Back to resultsStudy in Japan and Ex-Japan to Characterize the Pharmacokinetic and Pharmacodynamic Response to Orteronel (TAK-700) in Chemotherapy-Naive Participants With Castration-Resistant Prostate Cancer
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Orteronel
Orteronel Placebo
Prednisone
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring castrate resistant prostate cancer,, CRPC,, orteronel,, TAK-700
Eligibility Criteria
Inclusion Criteria:
- Male participants 18 years or older
- Voluntary written consent must be given before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care
- Histologically or cytologically confirmed diagnosis of prostate adenocarcinoma
- Prior surgical castration or concurrent use of an agent for medical castration [e.g. Gonadotropin-releasing hormone (GnRH) analogue]
- Prostate-Specific Antigen (PSA) ≥ 2 ng/mL at screening
- Progressive disease based on PSA and/or radiographic criteria
Exclusion Criteria:
- Prior therapy with orteronel, ketoconazole, aminoglutethimide, or abiraterone.
- Known hypersensitivity to compounds related to orteronel, orteronel excipients, prednisone (or commercially available equivalent), or GnRH analogue.
- All antiandrogen therapy (including bicalutamide) is excluded within 4 weeks before the first dose of study drug. Any other therapies for prostate cancer, other than GnRH analogue therapy, such as progesterone, medroxyprogesterone, progestins (megesterol), or 5- alpha reductase inhibitors (e.g., finasteride or dutasteride), must be discontinued 2 weeks before the first dose of study drug.
- Continuous daily use of oral prednisone (or commercially available equivalent), oral dexamethasone, or other systemic corticosteroids for more than 2 weeks within the 3 months before screening (inhaled, nasal, and local steroids [e.g., joint injection] are allowed).
- Prior chemotherapy for prostate cancer, with the exception of neoadjuvant/adjuvant therapy as part of initial primary treatment for local disease that was completed 2 or more years before screening.
Please note that there are additional inclusion and exclusion criteria. The study center will determine if you meet all of the criteria.
Site personnel will explain the trial in detail and answer any question you may have if you do qualify for the study. You can then decide whether or not you wish to participate. If you do not qualify for the trial, site personnel will explain the reasons.
Sites / Locations
- Urology Cancer Center, PC
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm Type
Other
Experimental
Other
Experimental
Other
Experimental
Other
Experimental
Arm Label
Placebo + Orteronel 200 mg (Japan)
Orteronel 200 mg (Japan)
Placebo + Orteronel 300 mg (Japan)
Orteronel 300 mg (Japan)
Placebo + Orteronel 200 mg (Ex-Japan)
Orteronel 200 mg (Ex-Japan)
Placebo + Orteronel 400 mg (Ex-Japan)
Orteronel 400 mg (Ex-Japan)
Arm Description
Orteronel placebo-matching tablets, orally, twice daily in Cycle 1 (28 days) followed by orteronel 200 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 3 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
Orteronel placebo-matching tablets, orally, twice daily in Cycle 1 followed by orteronel 300 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
Orteronel 300 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
Orteronel placebo-matching tablets, orally, twice daily in Cycle 1 followed by orteronel 200 mg, tablets, orally, twice daily in 28 day cycles outside of Japan (Ex-Japan) for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
Orteronel placebo-matching tablets, orally, twice daily in Cycle 1 followed by orteronel 400 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
Orteronel 400 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
Outcomes
Primary Outcome Measures
Percentage of Participants With Serum Testosterone Levels Reduced to ≤ 2 ng/dL After 4 Weeks of Treatment in Japan
Serum Ultra-sensitive testosterone was measured by liquid chromatography at a central laboratory.
Secondary Outcome Measures
Percentage of Participants With Serum Testosterone Levels Reduced to ≤ 2 ng/dL in Ex-Japan
Serum Ultra-sensitive testosterone was measured by liquid chromatography at a central laboratory.
Percent Change From Baseline in Serum Testosterone Level After 4 Weeks of Treatment
Serum Ultra-sensitive testosterone was measured by liquid chromatography at a central laboratory.
Percent Change From Baseline in Serum Testosterone Level After 12 Weeks of Treatment
Serum Ultra-sensitive testosterone was measured by liquid chromatography at a central laboratory.
Percentage of Participants With Prostate-Specific Antigen Reduction ≥ 50% (PSA50) After 4 Weeks of Treatment
A 50% PSA response rate (PSA50) was defined as PSA reduction ≥ 50% from Baseline.
Percentage of Participants With PSA50 After 12 Weeks of Treatment
A 50% PSA response rate (PSA50) was defined as PSA reduction ≥ 50% from Baseline.
Absolute Values for Testosterone
Serum Ultra-sensitive testosterone was measured by liquid chromatography at a central laboratory.
Absolute Values for Dehydroepiandrosterone Sulfate (DHEA-S)
Serum Ultra low level quantification of DHEA-S was measured by liquid chromatography and mass spectrometry (LC/MS) at a central laboratory.
Absolute Values for Adrenocorticotropic Hormone (ACTH)
Serum ACTH was measured by immunometric assay at the central laboratory.
Absolute Values for Corticosterone
Serum Corticosterone was measured by high pressure liquid chromatography with mass spectrometry at the central laboratory.
Absolute Values for Cortisol
Serum Cortisol was measured by immunometric assay at the central laboratory.
Absolute Values for Prostate-Specific Antigen (PSA)
Serum PSA was measured at the central laboratory.
Cmax: Maximum Observed Plasma Concentration for Orteronel and M-I Metabolite
Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.
AUC(0-12): Area Under the Plasma Concentration-Time Curve From Time 0 to 12 Hours Post-dose for Orteronel and M-I Metabolite
AUC(0-12) is measure of area under the curve over the dosing interval where the length of the dosing interval is time 0 to 12 hours in this study.
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Orteronel and M-I Metabolite
Tmax: Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax.
AE (0-24) Cumulative Amount of Drug Excreted Into the Urine for Orteronel and MI-Metabolite
Cumulative amount of urine excreted time 0 to 24 hour.
Cmax,ss: Maximum Observed Plasma Concentration at Steady State for Orteronel and MI-Metabolite
Maximum observed steady-state plasma concentration during a dosing interval.
Tmax,ss: Time to Reach the Maximum Plasma Concentration (Cmax), Equal to Time (Hours) to Cmax at Steady State for Orteronel and M-I Metabolite
Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax at steady state.
AUC(0-tau): Area Under the Plasma Concentration-time Curve From Time 0 to Time Tau Over the Dosing Interval for Orteronel and M-I Metabolite
Area under the plasma concentration-time curve during a dosing interval, where tau is the length of the dosing interval.
Rac: Accumulation Index for Orteronel and M-I Metabolite
Rac was calculated as the ratio of AUCtau to AUC12hr.
Ctrough,ss: Observed Predose Plasma Concentration at Steady State for Orteronel and M-I Metabolite
Observed predose plasma concentration at steady state.
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding),symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study A serious adverse event is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.
Full Information
NCT ID
NCT01666314
First Posted
August 6, 2012
Last Updated
February 19, 2018
Sponsor
Millennium Pharmaceuticals, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01666314
Brief Title
Study in Japan and Ex-Japan to Characterize the Pharmacokinetic and Pharmacodynamic Response to Orteronel (TAK-700) in Chemotherapy-Naive Participants With Castration-Resistant Prostate Cancer
Official Title
A Study in Japan and Ex-Japan to Characterize the Pharmacokinetic and Pharmacodynamic Response to Orteronel (TAK-700) in Chemotherapy-Naive Patients With Castration-Resistant Prostate Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
August 20, 2012 (Actual)
Primary Completion Date
September 12, 2013 (Actual)
Study Completion Date
September 1, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Millennium Pharmaceuticals, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a double-blind, placebo-controlled, multiregional Phase1/2 study to characterize the pharmacokinetic and pharmacodynamic responses to orteronel when administered concomitantly with prednisone in Chemotherapy-Naive Participants With Castration-Resistant Prostate Cancer
Detailed Description
The drug being tested in this study is called orteronel. Orteronel is being tested to treat adult males who have adenocarcinoma of the prostate. This study will look at the pharmacokinetics (how the drug moves through the body) and pharmacodynamics (how the drug effects the body) in people who take orteronel in addition to prednisone.
The study will enroll approximately 144 patients. Participants will be randomly assigned (by chance, like flipping a coin) to one of the eight treatment groups (4 in Japan, 4 in Ex-Japan) which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need).
In Japan:
Participants were randomized in a ratio of 2:1:2:1
200 mg orteronel or Placebo-matching orteronel [(dummy inactive pill) - this is a tablet that looks like the study drug but has no active ingredient] twice daily (BID) + prednisone
300 mg orteronel, or Placebo-matching orteronel, BID + prednisone Ex-Japan Participants were randomized in a ratio of 2:1:2:1
200 mg orteronel or Placebo-matching orteronel, BID in Cycle 1 + prednisone
400 mg orteronel, or Placebo-matching orteronel ,BID in Cycle 1 + Prednisone
Participants initially randomized to placebo received 4 weeks of placebo and then 12 weeks of active treatment with orteronel then entered a follow-up period treatment period. Participants initially randomized to orteronel received 16 weeks of treatment then entered a follow-up treatment period.
This multi-centre trial will be conducted worldwide. The overall time to participate in this study is approximately 3.2 years. Participants will make multiple visits to the clinic and a final visit 30 to 40 days after receiving their last dose of study drug for a follow-up assessment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
castrate resistant prostate cancer,, CRPC,, orteronel,, TAK-700
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
137 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo + Orteronel 200 mg (Japan)
Arm Type
Other
Arm Description
Orteronel placebo-matching tablets, orally, twice daily in Cycle 1 (28 days) followed by orteronel 200 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
Arm Title
Orteronel 200 mg (Japan)
Arm Type
Experimental
Arm Description
Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 3 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
Arm Title
Placebo + Orteronel 300 mg (Japan)
Arm Type
Other
Arm Description
Orteronel placebo-matching tablets, orally, twice daily in Cycle 1 followed by orteronel 300 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
Arm Title
Orteronel 300 mg (Japan)
Arm Type
Experimental
Arm Description
Orteronel 300 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
Arm Title
Placebo + Orteronel 200 mg (Ex-Japan)
Arm Type
Other
Arm Description
Orteronel placebo-matching tablets, orally, twice daily in Cycle 1 followed by orteronel 200 mg, tablets, orally, twice daily in 28 day cycles outside of Japan (Ex-Japan) for up to 3.1 years.
Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
Arm Title
Orteronel 200 mg (Ex-Japan)
Arm Type
Experimental
Arm Description
Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
Arm Title
Placebo + Orteronel 400 mg (Ex-Japan)
Arm Type
Other
Arm Description
Orteronel placebo-matching tablets, orally, twice daily in Cycle 1 followed by orteronel 400 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
Arm Title
Orteronel 400 mg (Ex-Japan)
Arm Type
Experimental
Arm Description
Orteronel 400 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
Intervention Type
Drug
Intervention Name(s)
Orteronel
Intervention Description
Orteronel tablets
Intervention Type
Drug
Intervention Name(s)
Orteronel Placebo
Intervention Description
Orteronel placebo-matching tablets
Intervention Type
Drug
Intervention Name(s)
Prednisone
Intervention Description
Prednisone 5 mg
Primary Outcome Measure Information:
Title
Percentage of Participants With Serum Testosterone Levels Reduced to ≤ 2 ng/dL After 4 Weeks of Treatment in Japan
Description
Serum Ultra-sensitive testosterone was measured by liquid chromatography at a central laboratory.
Time Frame
Baseline and Week 4
Secondary Outcome Measure Information:
Title
Percentage of Participants With Serum Testosterone Levels Reduced to ≤ 2 ng/dL in Ex-Japan
Description
Serum Ultra-sensitive testosterone was measured by liquid chromatography at a central laboratory.
Time Frame
Baseline and Week 4
Title
Percent Change From Baseline in Serum Testosterone Level After 4 Weeks of Treatment
Description
Serum Ultra-sensitive testosterone was measured by liquid chromatography at a central laboratory.
Time Frame
Baseline and Week 4
Title
Percent Change From Baseline in Serum Testosterone Level After 12 Weeks of Treatment
Description
Serum Ultra-sensitive testosterone was measured by liquid chromatography at a central laboratory.
Time Frame
Baseline and Week 12
Title
Percentage of Participants With Prostate-Specific Antigen Reduction ≥ 50% (PSA50) After 4 Weeks of Treatment
Description
A 50% PSA response rate (PSA50) was defined as PSA reduction ≥ 50% from Baseline.
Time Frame
Baseline and Week 4
Title
Percentage of Participants With PSA50 After 12 Weeks of Treatment
Description
A 50% PSA response rate (PSA50) was defined as PSA reduction ≥ 50% from Baseline.
Time Frame
Baseline and Week 12
Title
Absolute Values for Testosterone
Description
Serum Ultra-sensitive testosterone was measured by liquid chromatography at a central laboratory.
Time Frame
Baseline, Cycle 1 Day 8 and Cycle 2 Day 1
Title
Absolute Values for Dehydroepiandrosterone Sulfate (DHEA-S)
Description
Serum Ultra low level quantification of DHEA-S was measured by liquid chromatography and mass spectrometry (LC/MS) at a central laboratory.
Time Frame
Baseline, Cycle 1 Day 8 and Cycle 2 Day 1
Title
Absolute Values for Adrenocorticotropic Hormone (ACTH)
Description
Serum ACTH was measured by immunometric assay at the central laboratory.
Time Frame
Baseline, Cycle 1 Day 8 and Cycle 2 Day 1
Title
Absolute Values for Corticosterone
Description
Serum Corticosterone was measured by high pressure liquid chromatography with mass spectrometry at the central laboratory.
Time Frame
Baseline, Cycle 1 Day 8 and Cycle 2 Day 1
Title
Absolute Values for Cortisol
Description
Serum Cortisol was measured by immunometric assay at the central laboratory.
Time Frame
Baseline, Cycle 1 Day 8 and Cycle 2 Day 1
Title
Absolute Values for Prostate-Specific Antigen (PSA)
Description
Serum PSA was measured at the central laboratory.
Time Frame
Baseline and Cycle 2 Day 1
Title
Cmax: Maximum Observed Plasma Concentration for Orteronel and M-I Metabolite
Description
Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.
Time Frame
Cycle 1 Day 1 Predose, 0.5, 1, 2, 3, 5, 8, 12 hours post-dose
Title
AUC(0-12): Area Under the Plasma Concentration-Time Curve From Time 0 to 12 Hours Post-dose for Orteronel and M-I Metabolite
Description
AUC(0-12) is measure of area under the curve over the dosing interval where the length of the dosing interval is time 0 to 12 hours in this study.
Time Frame
Cycle 1 Day 1 Predose, 0.5, 1, 2, 3, 5, 8, 12 hours post-dose
Title
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Orteronel and M-I Metabolite
Description
Tmax: Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax.
Time Frame
Cycle 1 Day 1 Predose, 0.5, 1, 2, 3, 5, 8, 12 hours post-dose
Title
AE (0-24) Cumulative Amount of Drug Excreted Into the Urine for Orteronel and MI-Metabolite
Description
Cumulative amount of urine excreted time 0 to 24 hour.
Time Frame
Cycle 1 Day 1 Predose, 0.5, 1, 2, 3, 5, 8, 12 hours post-dose
Title
Cmax,ss: Maximum Observed Plasma Concentration at Steady State for Orteronel and MI-Metabolite
Description
Maximum observed steady-state plasma concentration during a dosing interval.
Time Frame
Cycle 1 Day 8 Predose, 0.5, 1, 2, 3, 5, 8, 12 hours post-dose
Title
Tmax,ss: Time to Reach the Maximum Plasma Concentration (Cmax), Equal to Time (Hours) to Cmax at Steady State for Orteronel and M-I Metabolite
Description
Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax at steady state.
Time Frame
Cycle 1 Day 8 Predose, 0.5, 1, 2, 3, 5, 8, 12 hours post-dose
Title
AUC(0-tau): Area Under the Plasma Concentration-time Curve From Time 0 to Time Tau Over the Dosing Interval for Orteronel and M-I Metabolite
Description
Area under the plasma concentration-time curve during a dosing interval, where tau is the length of the dosing interval.
Time Frame
Cycle 1 Day 8 Predose, 0.5, 1, 2, 3, 5, 8, 12 hours post-dose
Title
Rac: Accumulation Index for Orteronel and M-I Metabolite
Description
Rac was calculated as the ratio of AUCtau to AUC12hr.
Time Frame
Cycle 1 Day 8 Predose, 0.5, 1, 2, 3, 5, 8, 12 hours post-dose
Title
Ctrough,ss: Observed Predose Plasma Concentration at Steady State for Orteronel and M-I Metabolite
Description
Observed predose plasma concentration at steady state.
Time Frame
Cycle 1 Day 8 Predose
Title
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Description
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding),symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study A serious adverse event is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.
Time Frame
From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male participants 18 years or older
Voluntary written consent must be given before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care
Histologically or cytologically confirmed diagnosis of prostate adenocarcinoma
Prior surgical castration or concurrent use of an agent for medical castration [e.g. Gonadotropin-releasing hormone (GnRH) analogue]
Prostate-Specific Antigen (PSA) ≥ 2 ng/mL at screening
Progressive disease based on PSA and/or radiographic criteria
Exclusion Criteria:
Prior therapy with orteronel, ketoconazole, aminoglutethimide, or abiraterone.
Known hypersensitivity to compounds related to orteronel, orteronel excipients, prednisone (or commercially available equivalent), or GnRH analogue.
All antiandrogen therapy (including bicalutamide) is excluded within 4 weeks before the first dose of study drug. Any other therapies for prostate cancer, other than GnRH analogue therapy, such as progesterone, medroxyprogesterone, progestins (megesterol), or 5- alpha reductase inhibitors (e.g., finasteride or dutasteride), must be discontinued 2 weeks before the first dose of study drug.
Continuous daily use of oral prednisone (or commercially available equivalent), oral dexamethasone, or other systemic corticosteroids for more than 2 weeks within the 3 months before screening (inhaled, nasal, and local steroids [e.g., joint injection] are allowed).
Prior chemotherapy for prostate cancer, with the exception of neoadjuvant/adjuvant therapy as part of initial primary treatment for local disease that was completed 2 or more years before screening.
Please note that there are additional inclusion and exclusion criteria. The study center will determine if you meet all of the criteria.
Site personnel will explain the trial in detail and answer any question you may have if you do qualify for the study. You can then decide whether or not you wish to participate. If you do not qualify for the trial, site personnel will explain the reasons.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Millennium Pharmaceuticals, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Urology Cancer Center, PC
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68130
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study in Japan and Ex-Japan to Characterize the Pharmacokinetic and Pharmacodynamic Response to Orteronel (TAK-700) in Chemotherapy-Naive Participants With Castration-Resistant Prostate Cancer
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