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This is an open-label, multicenter, Phase 1/2 study of TAK-700 in combination with docetaxel and prednisone that will evaluate the safety and pharmacokinetics (PK) of the combination and will allow estimation of prostate-specific antigen (PSA) response in men with metastatic castration-resistant prostate cancer (mCRPC).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1: Orteronel 200 mg BID + Docetaxel + Prednisone | Experimental | Orteronel (TAK-700) 200 milligram (mg), tablets, orally, twice daily (BID) starting from Day 1 along with docetaxel 75 milligram per square meter (mg/m^2), infusion, intravenously over 1 hour on Day 1 and prednisone 5 mg, tablets , orally, twice daily from Day 8 up to Day 21 of each treatment cycle. Cycle 1 of Phase 1 consisted of a 28-day treatment period and subsequent cycles consisted of 21-day treatment periods. |
|
| Phase 1: Orteronel 400 mg BID + Docetaxel + Prednisone | Experimental | Orteronel (TAK-700) 400 mg, tablets, orally, twice daily starting from Day 1 along with docetaxel 75 mg/m^2, infusion, intravenously over 1 hour on Day 1 and prednisone 5 mg, tablets , orally, twice daily from Day 8 up to Day 21 of each treatment cycle. Cycle 1 of Phase 1 consisted of a 28-day treatment period and subsequent cycles consisted of 21-day treatment periods. |
|
| Phase 2: Orteronel 400 mg BID + Docetaxel + Prednisone | Experimental | Orteronel (TAK-700) 400 mg, tablets, orally, twice daily starting from Cycle 1 Day 15 along with docetaxel 75 mg/m^2, infusion, intravenously over 1 hour on Day 1 and prednisone 5 mg, tablets, orally, twice daily from Day 1 up to Day 21 of each 21-day treatment cycle until disease progression or end of treatment (EOT). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAK-700 | Drug | TAK-700 with docetaxel and prednisone on a continuous schedule. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAE) or Serious Adverse Events (SAE) | Baseline up to 30 days after last dose of study drug (Day of last dose for Phase 1: Cycle 84 Day 21; Phase 2: Cycle 48 Day 21) | |
| Number of Participants With TEAEs Related to Hematology and Serum Chemistry | Baseline up to 30 days after last dose of study drug (Day of last dose for Phase 1: Cycle 84 Day 21; Phase 2: Cycle 48 Day 21) | |
| Number of Participants With TEAEs Related to Vital Signs | Baseline up to 30 days after last dose of study drug (Day of last dose for Phase 1: Cycle 84 Day 21; Phase 2: Cycle 48 Day 21) | |
| Number of Participants With TEAEs Related to Electrocardiogram (ECG) | Baseline up to 30 days after last dose of study drug (Day of last dose for Phase 1: Cycle 84 Day 21; Phase 2: Cycle 48 Day 21) | |
| Phase 2: Cmax: Maximum Observed Plasma Concentration for Docetaxel | Cycle 1 Day 1: pre-dose and at multiple time points (up to 24 hours) post-end of docetaxel infusion; Cycle 2 Day 1: pre-dose and at multiple time points (up to 8 hours) post-end of docetaxel infusion | |
| Phase 2: AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Docetaxel | Cycle 1 Day 1: pre-dose and at multiple time points (up to 24 hours) post-end of docetaxel infusion; Cycle 2 Day 1: pre-dose and at multiple time points (up to 8 hours) post-end of docetaxel infusion | |
| Phase 2: AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Docetaxel | Cycle 1 Day 1: pre-dose and at multiple time points (up to 24 hours) post-end of docetaxel infusion; Cycle 2 Day 1: pre-dose and at multiple time points (up to 8 hours) post-end of docetaxel infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Phase 2: Time to PSA Progression | Time to PSA progression was defined as (date of PSA progression) - (date of first dose of drug) + 1, where PSA progression was defined as: For participants whose PSA concentrations never declined before the end of Cycle 4 of treatment: a) >=25% increase over the baseline level and an increase in absolute PSA concentration >=2 ng/mL; For participants who initially experienced a PSA decline: a) >=25% increase in PSA above the nadir concentration and an increase in absolute PSA concentration >=2 ng/mL. |
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Inclusion Criteria:
Each patient must meet all of the following inclusion criteria:
Exclusion Criteria:
Patients meeting any of the following exclusion criteria are not to be enrolled in the study:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Millennium Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alaska Clinical Research Center, LLC | Anchorage | Alaska | 99508 | United States |
Male participants with a historical diagnosis of metastatic-castration resistant prostate cancer (mCRPC) were enrolled in this 2 part study to receive orteronel (TAK-700) along with docetaxel 75 milligram per square meter (mg/m^2) and prednisone 5 milligram (mg) twice daily (BID).
Participants took part in the study at 10 investigative sites in the United States from 22 July 2010 to 03 March 2016.
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| ID | Title | Description |
|---|---|---|
| FG000 | Phase 1: Orteronel 200 mg BID + Docetaxel + Prednisone | Orteronel (TAK-700) 200 mg, tablets, orally, twice daily starting from Day 1 along with docetaxel 75 mg/m^2, infusion, intravenously over 1 hour on Day 1 and prednisone 5 mg, tablets, orally, twice daily from Day 8 up to Day 21 of each treatment cycle. Cycle 1 of Phase 1 consisted of a 28-day treatment period and subsequent cycles consisted of 21-day treatment periods. |
| FG001 | Phase 1: Orteronel 400 mg BID + Docetaxel + Prednisone | Orteronel (TAK-700) 400 mg, tablets, orally, twice daily starting from Day 1 along with docetaxel 75 mg/m^2, infusion, intravenously over 1 hour on Day 1 and prednisone 5 mg, tablets , orally, twice daily from Day 8 up to Day 21 of each treatment cycle. Cycle 1 of Phase 1 consisted of a 28-day treatment period and subsequent cycles consisted of 21-day treatment periods. |
| FG002 | Phase 2: Orteronel 400 mg BID + Docetaxel + Prednisone | Orteronel (TAK-700) 400 mg, tablets, orally, twice daily starting from Cycle 1 Day 15, then given continuously along with docetaxel 75 mg/m^2, infusion, intravenously over 1 hour on Day 1 and prednisone 5 mg, tablets, orally, twice daily from Day 1 up to Day 21 of each 21-day treatment cycle until disease progression or end of treatment (EOT). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The safety analysis set included all participants who were enrolled and received at least 1 dose of orteronel.
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| ID | Title | Description |
|---|---|---|
| BG000 | Phase 1: Orteronel 200 mg BID + Docetaxel + Prednisone | Orteronel (TAK-700) 200 mg, tablets, orally, twice daily starting from Day 1 along with docetaxel 75 mg/m^2, infusion, intravenously over 1 hour on Day 1 and prednisone 5 mg, tablets, orally, twice daily from Day 8 up to Day 21 of each treatment cycle. Cycle 1 of Phase 1 consisted of a 28-day treatment period and subsequent cycles consisted of 21-day treatment periods. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAE) or Serious Adverse Events (SAE) | The safety analysis set included all participants who were enrolled and received at least 1 dose of orteronel. | Posted | Number | participants | Baseline up to 30 days after last dose of study drug (Day of last dose for Phase 1: Cycle 84 Day 21; Phase 2: Cycle 48 Day 21) |
|
Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Part 1: Cycle 29 Day 21; Part 2: Cycle 12 Day 21).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Phase 1: Orteronel 200 mg BID + Docetaxel + Prednisone | Orteronel (TAK-700) 200 mg, tablets, orally, twice daily starting from Day 1 along with docetaxel 75 mg/m^2, infusion, intravenously over 1 hour on Day 1 and prednisone 5 mg, tablets, orally, twice daily from Day 8 up to Day 21 of each treatment cycle. Cycle 1 of Phase 1 consisted of a 28-day treatment period and subsequent cycles consisted of 21-day treatment periods. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cellulitis | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | MedDRA (15.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Takeda | +1-877-825-3327 | trialdisclosures@takeda.com |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C571806 | orteronel |
| D000077143 | Docetaxel |
| D011241 | Prednisone |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
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| Docetaxel | Drug | TAK-700 with docetaxel and prednisone on a continuous schedule. |
|
| Prednisone | Drug | TAK-700 with docetaxel and prednisone on a continuous schedule. |
|
| Phase 2: Terminal Phase Elimination Half-life (T1/2) for Docetaxel | Cycle 1 Day 1: pre-dose and at multiple time points (up to 24 hours) post-end of docetaxel infusion; Cycle 2 Day 1: pre-dose and at multiple time points (up to 8 hours) post-end of docetaxel infusion |
| Phase 2: Cmax, ss: Maximum Observed Plasma Concentration at Steady State for Orteronel | Cycle 1 Day 21: pre-dose and at multiple time points (up to 8 hours) post-dose for orteronel; Cycle 2 Day 1: pre-dose and at multiple time points (up to 8 hours) post-dose for orteronel |
| Phase 2: AUC 0-tau: Area Under the Plasma Concentration Versus Time Curve Zero to the Time of the End of the Dosing Interval for Orteronel | Cycle 1 Day 21: pre-dose and at multiple time points (up to 8 hours) post-dose for orteronel; Cycle 2 Day 1: pre-dose and at multiple time points (up to 8 hours) post-dose for orteronel |
| Phase 2: Percentage of Participants With Prostate-specific Antigen (PSA) Response of 30 Percent (%), 50%, and 90% | PSA response rates (PSA-30, PSA-50, and PSA-90) were defined as greater than or equal to (>=) 30%, 50%, and 90% reductions, respectively, from baseline in PSA concentration. | Cycle 4 Day 21 |
| Phase 2: Best PSA Response | Best PSA response was defined as the maximum PSA percent reduction from baseline at any time beyond Cycle 1. | Cycle 2 Day 1 up to Cycle 12 Day 21 |
| Baseline until disease progression or death, whichever occurred first (up to approximately 25.4 months) |
| Phase 2: Time to Radiographic Disease Progression | Time to Radiographic Disease Progression was defined as (date of Radiographic Disease progression) - (date of first dose of drug) + 1. Radiographic disease progression is defined as the presence of progressive disease (PD) according to Response Evaluation Criteria in Solid Tumors (RECIST) (Version 1.1) criteria and/or bone scan progression determined according to second Prostate Cancer Clinical Trials Working Group (PCWG2) bone scan criteria. | Baseline until disease progression or death, whichever occurred first (up to approximately 25.4 months) |
| Phase 2: Percentage of Participants With Objective Measurable Disease Response | Percentage of participants with objective measurable disease response based assessment of complete response (CR), partial response (PR), stable disease or PD according to RECIST (Version 1.1). A CR was defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have had reduction in short axis to less than (<)10 millimeter (mm). A PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of longest diameters of non-lymph node lesions and of the short diameter(s) or short axis of lymph nodes. | Baseline until disease progression or death, whichever occurred first (up to approximately 25.4 months) |
| Phase 2: Change From Baseline in Circulating Tumor Cells (CTCs) | Baseline is defined as the last scheduled observed measurement prior to the first dose of drug. | Cycle 2 Day 1, Cycle 5 Day 1, Cycle 9 Day 1, Cycle 13 Day 1, Cycle 17 Day 1, Cycle 21 Day 1, End of treatment (approximately up to Cycle 48), Last assessment (30 days after last dose of study drug, approximately up to 1038 days) |
| Adverse Event |
|
| Other |
|
| Symptomatic deterioration |
|
| Prostate-specificAntigen(PSA)progression |
|
| BG001 | Phase 1: Orteronel 400 mg BID + Docetaxel + Prednisone | Orteronel (TAK-700) 400 mg, tablets, orally, twice daily starting from Day 1 along with docetaxel 75 mg/m^2, infusion, intravenously over 1 hour on Day 1 and prednisone 5 mg, tablets , orally, twice daily from Day 8 up to Day 21 of each treatment cycle. Cycle 1 of Phase 1 consisted of a 28-day treatment period and subsequent cycles consisted of 21-day treatment periods. |
| BG002 | Phase 2: Orteronel 400 mg BID + Docetaxel + Prednisone | Orteronel (TAK-700) 400 mg, tablets, orally, twice daily starting from Cycle 1 Day 15, then given continuously along with docetaxel 75 mg/m^2, infusion, intravenously over 1 hour on Day 1 and prednisone 5 mg, tablets, orally, twice daily from Day 1 up to Day 21 of each 21-day treatment cycle until disease progression or end of treatment (EOT). |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Height | Mean | Standard Deviation | centimeter |
|
| Weight | Mean | Standard Deviation | kilogram |
|
| Body mass index (BMI) | Mean | Standard Deviation | kilogram per square meter (kg/m^2) |
|
| Phase 1: Orteronel 400 mg BID + Docetaxel + Prednisone |
Orteronel (TAK-700) 400 mg, tablets, orally, twice daily starting from Day 1 along with docetaxel 75 mg/m^2, infusion, intravenously over 1 hour on Day 1 and prednisone 5 mg, tablets , orally, twice daily from Day 8 up to Day 21 of each treatment cycle. Cycle 1 of Phase 1 consisted of a 28-day treatment period and subsequent cycles consisted of 21-day treatment periods. |
| OG002 | Phase 2: Orteronel 400 mg BID + Docetaxel + Prednisone | Orteronel (TAK-700) 400 mg, tablets, orally, twice daily starting from Cycle 1 Day 15, then given continuously along with docetaxel 75 mg/m^2, infusion, intravenously over 1 hour on Day 1 and prednisone 5 mg, tablets, orally, twice daily from Day 1 up to Day 21 of each 21-day treatment cycle until disease progression or end of treatment (EOT). |
|
|
| Primary | Number of Participants With TEAEs Related to Hematology and Serum Chemistry | The safety analysis set included all participants who were enrolled and received at least 1 dose of orteronel. | Posted | Number | participants | Baseline up to 30 days after last dose of study drug (Day of last dose for Phase 1: Cycle 84 Day 21; Phase 2: Cycle 48 Day 21) |
|
|
|
| Primary | Number of Participants With TEAEs Related to Vital Signs | The safety analysis set included all participants who were enrolled and received at least 1 dose of orteronel. | Posted | Number | participants | Baseline up to 30 days after last dose of study drug (Day of last dose for Phase 1: Cycle 84 Day 21; Phase 2: Cycle 48 Day 21) |
|
|
|
| Primary | Number of Participants With TEAEs Related to Electrocardiogram (ECG) | The safety analysis set included all participants who were enrolled and received at least 1 dose of orteronel. | Posted | Number | participants | Baseline up to 30 days after last dose of study drug (Day of last dose for Phase 1: Cycle 84 Day 21; Phase 2: Cycle 48 Day 21) |
|
|
|
| Primary | Phase 2: Cmax: Maximum Observed Plasma Concentration for Docetaxel | The pharmacokinetic (PK)-evaluable population included participants who had sufficient dosing data and plasma concentration-time data to permit calculation of at least 1 PK parameter. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram per milliliter (ng/mL) | Cycle 1 Day 1: pre-dose and at multiple time points (up to 24 hours) post-end of docetaxel infusion; Cycle 2 Day 1: pre-dose and at multiple time points (up to 8 hours) post-end of docetaxel infusion |
|
|
|
|
| Primary | Phase 2: AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Docetaxel | The PK-evaluable population included participants who had sufficient dosing data and plasma concentration-time data to permit calculation of at least 1 PK parameter. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram*hour per milliliter (ng*hr/mL) | Cycle 1 Day 1: pre-dose and at multiple time points (up to 24 hours) post-end of docetaxel infusion; Cycle 2 Day 1: pre-dose and at multiple time points (up to 8 hours) post-end of docetaxel infusion |
|
|
|
|
| Primary | Phase 2: AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Docetaxel | Data was not calculated since no participant was available for analysis. | Posted | Cycle 1 Day 1: pre-dose and at multiple time points (up to 24 hours) post-end of docetaxel infusion; Cycle 2 Day 1: pre-dose and at multiple time points (up to 8 hours) post-end of docetaxel infusion |
|
|
| Primary | Phase 2: Terminal Phase Elimination Half-life (T1/2) for Docetaxel | Data was not calculated since no participant was available for analysis. | Posted | Cycle 1 Day 1: pre-dose and at multiple time points (up to 24 hours) post-end of docetaxel infusion; Cycle 2 Day 1: pre-dose and at multiple time points (up to 8 hours) post-end of docetaxel infusion |
|
|
| Primary | Phase 2: Cmax, ss: Maximum Observed Plasma Concentration at Steady State for Orteronel | PK set where Cmax,ss data was available. The PK-evaluable population included participants who had sufficient dosing data and plasma concentration-time data to permit calculation of at least 1 PK parameter. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Cycle 1 Day 21: pre-dose and at multiple time points (up to 8 hours) post-dose for orteronel; Cycle 2 Day 1: pre-dose and at multiple time points (up to 8 hours) post-dose for orteronel |
|
|
|
|
| Primary | Phase 2: AUC 0-tau: Area Under the Plasma Concentration Versus Time Curve Zero to the Time of the End of the Dosing Interval for Orteronel | The PK-evaluable population included participants who had sufficient dosing data and plasma concentration-time data to permit calculation of at least 1 PK parameter. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | Cycle 1 Day 21: pre-dose and at multiple time points (up to 8 hours) post-dose for orteronel; Cycle 2 Day 1: pre-dose and at multiple time points (up to 8 hours) post-dose for orteronel |
|
|
|
|
| Primary | Phase 2: Percentage of Participants With Prostate-specific Antigen (PSA) Response of 30 Percent (%), 50%, and 90% | PSA response rates (PSA-30, PSA-50, and PSA-90) were defined as greater than or equal to (>=) 30%, 50%, and 90% reductions, respectively, from baseline in PSA concentration. | The PSA-evaluable population included all participants with a baseline PSA evaluation and at least 1 PSA evaluation beyond Cycle 1, or participants with baseline PSA evaluation without a beyond-cycle-1 PSA evaluation due to PSA progression, disease progression, unacceptable adverse event (AE), or death. | Posted | Number | 80% Confidence Interval | percentage of participants | Cycle 4 Day 21 |
|
|
|
| Primary | Phase 2: Best PSA Response | Best PSA response was defined as the maximum PSA percent reduction from baseline at any time beyond Cycle 1. | The PSA-evaluable population included all participants with a baseline PSA evaluation and at least 1 PSA evaluation beyond Cycle 1, or participants with baseline PSA evaluation without a beyond-cycle-1 PSA evaluation due to PSA progression, disease progression, unacceptable AE, or death. | Posted | Mean | Standard Deviation | percent change | Cycle 2 Day 1 up to Cycle 12 Day 21 |
|
|
|
| Secondary | Phase 2: Time to PSA Progression | Time to PSA progression was defined as (date of PSA progression) - (date of first dose of drug) + 1, where PSA progression was defined as: For participants whose PSA concentrations never declined before the end of Cycle 4 of treatment: a) >=25% increase over the baseline level and an increase in absolute PSA concentration >=2 ng/mL; For participants who initially experienced a PSA decline: a) >=25% increase in PSA above the nadir concentration and an increase in absolute PSA concentration >=2 ng/mL. | The safety analysis set included all participants who were enrolled and received at least 1 dose of orteronel. | Posted | Median | 95% Confidence Interval | days | Baseline until disease progression or death, whichever occurred first (up to approximately 25.4 months) |
|
|
|
| Secondary | Phase 2: Time to Radiographic Disease Progression | Time to Radiographic Disease Progression was defined as (date of Radiographic Disease progression) - (date of first dose of drug) + 1. Radiographic disease progression is defined as the presence of progressive disease (PD) according to Response Evaluation Criteria in Solid Tumors (RECIST) (Version 1.1) criteria and/or bone scan progression determined according to second Prostate Cancer Clinical Trials Working Group (PCWG2) bone scan criteria. | The safety analysis set included all participants who were enrolled and received at least 1 dose of orteronel. | Posted | Median | 95% Confidence Interval | days | Baseline until disease progression or death, whichever occurred first (up to approximately 25.4 months) |
|
|
|
| Secondary | Phase 2: Percentage of Participants With Objective Measurable Disease Response | Percentage of participants with objective measurable disease response based assessment of complete response (CR), partial response (PR), stable disease or PD according to RECIST (Version 1.1). A CR was defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have had reduction in short axis to less than (<)10 millimeter (mm). A PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of longest diameters of non-lymph node lesions and of the short diameter(s) or short axis of lymph nodes. | The RECIST-evaluable population was defined as all participants with measurable disease by RECIST (Version 1.1) at baseline, and with at least 1 postbaseline tumor response assessment (RECIST, Version 1.1). | Posted | Number | percentage of participants | Baseline until disease progression or death, whichever occurred first (up to approximately 25.4 months) |
|
|
|
| Secondary | Phase 2: Change From Baseline in Circulating Tumor Cells (CTCs) | Baseline is defined as the last scheduled observed measurement prior to the first dose of drug. | Safety analysis set where baseline and post-baseline assessments were available. The safety analysis set included all participants who were enrolled and received at least 1 dose of orteronel. | Posted | Mean | Standard Deviation | milliliter (mL) | Cycle 2 Day 1, Cycle 5 Day 1, Cycle 9 Day 1, Cycle 13 Day 1, Cycle 17 Day 1, Cycle 21 Day 1, End of treatment (approximately up to Cycle 48), Last assessment (30 days after last dose of study drug, approximately up to 1038 days) |
|
|
|
| 5 |
| 6 |
| 6 |
| 6 |
| EG001 | Phase 1: Orteronel 400 mg BID + Docetaxel + Prednisone | Orteronel (TAK-700) 400 mg, tablets, orally, twice daily starting from Day 1 along with docetaxel 75 mg/m^2, infusion, intravenously over 1 hour on Day 1 and prednisone 5 mg, tablets , orally, twice daily from Day 8 up to Day 21 of each treatment cycle. Cycle 1 of Phase 1 consisted of a 28-day treatment period and subsequent cycles consisted of 21-day treatment periods. | 5 | 8 | 8 | 8 |
| EG002 | Phase 2: Orteronel 400 mg BID + Docetaxel + Prednisone | Orteronel (TAK-700) 400 mg, tablets, orally, twice daily starting from Cycle 1 Day 15, then given continuously along with docetaxel 75 mg/m^2, infusion, intravenously over 1 hour on Day 1 and prednisone 5 mg, tablets, orally, twice daily from Day 1 up to Day 21 of each 21-day treatment cycle until disease progression or end of treatment (EOT). | 16 | 23 | 23 | 23 |
| Pneumonia bacterial | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
|
| Urosepsis | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
|
| Pseudomonal sepsis | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (15.0) | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA (15.0) | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA (15.0) | Systematic Assessment |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA (15.0) | Systematic Assessment |
|
| Pericardial effusion | Cardiac disorders | MedDRA (15.0) | Systematic Assessment |
|
| Cardio-respiratory arrest | Cardiac disorders | MedDRA (15.0) | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA (15.0) | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (15.0) | Systematic Assessment |
|
| Vitamin B12 deficiency | Metabolism and nutrition disorders | MedDRA (15.0) | Systematic Assessment |
|
| Pancreatitis | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Duodenal ulcer haemorrhage | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA (15.0) | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA (15.0) | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (15.0) | Systematic Assessment |
|
| Amylase increased | Investigations | MedDRA (15.0) | Systematic Assessment |
|
| Lipase increased | Investigations | MedDRA (15.0) | Systematic Assessment |
|
| International normalised ratio increased | Investigations | MedDRA (15.0) | Systematic Assessment |
|
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.0) | Systematic Assessment |
|
| Metastases to bone | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.0) | Systematic Assessment |
|
| Prostate cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.0) | Systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
| Bladder perforation | Renal and urinary disorders | MedDRA (15.0) | Systematic Assessment |
|
| Urinary bladder haemorrhage | Renal and urinary disorders | MedDRA (15.0) | Systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA (15.0) | Systematic Assessment |
|
| Hepatitis cholestatic | Hepatobiliary disorders | MedDRA (15.0) | Systematic Assessment |
|
| Drug hypersensitivity | Immune system disorders | MedDRA (15.0) | Systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA (15.0) | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA (15.0) | Systematic Assessment |
|
| Gastroenteritis viral | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
|
| Skin infection | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA (15.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | MedDRA (15.0) | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA (15.0) | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA (15.0) | Systematic Assessment |
|
| Leukocytosis | Blood and lymphatic system disorders | MedDRA (15.0) | Systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA (15.0) | Systematic Assessment |
|
| Lacrimation increased | Eye disorders | MedDRA (15.0) | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA (15.0) | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (15.0) | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA (15.0) | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA (15.0) | Systematic Assessment |
|
| Chills | General disorders | MedDRA (15.0) | Systematic Assessment |
|
| Pain | General disorders | MedDRA (15.0) | Systematic Assessment |
|
| Peripheral swelling | General disorders | MedDRA (15.0) | Systematic Assessment |
|
| Drug hypersensitivity | Immune system disorders | MedDRA (15.0) | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
|
| Conjunctivitis | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
|
| Fungal skin infection | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
|
| Oral candidiasis | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA (15.0) | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA (15.0) | Systematic Assessment |
|
| Post-traumatic pain | Injury, poisoning and procedural complications | MedDRA (15.0) | Systematic Assessment |
|
| Skin abrasion | Injury, poisoning and procedural complications | MedDRA (15.0) | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA (15.0) | Systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA (15.0) | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA (15.0) | Systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA (15.0) | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA (15.0) | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA (15.0) | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA (15.0) | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA (15.0) | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA (15.0) | Systematic Assessment |
|
| Blood phosphorus decreased | Investigations | MedDRA (15.0) | Systematic Assessment |
|
| Ejection fraction decreased | Investigations | MedDRA (15.0) | Systematic Assessment |
|
| Weight increased | Investigations | MedDRA (15.0) | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (15.0) | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (15.0) | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA (15.0) | Systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA (15.0) | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (15.0) | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (15.0) | Systematic Assessment |
|
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA (15.0) | Systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA (15.0) | Systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA (15.0) | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA (15.0) | Systematic Assessment |
|
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA (15.0) | Systematic Assessment |
|
| Neuropathy peripheral | Nervous system disorders | MedDRA (15.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (15.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (15.0) | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA (15.0) | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA (15.0) | Systematic Assessment |
|
| Restless legs syndrome | Nervous system disorders | MedDRA (15.0) | Systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA (15.0) | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA (15.0) | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA (15.0) | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA (15.0) | Systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA (15.0) | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA (15.0) | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA (15.0) | Systematic Assessment |
|
| Nocturia | Renal and urinary disorders | MedDRA (15.0) | Systematic Assessment |
|
| Micturition urgency | Renal and urinary disorders | MedDRA (15.0) | Systematic Assessment |
|
| Urinary incontinence | Renal and urinary disorders | MedDRA (15.0) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
| Nail discolouration | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
| Onychomadesis | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
| Rash macular | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (15.0) | Systematic Assessment |
|
| Flushing | Vascular disorders | MedDRA (15.0) | Systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA (15.0) | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA (15.0) | Systematic Assessment |
|
In general, Investigators may publish clinical data after the earlier of (i) publication by the Sponsor or (ii) 12 months following the abandonment, early termination or database lock; provided a copy of the publication provided to Sponsor at least 30 days ahead of publication, the Sponsor's confidential information is removed as may be requested by Sponsor and Investigator defers publication for up to 60 days in the event Sponsor provides notice that it intends to file a patent application.
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| Title | Measurements |
|---|---|
|
| Leukopenia |
|
| Leukocytosis |
|
| Neutrophil count decreased |
|
| Blood bilirubin increased |
|
| Blood creatinine increased |
|
| White blood cell count decreased |
|
| Gamma-glutamyltransferase increased |
|
| Blood alkaline phosphatase increased |
|
| Alanine aminotransferase increased |
|
| Aspartate aminotransferase increased |
|
| Hyperglycaemia |
|
| Hypomagnesaemia |
|
| Hyponatraemia |
|
| Hypophosphataemia |
|
| Hyperkalaemia |
|
| Title | Measurements |
|---|---|
|
| Accelerated hypertension |
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Progressive Disease |
|
|
| Change at Cycle 9 Day 1 (n=6) |
|
| Change at Cycle 13 Day 1 (n=7) |
|
| Change at Cycle 17 Day 1 (n=5) |
|
| Change at Cycle 21 Day 1 (n=1) |
|
| Change at End of treatment (n=11) |
|
| Change at Last assessment (n=18) |
|