancer)
  • Asymptomatic or mildly symptomatic (Brief Pain Inventory<4) prostate cancer
  • Information imparted to the patient and the informed consent form signed by the patient or his legal representative
  • Ability to comply with the protocol procedures
  • Patient affiliated to a social security system or beneficiary of the same
  • Sexually active male subjects unless surgically sterile, must agree to use condoms as an effective barrier method and refrain from sperm donation, and/or their female partners of reproductive potential to use a method of effective birth control, during the study treatment and for 3 months after the end of the treatment
  • adequate organ or bone marrow function as evidenced by:
  • Hemoglobin ≥ 9 g/dL
  • Absolute neutrophil count ≥ 1.5 x 109/L,
  • Platelet count ≥ 100 x 109/L, (subject must not have received any growth factor within 4 weeks or blood transfusion within 7 days of the hematology laboratory sample obtained at screening)
  • AST/SGOT and/or ALT/SGPT ≤1.5 x ULN;
  • Total bilirubin ≤ 1.5 x ULN, (except subjects with a diagnosis of Gilbert's disease),
  • Serum creatinine ≤ 2 x ULN. If creatinine 1.0 - 1.5 x ULN, creatinine clearance will be calculated according to the CKDEPI formula and patients with creatinine clearance <60 mL/min should be excluded.

Exclusion Criteria:

  • Prior treatment with abiraterone, enzalutamide, ODM-201, ARN- 509 or any other next-generation AR axis-targeting drug
  • Prior treatment with a taxane for CRPC (prior treatment with a taxane for castration-sensitive or castration-naïve prostate cancer is allowed)
  • Prior treatment with radium-223
  • Patients receiving an investigational drug within 4 weeks prior to enrolment (approved drugs with a long history of use such as aspirin, statins, heparins, or metformin, even used in an experimental setting are accepted)
  • Treatment with radiotherapy (external beam radiation therapy [EBRT], brachytherapy, or radiopharmaceuticals) within 2 weeks before randomization
  • Known hypersensitivity to any of the study drugs, study drug classes, or excipients in the formulation of the study drugs
  • Acute toxicities of prior treatments and procedures not resolved to grade <=1 or baseline before randomisation.
  • Had any of the following within 6 months before randomization: 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 as indicated by a resting systolic blood pressure (BP) ≥160 mmHg or diastolic BP ≥100 mmHg despite optimal medical management
  • Had a prior malignancy. Adequately treated basal cell or squamous cell carcinoma of skin or superficial bladder cancer that has not spread behind the connective tissue layer (i.e., pTis, pTa, and pT1) is allowed, as well as any other cancer for which treatment has been completed ≥5 years before randomization and from which the subject has been disease-free
  • A gastrointestinal disorder or procedure which is expected to interfere significantly with absorption of study treatment
  • An active viral hepatitis, active human immunodeficiency infection(HIV), or chronic liver disease with a need for treatment.
  • Any other serious or unstable illness or infection, or medical, social, or psychological condition, that could jeopardize the safety of the subject and/or his compliance with study procedures, or may interfere with the subject's participation in the study or evaluation of the study results
  • Inability to swallow oral medications

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): NCT03314324


Contacts
Layout table for location contacts
Contact: Karim FIZAZI, MD, PhD 0142114317 ext +33 karim.fizazi@gustaveroussy.fr
Contact: Geraldine MARTINEAU, MD 0142115607 ext +33 geraldine.martineau@gustaveroussy.fr

Locations
Layout table for location information
France
Gustave Roussy Recruiting
Villejuif, Val De Marne, France, 94805
Contact: Karim FIZAZI, MD    0142114317 ext +33    karim.fizazi@gustaveroussy.fr   
Contact: Geraldine MARTINEAU, MD    0142115607 ext +33    geraldine.martineau@gustaveroussy.fr   
Principal Investigator: Karim FIZAZI, MD         
Sponsors and Collaborators
Gustave Roussy, Cancer Campus, Grand Paris
Investigators
Layout table for investigator information
Study Chair: Karim FIZAZI, MD Gustave ROUSSY

Layout table for additonal information
Responsible Party: Gustave Roussy, Cancer Campus, Grand Paris
ClinicalTrials.gov Identifier: NCT03314324     History of Changes
Other Study ID Numbers: 2017-001606-14
2017/2555 ( Other Identifier: CSET number )
First Posted: October 19, 2017    Key Record Dates
Last Update Posted: February 19, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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