A Safety and Efficacy Study of Abiraterone Acetate in Participants With Prostate Cancer Who Have Failed Hormone Therapy
Sponsor
Cougar Biotechnology, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00473512
Collaborator
(none)
54
1
1
36
1.5
Study Details
Study Description
Brief Summary
The purpose of this study is to determine the maximum tolerated dose and evaluate the safety, tolerability, and activity at the recommended dose (maximum tolerated dose [MTD]) of abiraterone acetate (also known as CB7630) in participants with hormone refractory prostate (gland that makes fluid that aids movement of sperm) cancer (HRPC).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1/Phase 2 |
Detailed Description
This is an open-label (all people know the identity of the intervention) study to evaluate the safety, tolerability, and recommended dose of abiraterone acetate taken orally (by mouth), once daily in participants with HRPC. The study will consist of a dose escalation stage (Phase 1) that will be conducted to determine the MTD of abiraterone and an activity evaluation stage (Phase 2) to evaluate the activity of abiraterone in participants with HRPC. Escalated doses of abiraterone (starting at 250 milligram [mg] up to a maximum of 2000 mg) will be given for 28-day treatment periods to determine the MTD. Participants will be given MTD of abiraterone for up to 12 cycles (28 day each) in Phase 2 of the study. Participants' safety will be monitored throughout the study.
Study Design
Study Type:
Interventional
Actual Enrollment
:
54 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase I/II Open Label Study of the 17α-Hydroxylase/ C17,20 Lyase Inhibitor, Abiraterone Acetate in Patients With Prostate Cancer Who Have Failed Hormone Therapy
Study Start Date
:
Nov 1, 2005
Actual Primary Completion Date
:
Nov 1, 2008
Actual Study Completion Date
:
Nov 1, 2008
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Abiraterone acetate Abiraterone acetate 250 mg up to a maximum of 2000 mg capsules will be given orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants will receive MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg will be given orally (If participants have disease progression) daily up to 12 cycles. |
Drug: Abiraterone acetate
Abiraterone 250 mg (1 capsule) up to 2000 mg (8 capsules) once daily, each dose will be tested in sequential order for 28 days to determine the MTD.
Other Names:
Drug: Abiraterone acetate MTD
Abiraterone acetate MTD orally for 12 cycles (28 day each).
Other Names:
Drug: Dexamethasone
Dexamethasone 0.5 mg orally will be given (If participants have disease progression) daily up to 12 cycles.
|
Outcome Measures
Primary Outcome Measures
- Number of Participants With Confirmed Prostate Specific Antigen (PSA) Response at Week 12 [Baseline, Week 12]
The PSA response was measured according to PSA working group (PSAWG) criteria. All participants achieving a fall in PSA of greater than 50 percent from baseline, which has been confirmed by a second measurement at least 4 weeks after initial documentation, fulfill criteria for confirmed PSA response.
Secondary Outcome Measures
- Number of Participants With Objective Tumor Response [Baseline up to end of study (1160 days)]
Number of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as greater than or equal to 30 percent decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat imaging study greater than or equal to 4 weeks after initial documentation of response.
- Duration of Prostate Specific Antigen (PSA) Response [Baseline up to end of study (1160 days)]
Duration of PSA response in participants on abiraterone acetate therapy was measured as the duration between PSA 50 percent decline date and PSA progression date as defined by the PSAWG criteria.
- Duration of Objective Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST) [Baseline up to end of study (1160 days)]
Number of participants with objective response based on assessment of confirmed CR or confirmed PR according to RECIST. Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as greater than or equal to 30 percent decrease in sum of the LD of the target lesions taking as a reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat imaging study greater than or equal to 4 weeks after initial documentation of response.
- Time to Disease Progression [Baseline up to end of study (1160 days)]
Disease progression was defined as greater than 25 percent increase in sum of longest diameter of target lesions compared to baseline.
- Overall Survival [Baseline up to end of study (1160 days)]
Overall survival was the duration from enrollment to death. For participants who are alive, overall survival was censored at the last contact.
Other Outcome Measures
- Serum Blood Levels of Testosterone [Baseline, Cycle 2 (within 3 days prior to Day 29)]
Concentration of testosterone in blood was measured in nanogram per deciliter (ng/dL).
- Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) [Baseline up to 30 days after the last dose of study medication]
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.
- Serum Blood Levels of Testosterone Precursors [Baseline, Cycle 2 (within 3 days prior to Day 29)]
Concentration of Cortisol, Aldosterone, Corticosterone, 11-Deoxycortisol, Deoxycorticosterone and Dehydroepiandrostenedione Sulphate (DHEA-S) in blood was measured in nanogram per deciliter (ng/dL).
- Time to Prostate Cancer Pain Progression [Baseline up to 12 cycles]
The time from start of study treatment to the development/worsening of pain due to prostate cancer requiring one or more of the following treatments: 1- Opioid therapy (therapy with morphine like medicines for 10 out of 14 consecutive days); 2- Glucocorticoid therapy; 3- Initiation of >= 5 mg of prednisolone for 10 out of 14 consecutive days; 4- Radionuclide therapy; 5- Radiation therapy (x-ray or cobalt treatment); 6- Chemotherapy (treatment of disease by chemical agents). Participants who do not experience prostate cancer pain were censored on their last day on study. Time to prostate cancer pain progression was measured by Kaplan-Meier method.
- Number of Participants With Change From Baseline in Biochemical Bone Markers [Baseline, Cycle 2, 4, 8, 12]
- Mean Plasma Concentration of Abiraterone [Pre-dose on Day 1, 8 and 15 of Cycle 1, Day 1 of Cycle 2, Day 1 of Cycle 3; 1, 2, 4, 6, 8, 24, 48 and 72 hours after first dose was given]
- Maximum Observed Plasma Concentration (Cmax) of Abiraterone [Pre-dose on Day 1, 8 and 15 of Cycle 1, Day 1 of Cycle 2, Day 1 of Cycle 3; 1, 2, 4, 6, 8, 24, 48 and 72 hours after first dose was given]
The Cmax is defined as maximum observed analyte concentration.
- Time to Reach Maximum Observed Plasma Concentration (Tmax) of Abiraterone [Pre-dose on Day 1, 8 and 15 of Cycle 1, Day 1 of Cycle 2, Day 1 of Cycle 3; 1, 2, 4, 6, 8, 24, 48 and 72 hours after first dose was given]
The Tmax is defined as actual sampling time to reach maximum observed plasma concentration. The analyte concentration associated with Tmax is referred to as Cmax.
- Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Abiraterone [Pre-dose on Day 1, 8 and 15 of Cycle 1, Day 1 of Cycle 2, Day 1 of Cycle 3; 1, 2, 4, 6, 8, 24, 48 and 72 hours after first dose was given]
Area under the plasma concentration time-curve from time zero to the last quantifiable concentration (AUClast).
- Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of Abiraterone [Pre-dose on Day 1, 8 and 15 of Cycle 1, Day 1 of Cycle 2, Day 1 of Cycle 3; 1, 2, 4, 6, 8, 24, 48 and 72 hours after first dose was given]
AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).
- Plasma Decay Half-Life (t1/2) of Abiraterone [Pre-dose on Day 1, 8 and 15 of Cycle 1, Day 1 of Cycle 2, Day 1 of Cycle 3; 1, 2, 4, 6, 8, 24, 48 and 72 hours after first dose was given]
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
- Time to Last Quantifiable Plasma Concentration (Tlast) of Abiraterone [Pre-dose on Day 1, 8 and 15 of Cycle 1, Day 1 of Cycle 2, Day 1 of Cycle 3; 1, 2, 4, 6, 8, 24, 48 and 72 hours after first dose was given]
The actual sampling time of last measurable (non-below the limit of quantification [BQL]) analyte concentration. The analyte concentration associated with Tlast is referred to as Clast.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Histologically (pertaining to the disease status of body tissues or cells) documented adenocarcinoma of the prostate, clinically refractory (not responding to treatment) or resistant to hormone therapy, as documented by progression following at least one hormonal therapy
-
Prostate specific antigen (PSA) evidence for progressive prostate cancer
-
Participants who were withdrawn from anti-androgen therapy less than 6 months prior to inclusion in the study require one PSA higher than the last pre-withdrawal PSA or 2 increases in PSA documented after the post-withdrawal nadir(value) greater than or equal to 4 weeks from treatment withdrawal if treated with flutamide and greater than or equal to 6 weeks if treated with bicalutamide or nilutamide
-
Eastern Cooperative Oncology Group (ECOG) performance status score equal to 0 or 1
-
Life expectancy of greater than or equal to12 week
Exclusion Criteria:
-
Participants with central nervous system (the brain and spinal cord) disease and/or brain metastases
-
No currently active second malignancy (cancer or other progressively enlarging and spreading tumor) other than non-melanoma skin cancer
-
Myocardial infarction within the 6 months prior to start of study
-
No active or uncontrolled autoimmune disease (disorder in which a person's immune system attacks parts of his or her own body) that may require corticosteroid therapy during protocol treatment
-
Major surgery or significant traumatic injury within 4 weeks of start of study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sutton | United Kingdom |
Sponsors and Collaborators
- Cougar Biotechnology, Inc.
Investigators
- Study Director: Cougar Biotechnology Clinical Trial, Cougar Biotechnology, Inc.
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Cougar Biotechnology, Inc.
ClinicalTrials.gov Identifier:
NCT00473512
Other Study ID Numbers:
- CR016909
- COU-AA-001
First Posted:
May 15, 2007
Last Update Posted:
Mar 27, 2014
Last Verified:
Feb 1, 2014
Keywords provided by Cougar Biotechnology, Inc.
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | 250 mg/Day | 500 mg/Day | 750 mg/Day | 1000 mg/Day | 2000 mg/Day |
|---|---|---|---|---|---|
| Arm/Group Description | Abiraterone acetate 250 milligram (mg) capsule administered orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study. Participants received MTD (1000 mg) of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles. | Abiraterone acetate 500 mg capsules (2 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles. | Abiraterone acetate 750 mg capsules (3 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles. | Abiraterone acetate 1000 mg capsules (4 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles. | Abiraterone acetate 2000 mg capsules (8 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles. |
| Period Title: Period 1 (Phase 1) | |||||
| STARTED | 3 | 3 | 3 | 42 | 3 |
| COMPLETED | 2 | 2 | 3 | 25 | 2 |
| NOT COMPLETED | 1 | 1 | 0 | 17 | 1 |
| Period Title: Period 1 (Phase 1) | |||||
| STARTED | 1 | 2 | 2 | 23 | 2 |
| COMPLETED | 0 | 0 | 0 | 0 | 0 |
| NOT COMPLETED | 1 | 2 | 2 | 23 | 2 |
Baseline Characteristics
| Arm/Group Title | 250 mg/Day | 500 mg/Day | 750 mg/Day | 1000 mg/Day | 2000 mg/Day | Total |
|---|---|---|---|---|---|---|
| Arm/Group Description | Abiraterone acetate 250 mg capsule administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles. | Abiraterone acetate 500 mg capsules (2 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles. | Abiraterone acetate 750 mg capsules (3 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles. | Abiraterone acetate 1000 mg capsules (4 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles. | Abiraterone acetate 2000 mg capsules (8 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles. | Total of all reporting groups |
| Overall Participants | 3 | 3 | 3 | 42 | 3 | 54 |
| Age (years) [Mean (Standard Deviation) ] | ||||||
| Mean (Standard Deviation) [years] |
61.3
(9.07)
|
68.7
(10.41)
|
76
(8.19)
|
70.4
(7.42)
|
68
(12.17)
|
69.9
(8.04)
|
| Sex: Female, Male (Count of Participants) | ||||||
| Female |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Male |
3
100%
|
3
100%
|
3
100%
|
42
100%
|
3
100%
|
54
100%
|
Outcome Measures
| Title | Number of Participants With Confirmed Prostate Specific Antigen (PSA) Response at Week 12 |
|---|---|
| Description | The PSA response was measured according to PSA working group (PSAWG) criteria. All participants achieving a fall in PSA of greater than 50 percent from baseline, which has been confirmed by a second measurement at least 4 weeks after initial documentation, fulfill criteria for confirmed PSA response. |
| Time Frame | Baseline, Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants who were enrolled in the study and received 1000 milligram abiraterone acetate therapy with or without dexamethasone (including participants who received 1000 mg AA monotherapy). Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure. |
| Arm/Group Title | 1000 mg AA Monotherapy | 1000 mg AA Therapy |
|---|---|---|
| Arm/Group Description | Participants received 1000 milligram (mg) abiraterone acetate (AA) without dexamethasone. | Participants received 1000 mg abiraterone acetate with or without dexamethasone. |
| Measure Participants | 11 | 29 |
| Number [Participants] |
10
333.3%
|
25
833.3%
|
| Title | Number of Participants With Objective Tumor Response |
|---|---|
| Description | Number of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as greater than or equal to 30 percent decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat imaging study greater than or equal to 4 weeks after initial documentation of response. |
| Time Frame | Baseline up to end of study (1160 days) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants who were enrolled in the study and received 1000 milligram abiraterone acetate therapy with or without dexamethasone (including participants who received 1000 mg AA monotherapy). Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure. |
| Arm/Group Title | 1000 mg AA Therapy |
|---|---|
| Arm/Group Description | Participants received 1000 mg abiraterone acetate with or without dexamethasone. |
| Measure Participants | 38 |
| Complete response |
0
0%
|
| Partial response |
8
266.7%
|
| Title | Duration of Prostate Specific Antigen (PSA) Response |
|---|---|
| Description | Duration of PSA response in participants on abiraterone acetate therapy was measured as the duration between PSA 50 percent decline date and PSA progression date as defined by the PSAWG criteria. |
| Time Frame | Baseline up to end of study (1160 days) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants who were enrolled in the study and received 1000 milligram abiraterone acetate therapy with or without dexamethasone (including participants who received 1000 mg AA monotherapy). Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure. |
| Arm/Group Title | 1000 mg AA Therapy |
|---|---|
| Arm/Group Description | Participants received 1000 mg abiraterone acetate with or without dexamethasone. |
| Measure Participants | 27 |
| Median (Full Range) [Days] |
141
|
| Title | Duration of Objective Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST) |
|---|---|
| Description | Number of participants with objective response based on assessment of confirmed CR or confirmed PR according to RECIST. Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as greater than or equal to 30 percent decrease in sum of the LD of the target lesions taking as a reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat imaging study greater than or equal to 4 weeks after initial documentation of response. |
| Time Frame | Baseline up to end of study (1160 days) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Duration of response was not analyzed as majority of participants with objective tumor response were lost to follow-up. |
| Arm/Group Title | 1000 mg AA Therapy |
|---|---|
| Arm/Group Description | Participants received 1000 mg abiraterone acetate with or without dexamethasone. |
| Measure Participants | 0 |
| Title | Time to Disease Progression |
|---|---|
| Description | Disease progression was defined as greater than 25 percent increase in sum of longest diameter of target lesions compared to baseline. |
| Time Frame | Baseline up to end of study (1160 days) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Data was not analyzed because at the time to progression, participants also received dexamethasone treatment, making it impractical to accurately define disease progression. |
| Arm/Group Title | 1000 mg AA Therapy |
|---|---|
| Arm/Group Description | Participants received 1000 mg abiraterone acetate with or without dexamethasone. |
| Measure Participants | 0 |
| Title | Overall Survival |
|---|---|
| Description | Overall survival was the duration from enrollment to death. For participants who are alive, overall survival was censored at the last contact. |
| Time Frame | Baseline up to end of study (1160 days) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Data was not analyzed due to high number of participants censored for survival. |
| Arm/Group Title | 1000 mg AA Therapy |
|---|---|
| Arm/Group Description | Participants received 1000 mg abiraterone acetate with or without dexamethasone. |
| Measure Participants | 0 |
| Title | Serum Blood Levels of Testosterone |
|---|---|
| Description | Concentration of testosterone in blood was measured in nanogram per deciliter (ng/dL). |
| Time Frame | Baseline, Cycle 2 (within 3 days prior to Day 29) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants who were enrolled in the study and received 1000 mg abiraterone acetate therapy with or without dexamethasone (including participants who received 1000 mg AA monotherapy). Here 'N' (number of participants analyzed) signifies participants evaluable for this measure and 'n' signifies participants evaluable at specified time point. |
| Arm/Group Title | 1000 mg AA Therapy |
|---|---|
| Arm/Group Description | Participants received 1000 mg abiraterone acetate with or without dexamethasone. |
| Measure Participants | 28 |
| Baseline (n = 23) |
3
|
| Cycle 2 (n = 28) |
1
|
| Title | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) |
|---|---|
| Description | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. |
| Time Frame | Baseline up to 30 days after the last dose of study medication |
Outcome Measure Data
| Analysis Population Description |
|---|
| Included all participants who received any amount of the study medication. |
| Arm/Group Title | 250 mg/Day | 500 mg/Day | 750 mg/Day | 1000 mg/Day | 2000 mg/Day |
|---|---|---|---|---|---|
| Arm/Group Description | Abiraterone acetate 250 mg capsule administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles. | Abiraterone acetate 500 mg capsules (2 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles. | Abiraterone acetate 750 mg capsules (3 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles. | Abiraterone acetate 1000 mg capsules (4 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles. | Abiraterone acetate 2000 mg capsules (8 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles. |
| Measure Participants | 3 | 3 | 3 | 42 | 3 |
| AEs |
3
100%
|
3
100%
|
3
100%
|
41
97.6%
|
3
100%
|
| SAEs |
2
66.7%
|
2
66.7%
|
0
0%
|
20
47.6%
|
2
66.7%
|
| Title | Serum Blood Levels of Testosterone Precursors |
|---|---|
| Description | Concentration of Cortisol, Aldosterone, Corticosterone, 11-Deoxycortisol, Deoxycorticosterone and Dehydroepiandrostenedione Sulphate (DHEA-S) in blood was measured in nanogram per deciliter (ng/dL). |
| Time Frame | Baseline, Cycle 2 (within 3 days prior to Day 29) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants who were enrolled in the study and received 1000 mg abiraterone acetate therapy with or without dexamethasone (including participants who received 1000 mg AA monotherapy). Here 'N' (number of participants analyzed) signifies participants evaluable for this measure and 'n' signifies participants evaluable at specified time point. |
| Arm/Group Title | 1000 mg AA Therapy |
|---|---|
| Arm/Group Description | Participants received 1000 mg abiraterone acetate with or without dexamethasone. |
| Measure Participants | 33 |
| Cortisol; Baseline (n = 33) |
12000
|
| Cortisol; Cycle 2 (n = 29) |
4000
|
| Aldosterone; Baseline (n=33) |
8
|
| Aldosterone; Cycle 2 (n=29) |
8
|
| Corticosterone; Baseline (n=33) |
193
|
| Corticosterone; Cycle 2 (n=27) |
6797
|
| 11-Deoxycortisol; Baseline (n=31) |
39
|
| 11-Deoxycortisol; Cycle 2 (n=25) |
73
|
| Deoxycorticosterone; Baseline (n=32) |
6
|
| Deoxycorticosterone; Cycle 2 (n=28) |
121
|
| DHEA-S; Baseline (n=32) |
30000
|
| DHEA-S; Cycle 2 (n=28) |
15000
|
| Title | Time to Prostate Cancer Pain Progression |
|---|---|
| Description | The time from start of study treatment to the development/worsening of pain due to prostate cancer requiring one or more of the following treatments: 1- Opioid therapy (therapy with morphine like medicines for 10 out of 14 consecutive days); 2- Glucocorticoid therapy; 3- Initiation of >= 5 mg of prednisolone for 10 out of 14 consecutive days; 4- Radionuclide therapy; 5- Radiation therapy (x-ray or cobalt treatment); 6- Chemotherapy (treatment of disease by chemical agents). Participants who do not experience prostate cancer pain were censored on their last day on study. Time to prostate cancer pain progression was measured by Kaplan-Meier method. |
| Time Frame | Baseline up to 12 cycles |
Outcome Measure Data
| Analysis Population Description |
|---|
| Median time was not reached as data was not matured at the time of the analysis, hence no data could be reported. |
| Arm/Group Title | 1000 mg AA Therapy |
|---|---|
| Arm/Group Description | Participants received 1000 mg abiraterone acetate with or without dexamethasone. |
| Measure Participants | 0 |
| Title | Number of Participants With Change From Baseline in Biochemical Bone Markers |
|---|---|
| Description | |
| Time Frame | Baseline, Cycle 2, 4, 8, 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Data was reported in individual participant listings but not summarized due to statistical constraints. |
| Arm/Group Title | 1000 mg AA Therapy |
|---|---|
| Arm/Group Description | Participants received 1000 mg abiraterone acetate with or without dexamethasone. |
| Measure Participants | 0 |
| Title | Mean Plasma Concentration of Abiraterone |
|---|---|
| Description | |
| Time Frame | Pre-dose on Day 1, 8 and 15 of Cycle 1, Day 1 of Cycle 2, Day 1 of Cycle 3; 1, 2, 4, 6, 8, 24, 48 and 72 hours after first dose was given |
Outcome Measure Data
| Analysis Population Description |
|---|
| Data was not statistically summarized but reported in individual participant listing as per planned analysis. |
| Arm/Group Title | Abiraterone Acetate 250 mg | Abiraterone Acetate 500 mg | Abiraterone Acetate 750 mg | Abiraterone Acetate 1000 mg | Abiraterone Acetate 2000 mg |
|---|---|---|---|---|---|
| Arm/Group Description | Abiraterone acetate 250 mg capsule given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study. | Abiraterone acetate 500 mg capsules (2 x 250 mg capsules) given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study. | Abiraterone acetate 750 mg capsules (3 x 250 mg capsules) given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study. | Abiraterone acetate 1000 mg capsules (4 x 250 mg capsules) orally daily given for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study. | Abiraterone acetate 2000 mg capsules (8 x 250 mg capsules) given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study. |
| Measure Participants | 0 | 0 | 0 | 0 | 0 |
| Title | Maximum Observed Plasma Concentration (Cmax) of Abiraterone |
|---|---|
| Description | The Cmax is defined as maximum observed analyte concentration. |
| Time Frame | Pre-dose on Day 1, 8 and 15 of Cycle 1, Day 1 of Cycle 2, Day 1 of Cycle 3; 1, 2, 4, 6, 8, 24, 48 and 72 hours after first dose was given |
Outcome Measure Data
| Analysis Population Description |
|---|
| Included all participants who enrolled into the study regardless of the amount of the trial medication received. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure. |
| Arm/Group Title | Abiraterone Acetate 250 mg | Abiraterone Acetate 500 mg | Abiraterone Acetate 750 mg | Abiraterone Acetate 1000 mg | Abiraterone Acetate 2000 mg |
|---|---|---|---|---|---|
| Arm/Group Description | Abiraterone acetate 250 mg capsule given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study. | Abiraterone acetate 500 mg capsules (2 x 250 mg capsules) given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study. | Abiraterone acetate 750 mg capsules (3 x 250 mg capsules) given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study. | Abiraterone acetate 1000 mg capsules (4 x 250 mg capsules) orally daily given for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study. | Abiraterone acetate 2000 mg capsules (8 x 250 mg capsules) given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study. |
| Measure Participants | 3 | 3 | 2 | 9 | 3 |
| Mean (Standard Deviation) [nmol/L] |
219
(172.77)
|
284
(132.38)
|
1032
(344.01)
|
571
(443.18)
|
531
(219.02)
|
| Title | Time to Reach Maximum Observed Plasma Concentration (Tmax) of Abiraterone |
|---|---|
| Description | The Tmax is defined as actual sampling time to reach maximum observed plasma concentration. The analyte concentration associated with Tmax is referred to as Cmax. |
| Time Frame | Pre-dose on Day 1, 8 and 15 of Cycle 1, Day 1 of Cycle 2, Day 1 of Cycle 3; 1, 2, 4, 6, 8, 24, 48 and 72 hours after first dose was given |
Outcome Measure Data
| Analysis Population Description |
|---|
| Included all participants who enrolled into the study regardless of the amount of the trial medication received. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure. |
| Arm/Group Title | Abiraterone Acetate 250 mg | Abiraterone Acetate 500 mg | Abiraterone Acetate 750 mg | Abiraterone Acetate 1000 mg | Abiraterone Acetate 2000 mg |
|---|---|---|---|---|---|
| Arm/Group Description | Abiraterone acetate 250 mg capsule given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study. | Abiraterone acetate 500 mg capsules (2 x 250 mg capsules) given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study. | Abiraterone acetate 750 mg capsules (3 x 250 mg capsules) given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study. | Abiraterone acetate 1000 mg capsules (4 x 250 mg capsules) orally daily given for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study. | Abiraterone acetate 2000 mg capsules (8 x 250 mg capsules) given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study. |
| Measure Participants | 3 | 3 | 2 | 9 | 3 |
| Mean (Standard Deviation) [hours] |
2.050
(0.02)
|
2.588
(1.02)
|
1.709
(0.41)
|
3.159
(1.79)
|
2.672
(1.14)
|
| Title | Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Abiraterone |
|---|---|
| Description | Area under the plasma concentration time-curve from time zero to the last quantifiable concentration (AUClast). |
| Time Frame | Pre-dose on Day 1, 8 and 15 of Cycle 1, Day 1 of Cycle 2, Day 1 of Cycle 3; 1, 2, 4, 6, 8, 24, 48 and 72 hours after first dose was given |
Outcome Measure Data
| Analysis Population Description |
|---|
| Included all participants who enrolled into the study regardless of the amount of the trial medication received. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure. |
| Arm/Group Title | Abiraterone Acetate 250 mg | Abiraterone Acetate 500 mg | Abiraterone Acetate 750 mg | Abiraterone Acetate 1000 mg | Abiraterone Acetate 2000 mg |
|---|---|---|---|---|---|
| Arm/Group Description | Abiraterone acetate 250 mg capsule given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study. | Abiraterone acetate 500 mg capsules (2 x 250 mg capsules) given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study. | Abiraterone acetate 750 mg capsules (3 x 250 mg capsules) given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study. | Abiraterone acetate 1000 mg capsules (4 x 250 mg capsules) orally daily given for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study. | Abiraterone acetate 2000 mg capsules (8 x 250 mg capsules) given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study. |
| Measure Participants | 3 | 3 | 2 | 9 | 3 |
| Mean (Standard Deviation) [hours*nmol/L] |
1253
(519.78)
|
1334
(731.47)
|
4294
(1295.20)
|
4371
(3427.54)
|
4754
(1659.13)
|
| Title | Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of Abiraterone |
|---|---|
| Description | AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞). |
| Time Frame | Pre-dose on Day 1, 8 and 15 of Cycle 1, Day 1 of Cycle 2, Day 1 of Cycle 3; 1, 2, 4, 6, 8, 24, 48 and 72 hours after first dose was given |
Outcome Measure Data
| Analysis Population Description |
|---|
| Included all participants who enrolled into the study regardless of the amount of the trial medication received. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure. |
| Arm/Group Title | Abiraterone Acetate 250 mg | Abiraterone Acetate 500 mg | Abiraterone Acetate 750 mg | Abiraterone Acetate 1000 mg | Abiraterone Acetate 2000 mg |
|---|---|---|---|---|---|
| Arm/Group Description | Abiraterone acetate 250 mg capsule given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study. | Abiraterone acetate 500 mg capsules (2 x 250 mg capsules) given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study. | Abiraterone acetate 750 mg capsules (3 x 250 mg capsules) given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study. | Abiraterone acetate 1000 mg capsules (4 x 250 mg capsules) orally daily given for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study. | Abiraterone acetate 2000 mg capsules (8 x 250 mg capsules) given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study. |
| Measure Participants | 3 | 3 | 2 | 9 | 3 |
| Mean (Standard Deviation) [hours*nmol/L] |
1369
(505.39)
|
1448
(749.01)
|
4537
(1333.42)
|
4615
(3660.48)
|
4983
(1755.24)
|
| Title | Plasma Decay Half-Life (t1/2) of Abiraterone |
|---|---|
| Description | Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. |
| Time Frame | Pre-dose on Day 1, 8 and 15 of Cycle 1, Day 1 of Cycle 2, Day 1 of Cycle 3; 1, 2, 4, 6, 8, 24, 48 and 72 hours after first dose was given |
Outcome Measure Data
| Analysis Population Description |
|---|
| Included all participants who enrolled into the study regardless of the amount of the trial medication received. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure. |
| Arm/Group Title | Abiraterone Acetate 250 mg | Abiraterone Acetate 500 mg | Abiraterone Acetate 750 mg | Abiraterone Acetate 1000 mg | Abiraterone Acetate 2000 mg |
|---|---|---|---|---|---|
| Arm/Group Description | Abiraterone acetate 250 mg capsule given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study. | Abiraterone acetate 500 mg capsules (2 x 250 mg capsules) given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study. | Abiraterone acetate 750 mg capsules (3 x 250 mg capsules) given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study. | Abiraterone acetate 1000 mg capsules (4 x 250 mg capsules) orally daily given for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study. | Abiraterone acetate 2000 mg capsules (8 x 250 mg capsules) given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study. |
| Measure Participants | 3 | 3 | 2 | 9 | 3 |
| Mean (Standard Deviation) [hour] |
11.6
(10.14)
|
9.5
(7.02)
|
10.8
(5.91)
|
10.6
(4.69)
|
12.0
(2.29)
|
| Title | Time to Last Quantifiable Plasma Concentration (Tlast) of Abiraterone |
|---|---|
| Description | The actual sampling time of last measurable (non-below the limit of quantification [BQL]) analyte concentration. The analyte concentration associated with Tlast is referred to as Clast. |
| Time Frame | Pre-dose on Day 1, 8 and 15 of Cycle 1, Day 1 of Cycle 2, Day 1 of Cycle 3; 1, 2, 4, 6, 8, 24, 48 and 72 hours after first dose was given |
Outcome Measure Data
| Analysis Population Description |
|---|
| Data was not statistically summarized but reported in individual participant listing as per planned analysis. |
| Arm/Group Title | Abiraterone Acetate 250 mg | Abiraterone Acetate 500 mg | Abiraterone Acetate 750 mg | Abiraterone Acetate 1000 mg | Abiraterone Acetate 2000 mg |
|---|---|---|---|---|---|
| Arm/Group Description | Abiraterone acetate 250 mg capsule given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study. | Abiraterone acetate 500 mg capsules (2 x 250 mg capsules) given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study. | Abiraterone acetate 750 mg capsules (3 x 250 mg capsules) given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study. | Abiraterone acetate 1000 mg capsules (4 x 250 mg capsules) orally daily given for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study. | Abiraterone acetate 2000 mg capsules (8 x 250 mg capsules) given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study. |
| Measure Participants | 0 | 0 | 0 | 0 | 0 |
Adverse Events
| Time Frame | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||||
| Arm/Group Title | 250 mg/Day | 500 mg/Day | 750 mg/Day | 1000 mg/Day | 2000 mg/Day | |||||
| Arm/Group Description | Abiraterone acetate 250 mg capsule administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles. | Abiraterone acetate 500 mg capsules (2 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles. | Abiraterone acetate 750 mg capsules (3 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles. | Abiraterone acetate 1000 mg capsules (4 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles. | Abiraterone acetate 2000 mg capsules (8 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles. | |||||
All Cause Mortality |
||||||||||
| 250 mg/Day | 500 mg/Day | 750 mg/Day | 1000 mg/Day | 2000 mg/Day | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | |||||
Serious Adverse Events |
||||||||||
| 250 mg/Day | 500 mg/Day | 750 mg/Day | 1000 mg/Day | 2000 mg/Day | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 2/3 (66.7%) | 2/3 (66.7%) | 0/3 (0%) | 20/42 (47.6%) | 2/3 (66.7%) | |||||
| Blood and lymphatic system disorders | ||||||||||
| Eosinophilia | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/42 (2.4%) | 0/3 (0%) | |||||
| Cardiac disorders | ||||||||||
| Myocardial infarction | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/42 (2.4%) | 0/3 (0%) | |||||
| Palpitations | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/42 (2.4%) | 0/3 (0%) | |||||
| Gastrointestinal disorders | ||||||||||
| Vomiting | 1/3 (33.3%) | 0/3 (0%) | 0/3 (0%) | 1/42 (2.4%) | 0/3 (0%) | |||||
| General disorders | ||||||||||
| Oedema peripheral | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/42 (0%) | 1/3 (33.3%) | |||||
| Pain | 1/3 (33.3%) | 0/3 (0%) | 0/3 (0%) | 0/42 (0%) | 0/3 (0%) | |||||
| Pyrexia | 0/3 (0%) | 1/3 (33.3%) | 0/3 (0%) | 1/42 (2.4%) | 0/3 (0%) | |||||
| Infections and infestations | ||||||||||
| Cellulitis | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/42 (2.4%) | 0/3 (0%) | |||||
| Infection | 0/3 (0%) | 1/3 (33.3%) | 0/3 (0%) | 0/42 (0%) | 0/3 (0%) | |||||
| Infective exacerbation of chronic obstructive airways disease | 1/3 (33.3%) | 0/3 (0%) | 0/3 (0%) | 0/42 (0%) | 0/3 (0%) | |||||
| Lower respiratory tract infection | 1/3 (33.3%) | 0/3 (0%) | 0/3 (0%) | 1/42 (2.4%) | 0/3 (0%) | |||||
| Lyme disease | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/42 (2.4%) | 0/3 (0%) | |||||
| Pneumonia | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 2/42 (4.8%) | 0/3 (0%) | |||||
| Postoperative wound infection | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/42 (2.4%) | 0/3 (0%) | |||||
| Sepsis | 0/3 (0%) | 1/3 (33.3%) | 0/3 (0%) | 2/42 (4.8%) | 0/3 (0%) | |||||
| Urinary tract infection | 0/3 (0%) | 1/3 (33.3%) | 0/3 (0%) | 1/42 (2.4%) | 0/3 (0%) | |||||
| Injury, poisoning and procedural complications | ||||||||||
| Drug toxicity | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/42 (2.4%) | 0/3 (0%) | |||||
| Fall | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/42 (2.4%) | 0/3 (0%) | |||||
| Femur fracture | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/42 (2.4%) | 0/3 (0%) | |||||
| Investigations | ||||||||||
| Alanine aminotransferase increased | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/42 (2.4%) | 0/3 (0%) | |||||
| Aspartate aminotransferase increased | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/42 (2.4%) | 0/3 (0%) | |||||
| Metabolism and nutrition disorders | ||||||||||
| Dehydration | 0/3 (0%) | 1/3 (33.3%) | 0/3 (0%) | 1/42 (2.4%) | 0/3 (0%) | |||||
| Fluid retention | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/42 (2.4%) | 0/3 (0%) | |||||
| Hypokalaemia | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 3/42 (7.1%) | 0/3 (0%) | |||||
| Musculoskeletal and connective tissue disorders | ||||||||||
| Arthralgia | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/42 (2.4%) | 0/3 (0%) | |||||
| Bone pain | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/42 (2.4%) | 0/3 (0%) | |||||
| Mobility decreased | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/42 (2.4%) | 0/3 (0%) | |||||
| Pathological fracture | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/42 (2.4%) | 0/3 (0%) | |||||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||||
| Colon cancer | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/42 (0%) | 1/3 (33.3%) | |||||
| Metastases to liver | 0/3 (0%) | 1/3 (33.3%) | 0/3 (0%) | 0/42 (0%) | 0/3 (0%) | |||||
| Metastatic pain | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/42 (2.4%) | 0/3 (0%) | |||||
| Nervous system disorders | ||||||||||
| Headache | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/42 (2.4%) | 0/3 (0%) | |||||
| Migraine | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/42 (2.4%) | 0/3 (0%) | |||||
| Spinal cord compression | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/42 (2.4%) | 0/3 (0%) | |||||
| Psychiatric disorders | ||||||||||
| Confusional state | 1/3 (33.3%) | 0/3 (0%) | 0/3 (0%) | 0/42 (0%) | 0/3 (0%) | |||||
| Renal and urinary disorders | ||||||||||
| Renal failure | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 2/42 (4.8%) | 0/3 (0%) | |||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||
| Dyspnoea | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 2/42 (4.8%) | 0/3 (0%) | |||||
| Pulmonary embolism | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 2/42 (4.8%) | 0/3 (0%) | |||||
| Vascular disorders | ||||||||||
| Hypotension | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/42 (2.4%) | 0/3 (0%) | |||||
| Vasculitis | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/42 (2.4%) | 0/3 (0%) | |||||
Other (Not Including Serious) Adverse Events |
||||||||||
| 250 mg/Day | 500 mg/Day | 750 mg/Day | 1000 mg/Day | 2000 mg/Day | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 3/3 (100%) | 3/3 (100%) | 3/3 (100%) | 41/42 (97.6%) | 3/3 (100%) | |||||
| Blood and lymphatic system disorders | ||||||||||
| Anaemia | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 3/42 (7.1%) | 0/3 (0%) | |||||
| Neutropenia | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 2/42 (4.8%) | 1/3 (33.3%) | |||||
| Cardiac disorders | ||||||||||
| Atrial fibrillation | 0/3 (0%) | 1/3 (33.3%) | 0/3 (0%) | 0/42 (0%) | 0/3 (0%) | |||||
| Bundle branch block right | 0/3 (0%) | 1/3 (33.3%) | 0/3 (0%) | 0/42 (0%) | 0/3 (0%) | |||||
| Ear and labyrinth disorders | ||||||||||
| Tinnitus | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/42 (2.4%) | 1/3 (33.3%) | |||||
| Eye disorders | ||||||||||
| Eye inflammation | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/42 (0%) | 1/3 (33.3%) | |||||
| Ocular hyperaemia | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/42 (2.4%) | 1/3 (33.3%) | |||||
| Gastrointestinal disorders | ||||||||||
| Abdominal pain upper | 0/3 (0%) | 1/3 (33.3%) | 0/3 (0%) | 0/42 (0%) | 0/3 (0%) | |||||
| Anal fissure | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/42 (0%) | 1/3 (33.3%) | |||||
| Constipation | 2/3 (66.7%) | 0/3 (0%) | 1/3 (33.3%) | 11/42 (26.2%) | 0/3 (0%) | |||||
| Diarrhoea | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 9/42 (21.4%) | 0/3 (0%) | |||||
| Dry mouth | 1/3 (33.3%) | 1/3 (33.3%) | 0/3 (0%) | 3/42 (7.1%) | 0/3 (0%) | |||||
| Dyspepsia | 0/3 (0%) | 0/3 (0%) | 1/3 (33.3%) | 4/42 (9.5%) | 0/3 (0%) | |||||
| Flatulence | 1/3 (33.3%) | 0/3 (0%) | 1/3 (33.3%) | 2/42 (4.8%) | 0/3 (0%) | |||||
| Gastrooesophageal reflux disease | 0/3 (0%) | 0/3 (0%) | 1/3 (33.3%) | 0/42 (0%) | 0/3 (0%) | |||||
| Mouth ulceration | 1/3 (33.3%) | 0/3 (0%) | 0/3 (0%) | 2/42 (4.8%) | 0/3 (0%) | |||||
| Nausea | 3/3 (100%) | 0/3 (0%) | 2/3 (66.7%) | 5/42 (11.9%) | 1/3 (33.3%) | |||||
| Proctalgia | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/42 (0%) | 1/3 (33.3%) | |||||
| Rectal haemorrhage | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/42 (2.4%) | 1/3 (33.3%) | |||||
| Vomiting | 2/3 (66.7%) | 0/3 (0%) | 1/3 (33.3%) | 8/42 (19%) | 1/3 (33.3%) | |||||
| General disorders | ||||||||||
| Chest discomfort | 1/3 (33.3%) | 0/3 (0%) | 0/3 (0%) | 1/42 (2.4%) | 0/3 (0%) | |||||
| Facial pain | 1/3 (33.3%) | 0/3 (0%) | 0/3 (0%) | 0/42 (0%) | 0/3 (0%) | |||||
| Fatigue | 2/3 (66.7%) | 1/3 (33.3%) | 2/3 (66.7%) | 21/42 (50%) | 2/3 (66.7%) | |||||
| Feeling cold | 1/3 (33.3%) | 0/3 (0%) | 0/3 (0%) | 0/42 (0%) | 0/3 (0%) | |||||
| Inflammation | 1/3 (33.3%) | 0/3 (0%) | 0/3 (0%) | 0/42 (0%) | 0/3 (0%) | |||||
| Influenza like illness | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 4/42 (9.5%) | 0/3 (0%) | |||||
| Injection site discolouration | 1/3 (33.3%) | 0/3 (0%) | 0/3 (0%) | 0/42 (0%) | 0/3 (0%) | |||||
| Oedema peripheral | 0/3 (0%) | 0/3 (0%) | 1/3 (33.3%) | 19/42 (45.2%) | 3/3 (100%) | |||||
| Pitting oedema | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 2/42 (4.8%) | 2/3 (66.7%) | |||||
| Pyrexia | 1/3 (33.3%) | 1/3 (33.3%) | 1/3 (33.3%) | 0/42 (0%) | 0/3 (0%) | |||||
| Hepatobiliary disorders | ||||||||||
| Hepatomegaly | 0/3 (0%) | 1/3 (33.3%) | 0/3 (0%) | 0/42 (0%) | 0/3 (0%) | |||||
| Infections and infestations | ||||||||||
| Cellulitis | 0/3 (0%) | 0/3 (0%) | 1/3 (33.3%) | 0/42 (0%) | 0/3 (0%) | |||||
| Fungal infection | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/42 (0%) | 1/3 (33.3%) | |||||
| Gastroenteritis | 0/3 (0%) | 0/3 (0%) | 1/3 (33.3%) | 0/42 (0%) | 1/3 (33.3%) | |||||
| Gingival infection | 0/3 (0%) | 0/3 (0%) | 1/3 (33.3%) | 0/42 (0%) | 0/3 (0%) | |||||
| Groin abscess | 1/3 (33.3%) | 0/3 (0%) | 0/3 (0%) | 0/42 (0%) | 0/3 (0%) | |||||
| Herpes zoster | 0/3 (0%) | 0/3 (0%) | 1/3 (33.3%) | 1/42 (2.4%) | 0/3 (0%) | |||||
| Lower respiratory tract infection | 1/3 (33.3%) | 0/3 (0%) | 1/3 (33.3%) | 5/42 (11.9%) | 0/3 (0%) | |||||
| Nasopharyngitis | 1/3 (33.3%) | 0/3 (0%) | 1/3 (33.3%) | 3/42 (7.1%) | 0/3 (0%) | |||||
| Respiratory tract infection viral | 0/3 (0%) | 0/3 (0%) | 1/3 (33.3%) | 0/42 (0%) | 0/3 (0%) | |||||
| Rhinitis | 0/3 (0%) | 1/3 (33.3%) | 0/3 (0%) | 0/42 (0%) | 0/3 (0%) | |||||
| Tooth infection | 0/3 (0%) | 0/3 (0%) | 1/3 (33.3%) | 2/42 (4.8%) | 0/3 (0%) | |||||
| Upper respiratory tract infection | 1/3 (33.3%) | 0/3 (0%) | 0/3 (0%) | 8/42 (19%) | 0/3 (0%) | |||||
| Urinary tract infection | 1/3 (33.3%) | 1/3 (33.3%) | 0/3 (0%) | 5/42 (11.9%) | 0/3 (0%) | |||||
| Injury, poisoning and procedural complications | ||||||||||
| Contusion | 1/3 (33.3%) | 0/3 (0%) | 0/3 (0%) | 3/42 (7.1%) | 1/3 (33.3%) | |||||
| Fall | 1/3 (33.3%) | 0/3 (0%) | 0/3 (0%) | 0/42 (0%) | 0/3 (0%) | |||||
| Humerus fracture | 1/3 (33.3%) | 0/3 (0%) | 0/3 (0%) | 0/42 (0%) | 0/3 (0%) | |||||
| Limb injury | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/42 (0%) | 1/3 (33.3%) | |||||
| Radius fracture | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/42 (0%) | 1/3 (33.3%) | |||||
| Investigations | ||||||||||
| Alanine aminotransferase increased | 0/3 (0%) | 1/3 (33.3%) | 1/3 (33.3%) | 4/42 (9.5%) | 0/3 (0%) | |||||
| Aspartate aminotransferase increased | 0/3 (0%) | 1/3 (33.3%) | 1/3 (33.3%) | 3/42 (7.1%) | 0/3 (0%) | |||||
| Blood acid phosphatase increased | 0/3 (0%) | 0/3 (0%) | 1/3 (33.3%) | 0/42 (0%) | 0/3 (0%) | |||||
| Blood albumin decreased | 1/3 (33.3%) | 0/3 (0%) | 0/3 (0%) | 0/42 (0%) | 0/3 (0%) | |||||
| Blood alkaline phosphatase decreased | 0/3 (0%) | 0/3 (0%) | 1/3 (33.3%) | 0/42 (0%) | 0/3 (0%) | |||||
| Blood alkaline phosphatase increased | 0/3 (0%) | 0/3 (0%) | 1/3 (33.3%) | 1/42 (2.4%) | 0/3 (0%) | |||||
| Blood creatine increased | 0/3 (0%) | 1/3 (33.3%) | 0/3 (0%) | 0/42 (0%) | 0/3 (0%) | |||||
| Blood creatinine increased | 0/3 (0%) | 1/3 (33.3%) | 0/3 (0%) | 0/42 (0%) | 0/3 (0%) | |||||
| Blood lactate dehydrogenase increased | 1/3 (33.3%) | 0/3 (0%) | 0/3 (0%) | 0/42 (0%) | 0/3 (0%) | |||||
| C-reactive protein increased | 0/3 (0%) | 1/3 (33.3%) | 0/3 (0%) | 0/42 (0%) | 0/3 (0%) | |||||
| International normalised ratio increased | 1/3 (33.3%) | 0/3 (0%) | 0/3 (0%) | 0/42 (0%) | 0/3 (0%) | |||||
| Protein total decreased | 1/3 (33.3%) | 0/3 (0%) | 0/3 (0%) | 0/42 (0%) | 0/3 (0%) | |||||
| Weight decreased | 0/3 (0%) | 0/3 (0%) | 1/3 (33.3%) | 3/42 (7.1%) | 0/3 (0%) | |||||
| Weight increased | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 6/42 (14.3%) | 1/3 (33.3%) | |||||
| Metabolism and nutrition disorders | ||||||||||
| Anorexia | 0/3 (0%) | 2/3 (66.7%) | 1/3 (33.3%) | 3/42 (7.1%) | 0/3 (0%) | |||||
| Hyperglycaemia | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 3/42 (7.1%) | 0/3 (0%) | |||||
| Hypokalaemia | 1/3 (33.3%) | 2/3 (66.7%) | 3/3 (100%) | 34/42 (81%) | 1/3 (33.3%) | |||||
| Musculoskeletal and connective tissue disorders | ||||||||||
| Arthralgia | 0/3 (0%) | 0/3 (0%) | 2/3 (66.7%) | 12/42 (28.6%) | 0/3 (0%) | |||||
| Back pain | 0/3 (0%) | 0/3 (0%) | 2/3 (66.7%) | 8/42 (19%) | 0/3 (0%) | |||||
| Bone pain | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 6/42 (14.3%) | 0/3 (0%) | |||||
| Groin pain | 2/3 (66.7%) | 0/3 (0%) | 0/3 (0%) | 3/42 (7.1%) | 0/3 (0%) | |||||
| Muscle spasms | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 4/42 (9.5%) | 0/3 (0%) | |||||
| Muscular weakness | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 3/42 (7.1%) | 1/3 (33.3%) | |||||
| Musculoskeletal chest pain | 0/3 (0%) | 1/3 (33.3%) | 1/3 (33.3%) | 5/42 (11.9%) | 0/3 (0%) | |||||
| Musculoskeletal discomfort | 0/3 (0%) | 0/3 (0%) | 1/3 (33.3%) | 3/42 (7.1%) | 0/3 (0%) | |||||
| Musculoskeletal pain | 1/3 (33.3%) | 1/3 (33.3%) | 0/3 (0%) | 9/42 (21.4%) | 0/3 (0%) | |||||
| Musculoskeletal stiffness | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 4/42 (9.5%) | 0/3 (0%) | |||||
| Neck pain | 0/3 (0%) | 1/3 (33.3%) | 0/3 (0%) | 4/42 (9.5%) | 0/3 (0%) | |||||
| Pain in extremity | 1/3 (33.3%) | 0/3 (0%) | 0/3 (0%) | 7/42 (16.7%) | 2/3 (66.7%) | |||||
| Nervous system disorders | ||||||||||
| Balance disorder | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/42 (2.4%) | 1/3 (33.3%) | |||||
| Dizziness | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 6/42 (14.3%) | 1/3 (33.3%) | |||||
| Dysgeusia | 1/3 (33.3%) | 1/3 (33.3%) | 0/3 (0%) | 0/42 (0%) | 0/3 (0%) | |||||
| Headache | 1/3 (33.3%) | 1/3 (33.3%) | 2/3 (66.7%) | 5/42 (11.9%) | 0/3 (0%) | |||||
| Hypoaesthesia | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 3/42 (7.1%) | 0/3 (0%) | |||||
| Lethargy | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 5/42 (11.9%) | 0/3 (0%) | |||||
| Paraesthesia | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 3/42 (7.1%) | 0/3 (0%) | |||||
| Parosmia | 0/3 (0%) | 1/3 (33.3%) | 0/3 (0%) | 0/42 (0%) | 0/3 (0%) | |||||
| Peripheral sensory neuropathy | 1/3 (33.3%) | 0/3 (0%) | 0/3 (0%) | 0/42 (0%) | 0/3 (0%) | |||||
| Psychiatric disorders | ||||||||||
| Anxiety | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/42 (2.4%) | 1/3 (33.3%) | |||||
| Depressed mood | 0/3 (0%) | 0/3 (0%) | 1/3 (33.3%) | 0/42 (0%) | 0/3 (0%) | |||||
| Insomnia | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 4/42 (9.5%) | 0/3 (0%) | |||||
| Renal and urinary disorders | ||||||||||
| Bladder spasm | 0/3 (0%) | 1/3 (33.3%) | 0/3 (0%) | 0/42 (0%) | 0/3 (0%) | |||||
| Haematuria | 1/3 (33.3%) | 1/3 (33.3%) | 0/3 (0%) | 1/42 (2.4%) | 1/3 (33.3%) | |||||
| Nocturia | 0/3 (0%) | 0/3 (0%) | 1/3 (33.3%) | 2/42 (4.8%) | 0/3 (0%) | |||||
| Pyuria | 0/3 (0%) | 1/3 (33.3%) | 0/3 (0%) | 0/42 (0%) | 0/3 (0%) | |||||
| Urinary incontinence | 1/3 (33.3%) | 0/3 (0%) | 0/3 (0%) | 0/42 (0%) | 0/3 (0%) | |||||
| Urinary retention | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/42 (0%) | 1/3 (33.3%) | |||||
| Reproductive system and breast disorders | ||||||||||
| Pelvic pain | 0/3 (0%) | 0/3 (0%) | 1/3 (33.3%) | 3/42 (7.1%) | 0/3 (0%) | |||||
| Testicular atrophy | 0/3 (0%) | 1/3 (33.3%) | 0/3 (0%) | 0/42 (0%) | 0/3 (0%) | |||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||
| Cough | 1/3 (33.3%) | 0/3 (0%) | 1/3 (33.3%) | 6/42 (14.3%) | 1/3 (33.3%) | |||||
| Dyspnoea | 0/3 (0%) | 0/3 (0%) | 1/3 (33.3%) | 8/42 (19%) | 1/3 (33.3%) | |||||
| Dyspnoea exertional | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 3/42 (7.1%) | 0/3 (0%) | |||||
| Epistaxis | 1/3 (33.3%) | 0/3 (0%) | 0/3 (0%) | 1/42 (2.4%) | 0/3 (0%) | |||||
| Pharyngolaryngeal pain | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 5/42 (11.9%) | 0/3 (0%) | |||||
| Productive cough | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 3/42 (7.1%) | 0/3 (0%) | |||||
| Wheezing | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 3/42 (7.1%) | 0/3 (0%) | |||||
| Skin and subcutaneous tissue disorders | ||||||||||
| Dry skin | 1/3 (33.3%) | 0/3 (0%) | 1/3 (33.3%) | 3/42 (7.1%) | 0/3 (0%) | |||||
| Photosensitivity reaction | 0/3 (0%) | 1/3 (33.3%) | 0/3 (0%) | 0/42 (0%) | 0/3 (0%) | |||||
| Psoriasis | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/42 (2.4%) | 1/3 (33.3%) | |||||
| Rash | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 4/42 (9.5%) | 1/3 (33.3%) | |||||
| Rash maculo-papular | 0/3 (0%) | 0/3 (0%) | 1/3 (33.3%) | 1/42 (2.4%) | 0/3 (0%) | |||||
| Scab | 0/3 (0%) | 0/3 (0%) | 1/3 (33.3%) | 0/42 (0%) | 0/3 (0%) | |||||
| Skin atrophy | 0/3 (0%) | 0/3 (0%) | 1/3 (33.3%) | 1/42 (2.4%) | 1/3 (33.3%) | |||||
| Skin disorder | 0/3 (0%) | 1/3 (33.3%) | 0/3 (0%) | 0/42 (0%) | 0/3 (0%) | |||||
| Skin lesion | 1/3 (33.3%) | 0/3 (0%) | 0/3 (0%) | 0/42 (0%) | 0/3 (0%) | |||||
| Vascular disorders | ||||||||||
| Flushing | 0/3 (0%) | 0/3 (0%) | 1/3 (33.3%) | 0/42 (0%) | 0/3 (0%) | |||||
| Hot flush | 1/3 (33.3%) | 0/3 (0%) | 1/3 (33.3%) | 6/42 (14.3%) | 0/3 (0%) | |||||
| Hypertension | 1/3 (33.3%) | 0/3 (0%) | 1/3 (33.3%) | 15/42 (35.7%) | 2/3 (66.7%) | |||||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
| Name/Title | Senior Director, Clinical Research |
|---|---|
| Organization | Janssen R & D |
| Phone | (310) 943-8040 ext 2917 |
Responsible Party:
Cougar Biotechnology, Inc.
ClinicalTrials.gov Identifier:
NCT00473512
Other Study ID Numbers:
- CR016909
- COU-AA-001
First Posted:
May 15, 2007
Last Update Posted:
Mar 27, 2014
Last Verified:
Feb 1, 2014