Orteronel Maintenance Therapy in Patients With Metastatic Castration Resistant Prostate Cancer and Non-progressive Disease After First-line Docetaxel Therapy

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. Read our disclaimer for details. Identifier: NCT01707966
Recruitment Status : Completed
First Posted : October 16, 2012
Last Update Posted : July 26, 2016
Information provided by (Responsible Party):
Swiss Group for Clinical Cancer Research

Brief Summary:
The main objective of this multicenter, randomized, double-blind, placebo-controlled phase III trial is to assess the impact of maintenance orteronel on disease progression and hence on quality of life in patients with metastatic castration-resistant prostate cancer who have achieved at lease disease stabilization after first line chemotherapy with docetaxel.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: Orteronel Drug: Placebo Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Orteronel Maintenance Therapy in Patients With Metastatic Castration Resistant Prostate Cancer and Non-progressive Disease After First-line Docetaxel Therapy: a Multicenter Randomized Double-blind Placebo-controlled Phase III Trial.
Study Start Date : September 2012
Actual Primary Completion Date : September 2014
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
Drug Information available for: Docetaxel
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Orteronel and best supportive care
Arm A: 300mg Orteronel twice daily and best supportive care until occurrence of an event.
Drug: Orteronel
Other Name: TAK-700
Placebo Comparator: Placebo and best supportive care
Arm B: Placebo twice daily and best supportive care until occurrence of an event.
Drug: Placebo

Primary Outcome Measures :
  1. Event free survival (EFS) [ Time Frame: At baseline; every 4 weeks until disease progression (estimated up to 1 year) ]

Secondary Outcome Measures :
  1. Adverse events (AEs) [ Time Frame: Throughout treatment phase (estimated up to 1 year) until 30 days after last drug administration or prior to start of subsequent anticancer treatment (whichever occurs first) ]
  2. Prostate-specific antigen (PSA) response (30%, 50%, 90% and best) [ Time Frame: PSA level at baseline and every 4 weeks until disease progression (estimated up to 1 year) ]
  3. Time to PSA progression [ Time Frame: PSA level at baseline and every 4 weeks until disease progression (estimated up to 1 year) ]
  4. Radiographic progression-free survival (rPFS) [ Time Frame: Every 12 weeks until disease progression (estimated up to 1 year) ]
  5. QL and pain response [ Time Frame: First 6 months of trial treatment ]
  6. Overall survival (OS) [ Time Frame: time from trial randomization to the date of death from any cause (estimated up to 4 years) ]

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

Inclusion Criteria:

  • Patient has given voluntary written informed consent
  • Male patient 18 years or older
  • WHO performance status of ≤2
  • Adenocarcinoma of the prostate
  • Castration resistance: tumor progression after orchiectomy or during treatment with GnRH analogues
  • Metastatic disease, radiographically documented (
  • Total testosterone ≤ 50 ng/dL
  • Non-progressive disease after docetaxel first-line treatment with a cumulative dose ≥ 300mg/m2

    • No evidence of progression on imaging according to PCWG2 and modified RECIST 1.1 criteria
    • PSA levels not elevated ≥ 25% AND at least 2 ng/mL above the nadir since start of docetaxel treatment
  • Non-surgically castrated patient agrees on ongoing use of GnRH analogues (agonists or antagonists) during the trial
  • PSA ≥ 2 ng/mL; Potassium ≥ 3.5 mmol/L; Neutrophils ≥ 1.5 x 109/L; Platelets ≥ 100 x 10x9/L
  • Normal kidney and liver function
  • Planned start of trial treatment 3 to 6 weeks after last docetaxel administration
  • Screening calculated ejection fraction of ≥ 50% or normal according to local standard by echocardiogram or by multiple gated acquisition (MUGA) scan.
  • Baseline QL questionnaire completed
  • Patient is able and willing to swallow study drug as whole tablet
  • Patient compliance and geographic proximity allow proper staging and follow-up
  • Patient agrees to practice effective barrier contraception or to completely abstain from intercourse

Exclusion Criteria:

  • Prior therapy with aminoglutethimide, ketoconazole, orteronel, abiraterone or other modern CYP17 inhibitors
  • Prior chemotherapy for prostate cancer within 12 months before enrollment except from docetaxel
  • Retreatment with docetaxel after interruption of > 5 weeks
  • Concurrent disease requiring higher doses of corticosteroid than the equivalent of 10 mg prednisone per day
  • Known hypersensitivity to trial drug or hypersensitivity to any of its components
  • Patient has received other investigational drugs within 30 days before enrollment
  • Presence of a small cell component in histological specimen
  • Radiotherapy within the last 2 weeks before expected start of the trial treatment
  • Known history of central nervous system (CNS) or spinal cord metastases
  • Current spinal cord compression
  • Diagnosed or treated for another malignancy within 2 years of registration, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, or any in situ malignancies
  • History of myocardial infarction, unstable symptomatic ischemic heart disease, ongoing arrhythmias of Grade ≥ 3 (NCI CTCAE version 4.0) or thromboembolic events (e.g., deep vein thrombosis, pulmonary embolism, or symptomatic cerebrovascular events) within 6 months prior to first dose of study drug. Chronic stable atrial fibrillation on stable anticoagulant therapy is allowed
  • New York Heart Association Class III or IV heart failure
  • ECG abnormalities of:

    • Q-wave infarction, unless identified ≥ 6 months prior to registration
    • QTc interval > 460 msec
  • Uncontrolled hypertension despite appropriate medical therapy
  • Likely inability (e.g. due to a psychiatric disorder) to understand information on trial related topics, to give informed consent, to comply with the protocol, to fill in QL forms and to cooperate fully with the investigator and site personnel
  • Known gastrointestinal (GI) disease or GI procedure that could interfere with the GI absorption or tolerance of orteronel
  • Known active chronic hepatitis B or C, life-threatening illness unrelated to cancer, or any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with participation in this study

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 identifier (NCT number): NCT01707966

Kantonspital Aarau
Aarau, Switzerland, CH-5001
Universitaetsspital Basel
Basel, Switzerland, 4031
Istituto Oncologico della Svizzera Italiana - Ospedale Regionale Bellinzona e Valli
Bellinzona, Switzerland, 6500
Inselspital Bern
Bern, Switzerland, CH-3010
Kantonsspital Graubuenden
Chur, Switzerland, 7000
Kantonsspital Freiburg
Freiburg, Switzerland, 1708
Hôpitaux Universitaires de Genève HUG
Geneva 14, Switzerland, 1211
Centre Hospitalier Universitaire Vaudois CHUV
Lausanne, Switzerland, CH-1011
Kantonsspital Luzern
Luzern, Switzerland, 6000
Kantonsspital Muensterlingen
Muensterlingen, Switzerland, 8596
Spital Männedorf
Männedorf, Switzerland, 8708
Kantonsspital St. Gallen
St. Gallen, Switzerland, 9007
SpitalSTS AG Simmental-Thun-Saanenland
Thun, Switzerland, 3600
Kantonsspital Winterthur
Winterthur, Switzerland, 8401
UniversitaetsSpital Zuerich
Zurich, Switzerland, 8091
Sponsors and Collaborators
Swiss Group for Clinical Cancer Research
Study Chair: Richard Cathomas, MD Kantonsspital Graubünden
Study Chair: Silke Gillessen, Prof Cantonal Hospital of St. Gallen

Responsible Party: Swiss Group for Clinical Cancer Research Identifier: NCT01707966     History of Changes
Other Study ID Numbers: SAKK 08/11
2011-002965-39 ( EudraCT Number )
First Posted: October 16, 2012    Key Record Dates
Last Update Posted: July 26, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Swiss Group for Clinical Cancer Research:
adenocarcinoma of the prostate
metastatic castration-resistant prostate cancer
maintenance therapy

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action