Trial · NCT01666314
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
NCT01666314, Phase 1, Phase 2, Completed, Millennium Pharmaceuticals, Inc.; results first posted 2018-03-20
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. 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. Trials, record NCT01666314. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01666314
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- 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
- NCT number
- NCT01666314
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 137 participants, actual
- Lead sponsor
- Millennium Pharmaceuticals, Inc.
- Conditions
- Prostate Cancer
- Interventions
- Orteronel, Orteronel Placebo, Prednisone
- First posted
- 2012-08-16
- Last updated
- 2018-03-20
- Other registries' IDs
- eudract:2012-001539-30
- Results first posted
- 2018-03-20
Source ClinicalTrials.gov
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Serum Testosterone Levels Reduced to ≤ 2 ng/dL After 4 Weeks of Treatment in Japan | Baseline and Week 4 | Serum Ultra-sensitive testosterone was measured by liquid chromatography at a central laboratory. |
| Secondary | Percentage of Participants With Serum Testosterone Levels Reduced to ≤ 2 ng/dL in Ex-Japan | Baseline and Week 4 | Serum Ultra-sensitive testosterone was measured by liquid chromatography at a central laboratory. |
| Secondary | Percent Change From Baseline in Serum Testosterone Level After 4 Weeks of Treatment | Baseline and Week 4 | Serum Ultra-sensitive testosterone was measured by liquid chromatography at a central laboratory. |
| Secondary | Percent Change From Baseline in Serum Testosterone Level After 12 Weeks of Treatment | Baseline and Week 12 | Serum Ultra-sensitive testosterone was measured by liquid chromatography at a central laboratory. |
| Secondary | Percentage of Participants With Prostate-Specific Antigen Reduction ≥ 50% (PSA50) After 4 Weeks of Treatment | Baseline and Week 4 | A 50% PSA response rate (PSA50) was defined as PSA reduction ≥ 50% from Baseline. |
| Secondary | Percentage of Participants With PSA50 After 12 Weeks of Treatment | Baseline and Week 12 | A 50% PSA response rate (PSA50) was defined as PSA reduction ≥ 50% from Baseline. |
| Secondary | Absolute Values for Testosterone | Baseline, Cycle 1 Day 8 and Cycle 2 Day 1 | Serum Ultra-sensitive testosterone was measured by liquid chromatography at a central laboratory. |
| Secondary | Absolute Values for Dehydroepiandrosterone Sulfate (DHEA-S) | Baseline, Cycle 1 Day 8 and Cycle 2 Day 1 | Serum Ultra low level quantification of DHEA-S was measured by liquid chromatography and mass spectrometry (LC/MS) at a central laboratory. |
| Secondary | Absolute Values for Adrenocorticotropic Hormone (ACTH) | Baseline, Cycle 1 Day 8 and Cycle 2 Day 1 | Serum ACTH was measured by immunometric assay at the central laboratory. |
| Secondary | Absolute Values for Corticosterone | Baseline, Cycle 1 Day 8 and Cycle 2 Day 1 | Serum Corticosterone was measured by high pressure liquid chromatography with mass spectrometry at the central laboratory. |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 registered outcomesOutcomes22
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Serum Testosterone Levels Reduced to ≤ 2 ng/dL After 4 Weeks of Treatment in Japan | Baseline and Week 4 | Pharmacodynamics-evaluable population was defined as participants with a baseline and at least 1 post-baseline pharmacodynamics measurement. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Serum Testosterone Levels Reduced to ≤ 2 ng/dL in Ex-Japan | Baseline and Week 4 | Pharmacodynamics-evaluable population was defined as participants with a baseline and at least 1 post-baseline pharmacodynamics measurement. | percentage of participants | NUMBER |
| SECONDARY | Percent Change From Baseline in Serum Testosterone Level After 4 Weeks of Treatment | Baseline and Week 4 | Participants from the Pharmacodynamics-evaluable population, defined as participants with a baseline and at least 1 post-baseline pharmacodynamics measurement, with data available after 4 Weeks of Treatment. | percent change | MEAN |
| SECONDARY | Percent Change From Baseline in Serum Testosterone Level After 12 Weeks of Treatment | Baseline and Week 12 | Participants from the Pharmacodynamics-evaluable population, defined as participants with a baseline and at least 1 post-baseline pharmacodynamics measurement, with data available after 12 Weeks of Treatment. | percent change | MEAN |
| SECONDARY | Percentage of Participants With Prostate-Specific Antigen Reduction ≥ 50% (PSA50) After 4 Weeks of Treatment | Baseline and Week 4 | Participants from the Pharmacodynamics-evaluable population, defined as participants with a baseline and at least 1 post-baseline pharmacodynamics measurement, with data available after 4 Weeks of Treatment. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With PSA50 After 12 Weeks of Treatment | Baseline and Week 12 | Participants from the Pharmacodynamics-evaluable population, defined as participants with a baseline and at least 1 post-baseline pharmacodynamics measurement, with data available after 12 Weeks of Treatment. | percentage of participants | NUMBER |
| SECONDARY | Absolute Values for Testosterone | Baseline, Cycle 1 Day 8 and Cycle 2 Day 1 | Pharmacodynamics-evaluable population was defined as participants with a baseline and at least 1 post-baseline pharmacodynamics measurement. | ng/dL | MEAN |
| SECONDARY | Absolute Values for Dehydroepiandrosterone Sulfate (DHEA-S) | Baseline, Cycle 1 Day 8 and Cycle 2 Day 1 | Pharmacodynamics-evaluable population was defined as participants with a baseline and at least 1 post-baseline pharmacodynamics measurement. | nmol/L | MEAN |
| SECONDARY | Absolute Values for Adrenocorticotropic Hormone (ACTH) | Baseline, Cycle 1 Day 8 and Cycle 2 Day 1 | Pharmacodynamics-evaluable population was defined as participants with a baseline and at least 1 post-baseline pharmacodynamics measurement. | pmol/L | MEAN |
| SECONDARY | Absolute Values for Corticosterone | Baseline, Cycle 1 Day 8 and Cycle 2 Day 1 | Pharmacodynamics-evaluable population was defined as participants with a baseline and at least 1 post-baseline pharmacodynamics measurement. | nmol/L | MEAN |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 outcomesResults by group210
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Serum Testosterone Levels Reduced to ≤ 2 ng/dL After 4 Weeks of Treatment in Japan | Placebo (Japan) | 86.0 | 95% Confidence Interval 63.7 to 97.0 | percentage of participants | |
| Percentage of Participants With Serum Testosterone Levels Reduced to ≤ 2 ng/dL After 4 Weeks of Treatment in Japan | Orteronel 300 mg (Japan) | 100.0 | 95% Confidence Interval 84.6 to 100.0 | percentage of participants | |
| Percentage of Participants With Serum Testosterone Levels Reduced to ≤ 2 ng/dL in Ex-Japan | Placebo (Ex-Japan) | 48.0 | 95% Confidence Interval 26.8 to 69.4 | percentage of participants | |
| Percentage of Participants With Serum Testosterone Levels Reduced to ≤ 2 ng/dL in Ex-Japan | Orteronel 400 mg (Ex-Japan) | 79.0 | 95% Confidence Interval 57.8 to 92.9 | percentage of participants | |
| Percent Change From Baseline in Serum Testosterone Level After 4 Weeks of Treatment | Placebo (Japan) | -87.666 | Standard Deviation 10.4250 | percent change | |
| Percent Change From Baseline in Serum Testosterone Level After 4 Weeks of Treatment | Orteronel 200 mg (Japan) | -97.245 | Standard Deviation 1.2548 | percent change | |
| Percent Change From Baseline in Serum Testosterone Level After 4 Weeks of Treatment | Orteronel 300 mg (Japan) | -96.812 | Standard Deviation 2.7055 | percent change | |
| Percent Change From Baseline in Serum Testosterone Level After 4 Weeks of Treatment | Placebo (Ex-Japan) | -63.702 | Standard Deviation 43.3941 | percent change | |
| Percent Change From Baseline in Serum Testosterone Level After 4 Weeks of Treatment | Orteronel 200 mg (Ex-Japan) | -86.268 | Standard Deviation 37.2015 | percent change | |
| Percent Change From Baseline in Serum Testosterone Level After 4 Weeks of Treatment | Orteronel 400 mg (Ex-Japan) | -53.954 | Standard Deviation 118.8050 | percent change |
1 to 10 of 210Source ClinicalTrials.gov
See all 210 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo + Orteronel 200 mg (Japan) | 33 | |
| Overall Study | STARTED | Placebo + Orteronel 300 mg (Japan) | 32 | |
| Overall Study | STARTED | Placebo + Orteronel 200 mg (Ex-Japan) | 36 | |
| Overall Study | STARTED | Placebo + Orteronel 400 mg (Ex-Japan) | 36 | |
| Overall Study | COMPLETED | Placebo + Orteronel 200 mg (Japan) | 0 | |
| Overall Study | COMPLETED | Placebo + Orteronel 300 mg (Japan) | 0 | |
| Overall Study | COMPLETED | Placebo + Orteronel 200 mg (Ex-Japan) | 0 | |
| Overall Study | COMPLETED | Placebo + Orteronel 400 mg (Ex-Japan) | 0 | |
| Overall Study | NOT COMPLETED | Placebo + Orteronel 200 mg (Japan) | 33 | |
| Overall Study | NOT COMPLETED | Placebo + Orteronel 300 mg (Japan) | 32 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events1,100
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Lipase increased | Investigations | Placebo | 19 | 44 | 36 |
| other | Lipase increased | Investigations | Orteronel 200 mg (Japan) | 25 | 33 | 46 |
| other | Lipase increased | Investigations | Orteronel 300 mg (Japan) | 19 | 32 | 32 |
| other | Lipase increased | Investigations | Orteronel 200 mg (Ex-Japan) | 9 | 36 | 10 |
| other | Lipase increased | Investigations | Orteronel 400mg (Ex-Japan) | 7 | 36 | 9 |
| other | Amylase increased | Investigations | Placebo | 16 | 44 | 21 |
| other | Amylase increased | Investigations | Orteronel 200 mg (Japan) | 21 | 33 | 35 |
| other | Amylase increased | Investigations | Orteronel 300 mg (Japan) | 19 | 32 | 27 |
| other | Amylase increased | Investigations | Orteronel 200 mg (Ex-Japan) | 4 | 36 | 7 |
| other | Amylase increased | Investigations | Orteronel 400mg (Ex-Japan) | 6 | 36 | 10 |
1 to 10 of 1,100Source ClinicalTrials.gov
See all 1,100 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Orteronel 200 mg (Japan) | ||
| Total, all-cause mortality | Orteronel 300 mg (Japan) | ||
| Total, all-cause mortality | Orteronel 200 mg (Ex-Japan) | ||
| Total, all-cause mortality | Orteronel 400mg (Ex-Japan) | ||
| Total, other adverse events | Placebo | 44 | 44 |
| Total, other adverse events | Orteronel 200 mg (Japan) | 33 | 33 |
| Total, other adverse events | Orteronel 300 mg (Japan) | 32 | 32 |
| Total, other adverse events | Orteronel 200 mg (Ex-Japan) | 35 | 36 |
| Total, other adverse events | Orteronel 400mg (Ex-Japan) | 36 | 36 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
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