TriangleNCT03685591 · STUDY IN CONTEXT
PF-06952229 Treatment in Adult Patients With Advanced Solid Tumors
Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
Read the full study record and all posted results →
Linked outcomes
First cycle DLTs were utilized to determine the max tolerated dose and future escalations or deescalations. Any of the following adverse events occurred in the first cycle of treatment which were clinically significant were classified as DLTs: Hematologic: Thrombocytopenia Grade 4 for \>=7 days, or Grade 3 or 4 associated with \>= Grade 2 clinically significant bleeding or requiring platelet transfusion; Neutropenia Grade 4 for \>=7 days; Grade\>=3 neutropenia with infection; Anemia Grade 4 or Grade 3 requiring blood transfusion. Nonhematologic: Grade\>=3 toxicities that were considered clinically significant; Alanine aminotransferase/aspartate aminotransferase\>3x the upper limit of normal (ULN) with bilirubin\>2x ULN without another explanation; Grade 3 nausea, vomiting or diarrhea that did not resolve within 4 days despite maximal supportive therapy. Nonhematologic and Non-Hepatic: Any toxicity caused\>= 2 weeks of dose delay or preventing participants from receiving 75% of study drug.
Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of death; inpatient hospitalization; life-threatening experience; disability; congenital anomaly or deemed significant for any other reason. Symptoms of infusion-related reactions (IRRs) may include, but were not limited to, fever, chills, flushing, hypotension, dyspnea, wheezing, back pain, abdominal pain, and urticaria. Grade 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of existing hospitalization indicated, disabling, limiting self-care ADL; Grade 4: life-threatening consequence, urgent intervention indicated; Grade 5: death related to AE.
Laboratory parameters included: hematology (hemoglobin, hematocrit, red blood cell, platelet and white blood cell count, neutrophils, eosinophils, monocytes, basophils and lymphocytes), chemistry (blood urea nitrogen, creatinine, sodium, potassium, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, albumin, total protein and serum pregnancy test \[for all female participants\]) and urine (urine pregnancy test \[for all female participants\]). Clinical significance of laboratory parameters was determined at the investigator's discretion.
Cmax was directly observed from data. Cmax was defined as maximum observed plasma concentration.
Cmax was directly observed from data. Cmax was defined as maximum observed plasma concentration.
Tmax was defined as time to maximum observed concentration. Observed directly from data as time of first occurrence.
Reported safety
Quality of life and patient-reported measures
No linked quality-of-life measure is recorded for this setting and study.
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-prostate-neoplasm
- nct id
- NCT03685591
- trial label
- PF-06952229 Treatment in Adult Patients With Advanced Solid Tumors
- applicability
- narrower
- applicability note
- Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- registry-condition-search
- discovery note
- Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
- outcome Count
- 6
- harms Count
- 9
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-prostate-neoplasm
- nct id
- NCT03685591
- outcome key
- om-0000
- source section id
- NCT03685591-om-0000
- source outcome index
- 0
- endpoint
- Number of Participants With First-Cycle Dose-Limiting Toxicitys (DLTs) by Treatment
- endpoint definition
- First cycle DLTs were utilized to determine the max tolerated dose and future escalations or deescalations. Any of the following adverse events occurred in the first cycle of treatment which were clinically significant were classified as DLTs: Hematologic: Thrombocytopenia Grade 4 for \>=7 days, or Grade 3 or 4 associated with \>= Grade 2 clinically significant bleeding or requiring platelet transfusion; Neutropenia Grade 4 for \>=7 days; Grade\>=3 neutropenia with infection; Anemia Grade 4 or Grade 3 requiring blood transfusion. Nonhematologic: Grade\>=3 toxicities that were considered clinically significant; Alanine aminotransferase/aspartate aminotransferase\>3x the upper limit of normal (ULN) with bilirubin\>2x ULN without another explanation; Grade 3 nausea, vomiting or diarrhea that did not resolve within 4 days despite maximal supportive therapy. Nonhematologic and Non-Hepatic: Any toxicity caused\>= 2 weeks of dose delay or preventing participants from receiving 75% of study drug.
- time origin
- Within 28 days of first dose or until the participant completed the first cycle of therapy if there were treatment delayed (on average 28 days).
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Population included all enrolled participants who received at least one dose of investigational product and included data evaluated for a minimum DLT observation period of 28 days.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-prostate-neoplasm
- nct id
- NCT03685591
- outcome key
- om-0001
- source section id
- NCT03685591-om-0001
- source outcome index
- 1
- endpoint
- Number of Participants With Treatment-Emergent Adverse Events (Treatment Related)
- endpoint definition
- Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of death; inpatient hospitalization; life-threatening experience; disability; congenital anomaly or deemed significant for any other reason. Symptoms of infusion-related reactions (IRRs) may include, but were not limited to, fever, chills, flushing, hypotension, dyspnea, wheezing, back pain, abdominal pain, and urticaria. Grade 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of existing hospitalization indicated, disabling, limiting self-care ADL; Grade 4: life-threatening consequence, urgent intervention indicated; Grade 5: death related to AE.
- time origin
- Baseline up to 28 days after last dose of study treatment ( up to approximately 2 years)
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Population included all enrolled participants who received at least one dose of investigational product.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-prostate-neoplasm
- nct id
- NCT03685591
- outcome key
- om-0002
- source section id
- NCT03685591-om-0002
- source outcome index
- 2
- endpoint
- Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
- endpoint definition
- Laboratory parameters included: hematology (hemoglobin, hematocrit, red blood cell, platelet and white blood cell count, neutrophils, eosinophils, monocytes, basophils and lymphocytes), chemistry (blood urea nitrogen, creatinine, sodium, potassium, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, albumin, total protein and serum pregnancy test \[for all female participants\]) and urine (urine pregnancy test \[for all female participants\]). Clinical significance of laboratory parameters was determined at the investigator's discretion.
- time origin
- Baseline up to 28 days after last dose of study treatment ( up to approximately 2 years)
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Population included all enrolled participants who received at least one dose of investigational product and with at least one observation of the given laboratory test during treatment period. Here, "number analyzed" signifies participant evaluable for each row.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-prostate-neoplasm
- nct id
- NCT03685591
- outcome key
- om-0003
- source section id
- NCT03685591-om-0003
- source outcome index
- 3
- endpoint
- Maximum Observed Plasma Concentration (Cmax) of PF-06952229 (Part 1A)
- endpoint definition
- Cmax was directly observed from data. Cmax was defined as maximum observed plasma concentration.
- time origin
- 0 (pre dose), 0.5, 1, 2, 4, 6 and 12 hours (post dose) on Day 1 and 7 of cycle 1, 0 (pre dose), 0.5, 1, 2, 4, 6 and 12 hours (post dose) on Day 1 of cycle 2.
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Participants with advanced/metastatic tumors in PF-06952229 single agent dose escalation phase, who had sufficient information to estimate at least 1 of the pharmacokinetic (PK) parameters of interest. Here, "number analyzed" signifies participant evaluable for each row.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-prostate-neoplasm
- nct id
- NCT03685591
- outcome key
- om-0004
- source section id
- NCT03685591-om-0004
- source outcome index
- 4
- endpoint
- Maximum Observed Plasma Concentration (Cmax) of PF-06952229 (Part 1B)
- endpoint definition
- Cmax was directly observed from data. Cmax was defined as maximum observed plasma concentration.
- time origin
- 0 (pre dose), 0.5, 1, 2, 4, 6 and 12 hours (post dose) on Day 1 and 21 of cycle 1, 0 (pre dose), 0.5, 1, 2, 4, 6 and 12 hours (post dose) on Day 1 of cycle 2.
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Participants with metastatic castration-resistant prostate cancer (mCRPC), conducted dose escalation of PF-06952229 in combination with enzalutamide, who had sufficient information to estimate at least 1 of the PK parameters of interest. Here, "number analyzed" signifies participant evaluable for each row
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-prostate-neoplasm
- nct id
- NCT03685591
- outcome key
- om-0005
- source section id
- NCT03685591-om-0005
- source outcome index
- 5
- endpoint
- Time of Observed Maximum Plasma Concentration (Tmax) of PF-06952229 (Part 1A)
- endpoint definition
- Tmax was defined as time to maximum observed concentration. Observed directly from data as time of first occurrence.
- time origin
- 0 (pre dose), 0.5, 1, 2, 4, 6 and 12 hours (post dose) on Day 1 and 7 of cycle 1, 0 (pre dose), 0.5, 1, 2, 4, 6 and 12 hours (post dose) on Day 1 of cycle 2.
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Participants with advanced/metastatic tumors in PF-06952229 single agent dose escalation phase, who had sufficient information to estimate at least 1 of the PK parameters of interest. Here, "number analyzed" signifies participant evaluable for each row.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-prostate-neoplasm
- nct id
- NCT03685591
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Part 1A: PF-06952229 20mg Monotherapy
- regimen
- PF-06952229 was administered at a dose of 20 mg orally twice daily (BID) for 7 days on, 7 days off for each Cycle (one cycle = 28 days).
- analyzed count
- 1
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03685591-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-prostate-neoplasm
- nct id
- NCT03685591
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Part 1A: PF-06952229 40mg Monotherapy
- regimen
- PF-06952229 was administered at a dose of 40 mg orally BID for 7 days on, 7 days off for each Cycle (one cycle = 28 days).
- analyzed count
- 1
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03685591-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-prostate-neoplasm
- nct id
- NCT03685591
- outcome key
- om-0000
- arm key
- OG002
- arm label
- Part 1A: PF-06952229 80mg Monotherapy
- regimen
- PF-06952229 was administered at a dose of 80 mg orally BID for 7 days on, 7 days off for each Cycle (one cycle = 28 days).
- analyzed count
- 1
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03685591-om-0000#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-prostate-neoplasm
- nct id
- NCT03685591
- outcome key
- om-0000
- arm key
- OG003
- arm label
- Part 1A: PF-06952229 150mg Monotherapy
- regimen
- PF-06952229 was administered at a dose of 150 mg orally BID for 7 days on, 7 days off for each Cycle (one cycle = 28 days).
- analyzed count
- 4
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03685591-om-0000#groups/OG003
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-prostate-neoplasm
- nct id
- NCT03685591
- outcome key
- om-0000
- arm key
- OG004
- arm label
- Part 1A: PF-06952229 250mg Monotherapy
- regimen
- PF-06952229 was administered at a dose of 250 mg orally BID for 7 days on, 7 days off for each Cycle (one cycle = 28 days).
- analyzed count
- 9
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03685591-om-0000#groups/OG004
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-prostate-neoplasm
- nct id
- NCT03685591
- outcome key
- om-0000
- arm key
- OG005
- arm label
- Part 1A: PF-06952229 375mg Monotherapy
- regimen
- PF-06952229 was administered at a dose of 375 mg orally BID for 7 days on, 7 days off for each Cycle (one cycle = 28 days).
- analyzed count
- 15
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03685591-om-0000#groups/OG005
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-prostate-neoplasm
- nct id
- NCT03685591
- outcome key
- om-0000
- arm key
- OG006
- arm label
- Part 1A: PF-06952229 500mg Monotherapy
- regimen
- PF-06952229 was administered at a dose of 500 mg orally BID for 7 days on, 7 days off for each Cycle (one cycle = 28 days).
- analyzed count
- 4
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03685591-om-0000#groups/OG006
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-prostate-neoplasm
- nct id
- NCT03685591
- outcome key
- om-0000
- arm key
- OG007
- arm label
- Part 1B: PF-06952229 250mg + Enzalutamide
- regimen
- PF-06952229 was administered at a dose of 250 mg orally twice daily (BID) for 7 days on, 7 days off for each Cycle (one cycle = 28 days) in combination with enzalutamide at 160 mg orally once a day (QD) as continuous daily dosing.
- analyzed count
- 4
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03685591-om-0000#groups/OG007
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-prostate-neoplasm
- nct id
- NCT03685591
- outcome key
- om-0000
- arm key
- OG008
- arm label
- Part 1B: PF-06952229 375mg + Enzalutamide
- regimen
- PF-06952229 was administered at a dose of 375 mg orally twice daily (BID) for 7 days on, 7 days off for each Cycle (one cycle = 28 days) in combination with enzalutamide at 160 mg orally QD as continuous daily dosing.
- analyzed count
- 3
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03685591-om-0000#groups/OG008
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-prostate-neoplasm
- nct id
- NCT03685591
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Part 1A: PF-06952229 20mg Monotherapy
- regimen
- PF-06952229 was administered at a dose of 20 mg orally twice daily (BID) for 7 days on, 7 days off for each Cycle (one cycle = 28 days).
- analyzed count
- 1
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03685591-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-prostate-neoplasm
- nct id
- NCT03685591
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Part 1A: PF-06952229 40mg Monotherapy
- regimen
- PF-06952229 was administered at a dose of 40 mg orally BID for 7 days on, 7 days off for each Cycle (one cycle = 28 days).
- analyzed count
- 1
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03685591-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-prostate-neoplasm
- nct id
- NCT03685591
- outcome key
- om-0001
- arm key
- OG002
- arm label
- Part 1A: PF-06952229 80mg Monotherapy
- regimen
- PF-06952229 was administered at a dose of 80 mg orally BID for 7 days on, 7 days off for each Cycle (one cycle = 28 days).
- analyzed count
- 1
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03685591-om-0001#groups/OG002
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-prostate-neoplasm
- nct id
- NCT03685591
- harm key
- EG000
- source section id
- NCT03685591-ae
- event group key
- EG000
- event group label
- Part 1A: PF-06952229 20mg Monotherapy
- serious affected
- 0
- serious at risk
- 1
- other affected
- 1
- other at risk
- 1
- frequency threshold
- 5
- collection period
- Baseline up to 28 days after last dose of study treatment ( up to approximately 2 years)
- event definition
- The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-prostate-neoplasm
- nct id
- NCT03685591
- harm key
- EG001
- source section id
- NCT03685591-ae
- event group key
- EG001
- event group label
- Part 1A: PF-06952229 40mg Monotherapy
- serious affected
- 0
- serious at risk
- 1
- other affected
- 1
- other at risk
- 1
- frequency threshold
- 5
- collection period
- Baseline up to 28 days after last dose of study treatment ( up to approximately 2 years)
- event definition
- The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-prostate-neoplasm
- nct id
- NCT03685591
- harm key
- EG002
- source section id
- NCT03685591-ae
- event group key
- EG002
- event group label
- Part 1A: PF-06952229 80mg Monotherapy
- serious affected
- 0
- serious at risk
- 1
- other affected
- 1
- other at risk
- 1
- frequency threshold
- 5
- collection period
- Baseline up to 28 days after last dose of study treatment ( up to approximately 2 years)
- event definition
- The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-prostate-neoplasm
- nct id
- NCT03685591
- harm key
- EG003
- source section id
- NCT03685591-ae
- event group key
- EG003
- event group label
- Part 1A: PF-06952229 150mg Monotherapy
- serious affected
- 3
- serious at risk
- 5
- other affected
- 4
- other at risk
- 5
- frequency threshold
- 5
- collection period
- Baseline up to 28 days after last dose of study treatment ( up to approximately 2 years)
- event definition
- The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-prostate-neoplasm
- nct id
- NCT03685591
- harm key
- EG004
- source section id
- NCT03685591-ae
- event group key
- EG004
- event group label
- Part 1A: PF-06952229 250mg Monotherapy
- serious affected
- 3
- serious at risk
- 13
- other affected
- 13
- other at risk
- 13
- frequency threshold
- 5
- collection period
- Baseline up to 28 days after last dose of study treatment ( up to approximately 2 years)
- event definition
- The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-prostate-neoplasm
- nct id
- NCT03685591
- harm key
- EG005
- source section id
- NCT03685591-ae
- event group key
- EG005
- event group label
- Part 1A: PF-06952229 375mg Monotherapy
- serious affected
- 5
- serious at risk
- 17
- other affected
- 16
- other at risk
- 17
- frequency threshold
- 5
- collection period
- Baseline up to 28 days after last dose of study treatment ( up to approximately 2 years)
- event definition
- The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-prostate-neoplasm
- nct id
- NCT03685591
- harm key
- EG006
- source section id
- NCT03685591-ae
- event group key
- EG006
- event group label
- Part 1A: PF-06952229 500mg Monotherapy
- serious affected
- 0
- serious at risk
- 4
- other affected
- 4
- other at risk
- 4
- frequency threshold
- 5
- collection period
- Baseline up to 28 days after last dose of study treatment ( up to approximately 2 years)
- event definition
- The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-prostate-neoplasm
- nct id
- NCT03685591
- harm key
- EG007
- source section id
- NCT03685591-ae
- event group key
- EG007
- event group label
- Part 1B: PF-06952229 250mg + Enzalutamide
- serious affected
- 0
- serious at risk
- 4
- other affected
- 4
- other at risk
- 4
- frequency threshold
- 5
- collection period
- Baseline up to 28 days after last dose of study treatment ( up to approximately 2 years)
- event definition
- The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-prostate-neoplasm
- nct id
- NCT03685591
- harm key
- EG008
- source section id
- NCT03685591-ae
- event group key
- EG008
- event group label
- Part 1B: PF-06952229 375mg + Enzalutamide
- serious affected
- 0
- serious at risk
- 3
- other affected
- 3
- other at risk
- 3
- frequency threshold
- 5
- collection period
- Baseline up to 28 days after last dose of study treatment ( up to approximately 2 years)
- event definition
- The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- quality of life
- setting source links
Preserved source evidence · Not medical advice