Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| C3431017 | Other Identifier | Alias Study Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Astellas Pharma Inc | INDUSTRY |
| Medivation LLC, a wholly owned subsidiary of Pfizer Inc. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study is being conducted to determine the effect of enzalutamide on the androgen signaling pathway in correlation with the anti-tumor effects of enzalutamide to identify potential predictors of response or resistance to therapy.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enzalutamide | Experimental | Participants received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth. Study drug treatment continued until disease progression, unacceptable toxicity, or withdrawal. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enzalutamide | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Bone Marrow Testosterone | Bone marrow biopsies were performed at the Day 1 visit prior to initiation of enzalutamide administration. Repeat bone marrow biopsies were performed at the Week 9 visit. If a repeat bone marrow was not performed at the Week 9 visit or if a patient discontinued the study before the Week 9 visit, a bone marrow biopsy was obtained at the Safety Follow-up visit. Assessment of intratumoral testosterone was assessed by liquid chromatography mass spectrometry. | Baseline, Week 9 |
| Change From Baseline in Bone Marrow Dihydrotestosterone | Bone marrow biopsies were performed at the Day 1 visit prior to initiation of enzalutamide administration. Repeat bone marrow biopsies were performed at the Week 9 visit. If a repeat bone marrow was not performed at the Week 9 visit or if a patient discontinued the study before the Week 9 visit, a bone marrow biopsy was obtained at the Safety Follow-up visit. Assessment of intratumoral dihydrotestosterone was assessed by liquid chromatography mass spectrometry. | Baseline, Week 9 |
| Change From Baseline in Bone Marrow Testosterone at Week 9 by Prostate-Specific Antigen (PSA) Response Status | Bone marrow biopsies were performed at the Day 1 visit prior to initiation of enzalutamide administration. Repeat bone marrow biopsies were performed at the Week 9 visit. If a repeat bone marrow was not performed at the Week 9 visit or if a patient discontinued the study before the Week 9 visit, a bone marrow biopsy was obtained at the Safety Follow-up visit. Assessment of intratumoral testosterone was assessed by liquid chromatography mass spectrometry. Serum samples for measurement of PSA levels were obtained at baseline prior to initiation of enzalutamide administration and at the Week 9 visit. The change from baseline in bone marrow testosterone levels at Week 9 was correlated with PSA response status at Week 9. | Baseline, Week 9 |
| Change From Baseline in Bone Marrow Dihydrotestosterone at Week 9 by Prostate-Specific Antigen (PSA) Response Status |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants at Week 9 With a Response in Prostate-Specific Antigen (PSA) | Serum samples for measurement of PSA levels were obtained at baseline prior to initiation of enzalutamide administration and at the Week 9 visit. | Baseline, Week 9 |
| Median Time to Study Drug Discontinuation |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Medical Monitor | Medivation, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MD Anderson Cancer Center | Houston | Texas | 77303 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24882673 | Derived | Efstathiou E, Titus M, Wen S, Hoang A, Karlou M, Ashe R, Tu SM, Aparicio A, Troncoso P, Mohler J, Logothetis CJ. Molecular characterization of enzalutamide-treated bone metastatic castration-resistant prostate cancer. Eur Urol. 2015 Jan;67(1):53-60. doi: 10.1016/j.eururo.2014.05.005. Epub 2014 May 29. |
Not provided
Not provided
Not provided
Single center clinical trial
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Enzalutamide | Participants received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Bone marrow biopsies were performed at the Day 1 visit prior to initiation of enzalutamide administration. Repeat bone marrow biopsies were performed at the Week 9 visit. If a repeat bone marrow was not performed at the Week 9 visit or if a patient discontinued the study before the Week 9 visit, a bone marrow biopsy was obtained at the Safety Follow-up visit. Assessment of intratumoral dihydrotestosterone was assessed by liquid chromatography mass spectrometry.
Serum samples for measurement of PSA levels were obtained at baseline prior to initiation of enzalutamide administration and at the Week 9 visit.
The change from baseline in bone marrow dihydrotestosterone levels at Week 9 was correlated with PSA response status at Week 9.
| Baseline, Week 9 |
Exposure to study drug through the data cutoff of 26AUG2011 only. Fifteen participants (25.0%) were still on study drug as of the data cut-off date and were censored at this date. |
| Duration of study treatment through the data cutoff, up to 3 years. |
| Change From Baseline in Urinary N-Telopeptide | Samples for measurement of urinary N-telopeptide were collected at baseline prior to initiation of enzalutamide administration and at Week 5. | Baseline, Week 5 |
| Change From Baseline in Urinary N-Telopeptide | Samples for measurement of urinary N-telopeptide were collected at baseline prior to initiation of enzalutamide administration and at Week 9. | Baseline, Week 9 |
| Change From Baseline in Urinary N-Telopeptide | Samples for measurement of urinary N-telopeptide were collected at baseline prior to initiation of enzalutamide administration and at Week 17. | Baseline, Week 17 |
| Change From Baseline in Urinary N-Telopeptide | Samples for measurement of urinary N-telopeptide were collected at baseline prior to initiation of enzalutamide administration and at Week 25. | Baseline, Week 25 |
| Change From Baseline in Urinary N-Telopeptide | Baseline, Week 33 |
| Change From Baseline in Urinary N-Telopeptide | Samples for measurement of urinary N-telopeptide were collected at baseline prior to initiation of enzalutamide administration and at Week 41. | Baseline, Week 41 |
| Change From Baseline in Urinary N-Telopeptide | Samples for measurement of urinary N-telopeptide were collected at baseline prior to initiation of enzalutamide administration and at Week 49. | Baseline, Week 49 |
| Change From Baseline in Urinary N-Telopeptide | Samples for measurement of urinary N-telopeptide were collected at baseline prior to initiation of enzalutamide administration and at Week 57. | Baseline, Week 57 |
| Change From Baseline in Urinary N-Telopeptide | Samples for measurement of urinary N-telopeptide were collected at baseline prior to initiation of enzalutamide administration and at Week 65. | Baseline, Week 65 |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Enzalutamide | Participants received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Age, Customized | Number | years |
| |||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 | Change From Baseline in Bone Marrow Testosterone | Bone marrow biopsies were performed at the Day 1 visit prior to initiation of enzalutamide administration. Repeat bone marrow biopsies were performed at the Week 9 visit. If a repeat bone marrow was not performed at the Week 9 visit or if a patient discontinued the study before the Week 9 visit, a bone marrow biopsy was obtained at the Safety Follow-up visit. Assessment of intratumoral testosterone was assessed by liquid chromatography mass spectrometry. | Participants who received any amount of enzalutamide and had bone marrow testosterone measurements at baseline and at least 1 post-baseline assessment. Note that the documentation of bone marrow involvement with cancer was not required. | Posted | Mean | Standard Deviation | ng/mL | Baseline, Week 9 |
|
|
| |||||||||||||||||||||||||
| Secondary | Percentage of Participants at Week 9 With a Response in Prostate-Specific Antigen (PSA) | Serum samples for measurement of PSA levels were obtained at baseline prior to initiation of enzalutamide administration and at the Week 9 visit. | Participants who received any amount of enzalutamide and had PSA values at baseline and at the Week 9 Visit. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline, Week 9 |
|
| ||||||||||||||||||||||||||
| Primary | Change From Baseline in Bone Marrow Dihydrotestosterone | Bone marrow biopsies were performed at the Day 1 visit prior to initiation of enzalutamide administration. Repeat bone marrow biopsies were performed at the Week 9 visit. If a repeat bone marrow was not performed at the Week 9 visit or if a patient discontinued the study before the Week 9 visit, a bone marrow biopsy was obtained at the Safety Follow-up visit. Assessment of intratumoral dihydrotestosterone was assessed by liquid chromatography mass spectrometry. | Participants who received any amount of enzalutamide and had bone marrow dihydrotestosterone measurements at baseline and at least 1 post-baseline assessment. Note that the documentation of bone marrow involvement with cancer was not required. | Posted | Mean | Standard Deviation | ng/mL | Baseline, Week 9 |
|
| ||||||||||||||||||||||||||
| Primary | Change From Baseline in Bone Marrow Testosterone at Week 9 by Prostate-Specific Antigen (PSA) Response Status | Bone marrow biopsies were performed at the Day 1 visit prior to initiation of enzalutamide administration. Repeat bone marrow biopsies were performed at the Week 9 visit. If a repeat bone marrow was not performed at the Week 9 visit or if a patient discontinued the study before the Week 9 visit, a bone marrow biopsy was obtained at the Safety Follow-up visit. Assessment of intratumoral testosterone was assessed by liquid chromatography mass spectrometry. Serum samples for measurement of PSA levels were obtained at baseline prior to initiation of enzalutamide administration and at the Week 9 visit. The change from baseline in bone marrow testosterone levels at Week 9 was correlated with PSA response status at Week 9. | Participants who received any amount of enzalutamide and had bone marrow testosterone measurements at baseline and at least 1 post-baseline assessment. Note that the documentation of bone marrow involvement with cancer was not required. | Posted | Mean | Standard Deviation | ng/mL | Baseline, Week 9 |
| |||||||||||||||||||||||||||
| Primary | Change From Baseline in Bone Marrow Dihydrotestosterone at Week 9 by Prostate-Specific Antigen (PSA) Response Status | Bone marrow biopsies were performed at the Day 1 visit prior to initiation of enzalutamide administration. Repeat bone marrow biopsies were performed at the Week 9 visit. If a repeat bone marrow was not performed at the Week 9 visit or if a patient discontinued the study before the Week 9 visit, a bone marrow biopsy was obtained at the Safety Follow-up visit. Assessment of intratumoral dihydrotestosterone was assessed by liquid chromatography mass spectrometry. Serum samples for measurement of PSA levels were obtained at baseline prior to initiation of enzalutamide administration and at the Week 9 visit. The change from baseline in bone marrow dihydrotestosterone levels at Week 9 was correlated with PSA response status at Week 9. | Participants who received any amount of enzalutamide and had bone marrow dihydrotestosterone measurements at baseline and at least 1 post-baseline assessment. Note that the documentation of bone marrow involvement with cancer was not required. | Posted | Mean | Standard Deviation | ng/mL | Baseline, Week 9 |
| |||||||||||||||||||||||||||
| Secondary | Median Time to Study Drug Discontinuation | Exposure to study drug through the data cutoff of 26AUG2011 only. Fifteen participants (25.0%) were still on study drug as of the data cut-off date and were censored at this date. | All participants who received any amount of enzalutamide. Fifteen (25.0%) participants were still on study drug as of the data cutoff date and were censored at the data cutoff date. | Posted | Median | 95% Confidence Interval | months | Duration of study treatment through the data cutoff, up to 3 years. |
|
| ||||||||||||||||||||||||||
| Secondary | Change From Baseline in Urinary N-Telopeptide | Samples for measurement of urinary N-telopeptide were collected at baseline prior to initiation of enzalutamide administration and at Week 5. | Participants who received any amount of enzalutamide and had urinary N-telopeptide measurements at baseline and at Week 5. | Posted | Mean | Standard Deviation | mmol/mmol creatinine | Baseline, Week 5 |
|
| ||||||||||||||||||||||||||
| Secondary | Change From Baseline in Urinary N-Telopeptide | Samples for measurement of urinary N-telopeptide were collected at baseline prior to initiation of enzalutamide administration and at Week 9. | Participants who received any amount of enzalutamide and had urinary N-telopeptide measurements at baseline and at Week 9. | Posted | Mean | Standard Deviation | mmol/mmol creatinine | Baseline, Week 9 |
|
| ||||||||||||||||||||||||||
| Secondary | Change From Baseline in Urinary N-Telopeptide | Samples for measurement of urinary N-telopeptide were collected at baseline prior to initiation of enzalutamide administration and at Week 17. | Participants who received any amount of enzalutamide and had urinary N-telopeptide measurements at baseline and at Week 17. | Posted | Mean | Standard Deviation | mmol/mmol creatinine | Baseline, Week 17 |
|
| ||||||||||||||||||||||||||
| Secondary | Change From Baseline in Urinary N-Telopeptide | Samples for measurement of urinary N-telopeptide were collected at baseline prior to initiation of enzalutamide administration and at Week 25. | Participants who received any amount of enzalutamide and had urinary N-telopeptide measurements at baseline and at Week 25. | Posted | Mean | Standard Deviation | mmol/mmol creatinine | Baseline, Week 25 |
|
| ||||||||||||||||||||||||||
| Secondary | Change From Baseline in Urinary N-Telopeptide | Participants who received any amount of enzalutamide and had urinary N-telopeptide measurements at baseline and at Week 33. | Posted | Mean | Standard Deviation | mmol/mmol creatinine | Baseline, Week 33 |
|
| |||||||||||||||||||||||||||
| Secondary | Change From Baseline in Urinary N-Telopeptide | Samples for measurement of urinary N-telopeptide were collected at baseline prior to initiation of enzalutamide administration and at Week 41. | Participants who received any amount of enzalutamide and had urinary N-telopeptide measurements at baseline and at Week 41. | Posted | Mean | Standard Deviation | mmol/mmol creatinine | Baseline, Week 41 |
|
| ||||||||||||||||||||||||||
| Secondary | Change From Baseline in Urinary N-Telopeptide | Samples for measurement of urinary N-telopeptide were collected at baseline prior to initiation of enzalutamide administration and at Week 49. | Participants who received any amount of enzalutamide and had urinary N-telopeptide measurements at baseline and at Week 49. | Posted | Mean | Standard Deviation | mmol/mmol creatinine | Baseline, Week 49 |
|
| ||||||||||||||||||||||||||
| Secondary | Change From Baseline in Urinary N-Telopeptide | Samples for measurement of urinary N-telopeptide were collected at baseline prior to initiation of enzalutamide administration and at Week 57. | Participants who received any amount of enzalutamide and had urinary N-telopeptide measurements at baseline and at Week 57. | Posted | Mean | Standard Deviation | mmol/mmol creatinine | Baseline, Week 57 |
|
| ||||||||||||||||||||||||||
| Secondary | Change From Baseline in Urinary N-Telopeptide | Samples for measurement of urinary N-telopeptide were collected at baseline prior to initiation of enzalutamide administration and at Week 65. | Participants who received any amount of enzalutamide and had urinary N-telopeptide measurements at baseline and at Week 65. | Posted | Mean | Standard Deviation | mmol/mmol creatinine | Baseline, Week 65 |
|
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Enzalutamide | Participants received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth. | 13 | 60 | 59 | 60 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Bundle branch block left | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Periorbital cellulitis | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (12.0) | Systematic Assessment |
| |
| Incisional hernia | Injury, poisoning and procedural complications | MedDRA (12.0) | Systematic Assessment |
| |
| Postoperative wound complication | Injury, poisoning and procedural complications | MedDRA (12.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Embolic stroke | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Third nerve disorder | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Spinal cord compression | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Hot Flush | Vascular disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA (12.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (12.0) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (12.0) | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Pain | General disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Systematic Assessment |
|
PI agrees not to independently publish the results before the publication of the multi-center PI paper. Sponsor shall review and comment 30 days prior to submission or disclosure. If publication or disclosure contains Sponsor Confidential Information, other than Study Data, PI agrees to remove Confidential Information from publication or disclosure. Sponsor may request that PI delay such publication for an additional 60 days to protect the patentability of any Invention described.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mohammad Hirmand, MD, VP, Clinical Development | Medivation, Inc. | 415-829-4126 | mohammad.hirmand@medivation.com |
| ID | Term |
|---|---|
| C540278 | enzalutamide |
Not provided
Not provided
Not provided
| 65 to < 75 |
|
| >= 75 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Title |
|---|
| Denominators |
|---|
| Categories |
|---|
|
|
|
|
|