NCT01666314 is a Phase 1, PHASE2 clinical trial of Orteronel in Prostate Cancer, sponsored by Millennium Pharmaceuticals, Inc..

Who is sponsoring NCT01666314?

NCT01666314 is sponsored by Millennium Pharmaceuticals, Inc..

What drugs are being tested in NCT01666314?

Interventions in NCT01666314: Orteronel, Orteronel Placebo, Prednisone.

What condition does NCT01666314 study?

NCT01666314 studies Prostate Cancer.

Is NCT01666314 still recruiting?

NCT01666314 is currently completed. Last updated 20 March 2018.

Are results published for NCT01666314?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2018-03-20 · How we verify

NCT01666314

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 1, PHASE2 Results posted Last updated 20 March 2018

What this trial tests

Phase 1, PHASE2 trial testing Orteronel in Prostate Cancer in 137 participants. Completed in 1 September 2016.

Timeline

20 August 2012

Primary endpoint
12 September 2013

1 September 2016

Quick facts

Lead sponsor	Millennium Pharmaceuticals, Inc.
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	137
Start date	20 August 2012
Primary completion	12 September 2013
Estimated completion	1 September 2016
Sites	1 location across United States

Drugs / interventions tested

Orteronel — full drug profile →
Orteronel Placebo — full drug profile →
Prednisone (prednisone) — full drug profile →

Conditions studied

Prostate Cancer — all drugs for Prostate Cancer →

Sponsor

Millennium Pharmaceuticals, Inc. — full company profile →

Who can join

18 and older, male only, with Prostate Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Participants With Serum Testosterone Levels Reduced to ≤ 2 ng/dL After 4 Weeks of Treatment in Japan Primary · Baseline and Week 4

Serum Ultra-sensitive testosterone was measured by liquid chromatography at a central laboratory.

Group	Value	95% CI
Placebo (Japan)	86.0	63.7 – 97.0
Orteronel 300 mg (Japan)	100.0	84.6 – 100.0

Percentage of Participants With Serum Testosterone Levels Reduced to ≤ 2 ng/dL in Ex-Japan Secondary · Baseline and Week 4

Serum Ultra-sensitive testosterone was measured by liquid chromatography at a central laboratory.

Group	Value	95% CI
Placebo (Ex-Japan)	48.0	26.8 – 69.4
Orteronel 400 mg (Ex-Japan)	79.0	57.8 – 92.9

Percent Change From Baseline in Serum Testosterone Level After 4 Weeks of Treatment Secondary · Baseline and Week 4

Serum Ultra-sensitive testosterone was measured by liquid chromatography at a central laboratory.

Group	Value	95% CI
Placebo (Japan)	-87.666	± 10.4250
Orteronel 200 mg (Japan)	-97.245	± 1.2548
Orteronel 300 mg (Japan)	-96.812	± 2.7055
Placebo (Ex-Japan)	-63.702	± 43.3941
Orteronel 200 mg (Ex-Japan)	-86.268	± 37.2015
Orteronel 400 mg (Ex-Japan)	-53.954	± 118.8050

Percent Change From Baseline in Serum Testosterone Level After 12 Weeks of Treatment Secondary · Baseline and Week 12

Serum Ultra-sensitive testosterone was measured by liquid chromatography at a central laboratory.

Group	Value	95% CI
Orteronel 200 mg (Japan)	-95.804	± 5.3367
Orteronel 300 mg (Japan)	-95.703	± 5.7468
Orteronel 200 mg (Ex-Japan)	-91.311	± 17.5217
Orteronel 400 mg (Ex-Japan)	-14.442	± 406.3116

Percentage of Participants With Prostate-Specific Antigen Reduction ≥ 50% (PSA50) After 4 Weeks of Treatment Secondary · Baseline and Week 4

A 50% PSA response rate (PSA50) was defined as PSA reduction ≥ 50% from Baseline.

Group	Value	95% CI
Placebo (Japan)	48.0	25.7 – 70.2
Orteronel 200 mg (Japan)	50.0	28.2 – 71.8
Orteronel 300 mg (Japan)	41.0	20.7 – 63.6
Placebo (Ex-Japan)	17.0	5.0 – 38.8
Orteronel 200 mg (Ex-Japan)	48.0	27.8 – 68.7
Orteronel 400 mg (Ex-Japan)	46.0	25.6 – 67.2

Percentage of Participants With PSA50 After 12 Weeks of Treatment Secondary · Baseline and Week 12

A 50% PSA response rate (PSA50) was defined as PSA reduction ≥ 50% from Baseline.

Group	Value	95% CI
Orteronel 200 mg (Japan)	55.0	36.4 – 71.9
Orteronel 300 mg (Japan)	47.0	29.1 – 65.3
Orteronel 200 mg (Ex-Japan)	56.0	38.1 – 72.1
Orteronel 400 mg (Ex-Japan)	44.0	27.9 – 61.9

Absolute Values for Testosterone Secondary · Baseline, Cycle 1 Day 8 and Cycle 2 Day 1

Serum Ultra-sensitive testosterone was measured by liquid chromatography at a central laboratory.

Baseline

Group	Value	95% CI
Placebo (Japan)	9.749	± 3.8460
Orteronel 200 mg (Japan)	9.079	± 4.4581
Orteronel 300 mg (Japan)	10.148	± 4.6504
Placebo (Ex-Japan)	9.173	± 5.6123
Orteronel 200 mg (Ex-Japan)	9.263	± 5.6572
Orteronel 400 mg (Ex-Japan)	14.588	± 13.9833

Cycle 1 Day 8

Group	Value	95% CI
Placebo (Japan)	1.957	± 2.2843
Orteronel 200 mg (Japan)	0.213	± 0.0449
Orteronel 300 mg (Japan)	0.251	± 0.1727
Placebo (Ex-Japan)	3.509	± 4.3471
Orteronel 200 mg (Ex-Japan)	0.345	± 0.2770
Orteronel 400 mg (Ex-Japan)	6.658	± 20.4347

Cycle 2 Day 1

Group	Value	95% CI
Placebo (Japan)	1.096	± 0.7751
Orteronel 200 mg (Japan)	0.203	± 0.0145
Orteronel 300 mg (Japan)	0.270	± 0.2311
Placebo (Ex-Japan)	3.095	± 3.7254
Orteronel 200 mg (Ex-Japan)	0.266	± 0.1837
Orteronel 400 mg (Ex-Japan)	11.720	± 45.1753

Absolute Values for Dehydroepiandrosterone Sulfate (DHEA-S) Secondary · 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.

Baseline

Group	Value	95% CI
Placebo (Japan)	1928.0	± 1306.59
Orteronel 200 mg (Japan)	2529.0	± 1309.39
Orteronel 300 mg (Japan)	2340.9	± 1606.36
Placebo (Ex-Japan)	2601.7	± 3009.41
Orteronel 200 mg (Ex-Japan)	1783.0	± 1554.76
Orteronel 400 mg (Ex-Japan)	2155.7	± 1591.51

Cycle 1 Day 8

Group	Value	95% CI
Placebo (Japan)	414.9	± 392.63
Orteronel 200 mg (Japan)	63.4	± 55.11
Orteronel 300 mg (Japan)	71.8	± 80.23
Placebo (Ex-Japan)	973.8	± 1677.95
Orteronel 200 mg (Ex-Japan)	116.9	± 161.01
Orteronel 400 mg (Ex-Japan)	226.6	± 328.70

Cycle 2 Day 1

Group	Value	95% CI
Placebo (Japan)	268.9	± 357.32
Orteronel 200 mg (Japan)	14.5	± 21.83
Orteronel 300 mg (Japan)	36.3	± 123.48
Placebo (Ex-Japan)	815.7	± 1918.88
Orteronel 200 mg (Ex-Japan)	21.5	± 25.68
Orteronel 400 mg (Ex-Japan)	180.6	± 527.03

Absolute Values for Adrenocorticotropic Hormone (ACTH) Secondary · Baseline, Cycle 1 Day 8 and Cycle 2 Day 1

Serum ACTH was measured by immunometric assay at the central laboratory.

Baseline

Group	Value	95% CI
Placebo (Japan)	5.0	± 1.66
Orteronel 200 mg (Japan)	5.5	± 2.54
Orteronel 300 mg (Japan)	8.3	± 4.98
Placebo (Ex-Japan)	4.7	± 2.06
Orteronel 200 mg (Ex-Japan)	6.0	± 4.05
Orteronel 400 mg (Ex-Japan)	6.4	± 4.04

Cycle 1 Day 8

Group	Value	95% CI
Placebo (Japan)	3.1	± 2.68
Orteronel 200 mg (Japan)	2.3	± 1.55
Orteronel 300 mg (Japan)	3.0	± 2.70
Placebo (Ex-Japan)	3.1	± 2.62
Orteronel 200 mg (Ex-Japan)	3.8	± 3.04
Orteronel 400 mg (Ex-Japan)	3.2	± 2.56

Cycle 2 Day 1

Group	Value	95% CI
Placebo (Japan)	1.7	± 1.19
Orteronel 200 mg (Japan)	1.7	± 1.08
Orteronel 300 mg (Japan)	2.7	± 2.17
Placebo (Ex-Japan)	3.0	± 1.73
Orteronel 200 mg (Ex-Japan)	3.7	± 4.38
Orteronel 400 mg (Ex-Japan)	3.6	± 2.26

Absolute Values for Corticosterone Secondary · 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.

Baseline

Group	Value	95% CI
Placebo (Japan)	5.946	± 3.4433
Orteronel 200 mg (Japan)	6.515	± 4.8246
Orteronel 300 mg (Japan)	7.768	± 6.8625
Placebo (Ex-Japan)	6.317	± 4.1467
Orteronel 200 mg (Ex-Japan)	10.030	± 7.7341
Orteronel 400 mg (Ex-Japan)	17.975	± 35.0695

Cycle 1 Day 8

Group	Value	95% CI
Placebo (Japan)	1.530	± 1.6404
Orteronel 200 mg (Japan)	11.067	± 14.4220
Orteronel 300 mg (Japan)	9.709	± 13.4538
Placebo (Ex-Japan)	5.598	± 7.1366
Orteronel 200 mg (Ex-Japan)	48.668	± 66.3904
Orteronel 400 mg (Ex-Japan)	60.301	± 77.5434

Cycle 2 Day 1

Group	Value	95% CI
Placebo (Japan)	0.758	± 0.5108
Orteronel 200 mg (Japan)	11.108	± 9.0708
Orteronel 300 mg (Japan)	14.654	± 9.2064
Placebo (Ex-Japan)	4.321	± 6.4063
Orteronel 200 mg (Ex-Japan)	29.929	± 35.5565
Orteronel 400 mg (Ex-Japan)	47.204	± 53.4566

Absolute Values for Cortisol Secondary · Baseline, Cycle 1 Day 8 and Cycle 2 Day 1

Serum Cortisol was measured by immunometric assay at the central laboratory.

Baseline

Group	Value	95% CI
Placebo (Japan)	366.5	± 116.69
Orteronel 200 mg (Japan)	371.3	± 119.38
Orteronel 300 mg (Japan)	383.4	± 125.98
Placebo (Ex-Japan)	384.8	± 117.14
Orteronel 200 mg (Ex-Japan)	449.0	± 131.54
Orteronel 400 mg (Ex-Japan)	446.8	± 193.09

Cycle 1 Day 8

Group	Value	95% CI
Placebo (Japan)	82.3	± 46.16
Orteronel 200 mg (Japan)	49.5	± 25.53
Orteronel 300 mg (Japan)	55.5	± 55.97
Placebo (Ex-Japan)	175.8	± 107.82
Orteronel 200 mg (Ex-Japan)	100.9	± 87.38
Orteronel 400 mg (Ex-Japan)	122.0	± 88.70

Cycle 2 Day 1

Group	Value	95% CI
Placebo (Japan)	53.9	± 24.92
Orteronel 200 mg (Japan)	49.2	± 21.71
Orteronel 300 mg (Japan)	54.3	± 39.93
Placebo (Ex-Japan)	149.6	± 122.91
Orteronel 200 mg (Ex-Japan)	97.2	± 85.66
Orteronel 400 mg (Ex-Japan)	109.1	± 83.19

Absolute Values for Prostate-Specific Antigen (PSA) Secondary · Baseline and Cycle 2 Day 1

Serum PSA was measured at the central laboratory.

Baseline

Group	Value	95% CI
Placebo (Japan)	37.588	± 48.9413
Orteronel 200 mg (Japan)	27.227	± 24.8821
Orteronel 300 mg (Japan)	97.504	± 293.9496
Placebo (Ex-Japan)	133.238	± 189.9345
Orteronel 200 mg (Ex-Japan)	165.992	± 368.5016
Orteronel 400 mg (Ex-Japan)	100.237	± 210.5675

Cycle 2 Day 1

Group	Value	95% CI
Placebo (Japan)	24.325	± 46.9725
Orteronel 200 mg (Japan)	18.005	± 16.9858
Orteronel 300 mg (Japan)	38.892	± 95.0124
Placebo (Ex-Japan)	152.940	± 261.9735
Orteronel 200 mg (Ex-Japan)	117.257	± 286.1870
Orteronel 400 mg (Ex-Japan)	56.437	± 97.1621

Adverse events — posted to ClinicalTrials.gov

Time frame: From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Placebo

Serious: 10/44 (23%)

Deaths: —

Orteronel 200 mg (Japan)

Serious: 8/33 (24%)

Deaths: —

Orteronel 300 mg (Japan)

Serious: 18/32 (56%)

Deaths: —

Orteronel 200 mg (Ex-Japan)

Serious: 16/36 (44%)

Deaths: —

Orteronel 400mg (Ex-Japan)

Serious: 12/36 (33%)

Deaths: —

Serious adverse events (81 terms)

Reaction	System	Placebo	Orteronel 200 mg (Japan)	Orteronel 300 mg (Japan)	Orteronel 200 mg (Ex-Japan)	Orteronel 400mg (Ex-Japan)
Dehydration	Metabolism and nutrition disorders	—	—	—	—	—
Diabetes mellitus	Metabolism and nutrition disorders	—	—	—	—	—
Pneumonia	Infections and infestations	—	—	—	—	—
Hepatic function abnormal	Hepatobiliary disorders	—	—	—	—	—
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—
Gastroenteritis viral	Infections and infestations	—	—	—	—	—
Haematuria	Renal and urinary disorders	—	—	—	—	—
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—
Diabetic ketoacidosis	Metabolism and nutrition disorders	—	—	—	—	—
Hyponatraemia	Metabolism and nutrition disorders	—	—	—	—	—
Pancreatitis	Gastrointestinal disorders	—	—	—	—	—
Pancreatitis acute	Gastrointestinal disorders	—	—	—	—	—
Duodenal ulcer	Gastrointestinal disorders	—	—	—	—	—
Bronchopneumonia	Infections and infestations	—	—	—	—	—
Influenza	Infections and infestations	—	—	—	—	—
Lung adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—
Cancer pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—
Rectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—
Renal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—
Pancreatic enzymes increased	Investigations	—	—	—	—	—
Liver function test abnormal	Investigations	—	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—	—
Cardiac disorder	Cardiac disorders	—	—	—	—	—
General physical health deterioration	General disorders	—	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—	—

Other adverse events (139 terms — click to expand)

Reaction	System	Placebo	Orteronel 200 mg (Japan)	Orteronel 300 mg (Japan)	Orteronel 200 mg (Ex-Japan)	Orteronel 400mg (Ex-Japan)
Lipase increased	Investigations	—	—	—	—	—
Amylase increased	Investigations	—	—	—	—	—
Fatigue	General disorders	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—	—
Muscle spasms	Musculoskeletal and connective tissue disorders	—	—	—	—	—
Hot flush	Vascular disorders	—	—	—	—	—
Diabetes mellitus	Metabolism and nutrition disorders	—	—	—	—	—
Decreased appetite	Metabolism and nutrition disorders	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—
Oedema peripheral	General disorders	—	—	—	—	—
Gamma-glutamyltransferase increased	Investigations	—	—	—	—	—
Hypertension	Vascular disorders	—	—	—	—	—
Nasopharyngitis	Infections and infestations	—	—	—	—	—
Blood lactate dehydrogenase increased	Investigations	—	—	—	—	—
Alanine aminotransferase increased	Investigations	—	—	—	—	—
Aspartate aminotransferase increased	Investigations	—	—	—	—	—
Weight decreased	Investigations	—	—	—	—	—
Insomnia	Psychiatric disorders	—	—	—	—	—
Upper respiratory trat infection	Infections and infestations	—	—	—	—	—
Malaise	General disorders	—	—	—	—	—
Blood alkaline phosphatase increased	Investigations	—	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—
Blood creatinine increased	Investigations	—	—	—	—	—
Fall	Injury, poisoning and procedural complications	—	—	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—
Hypokalaemia	Metabolism and nutrition disorders	—	—	—	—	—
Somnolence	Nervous system disorders	—	—	—	—	—
Dysgeusia	Nervous system disorders	—	—	—	—	—
Abdominal discomfort	Gastrointestinal disorders	—	—	—	—	—
Abdominal pain upper	Gastrointestinal disorders	—	—	—	—	—
Hyponatraemia	Metabolism and nutrition disorders	—	—	—	—	—
Dehydration	Metabolism and nutrition disorders	—	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—	—
Blood urea increased	Investigations	—	—	—	—	—
Rash macular	Skin and subcutaneous tissue disorders	—	—	—	—	—
Stomatitis	Gastrointestinal disorders	—	—	—	—	—

Most-reported serious reactions: Dehydration, Diabetes mellitus, Pneumonia, Hepatic function abnormal, Chronic obstructive pulmonary disease, Gastroenteritis viral, Haematuria, Pulmonary embolism.

Data from ClinicalTrials.gov NCT01666314 adverse events section.

Sponsor's own description

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

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Recent progress in pharmaceutical therapies for castration-resistant prostate cancer.
Yin L, Hu Q, Hartmann RW. · · 2013 · cited 35× · PMID 23880851 · DOI 10.3390/ijms140713958
A narrative review of the role of glucocorticoid receptors in prostate cancer: developments in last 5 years.
Zhou F, Shi Y, Zhao G, Aufderklamm S, et al · · 2022 · cited 5× · PMID 36092840 · DOI 10.21037/tau-22-501
Targeted and immunotherapeutic strategies for castration-resistant prostate cancer: emerging strategies, challenges, and future directions.
Wang B, Xiang Y, Fang Z, Le J, et al · · 2025 · cited 1× · PMID 41200193 · DOI 10.3389/fimmu.2025.1668188

Verify or expand the search:

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01666314 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Millennium Pharmaceuticals, Inc.
Last refreshed: 20 March 2018

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01666314.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT01666314

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (81 terms)

Sponsor's own description

Publications & conference data

Related trials

Other trials of Orteronel

Other recruiting trials for Prostate Cancer

Other Millennium Pharmaceuticals, Inc. trials

Verify against primary sources