- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01658527
TAK-700 in Castration Resistant Prostate Cancer
Phase II Randomized Comparative Trial of TAK-700 (Orteronel) Versus Bicalutamide in Metastatic Prostate Cancer Patients Failing 1st Line Treatment With LHRH Agonists or Surgical Castration.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
-
Aals, Belgium
- Onze Lieve Vrouw Ziekenhuis
-
Brussels, Belgium
- Cliniques Universitaires Saint-Luc
-
Kortrijck, Belgium
- AZ Groeninge Kortrijk - Campus Vercruysselaan
-
Yvoir, Belgium
- CHU Dinant Godinne - UCL Namur
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion criteria:
- Histologically confirmed diagnosis of prostate adenocarcinoma
- Metastatic disease in bone or other lesions documented by imaging. Abnormal 99mTc-bone scan imaging must be confirmed by Computed Tomography (CT) Scan or Magnetic resonance Imaging (MRI)
- Progressive disease following 1st line androgen deprivation therapy with LHRH (luteinizing hormone-releasing hormone) Agonists or surgical castration. Recommendations of Prostate Cancer Working Group 2 (PCWG2)
- WHO (World health organization) performance status ≤ 2
- Life expectancy > 12 weeks
- Adequate bone marrow function (Absolute neutrophil count (ANC) 1500/μL; platelets 100,000/μL)
- Castrate serum levels of testosterone (< 50 ng/dL)
- Adequate renal function: calculated creatinine clearance > 40 mL/minute
Adequate hepatic function:
- Bilirubin: total bilirubin 1.5 Upper limit of Normal (ULN)
- Asparate aminotransferase (AST) and/or Alanine aminotransferase (ALT) ≤ 2.5 x ULN in the absence of liver metastases or ≤ 5 x ULN if liver metastases are present
- Patients of reproductive potential should use adequate birth control measures, as defined by the investigator, during the study treatment period and for at least 4 months following the last study treatment. A highly effective method of birth control is defined as those that result in low failure rate (i.e. less than 1% per year) when used consistently and correctly
- Before patient registration/randomization, written informed consent must be given according to ICH/GCP (International conference on Harmonization-Good Clinical Practices), and national/local regulations
Exclusion criteria
Cardiac function:
- Screening calculated ejection fraction (Multi Gated Acquisition Scan (MUGA) scan, or by echocardiogram) must be ≥ 50%
- No history of myocardial infarction, unstable symptomatic ischemic heart disease, ongoing arrhythmias of Grade > 2 thromboembolic events (e.g., deep vein thrombosis, pulmonary embolism, or symptomatic cerebrovascular events), or any other cardiac condition (e.g., pericardial effusion restrictive cardiomyopathy) within 6 months prior to first dose of study drug
- Chronic stable atrial fibrillation on stable anticoagulant therapy is allowed
- Absence of New York Heart Association Class III or IV heart failure
- Absence of Electrocardiogram (ECG) abnormalities of: Q-wave infarction, unless identified 6 or more months prior to screening and QTc interval > 470 msec
- No uncontrolled hypertension despite appropriate medical therapy defined as blood pressure >160/90 mmHg at 2 separate measurements no more than 60 minutes apart during the Screening visit
- Prior radiotherapy but only for lymph nodes is allowed
Prior or concomitant therapy:
- No intake of narcotic analgesia for bone pain
- No prior treatment with non-steroidal antiandrogens, within 6 months prior to randomization
- No anticancer therapy or treatment with another investigational agent within the last 4 weeks prior to randomization
- No prior therapy with TAK-700, ketoconazole, abiraterone, aminoglutethimide or MDV3100
- Patients taking bisphosphonates or denosumab are eligible if they have received a stable dose for 4 weeks or more prior to randomization. (These treatments may then be continued on study)
- No known hypersensitivity to compounds related to TAK-700 or to TAK-700 excipients (refer to Investigator's brochure)
- No known gastrointestinal (GI) disease or GI procedure that could interfere with the GI absorption or tolerance of TAK-700, including difficulty swallowing tablets
- No prior history of adrenal insufficiency
- No prior history of malignancies other than prostate adenocarcinoma (except for basal cell or squamous cell carcinoma of the skin), or the patient has been free of malignancy for a period of 3 years prior to first dose of study drug
- No 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
- No drug or alcohol abuse
- Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Orteronel, 300 mg twice daily
|
Tak-700 will be administered until disease progression, diagnosis of a second malignancy, patient refusal to continue the treatment, excessive toxicity precluding further therapy according to protocol and /or according to the responsible physician. Upon progression, patient may stay on study medication until the initiation of a new therapy
Other Names:
|
Active Comparator: Bicalutamide 50 mg per day
|
Bicalutamide will be given at the standard daily dose of 50 mg PO (per os).
Bicalutamide will be maintained until disease progression diagnosis of a second malignancy, patient refusal to continue the treatment, excessive toxicity precluding further therapy according to protocol and /or according to the responsible physician.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
---|---|
The primary endpoint of the trial is clinical progression free survival.
|
The primary endpoint of the trial is clinical progression free survival.
In this protocol, it is defined according to the recommendations of the "Prostate-Cancer clinical trials Working Group 2" and referred to as the "PCWG2" for the setting "delay/prevent" progression.
|
Secondary Outcome Measures
Outcome Measure |
---|
Overall survival
|
RECIST (Response Evaluation Criteria In Solid Tumors) response in patients presenting with measurable disease
|
Time to PSA (Prostate specific antigen) progression and PSA change from baseline
|
Safety according to Common Terminology Criteria for Adverse Events, version 4.03
|
Pain (when an SAE (Serious Adverse Event)) or pain requiring initiation of narcotic analgesia
|
Skeletal related events, including requirement to initiate chemotherapy, radiotherapy, cord compression or requirement for surgery to the bone
|
Collaborators and Investigators
Investigators
- Principal Investigator: Cora Sternberg, San Camillo Forlanini Hospitals, Rome, Italy
- Study Chair: Bertrand Tombal, Cliniques Universitaires de St Luc, Brussels, Belgium
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- EORTC-1211-GUCG-IG
- 2012-002122-67 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Prostate Cancer
-
Roswell Park Cancer InstituteRecruitingObesity | Overweight | Cancer Survivor | Prostate Adenocarcinoma | Stage I Prostate Cancer | Stage II Prostate Cancer | Stage III Prostate Cancer | Stage IV Prostate Cancer | Stage IIA Prostate Cancer | Stage IIB Prostate Cancer | Stage IVA Prostate Cancer | Stage IVB Prostate Cancer | Stage A Prostate Cancer | Stage... and other conditionsUnited States
-
Sidney Kimmel Cancer Center at Thomas Jefferson...Regeneron Pharmaceuticals; Prostate Cancer FoundationWithdrawnStage III Prostate Cancer | Stage IV Prostate Cancer | Stage IVA Prostate Cancer | Stage IVB Prostate Cancer | Stage IIIA Prostate Cancer | Stage IIIB Prostate Cancer | Stage IIIC Prostate Cancer
-
Jonsson Comprehensive Cancer CenterProgenics Pharmaceuticals, Inc.TerminatedRandomized Trial of PSMA PET Scan Before Definitive Radiation Therapy for Prostate Cancer (PSMA-dRT)Stage II Prostate Cancer AJCC v8 | Stage IIIA Prostate Cancer AJCC v8 | Stage IIIB Prostate Cancer AJCC v8 | Stage IIC Prostate Cancer AJCC v8 | Stage III Prostate Cancer AJCC v8 | Stage IIIC Prostate Cancer AJCC v8 | Stage IIA Prostate Cancer AJCC v8 | Stage IIB Prostate Cancer AJCC v8 | Stage I Prostate...United States
-
University of Southern CaliforniaNational Cancer Institute (NCI); SanofiTerminatedDiarrhea | Recurrent Prostate Cancer | Hormone-resistant Prostate Cancer | Stage I Prostate Cancer | Stage III Prostate Cancer | Stage IV Prostate Cancer | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
-
Jonsson Comprehensive Cancer CenterNational Cancer Institute (NCI)CompletedRecurrent Prostate Cancer | Stage I Prostate Cancer | Stage III Prostate Cancer | Adenocarcinoma of the Prostate | Stage IV Prostate Cancer | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
-
Ryan Kohlbrenner, MDRadiological Society of North AmericaCompletedProstate Adenocarcinoma | Stage IV Prostate Cancer AJCC v8 | Prostate Carcinoma | Stage IIIA Prostate Cancer AJCC v8 | Stage IIIB Prostate Cancer AJCC v8 | Stage IIC Prostate Cancer AJCC v8 | Stage III Prostate Cancer AJCC v8 | Stage IIIC Prostate Cancer AJCC v8 | Stage IVA Prostate Cancer AJCC v8 | Stage...United States
-
Mayo ClinicNational Cancer Institute (NCI)WithdrawnStage I Prostate Cancer AJCC v8 | Stage II Prostate Cancer AJCC v8 | Stage IIIA Prostate Cancer AJCC v8 | Stage IIIB Prostate Cancer AJCC v8 | Stage IIC Prostate Cancer AJCC v8 | Stage III Prostate Cancer AJCC v8 | Stage IIIC Prostate Cancer AJCC v8 | Stage IIA Prostate Cancer AJCC v8 | Stage IIB Prostate...United States
-
Barbara Ann Karmanos Cancer InstituteGenentech, Inc.CompletedRecurrent Prostate Cancer | Stage I Prostate Cancer | Stage III Prostate Cancer | Adenocarcinoma of the Prostate | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
-
Ohio State University Comprehensive Cancer CenterRiverside Methodist HospitalCompletedStage I Prostate Cancer | Stage III Prostate Cancer | Stage IV Prostate Cancer | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
-
University of California, IrvineCompletedRecurrent Prostate Cancer | Stage I Prostate Cancer | Stage III Prostate Cancer | Adenocarcinoma of the Prostate | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
Clinical Trials on Orteronel
-
Grupo Español de Tumores Huérfanos e InfrecuentesTakedaTerminatedMetastatic or Advanced Non-resectable Granulosa Cell Ovarian TumorsSpain
-
University of Wisconsin, MadisonMillennium Pharmaceuticals, Inc.CompletedPost Menopausal, Hormone Receptor Positive Breast CancerUnited States
-
Millennium Pharmaceuticals, Inc.Completed
-
Swiss Group for Clinical Cancer ResearchCompleted
-
SCRI Development Innovations, LLCMillennium Pharmaceuticals, Inc.CompletedMetastatic Breast CancerUnited States
-
Swiss Group for Clinical Cancer ResearchWithdrawnProstate CancerSwitzerland
-
Millennium Pharmaceuticals, Inc.CompletedProstate CancerFrance, United States, Belgium, Spain, Australia, Canada, Netherlands, Italy, Poland, Czechia, Estonia, Finland, Hungary, Greece
-
University of Southern CaliforniaNational Cancer Institute (NCI); Millennium Pharmaceuticals, Inc.TerminatedRecurrent Prostate Cancer | Hormone-resistant Prostate Cancer | Adenocarcinoma of the Prostate | Stage IV Prostate CancerUnited States
-
Millennium Pharmaceuticals, Inc.CompletedProstate CancerUnited States, France, Ukraine, United Kingdom, Belgium, Germany, Taiwan, Spain, Belarus, Israel, Portugal, Bulgaria, Romania, South Africa, Japan, Switzerland, Canada, Australia, Netherlands, Greece, Chile, New Zealand, Peru, Singapore, Russian Federation and more
-
Millennium Pharmaceuticals, Inc.Completed