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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-003741-26 | EudraCT Number |
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This study consists of two phases: Dose Escalation (Phase 1b) and Dose Expansion (Phase 2)
The Dose Escalation phase will characterize the safety, tolerability, and determine the maximum tolerated dose (MTD) of alobresib as a single agent and in combination with enzalutamide, in participants with metastatic castrate-resistant prostate cancer (mCRPC).
The Dose Expansion phase will evaluate the following:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alobresib Dose Escalation | Experimental | Participants who have progressed on either abiraterone and/or enzalutamide will be enrolled to receive increasing doses of alobresib up to 9 mg to determine the MTD. |
|
| Alobresib + Enzalutamide Dose Escalation | Experimental | Following a two week lead-in with enzalutamide once daily, participants who have progressed on abiraterone will receive less than or equal to MTD of alobresib in combination with enzalutamide 160 mg once daily. Based on observed pharmacokinetics (PK) interaction, toxicity, and tolerability observed in the single agent dose escalation, the dose of alobresib may be increased. |
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| Alobresib Dose Expansion (Group 1) | Experimental | Participants will receive a dose less than or equal to MTD of alobresib (based on safety, pharmacodynamics (PD), and tolerability). |
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| Alobresib + Enzalutamide Dose Expansion (Group 2) | Experimental | Participants will receive a dose less than or equal to MTD of alobresib plus enzalutamide (based on safety, PD, and tolerability). |
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| Alobresib + Enzalutamide Dose Expansion (Group 3) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alobresib | Drug | Tablet administered orally once daily. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1b Dose Escalation: Number of Participants Experienced Dose Limiting Toxicities (DLTs) | A DLT was a toxicity, considered possibly related to alobresib, and which occurred during the DLT assessment window (Days 1 through 28) in each cohort: Grade ≥ 4 neutropenia (absolute neutrophil count (ANC) < 500/mm^3), Grade ≥ 3 neutropenia (ANC< 1000/mm^3) with fever (a single temperature > 38.3°C or a sustained temperature of ≥ 38°C for more than 1 hour (h)), Grade ≥ 3 thrombocytopenia, Grade ≥ 2 bleeding (eg, gastrointestinal, respiratory, epistaxis, purpura), Grade ≥ 3 non hematologic toxicity, except- Grade 3 nausea or emesis with maximum duration of 48 h on adequate medical therapy and Grade 3 diarrhea which persists for < 72 h in the absence of maximal medical therapy, Grade ≥ 2 non hematologic treatment emergent adverse event (TEAE) that in the opinion of the investigator was of potential clinical significance such that further dose escalation would expose participants to unacceptable risk, treatment interruption ≥ 7 days due to unresolved toxicity. | Day 1 through Day 28 |
| Phase 2 Dose Expansion: Non-progression Rate at Week 24 According to Prostate Cancer Working Group (PCWG2) Criteria | The non-progression rate at Week 24 was defined as the proportion of participants who did not progress by Week 24. | Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1b Dose Escalation: Cmax: Maximum Observed Plasma Concentration of Alobresib | Cmax is the maximum observed concentration of drug in plasma. | Monotherapy: Predose, 0.5, 1, 2, 3, 4, 6, 8, and 24 hours postdose on Cycle 1 Day 8 and Cycle 2 Day 1; Combination therapy: Predose, 0.5, 1, 2, 3, 4, 6, 8, and 24 hours postdose on Cycle 1 Days 1 and 15 |
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Key Inclusion Criteria:
Histologically or cytologically confirmed prostate cancer (individuals with primary neuroendocrine carcinoma of prostate are excluded)
Must have documented progressive disease by meeting at least one of the Prostate Cancer Working Group 2 Criteria
Castration resistant disease defined as ongoing androgen deprivation therapy with gonadotropin-releasing hormone (GnRH) analogue or bilateral orchiectomy and serum testosterone level ≤ 1.73 nmol/l (50 ng/dL) at screening visit. Individuals who have not had a bilateral orchiectomy must have a plan to maintain effective GnRH-analogue therapy for the duration of the trial.
Metastatic disease documented by bone lesions on bone scan or by measurable soft tissue disease by computerized tomography/magnetic resonance imaging (CT/MRI). Patients whose disease spread is limited to regional pelvic lymph nodes are not eligible
Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1
Adequate organ function defined as follows:
Coagulation: International Normalized Ratio (INR) ≤ 1.2
Key Exclusion Criteria:
NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Gilead Study Director | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Francisco | California | 94158 | United States | |||
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43 participants were screened.
Participants were enrolled at 4 study sites in the United States. The first participant was screened on 08 December 2015. The last study visit occurred on 03 September 2019. Phase 2 Dose Expansion of the study was not conducted. Results are reported for only Dose Escalation Monotherapy and Combination Therapy.
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| ID | Title | Description |
|---|---|---|
| FG000 | Monotherapy: Alobresib 2 mg | Participants who had progressed on either abiraterone and/or enzalutamide, received alobresib 2 mg tablets administered orally once daily to determine the maximum tolerated dose (MTD). |
| FG001 | Monotherapy: Alobresib 3 mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 30, 2016 | Jul 29, 2020 |
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Participants will receive alobresib plus enzalutamide (dose will be equivalent to the dose chosen for Group 2). |
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| Enzalutamide | Drug | Capsules administered orally once daily. |
|
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| Phase 1b Dose Escalation: Ctau: Observed Drug Concentration at the End of the Dosing Interval of Alobresib | Ctau is the observed concentration of drug in plasma at the end of dosing. | Monotherapy: Predose, 0.5, 1, 2, 3, 4, 6, 8, and 24 hours postdose on Cycle 1 Day 8 and Cycle 2 Day 1; Combination therapy: Predose, 0.5, 1, 2, 3, 4, 6, 8, and 24 hours postdose on Cycle 1 Day 15 |
| Phase 1b Dose Escalation: AUClast: Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Quantifiable Concentration of Alobresib | AUClast is the concentration of drug over time zero to last concentration (area under the plasma concentration versus time curve). | Monotherapy: Predose, 0.5, 1, 2, 3, 4, 6, 8, and 24 hours postdose on Cycle 1 Day 8 and Cycle 2 Day 1; Combination therapy: Predose, 0.5, 1, 2, 3, 4, 6, 8, and 24 hours postdose on Cycle 1 Days 1 and 15 |
| Phase 1b Dose Escalation: AUCtau: Area Under the Plasma Concentration Versus Time Curve Over the Dosing Interval of Alobresib | AUCtau is defined as the concentration of drug over time (the area under the concentration verses time curve over the dosing interval). | Monotherapy: Predose, 0.5, 1, 2, 3, 4, 6, 8, and 24 hours postdose on Cycle 1 Day 8 and Cycle 2 Day 1; Combination therapy: Predose, 0.5, 1, 2, 3, 4, 6, 8, and 24 hours postdose on Cycle 1 Day 15 |
| Phase 1b Dose Escalation: Tmax: Time (Observed Time Point) of Cmax of Alobresib | Tmax is the time observed for the Cmax of alobresib. | Monotherapy: Predose, 0.5, 1, 2, 3, 4, 6, 8, and 24 hours postdose on Cycle 1 Day 8 and Cycle 2 Day 1; Combination therapy: Predose, 0.5, 1, 2, 3, 4, 6, 8, and 24 hours postdose on Cycle 1 Days 1 and 15 |
| Percentage of Participants Who Had ≥ 30% Reduction in Prostate Specific Antigen (PSA) From Baseline at Week 12 | PSA response was defined as percentage of participants with ≥ 30% decline in PSA from baseline by 12 weeks. | Baseline; Week 12 |
| Progression Free Survival (PFS) | PFS was defined as the interval from first dose date of study drug to the earlier of the first documentation of definitive disease progression (assessed per PCWG2) or death from any cause. PCWG2 criteria for progression was determined as 'Decline from baseline' when record start of therapy to first prostate-specific antigen (PSA) increase that is ≥ 25% and ≥ 2 ng/mL above the nadir and confirmed by a second value 3 or more weeks later; 'No decline from baseline' when PSA progression ≥ 25% and ≥ 2 ng/mL after 12 weeks. | Up to approximately 4 years |
| Overall Survival (OS) | OS is defined as the interval from first dose date of study drug to death from any cause. | Up to approximately 4 years |
| Baltimore |
| Maryland |
| 21231 |
| United States |
| Boston | Massachusetts | 02114 | United States |
| Durham | North Carolina | 27710 | United States |
Participants who had progressed on either abiraterone and/or enzalutamide, received alobresib 3 mg tablets administered orally once daily to determine the MTD. |
| FG002 | Monotherapy: Alobresib 4 mg | Participants who had progressed on either abiraterone and/or enzalutamide, received alobresib 4 mg tablets administered orally once daily to determine the MTD. |
| FG003 | Monotherapy: Alobresib 6 mg | Participants who had progressed on either abiraterone and/or enzalutamide, received alobresib 6 mg tablets administered orally once daily to determine the MTD. |
| FG004 | Monotherapy: Alobresib 9 mg | Participants who had progressed on either abiraterone and/or enzalutamide, received alobresib 9 mg tablets administered orally once daily to determine the MTD. |
| FG005 | Combination Therapy: Alobresib 3 mg + Enzalutamide | Participants who had progressed on abiraterone, received alobresib 3 mg tablets administered orally once daily in combination with enzalutamide 160 mg capsules administered orally once daily. |
| FG006 | Combination Therapy: Alobresib 6 mg + Enzalutamide | Participants who had progressed on abiraterone, received alobresib 6 mg tablets administered orally once daily in combination with enzalutamide 160 mg capsules administered orally once daily. |
| COMPLETED |
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| NOT COMPLETED |
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All Enrolled Analysis Set included all participants who received a study participant identification number in the study after screening.
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| ID | Title | Description |
|---|---|---|
| BG000 | Monotherapy: Alobresib 2 mg | Participants who had progressed on either abiraterone and/or enzalutamide, received alobresib 2 mg tablets administered orally once daily to determine the maximum tolerated dose (MTD). |
| BG001 | Monotherapy: Alobresib 3 mg | Participants who had progressed on either abiraterone and/or enzalutamide, received alobresib 3 mg tablets administered orally once daily to determine the MTD. |
| BG002 | Monotherapy: Alobresib 4 mg | Participants who had progressed on either abiraterone and/or enzalutamide, received alobresib 4 mg tablets administered orally once daily to determine the MTD. |
| BG003 | Monotherapy: Alobresib 6 mg | Participants who had progressed on either abiraterone and/or enzalutamide, received alobresib 6 mg tablets administered orally once daily to determine the MTD. |
| BG004 | Monotherapy: Alobresib 9 mg | Participants who had progressed on either abiraterone and/or enzalutamide, received alobresib 9 mg tablets administered orally once daily to determine the MTD. |
| BG005 | Combination Therapy: Alobresib 3 mg + Enzalutamide | Participants who had progressed on abiraterone, received alobresib 3 mg tablets administered orally once daily in combination with enzalutamide 160 mg capsules administered orally once daily. |
| BG006 | Combination Therapy: Alobresib 6 mg + Enzalutamide | Participants who had progressed on abiraterone, received alobresib 6 mg tablets administered orally once daily in combination with enzalutamide 160 mg capsules administered orally once daily. |
| BG007 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants | No |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
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| Race/Ethnicity, Customized | Count of Participants | Participants | No |
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| Region of Enrollment | Count of Participants | Participants | No |
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| 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 1b Dose Escalation: Number of Participants Experienced Dose Limiting Toxicities (DLTs) | A DLT was a toxicity, considered possibly related to alobresib, and which occurred during the DLT assessment window (Days 1 through 28) in each cohort: Grade ≥ 4 neutropenia (absolute neutrophil count (ANC) < 500/mm^3), Grade ≥ 3 neutropenia (ANC< 1000/mm^3) with fever (a single temperature > 38.3°C or a sustained temperature of ≥ 38°C for more than 1 hour (h)), Grade ≥ 3 thrombocytopenia, Grade ≥ 2 bleeding (eg, gastrointestinal, respiratory, epistaxis, purpura), Grade ≥ 3 non hematologic toxicity, except- Grade 3 nausea or emesis with maximum duration of 48 h on adequate medical therapy and Grade 3 diarrhea which persists for < 72 h in the absence of maximal medical therapy, Grade ≥ 2 non hematologic treatment emergent adverse event (TEAE) that in the opinion of the investigator was of potential clinical significance such that further dose escalation would expose participants to unacceptable risk, treatment interruption ≥ 7 days due to unresolved toxicity. | The DLT Analysis Set included all participants in the Safety Analysis Set who completed all treatment and safety procedures through Day 28, inclusive, or experienced a DLT prior to Day 28, exclusive. | Posted | Count of Participants | Participants | Day 1 through Day 28 |
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| Primary | Phase 2 Dose Expansion: Non-progression Rate at Week 24 According to Prostate Cancer Working Group (PCWG2) Criteria | The non-progression rate at Week 24 was defined as the proportion of participants who did not progress by Week 24. | The Phase 2 Dose Expansion of the study was not conducted. | Posted | Week 24 |
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| Secondary | Phase 1b Dose Escalation: Cmax: Maximum Observed Plasma Concentration of Alobresib | Cmax is the maximum observed concentration of drug in plasma. | The PK Analysis Set included participants who took at least 1 dose of study drug and have at least 1 non-missing postdose concentration value. Participants with available data were analyzed. Monotherapy: Samples were not collected at Cycle 1 Day 1 and Cycle 1 Day 15; samples were only collected for participants who received alobresib 3 mg, 6 mg and 9 mg doses at Cycle 2 Day 1. Combination Therapy: Samples were not collected at Cycle 1 Day 8 and Cycle 2 Day 1. | Posted | Mean | Standard Deviation | ng/mL | Monotherapy: Predose, 0.5, 1, 2, 3, 4, 6, 8, and 24 hours postdose on Cycle 1 Day 8 and Cycle 2 Day 1; Combination therapy: Predose, 0.5, 1, 2, 3, 4, 6, 8, and 24 hours postdose on Cycle 1 Days 1 and 15 |
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| Secondary | Phase 1b Dose Escalation: Ctau: Observed Drug Concentration at the End of the Dosing Interval of Alobresib | Ctau is the observed concentration of drug in plasma at the end of dosing. | Participants in the PK Analysis Set with available data were analyzed. Monotherapy: Samples were not collected at Cycle 1 Day 15; samples were only collected for participants who received alobresib 3 mg, 6 mg and 9 mg doses at Cycle 2 Day 1. Combination Therapy: Samples were not collected at Cycle 1 Day 8 and Cycle 2 Day 1. | Posted | Mean | Standard Deviation | ng/mL | Monotherapy: Predose, 0.5, 1, 2, 3, 4, 6, 8, and 24 hours postdose on Cycle 1 Day 8 and Cycle 2 Day 1; Combination therapy: Predose, 0.5, 1, 2, 3, 4, 6, 8, and 24 hours postdose on Cycle 1 Day 15 |
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| Secondary | Phase 1b Dose Escalation: AUClast: Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Quantifiable Concentration of Alobresib | AUClast is the concentration of drug over time zero to last concentration (area under the plasma concentration versus time curve). | Participants in the PK Analysis Set with available data were analyzed. Monotherapy: Samples were not collected at Cycle 1 Day 1 and Cycle 1 Day 15; samples were only collected for participants who received alobresib 3 mg, 6 mg and 9 mg doses at Cycle 2 Day 1. Combination Therapy: Samples were not collected at Cycle 1 Day 8 and Cycle 2 Day 1. | Posted | Mean | Standard Deviation | h*ng/mL | Monotherapy: Predose, 0.5, 1, 2, 3, 4, 6, 8, and 24 hours postdose on Cycle 1 Day 8 and Cycle 2 Day 1; Combination therapy: Predose, 0.5, 1, 2, 3, 4, 6, 8, and 24 hours postdose on Cycle 1 Days 1 and 15 |
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| Secondary | Phase 1b Dose Escalation: AUCtau: Area Under the Plasma Concentration Versus Time Curve Over the Dosing Interval of Alobresib | AUCtau is defined as the concentration of drug over time (the area under the concentration verses time curve over the dosing interval). | Participants in the PK Analysis Set with available data were analyzed. Monotherapy: Samples were not collected at Cycle 1 Day 15; samples were only collected for participants who received alobresib 3 mg, 6 mg and 9 mg doses at Cycle 2 Day 1. Combination Therapy: Samples were not collected at Cycle 1 Day 8 and Cycle 2 Day 1. | Posted | Mean | Standard Deviation | h*ng/mL | Monotherapy: Predose, 0.5, 1, 2, 3, 4, 6, 8, and 24 hours postdose on Cycle 1 Day 8 and Cycle 2 Day 1; Combination therapy: Predose, 0.5, 1, 2, 3, 4, 6, 8, and 24 hours postdose on Cycle 1 Day 15 |
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| Secondary | Phase 1b Dose Escalation: Tmax: Time (Observed Time Point) of Cmax of Alobresib | Tmax is the time observed for the Cmax of alobresib. | Participants in the PK Analysis Set with available data were analyzed. Monotherapy: Samples were not collected at Cycle 1 Day 1 and Cycle 1 Day 15; samples were only collected for participants who received alobresib 3 mg, 6 mg and 9 mg doses at Cycle 2 Day 1. Combination Therapy: Samples were not collected at Cycle 1 Day 8 and Cycle 2 Day 1. | Posted | Median | Full Range | hours | Monotherapy: Predose, 0.5, 1, 2, 3, 4, 6, 8, and 24 hours postdose on Cycle 1 Day 8 and Cycle 2 Day 1; Combination therapy: Predose, 0.5, 1, 2, 3, 4, 6, 8, and 24 hours postdose on Cycle 1 Days 1 and 15 |
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| Secondary | Percentage of Participants Who Had ≥ 30% Reduction in Prostate Specific Antigen (PSA) From Baseline at Week 12 | PSA response was defined as percentage of participants with ≥ 30% decline in PSA from baseline by 12 weeks. | Participants in the Full Analysis Set were analyzed. | Posted | Number | percentage of participants | Baseline; Week 12 |
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| Secondary | Progression Free Survival (PFS) | PFS was defined as the interval from first dose date of study drug to the earlier of the first documentation of definitive disease progression (assessed per PCWG2) or death from any cause. PCWG2 criteria for progression was determined as 'Decline from baseline' when record start of therapy to first prostate-specific antigen (PSA) increase that is ≥ 25% and ≥ 2 ng/mL above the nadir and confirmed by a second value 3 or more weeks later; 'No decline from baseline' when PSA progression ≥ 25% and ≥ 2 ng/mL after 12 weeks. | Participants in the Full Analysis Set were analyzed. | Posted | Median | 95% Confidence Interval | months | Up to approximately 4 years |
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| Secondary | Overall Survival (OS) | OS is defined as the interval from first dose date of study drug to death from any cause. | Participants in the Full Analysis Set were analyzed. | Posted | Median | 95% Confidence Interval | months | Up to approximately 4 years |
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Adverse Events: From first dose through last dose of the study drug (maximum: 131 weeks) plus 30 days; All-Cause Mortality: First dose date up to approximately 4 years
The Safety Analysis Set included all participants who received >= 1 dose of study treatment with treatment group designated according to actual treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Monotherapy: Alobresib 2 mg | Participants who had progressed on either abiraterone and/or enzalutamide, received alobresib 2 mg tablets administered orally once daily to determine the maximum tolerated dose (MTD). | 0 | 5 | 2 | 5 | 5 | 5 |
| EG001 | Monotherapy: Alobresib 3 mg | Participants who had progressed on either abiraterone and/or enzalutamide, received alobresib 3 mg tablets administered orally once daily to determine the MTD. | 1 | 4 | 0 | 4 | 3 | 4 |
| EG002 | Monotherapy: Alobresib 4 mg | Participants who had progressed on either abiraterone and/or enzalutamide, received alobresib 4 mg tablets administered orally once daily to determine the MTD. | 0 | 3 | 1 | 3 | 3 | 3 |
| EG003 | Monotherapy: Alobresib 6 mg | Participants who had progressed on either abiraterone and/or enzalutamide, received alobresib 6 mg tablets administered orally once daily to determine the MTD. | 0 | 6 | 1 | 6 | 6 | 6 |
| EG004 | Monotherapy: Alobresib 9 mg | Participants who had progressed on either abiraterone and/or enzalutamide, received alobresib 9 mg tablets administered orally once daily to determine the MTD. | 0 | 5 | 2 | 5 | 5 | 5 |
| EG005 | Combination Therapy: Alobresib 3 mg + Enzalutamide | Participants who had progressed on abiraterone, received alobresib 3 mg tablets administered orally once daily in combination with enzalutamide 160 mg capsules administered orally once daily. | 1 | 6 | 2 | 6 | 5 | 6 |
| EG006 | Combination Therapy: Alobresib 6 mg + Enzalutamide | Participants who had progressed on abiraterone, received alobresib 6 mg tablets administered orally once daily in combination with enzalutamide 160 mg capsules administered orally once daily. | 0 | 2 | 1 | 2 | 2 | 2 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Retinal detachment | Eye disorders | MedDRA Version 22.0 | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA Version 22.0 | Systematic Assessment |
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| Diverticular perforation | Gastrointestinal disorders | MedDRA Version 22.0 | Systematic Assessment |
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| Asthenia | General disorders | MedDRA Version 22.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA Version 22.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA Version 22.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Central nervous system lesion | Nervous system disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Embolic stroke | Nervous system disorders | MedDRA Version 22.0 | Systematic Assessment |
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| Acute kidney injury | Renal and urinary disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Pelvic pain | Reproductive system and breast disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 22.0 | Systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Ear pruritus | Ear and labyrinth disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 22.0 | Systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | MedDRA Version 22.0 | Systematic Assessment |
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| Dysphagia | Gastrointestinal disorders | MedDRA Version 22.0 | Systematic Assessment |
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| Eructation | Gastrointestinal disorders | MedDRA Version 22.0 | Systematic Assessment |
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| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA Version 22.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA Version 22.0 | Systematic Assessment |
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| Stomatitis | Gastrointestinal disorders | MedDRA Version 22.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Catheter site extravasation | General disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA Version 22.0 | Systematic Assessment |
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| Device related thrombosis | General disorders | MedDRA Version 22.0 | Systematic Assessment |
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| Early satiety | General disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA Version 22.0 | Systematic Assessment |
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| Feeling cold | General disorders | MedDRA Version 22.0 | Systematic Assessment |
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| Gait disturbance | General disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA Version 22.0 | Systematic Assessment |
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| Non-cardiac chest pain | General disorders | MedDRA Version 22.0 | Systematic Assessment |
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| Oedema peripheral | General disorders | MedDRA Version 22.0 | Systematic Assessment |
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| Pain | General disorders | MedDRA Version 22.0 | Systematic Assessment |
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| Abdominal infection | Infections and infestations | MedDRA Version 22.0 | Systematic Assessment |
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| Herpes zoster | Infections and infestations | MedDRA Version 22.0 | Systematic Assessment |
| |
| Kidney infection | Infections and infestations | MedDRA Version 22.0 | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA Version 22.0 | Systematic Assessment |
| |
| Tooth infection | Infections and infestations | MedDRA Version 22.0 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA Version 22.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA Version 22.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA Version 22.0 | Systematic Assessment |
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| Iliotibial band syndrome | Injury, poisoning and procedural complications | MedDRA Version 22.0 | Systematic Assessment |
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| Joint injury | Injury, poisoning and procedural complications | MedDRA Version 22.0 | Systematic Assessment |
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| Muscle strain | Injury, poisoning and procedural complications | MedDRA Version 22.0 | Systematic Assessment |
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| Skin abrasion | Injury, poisoning and procedural complications | MedDRA Version 22.0 | Systematic Assessment |
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| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA Version 22.0 | Systematic Assessment |
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| Wound haemorrhage | Injury, poisoning and procedural complications | MedDRA Version 22.0 | Systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | MedDRA Version 22.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA Version 22.0 | Systematic Assessment |
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| Blood creatinine increased | Investigations | MedDRA Version 22.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA Version 22.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA Version 22.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Pathological fracture | Musculoskeletal and connective tissue disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Burning sensation | Nervous system disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Cognitive disorder | Nervous system disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Hemiparesis | Nervous system disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Memory impairment | Nervous system disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Abnormal dreams | Psychiatric disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Renal pain | Renal and urinary disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Urinary tract disorder | Renal and urinary disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Urinary tract obstruction | Renal and urinary disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Erectile dysfunction | Reproductive system and breast disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Pelvic pain | Reproductive system and breast disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Pain of skin | Skin and subcutaneous tissue disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA Version 22.0 | Systematic Assessment |
|
After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:
The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or The study has been completed at all study sites for at least 2 years.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gilead Clinical Study Information Center | Gilead Sciences | 1-833-445-3230 (GILEAD-0) | GileadClinicalTrials@gilead.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 21, 2019 | Jul 29, 2020 | SAP_001.pdf |
| ID | Term |
|---|---|
| C540278 | enzalutamide |
Not provided
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| White |
|
| Other |
|
Participants who had progressed on abiraterone, received alobresib 6 mg tablets administered orally once daily in combination with enzalutamide 160 mg capsules administered orally once daily. |
| OG004 | Monotherapy: Alobresib 9 mg | Participants who had progressed on either abiraterone and/or enzalutamide, received alobresib 9 mg tablets administered orally once daily to determine the MTD. |
| OG005 | Combination Therapy: Alobresib 3 mg + Enzalutamide | Participants who had progressed on abiraterone, received alobresib 3 mg tablets administered orally once daily in combination with enzalutamide 160 mg capsules administered orally once daily. |
| OG006 | Combination Therapy: Alobresib 6 mg + Enzalutamide | Participants who had progressed on abiraterone, received alobresib 6 mg tablets administered orally once daily in combination with enzalutamide 160 mg capsules administered orally once daily. |
|
Participants who had progressed on either abiraterone and/or enzalutamide, received alobresib 4 mg tablets administered orally once daily to determine the MTD. |
| OG003 | Monotherapy: Alobresib 6 mg | Participants who had progressed on either abiraterone and/or enzalutamide, received alobresib 6 mg tablets administered orally once daily to determine the MTD. |
| OG004 | Monotherapy: Alobresib 9 mg | Participants who had progressed on either abiraterone and/or enzalutamide, received alobresib 9 mg tablets administered orally once daily to determine the MTD. |
| OG005 | Combination Therapy: Alobresib 3 mg + Enzalutamide | Participants who had progressed on abiraterone, received alobresib 3 mg tablets administered orally once daily in combination with enzalutamide 160 mg capsules administered orally once daily. |
| OG006 | Combination Therapy: Alobresib 6 mg + Enzalutamide | Participants who had progressed on abiraterone, received alobresib 6 mg tablets administered orally once daily in combination with enzalutamide 160 mg capsules administered orally once daily. |
|
|
Participants who had progressed on either abiraterone and/or enzalutamide, received alobresib 4 mg tablets administered orally once daily to determine the MTD.
| OG003 | Monotherapy: Alobresib 6 mg | Participants who had progressed on either abiraterone and/or enzalutamide, received alobresib 6 mg tablets administered orally once daily to determine the MTD. |
| OG004 | Monotherapy: Alobresib 9 mg | Participants who had progressed on either abiraterone and/or enzalutamide, received alobresib 9 mg tablets administered orally once daily to determine the MTD. |
| OG005 | Combination Therapy: Alobresib 3 mg + Enzalutamide | Participants who had progressed on abiraterone, received alobresib 3 mg tablets administered orally once daily in combination with enzalutamide 160 mg capsules administered orally once daily. |
| OG006 | Combination Therapy: Alobresib 6 mg + Enzalutamide | Participants who had progressed on abiraterone, received alobresib 6 mg tablets administered orally once daily in combination with enzalutamide 160 mg capsules administered orally once daily. |
|
|
Participants who had progressed on either abiraterone and/or enzalutamide, received alobresib 4 mg tablets administered orally once daily to determine the MTD. |
| OG003 | Monotherapy: Alobresib 6 mg | Participants who had progressed on either abiraterone and/or enzalutamide, received alobresib 6 mg tablets administered orally once daily to determine the MTD. |
| OG004 | Monotherapy: Alobresib 9 mg | Participants who had progressed on either abiraterone and/or enzalutamide, received alobresib 9 mg tablets administered orally once daily to determine the MTD. |
| OG005 | Combination Therapy: Alobresib 3 mg + Enzalutamide | Participants who had progressed on abiraterone, received alobresib 3 mg tablets administered orally once daily in combination with enzalutamide 160 mg capsules administered orally once daily. |
| OG006 | Combination Therapy: Alobresib 6 mg + Enzalutamide | Participants who had progressed on abiraterone, received alobresib 6 mg tablets administered orally once daily in combination with enzalutamide 160 mg capsules administered orally once daily. |
|
|
Participants who had progressed on either abiraterone and/or enzalutamide, received alobresib 4 mg tablets administered orally once daily to determine the MTD. |
| OG003 | Monotherapy: Alobresib 6 mg | Participants who had progressed on either abiraterone and/or enzalutamide, received alobresib 6 mg tablets administered orally once daily to determine the MTD. |
| OG004 | Monotherapy: Alobresib 9 mg | Participants who had progressed on either abiraterone and/or enzalutamide, received alobresib 9 mg tablets administered orally once daily to determine the MTD. |
| OG005 | Combination Therapy: Alobresib 3 mg + Enzalutamide | Participants who had progressed on abiraterone, received alobresib 3 mg tablets administered orally once daily in combination with enzalutamide 160 mg capsules administered orally once daily. |
| OG006 | Combination Therapy: Alobresib 6 mg + Enzalutamide | Participants who had progressed on abiraterone, received alobresib 6 mg tablets administered orally once daily in combination with enzalutamide 160 mg capsules administered orally once daily. |
|
|
| OG003 | Monotherapy: Alobresib 6 mg | Participants who had progressed on either abiraterone and/or enzalutamide, received alobresib 6 mg tablets administered orally once daily to determine the MTD. |
| OG004 | Monotherapy: Alobresib 9 mg | Participants who had progressed on either abiraterone and/or enzalutamide, received alobresib 9 mg tablets administered orally once daily to determine the MTD. |
| OG005 | Combination Therapy: Alobresib 3 mg + Enzalutamide | Participants who had progressed on abiraterone, received alobresib 3 mg tablets administered orally once daily in combination with enzalutamide 160 mg capsules administered orally once daily. |
| OG006 | Combination Therapy: Alobresib 6 mg + Enzalutamide | Participants who had progressed on abiraterone, received alobresib 6 mg tablets administered orally once daily in combination with enzalutamide 160 mg capsules administered orally once daily. |
|
|
Participants who had progressed on either abiraterone and/or enzalutamide, received alobresib 6 mg tablets administered orally once daily to determine the MTD.
| OG004 | Monotherapy: Alobresib 9 mg | Participants who had progressed on either abiraterone and/or enzalutamide, received alobresib 9 mg tablets administered orally once daily to determine the MTD. |
| OG005 | Combination Therapy: Alobresib 3 mg + Enzalutamide | Participants who had progressed on abiraterone, received alobresib 3 mg tablets administered orally once daily in combination with enzalutamide 160 mg capsules administered orally once daily. |
| OG006 | Combination Therapy: Alobresib 6 mg + Enzalutamide | Participants who had progressed on abiraterone, received alobresib 6 mg tablets administered orally once daily in combination with enzalutamide 160 mg capsules administered orally once daily. |
|
|
| OG003 | Monotherapy: Alobresib 6 mg | Participants who had progressed on either abiraterone and/or enzalutamide, received alobresib 6 mg tablets administered orally once daily to determine the MTD. |
| OG004 | Monotherapy: Alobresib 9 mg | Participants who had progressed on either abiraterone and/or enzalutamide, received alobresib 9 mg tablets administered orally once daily to determine the MTD. |
| OG005 | Combination Therapy: Alobresib 3 mg + Enzalutamide | Participants who had progressed on abiraterone, received alobresib 3 mg tablets administered orally once daily in combination with enzalutamide 160 mg capsules administered orally once daily. |
| OG006 | Combination Therapy: Alobresib 6 mg + Enzalutamide | Participants who had progressed on abiraterone, received alobresib 6 mg tablets administered orally once daily in combination with enzalutamide 160 mg capsules administered orally once daily. |
|
|
| OG004 | Monotherapy: Alobresib 9 mg | Participants who had progressed on either abiraterone and/or enzalutamide, received alobresib 9 mg tablets administered orally once daily to determine the MTD. |
| OG005 | Combination Therapy: Alobresib 3 mg + Enzalutamide | Participants who had progressed on abiraterone, received alobresib 3 mg tablets administered orally once daily in combination with enzalutamide 160 mg capsules administered orally once daily. |
| OG006 | Combination Therapy: Alobresib 6 mg + Enzalutamide | Participants who had progressed on abiraterone, received alobresib 6 mg tablets administered orally once daily in combination with enzalutamide 160 mg capsules administered orally once daily. |
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