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| ID | Type | Description | Link |
|---|---|---|---|
| COU-AA-002 | Other Identifier | Janssen Research & Development, LLC |
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The purpose of this study is to evaluate the safety, pharmacokinetics, pharmacodynamics, and anti-tumor activities of abiraterone acetate (also referred to as CB7630) in patients with hormone refractory prostate cancer (HRPC).
This is an open-label (identity of assigned study drug will be known) study to evaluate the safety, pharmacokinetics (study of what the body does to a drug), pharmacodynamics (study of what a drug does to the body), and anti-tumor activities of abiraterone acetate (also known as CB7630) in patients with HRPC. The study will be conducted in 2 phases (Phase 1 and Phase 2). In the first part of the study (Phase 1), the maximum tolerated dose (MTD) of abiraterone acetate will be determined for use in the second part of the study (Phase 2) where the number of patients who achieve at least a 50% decrease in prostate specific antigen (PSA) during treatment with abiraterone acetate will be assessed (MTD from Phase 1). Abiraterone acetate will be taken orally (by mouth) in fed and fasted patients once daily. Doses of abiraterone acetate (starting at 250 mg up to a maximum of 2000 mg) will be taken for 28-day treatment periods to determine the MTD. Patients will take MTD of abiraterone acetate for up to twelve 28 day cycles (12 months; patients will be given the option of staying on abiraterone acetate treatment if they are deriving benefit). In Phase 2, prednisone or dexamethasone will be administered concurrently with abiraterone acetate. Serial pharmacokinetic and pharmacodynamic samples will be collected and safety will be monitored throughout the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase I Dose Escalation | Experimental |
| |
| Phase II Dose Treatment | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abiraterone acetate | Drug | The first cohort was a abiraterone acetate 250 mg/day orally (by mouth), once daily for 28-day treatment periods , if no dose limiting toxicity (DLT) was documented at this dose, the dose will be escalated to next dose levels 500, 750, and 1000 mg/day. The dose escalation will continue to a maximum of 1000mg/day until Maximum Tolerated Dose (MTD) and a recommended Phase II dose was established. |
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1: Maximum Tolerated Dose (MTD) of Abiraterone Acetate | The MTD is the highest dose of a drug or treatment that does not cause unacceptable side effects. | Up to Cycle 12 |
| Phase 2: Participants With Greater Than or Equal to 50 Percent Decline in Prostate Specific Antigen (PSA) | Number of participants with greater than or equal to 50 percent decrease in PSA levels were assessed. PSA decline was evaluated according to (Prostate Specific Antigen Working Group) PSAWG criteria. Decrease in PSA levels represented improvement. | Up to 12 weeks from start of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1: Maximum Plasma Concentration (Cmax) of Abiraterone Acetate | Blood samples for pharmacokinetic (PK) measurements was taken on Day -7 at hour 0 (predose), at hours 1, 2, 4, 6, 8, and 12 (postdose). On Day -6 at 24 hour (postdose) and Day -5 at 48 hour (postdose). On Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 2 and 3 (Predose). | At hours 1, 2, 4, 6, 8, 12, 24 and 48 post dose and pre-dose on day 1, day 8, day 15 and day 22 cycle 1, day 1 cycle 2 and day 1 cycle 3. |
Not provided
Inclusion Criteria:
Phase 1
Phase 2
Exclusion Criteria:
Phase 1
Phase 2
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Francisco | California | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24787968 | Derived | Aggarwal R, Harris A, Formaker C, Small EJ, Molina A, Griffin TW, Ryan CJ. Response to subsequent docetaxel in a patient cohort with metastatic castration-resistant prostate cancer after abiraterone acetate treatment. Clin Genitourin Cancer. 2014 Oct;12(5):e167-72. doi: 10.1016/j.clgc.2014.03.010. Epub 2014 Mar 28. |
| Label | URL |
|---|---|
| NATIONAL CANCER INSTITUTE | View source |
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66 participants participated in the study, including 33 participants enrolled in Phase 1 of the study, and 33 participants enrolled in Phase 2 of the study.
The study was conducted between 10 July 2006 and 22 December 2012.
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| ID | Title | Description |
|---|---|---|
| FG000 | Phase 1 250 MG/DAY | Abiraterone acetate |
| FG001 | Phase 1 500 MG/DAY | Abiraterone acetate |
| FG002 | Phase 1 750 MG/DAY | Abiraterone acetate |
| FG003 | Phase 1 1000 MG/DAY | Abiraterone acetate |
| FG004 | Phase 2 1000 MG/DAY | Abiraterone acetate |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 (Phase 1) |
|
| ||||||||||||||||||
| Period 2 (Phase 2) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Phase 1 250 MG/DAY | Abiraterone acetate |
| BG001 | Phase 1 500 MG/DAY | Abiraterone acetate |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Phase 1: Maximum Tolerated Dose (MTD) of Abiraterone Acetate | The MTD is the highest dose of a drug or treatment that does not cause unacceptable side effects. | Safety population included all enrolled participants who received any study drug. MTD of abiraterone acetate was not reached because the doses administered appear to be well tolerated with no Dose Limiting Toxicity (DLT) even at 1000 milligram per day (mg/day [recommended maximum dose for phase 1]) and 1000 mg/day was taken as test dose in phase 2. | Posted | Number | mg/day | Up to Cycle 12 |
|
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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 | Phase 1 250 MG/DAY | Abiraterone acetate |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphopenia | Blood and lymphatic system disorders | MedDRA Version 11.0 | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sr. Director, Clinical Research | Janssen R&D US | (310)914-2917 |
Not provided
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069501 | Abiraterone Acetate |
| D011241 | Prednisone |
| D011239 | Prednisolone |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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|
| Abiraterone acetate | Drug | Abiraterone acetate 1000 mg daily under fasted conditions upto 10 cycles of therapy. |
|
| prednisone/prednisolone or dexamethasone | Drug | prednisone/prednisolone (5 mg twice daily) or dexamethasone (0.5 mg once daily) concurrent with abiraterone acetate |
|
| Phase 1: Time to Reach the Maximum Plasma Concentration (Tmax) of Abiraterone Acetate | Blood samples for pharmacokinetic (PK) measurements was taken on Day -7 at hour 0 (predose), at hours 1, 2, 4, 6, 8, and 12 (postdose). On Day -6 at 24 hour (postdose) and Day -5 at 48 hour (postdose). On Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 2 and 3 (Predose) | At hours 1, 2, 4, 6, 8, 12, 24 and 48 post dose and pre-dose on day 1, day 8, day 15 and day 22 cycle 1, day 1 cycle 2 and day 1 cycle 3 |
| Phase 1: Area Under the Plasma-Concentration-Time Curve From Time 0 to the Last Quantifiable Concentration (AUClast) of Abiraterone Acetate | Blood samples for pharmacokinetic (PK) measurements was taken on Day -7 at hour 0 (predose), at hours 1, 2, 4, 6, 8, and 12 (postdose). On Day -6 at 24 hour (postdose) and Day -5 at 48 hour (postdose). On Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 2 and 3 (Predose). | At hours 1, 2, 4, 6, 8, 12, 24 and 48 post dose and pre-dose on day 1, day 8, day 15 and day 22 cycle 1, day 1 cycle 2 and day 1 cycle 3 |
| Phase 1: Area Under the Plasma-Concentration-time Curve From Time 0 to Infinite Time (AUCINF_obs) of Abiraterone Acetate | Blood samples for pharmacokinetic (PK) measurements was taken on Day -7 at hour 0 (predose), at hours 1, 2, 4, 6, 8, and 12 (postdose). On Day -6 at 24 hour (postdose) and Day -5 at 48 hour (postdose). On Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 2 and 3 (Predose). | At hours 1, 2, 4, 6, 8, 12, 24 and 48 post dose and pre-dose on day 1, day 8, day 15 and day 22 cycle 1, day 1 cycle 2 and day 1 cycle 3 |
| Phase 1: Terminal Half-life (HL_Lambda_z) of Abiraterone Acetate | Blood samples for pharmacokinetic (PK) measurements was taken on Day -7 at hour 0 (predose), at hours 1, 2, 4, 6, 8, and 12 (postdose). On Day -6 at 24 hour (postdose) and Day -5 at 48 hour (postdose). On Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 2 and 3 (Predose). | At hours 1, 2, 4, 6, 8, 12, 24 and 48 post dose and pre-dose on day 1, day 8, day 15 and day 22 cycle 1, day 1 cycle 2 and day 1 cycle 3 |
| Phase 1: Total Body Clearance (Cl_F_obs) of Abiraterone Acetate | Blood samples for pharmacokinetic (PK) measurements was taken on Day -7 at hour 0 (predose), at hours 1, 2, 4, 6, 8, and 12 (postdose). On Day -6 at 24 hour (postdose) and Day -5 at 48 hour (postdose). On Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 2 and 3 (Predose). | At hours 1, 2, 4, 6, 8, 12, 24 and 48 post dose and pre-dose on day 1, day 8, day 15 and day 22 cycle 1, day 1 cycle 2 and day 1 cycle 3 |
| Phase 1: Volume of Distribution (Vz_F_obs) of Abiraterone Acetate | Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Volume of distribution is normally calculated by using equation volume of distribution =dose/initial concentration. Blood samples for pharmacokinetic (PK) measurements was taken on Day -7 at hour 0 (predose), at hours 1, 2, 4, 6, 8, and 12 (postdose). On Day -6 at 24 hour (postdose) and Day -5 at 48 hour (postdose). On Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 2 and 3 (Predose). | At hours 1, 2, 4, 6, 8, 12, 24 and 48 post dose and pre-dose on day 1, day 8, day 15 and day 22 cycle 1, day 1 cycle 2 and day 1 cycle 3 |
| Phase 2: Radiographic Progression Free Survival (RAD-PFS) | RAD-PFS is the time interval from the date of first dose of abiraterone acetate therapy to the date of death or radiographic disease progression according to the RECIST (Response Evaluation Criteria In Solid Tumors) criteria. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. | Up to 12 weeks from start of treatment |
| Phase 2: PSA Progression Free Survival (PSA-PFS) | PSA-PFS is the time interval from the date of first dose of abiraterone acetate therapy to the date of death or the PSA progression as defined by the Prostate Specific Antigen Working Group (PSAWG) criteria. | Up to 12 weeks from start of treatment |
| Phase 2: Radiographic Objective Response Rate (RAD-ORR) | The objective response rate is defined as the proportion of participants with measurable lesions achieving a Complete Response (CR) or Partial Response (PR) based on Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. | Up to 12 weeks from start of treatment |
| Phase 2: Time to PSA Progression | The time interval from the date of first dose of abiraterone acetate therapy to the date of the PSA progression as defined by the PSAWG criteria. | Up to 12 weeks from start of treatment |
| Phase 2: Duration of PSA Response | Duration of PSA response was defined as the duration between the date of confirmed PSA response and subsequent PSA progression date as defined by the PSAWG criteria. | Up to 12 weeks from start of treatment |
| Phase 2: Participants With Change in Eastern Cooperative Oncology Group (ECOG) Performance Status Score | ECOG performance status score ranges from 0 to 5 where 0=fully active, perform all pre-disease activities without restriction. 1=restricted in physically strenuous activity but ambulatory, carry out work of a light or sedentary nature. 2=ambulatory, capable of self-care, unable to carry out any work activities, up and about more than (>) 50% of waking hours. 3=capable of limited self-care, confined to bed or chair >50% of waking hours. 4=completely disabled, not capable of any self-care, totally confined to bed or chair. 5=dead. | Up to 12 weeks from start of treatment |
| Phase 2: Overall Survival | Overall survival is the time interval from the date of first dose (cycle 1 day 1) of abiraterone acetate therapy to the date of death from any cause. | Up to Month 60 |
| Phase 2: Duration of Objective Response | Duration of objective response was assessed only in participants who achieved a CR or PR, and measured from the first documented date of response to the first documented date of disease progression according to the RECIST criteria. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. | Up to 12 weeks from start of treatment |
| Boston |
| Massachusetts |
| United States |
| Houston | Texas | United States |
| PROSTATE CANCER | View source |
| Withdrawal by Subject |
|
| Progressive Disease |
|
| Symptomatic Deterioration |
|
| Reason not specified |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| BG002 |
| Phase 1 750 MG/DAY |
Abiraterone acetate |
| BG003 | Phase 1 1000 MG/DAY | Abiraterone acetate |
| BG004 | Phase 2 1000 MG/DAY | Abiraterone acetate |
| BG005 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | Phase 2: Participants With Greater Than or Equal to 50 Percent Decline in Prostate Specific Antigen (PSA) | Number of participants with greater than or equal to 50 percent decrease in PSA levels were assessed. PSA decline was evaluated according to (Prostate Specific Antigen Working Group) PSAWG criteria. Decrease in PSA levels represented improvement. | Intent-to-treat (ITT) population included all participants who were enrolled into the study. | Posted | Number | participants | Up to 12 weeks from start of treatment |
|
|
|
| Secondary | Phase 1: Maximum Plasma Concentration (Cmax) of Abiraterone Acetate | Blood samples for pharmacokinetic (PK) measurements was taken on Day -7 at hour 0 (predose), at hours 1, 2, 4, 6, 8, and 12 (postdose). On Day -6 at 24 hour (postdose) and Day -5 at 48 hour (postdose). On Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 2 and 3 (Predose). | ITT population included all participants who were enrolled into the study. | Posted | Mean | Standard Deviation | nanomoles per liter (nmol/L) | At hours 1, 2, 4, 6, 8, 12, 24 and 48 post dose and pre-dose on day 1, day 8, day 15 and day 22 cycle 1, day 1 cycle 2 and day 1 cycle 3. |
|
|
|
| Secondary | Phase 1: Time to Reach the Maximum Plasma Concentration (Tmax) of Abiraterone Acetate | Blood samples for pharmacokinetic (PK) measurements was taken on Day -7 at hour 0 (predose), at hours 1, 2, 4, 6, 8, and 12 (postdose). On Day -6 at 24 hour (postdose) and Day -5 at 48 hour (postdose). On Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 2 and 3 (Predose) | ITT population included all participants who were enrolled into the study. | Posted | Mean | Standard Deviation | hour (hr) | At hours 1, 2, 4, 6, 8, 12, 24 and 48 post dose and pre-dose on day 1, day 8, day 15 and day 22 cycle 1, day 1 cycle 2 and day 1 cycle 3 |
|
|
|
| Secondary | Phase 1: Area Under the Plasma-Concentration-Time Curve From Time 0 to the Last Quantifiable Concentration (AUClast) of Abiraterone Acetate | Blood samples for pharmacokinetic (PK) measurements was taken on Day -7 at hour 0 (predose), at hours 1, 2, 4, 6, 8, and 12 (postdose). On Day -6 at 24 hour (postdose) and Day -5 at 48 hour (postdose). On Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 2 and 3 (Predose). | ITT population included all participants who were enrolled into the study. | Posted | Mean | Standard Deviation | hr*nmol/L | At hours 1, 2, 4, 6, 8, 12, 24 and 48 post dose and pre-dose on day 1, day 8, day 15 and day 22 cycle 1, day 1 cycle 2 and day 1 cycle 3 |
|
|
|
| Secondary | Phase 1: Area Under the Plasma-Concentration-time Curve From Time 0 to Infinite Time (AUCINF_obs) of Abiraterone Acetate | Blood samples for pharmacokinetic (PK) measurements was taken on Day -7 at hour 0 (predose), at hours 1, 2, 4, 6, 8, and 12 (postdose). On Day -6 at 24 hour (postdose) and Day -5 at 48 hour (postdose). On Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 2 and 3 (Predose). | ITT population included all participants who were enrolled into the study. | Posted | Mean | Standard Deviation | hr*nmol/L | At hours 1, 2, 4, 6, 8, 12, 24 and 48 post dose and pre-dose on day 1, day 8, day 15 and day 22 cycle 1, day 1 cycle 2 and day 1 cycle 3 |
|
|
|
| Secondary | Phase 1: Terminal Half-life (HL_Lambda_z) of Abiraterone Acetate | Blood samples for pharmacokinetic (PK) measurements was taken on Day -7 at hour 0 (predose), at hours 1, 2, 4, 6, 8, and 12 (postdose). On Day -6 at 24 hour (postdose) and Day -5 at 48 hour (postdose). On Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 2 and 3 (Predose). | ITT population included all participants who were enrolled into the study. | Posted | Mean | Standard Deviation | hour (hr) | At hours 1, 2, 4, 6, 8, 12, 24 and 48 post dose and pre-dose on day 1, day 8, day 15 and day 22 cycle 1, day 1 cycle 2 and day 1 cycle 3 |
|
|
|
| Secondary | Phase 1: Total Body Clearance (Cl_F_obs) of Abiraterone Acetate | Blood samples for pharmacokinetic (PK) measurements was taken on Day -7 at hour 0 (predose), at hours 1, 2, 4, 6, 8, and 12 (postdose). On Day -6 at 24 hour (postdose) and Day -5 at 48 hour (postdose). On Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 2 and 3 (Predose). | ITT population included all participants who were enrolled into the study. | Posted | Mean | Standard Deviation | liter per hour (l/hr) | At hours 1, 2, 4, 6, 8, 12, 24 and 48 post dose and pre-dose on day 1, day 8, day 15 and day 22 cycle 1, day 1 cycle 2 and day 1 cycle 3 |
|
|
|
| Secondary | Phase 1: Volume of Distribution (Vz_F_obs) of Abiraterone Acetate | Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Volume of distribution is normally calculated by using equation volume of distribution =dose/initial concentration. Blood samples for pharmacokinetic (PK) measurements was taken on Day -7 at hour 0 (predose), at hours 1, 2, 4, 6, 8, and 12 (postdose). On Day -6 at 24 hour (postdose) and Day -5 at 48 hour (postdose). On Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 2 and 3 (Predose). | ITT population included all participants who were enrolled into the study. | Posted | Mean | Standard Deviation | Liter (L) | At hours 1, 2, 4, 6, 8, 12, 24 and 48 post dose and pre-dose on day 1, day 8, day 15 and day 22 cycle 1, day 1 cycle 2 and day 1 cycle 3 |
|
|
|
| Secondary | Phase 2: Radiographic Progression Free Survival (RAD-PFS) | RAD-PFS is the time interval from the date of first dose of abiraterone acetate therapy to the date of death or radiographic disease progression according to the RECIST (Response Evaluation Criteria In Solid Tumors) criteria. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. | ITT population included all participants who were enrolled into the study. RAD-PFS was not analyzed because of insufficient data to provide a meaningful estimate of the median and associated confidence interval (CI) | Posted | Median | Full Range | days | Up to 12 weeks from start of treatment |
|
|
|
| Secondary | Phase 2: PSA Progression Free Survival (PSA-PFS) | PSA-PFS is the time interval from the date of first dose of abiraterone acetate therapy to the date of death or the PSA progression as defined by the Prostate Specific Antigen Working Group (PSAWG) criteria. | ITT population included all participants who were enrolled into the study. | Posted | Median | 95% Confidence Interval | days | Up to 12 weeks from start of treatment |
|
|
|
| Secondary | Phase 2: Radiographic Objective Response Rate (RAD-ORR) | The objective response rate is defined as the proportion of participants with measurable lesions achieving a Complete Response (CR) or Partial Response (PR) based on Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. | Thirteen evaluable participants with measurable disease at baseline were evaluated for radiographic objective response rate. | Posted | Number | participants | Up to 12 weeks from start of treatment |
|
|
|
| Secondary | Phase 2: Time to PSA Progression | The time interval from the date of first dose of abiraterone acetate therapy to the date of the PSA progression as defined by the PSAWG criteria. | ITT population included all participants who were enrolled into the study. | Posted | Median | 95% Confidence Interval | days | Up to 12 weeks from start of treatment |
|
|
|
| Secondary | Phase 2: Duration of PSA Response | Duration of PSA response was defined as the duration between the date of confirmed PSA response and subsequent PSA progression date as defined by the PSAWG criteria. | ITT population included all participants who were enrolled into the study. | Posted | Median | 95% Confidence Interval | days | Up to 12 weeks from start of treatment |
|
|
|
| Secondary | Phase 2: Participants With Change in Eastern Cooperative Oncology Group (ECOG) Performance Status Score | ECOG performance status score ranges from 0 to 5 where 0=fully active, perform all pre-disease activities without restriction. 1=restricted in physically strenuous activity but ambulatory, carry out work of a light or sedentary nature. 2=ambulatory, capable of self-care, unable to carry out any work activities, up and about more than (>) 50% of waking hours. 3=capable of limited self-care, confined to bed or chair >50% of waking hours. 4=completely disabled, not capable of any self-care, totally confined to bed or chair. 5=dead. | ITT population included all participants who were enrolled into the study. | Posted | Number | participants | Up to 12 weeks from start of treatment |
|
|
|
| Secondary | Phase 2: Overall Survival | Overall survival is the time interval from the date of first dose (cycle 1 day 1) of abiraterone acetate therapy to the date of death from any cause. | ITT population included all participants who were enrolled into the study. | Posted | Median | 95% Confidence Interval | days | Up to Month 60 |
|
|
|
| Secondary | Phase 2: Duration of Objective Response | Duration of objective response was assessed only in participants who achieved a CR or PR, and measured from the first documented date of response to the first documented date of disease progression according to the RECIST criteria. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. | Thirteen evaluable participants with measurable disease at baseline were evaluated for radiographic duration of objective response. | Posted | Median | 95% Confidence Interval | days | Up to 12 weeks from start of treatment |
|
|
|
| 1 |
| 6 |
| 6 |
| 6 |
| EG001 | Phase 1 500 MG/DAY | Abiraterone acetate | 2 | 9 | 9 | 9 |
| EG002 | Phase 1 750 MG/DAY | Abiraterone acetate | 0 | 6 | 6 | 6 |
| EG003 | Phase 1 1000 MG/DAY | Abiraterone acetate | 0 | 12 | 12 | 12 |
| EG004 | Phase 2 1000 MG/DAY | Abiraterone acetate | 10 | 33 | 33 | 33 |
| Arrhythmia Supraventricular | Cardiac disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Myocardial Infarction | Cardiac disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Ventricular Extrasystoles | Cardiac disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Oedema Peripheral | General disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Device Related Infection | Infections and infestations | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Infection | Infections and infestations | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Urinary Tract Infection | Infections and infestations | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Urosepsis | Infections and infestations | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Troponin Increased | Investigations | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Pathological Fracture | Musculoskeletal and connective tissue disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Squamous Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Calculus Bladder | Renal and urinary disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Renal Failure | Renal and urinary disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Urinary Bladder Haemorrhage | Renal and urinary disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Urinary Incontinence | Renal and urinary disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Urinary Retention | Renal and urinary disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Atrial Fibrillation | Cardiac disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Cerumen Impaction | Ear and labyrinth disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Hypoacusis | Ear and labyrinth disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Adrenal Insufficiency | Endocrine disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Gynaecomastia | Endocrine disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Cataract | Eye disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Ocular Discomfort | Eye disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Ocular Hyperaemia | Eye disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Visual Acuity Reduced | Eye disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Abdominal Discomfort | Gastrointestinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Abdominal Distension | Gastrointestinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Defaecation Urgency | Gastrointestinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Dry Mouth | Gastrointestinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Gastrointestinal Haemorrhage | Gastrointestinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Gastrooesophageal Reflux Disease | Gastrointestinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Gingival Pain | Gastrointestinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Haematochezia | Gastrointestinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Lip Dry | Gastrointestinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Rectal Haemorrhage | Gastrointestinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Asthenia | General disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Chills | General disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Irritability | General disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Mucosal Dryness | General disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Oedema | General disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Oedema Peripheral | General disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Pain | General disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Tenderness | General disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Thirst | General disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Infection | Infections and infestations | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Lower Respiratory Tract Infection | Infections and infestations | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Tinea Versicolour | Infections and infestations | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Urinary Tract Infection | Infections and infestations | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Contrast Media Reaction | Injury, poisoning and procedural complications | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Excoriation | Injury, poisoning and procedural complications | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Joint Sprain | Injury, poisoning and procedural complications | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Muscle Injury | Injury, poisoning and procedural complications | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Rib Fracture | Injury, poisoning and procedural complications | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Skin Laceration | Injury, poisoning and procedural complications | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Spinal Compression Fracture | Injury, poisoning and procedural complications | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Alanine Aminotransferase Increased | Investigations | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Aspartate Aminotransferase Increased | Investigations | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Blood Alkaline Phosphatase Increased | Investigations | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Blood Bicarbonate Decreased | Investigations | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Blood Creatinine Increased | Investigations | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Platelet Count Decreased | Investigations | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Weight Decreased | Investigations | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Weight Increased | Investigations | MedDRA Version 11.0 | Non-systematic Assessment |
|
| White Blood Cell Count Decreased | Investigations | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Hyperchloraemia | Metabolism and nutrition disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Hypernatraemia | Metabolism and nutrition disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Bone Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Flank Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Hypercreatinaemia | Musculoskeletal and connective tissue disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Muscle Fatigue | Musculoskeletal and connective tissue disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Muscle Spasms | Musculoskeletal and connective tissue disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Muscular Weakness | Musculoskeletal and connective tissue disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Musculoskeletal Discomfort | Musculoskeletal and connective tissue disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Neck Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Rotator Cuff Syndrome | Musculoskeletal and connective tissue disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Basal Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Squamous Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Aphasia | Nervous system disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Ataxia | Nervous system disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Dizziness Postural | Nervous system disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Lethargy | Nervous system disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Peripheral Sensory Neuropathy | Nervous system disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Transient Ischaemic Attack | Nervous system disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Confusional State | Psychiatric disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Depressed Mood | Psychiatric disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Euphoric Mood | Psychiatric disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Mood Altered | Psychiatric disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Personality Change | Psychiatric disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Stress | Psychiatric disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Micturition Urgency | Renal and urinary disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Nocturia | Renal and urinary disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Urinary Incontinence | Renal and urinary disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Urinary Retention | Renal and urinary disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Urinary Tract Obstruction | Renal and urinary disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Pelvic Pain | Reproductive system and breast disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Testicular Pain | Reproductive system and breast disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Pharyngolaryngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Postnasal Drip | Respiratory, thoracic and mediastinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Productive Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Rales | Respiratory, thoracic and mediastinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Sinus Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Actinic Keratosis | Skin and subcutaneous tissue disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Dry Skin | Skin and subcutaneous tissue disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Skin Hyperpigmentation | Skin and subcutaneous tissue disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Hot Flush | Vascular disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Orthostatic Hypotension | Vascular disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
Not provided
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D011083 |
| Polycyclic Compounds |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D011246 | Pregnadienetriols |
| D013259 | Steroids, Fluorinated |
| Title | Measurements |
|---|
|
| Fed |
|
| Fed |
|
| Fed |
|
| Fed |
|
| Fed |
|
| Fed |
|
| Fed |
|
| Title | Measurements |
|---|---|
|
| Baseline ECOG 3 |
|
| Baseline ECOG 4 |
|
| Best Post-Baseline ECOG 0 |
|
| Best Post-Baseline ECOG 1 |
|
| Best Post-Baseline ECOG 2 |
|
| Best Post-Baseline ECOG 3 |
|
| Best Post-Baseline ECOG 4 |
|