TAK-700 in Castration Resistant Prostate Cancer
Primary Purpose
Prostate Cancer
Status
Withdrawn
Phase
Phase 2
Locations
Belgium
Study Type
Interventional
Intervention
Orteronel
Bicalutamide
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring metastatic, prostate cancer
Eligibility Criteria
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
Sites / Locations
- Onze Lieve Vrouw Ziekenhuis
- Cliniques Universitaires Saint-Luc
- AZ Groeninge Kortrijk - Campus Vercruysselaan
- CHU Dinant Godinne - UCL Namur
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Orteronel, 300 mg twice daily
Bicalutamide 50 mg per day
Arm Description
Outcomes
Primary Outcome Measures
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
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
Overall survival
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
Full Information
NCT ID
NCT01658527
First Posted
July 27, 2012
Last Updated
June 9, 2016
Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
1. Study Identification
Unique Protocol Identification Number
NCT01658527
Brief Title
TAK-700 in Castration Resistant Prostate Cancer
Official Title
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 Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Withdrawn
Why Stopped
Pharmaceutical company has terminated orteronel (TAK-700) development for Prostate Cancer
Study Start Date
January 2014 (undefined)
Primary Completion Date
January 2016 (Anticipated)
Study Completion Date
January 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The objective of this randomized phase II open label trial is to determine the anti-tumor activity of TAK-700 (Orteronel) as compared to bicalutamide in terms of clinical progression-free survival in prostate cancer patients who failed 1st line treatment with LHRH (luteinizing hormone-releasing hormone) agonists or surgical castration.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
metastatic, prostate cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Orteronel, 300 mg twice daily
Arm Type
Experimental
Arm Title
Bicalutamide 50 mg per day
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Orteronel
Other Intervention Name(s)
TAK 700
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Bicalutamide
Intervention Description
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.
Primary Outcome Measure Information:
Title
The primary endpoint of the trial is clinical progression free survival.
Description
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 Measure Information:
Title
RECIST (Response Evaluation Criteria In Solid Tumors) response in patients presenting with measurable disease
Title
Time to PSA (Prostate specific antigen) progression and PSA change from baseline
Title
Overall survival
Title
Safety according to Common Terminology Criteria for Adverse Events, version 4.03
Title
Pain (when an SAE (Serious Adverse Event)) or pain requiring initiation of narcotic analgesia
Title
Skeletal related events, including requirement to initiate chemotherapy, radiotherapy, cord compression or requirement for surgery to the bone
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cora Sternberg
Organizational Affiliation
San Camillo Forlanini Hospitals, Rome, Italy
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bertrand Tombal
Organizational Affiliation
Cliniques Universitaires de St Luc, Brussels, Belgium
Official's Role
Study Chair
Facility Information:
Facility Name
Onze Lieve Vrouw Ziekenhuis
City
Aals
Country
Belgium
Facility Name
Cliniques Universitaires Saint-Luc
City
Brussels
Country
Belgium
Facility Name
AZ Groeninge Kortrijk - Campus Vercruysselaan
City
Kortrijck
Country
Belgium
Facility Name
CHU Dinant Godinne - UCL Namur
City
Yvoir
Country
Belgium
12. IPD Sharing Statement
Learn more about this trial
TAK-700 in Castration Resistant Prostate Cancer
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