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See termination reason in detailed description.
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PF-04691502 is an inhibitor of PI3K and mTOR kinase. Published data support the hypothesis that a PI3K/mTOR antagonist in combination with letrozole might mitigate the intrinsic or acquired resistance to hormonal therapy and restore hormone sensitivity in high risk (high Ki-67) patient population of hormone-sensitive breast cancers. In addition, Ki-67, a marker of cellular proliferation, could be used to select those patients who benefit from treatment with a PI3K-pathway inhibitor.
The study was prematurely discontinued on 09Oct2012 due to the tolerability findings in 2 clinical studies testing PF-04691502 that have prompted the Sponsor to re-evaluate the strategic goals of the program. In the study B1271003 an unexpected frequency of severe skin toxicity was observed and in the study B1271004 5 cases of drug induced pneumonitis were reported.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental |
| |
| B | Experimental |
| |
| C | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-04691502 | Drug | PF-04691502 administered as single agent for 2 weeks. After this period, patients in this arm will take PF-04691502 in combination with Letrozole until Week 6. Beyond Week 6, if considered appropriate, patients can be treated with the combination for up to 10 additional weeks until breast surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs): Phase 1B | An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. SAE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study treatment and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. | Phase 1B: Baseline up to 28 days after last administration of study treatment |
| Change From Baseline in Ki-67 Percent Positive Tumor Cells in Biopsied Tumor Tissue at Week 6: Phase 2 | Nuclear proliferation marker Ki-67 was to be assessed by immunohistochemistry technique in all specimens. | Phase 2: Baseline, Week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs): Phase 2 | An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. SAE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study treatment and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Charleroi | 6000 | Belgium | |||
| Pfizer Investigational Site |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Due to premature termination of the study, the planned treatments of Phase 2, PF-04691502, then PF-04691502 + Letrozole (Phase 2), PF-04691502 + Letrozole (Phase 2) and Letrozole (Phase 2), were not administered.
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| ID | Title | Description |
|---|---|---|
| FG000 | PF-04691502 + Letrozole (Phase 1B) | Letrozole 2.5 milligram (mg) tablet orally on Day 1 followed by PF-04691502 8 mg tablet orally once daily from Day 2 until Day 11 and then a combination of PF-04691502 8 mg tablet and letrozole 2.5 mg tablet orally once daily from Day 12 until progression of disease, occurrence of unacceptable toxicity or withdrawal of consent. Dose of PF-04691502 was reduced to 6 mg orally once daily based on preliminary safety analysis conducted in the first 7 participants evaluable for safety. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| PF-04691502 in combination with Letrozole | Drug | PF-04691502 in combination with Letrozole will be administered for 6 weeks. Beyond Week 6, if considered appropriate, patients can be treated for up to 10 additional weeks until breast surgery. |
|
| Letrozole | Drug | Letrozole will be administered for 6 weeks. Beyond Week 6, if considered appropriate, patients can be treated for up to 10 additional weeks until breast surgery. |
|
| Phase 2: Baseline up to 28 days after last administration of study treatment |
| Number of Participants With Clinically Significant Laboratory Tests Abnormalities: Phase 1B and 2 | Laboratory analysis planned to include blood chemistry, hematology and urinalysis. | Phase 1B: Baseline up to end of treatment (Week 34); Phase 2: Baseline up to Week 16 or early termination (ET) |
| Number of Participants With Clinically Significant Abnormalities in Vital Signs: Phase 1B and 2 | Vital signs assessments planned to include measurement of blood pressure and heart rate. | Phase 1B: Baseline up to 28 days after last dose of study treatment (Week 34); Phase 2: Baseline up to Week 16 or ET |
| Number of Participants With Clinically Significant Abnormalities in Corrected QT (QTc) Interval: Phase 1B | Phase 1B: Baseline up to end of treatment (Week 34) |
| Number of Participants With Objective Response (OR): Phase 1B and 2 | Number of participants with objective response based on assessment of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as complete disappearance of all target lesions and non-target lesions, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis less than [<] 10 millimeter [mm]). No appearance of new lesions and normalization of tumor marker levels. PR was defined as greater than or equal to (>=) 30 percent (%) decrease from baseline of the sum of diameters of all target lesions, using the short diameter in the sum for target nodes and the longest diameter in the sum for all other target lesions. | Phase 1B: Baseline, Week 12, end of treatment (Week 34); Phase 2: Baseline, Week 6, 16 or ET |
| Pharmacokinetic (PK) Parameters of PF-04691502 and Letrozole: Phase 1B and 2 | Phase 1B: Following PK parameters were planned to be calculated from the plasma concentration time data using standard non-compartmental methods. For PF-04691502: area under the curve from time zero to last quantifiable concentration (AUClast), area under the curve from time zero to end of dosing interval (AUCtau), maximum observed plasma concentration (Cmax), minimum observed plasma trough concentration (Cmin), average plasma concentration (Cavg), time to reach maximum observed plasma concentration (Tmax), observed accumulation ratio (Rac [obs]); for letrozole: AUClast, Cmax. Phase 2: Following PK parameters were planned to be calculated for PF-04691502 from the plasma concentration time data using standard non-compartmental methods- AUClast, Cmax and Tmax. | Phase 1B: 0 (pre-dose), 1, 2, 4, 6, 24 hours on Day 1 (letrozole alone), Day 2 (PF-0491502 alone), Day 12, Week 5 (PF-0491502 and letrozole in combination); Phase 2: 0 (pre-dose), 1, 2, 4, 6, 24 hours on Day 1, pre-dose on Week 2, 6 |
| Change From Baseline in Pharmacodynamic, Cell Proliferation and Survival Biomarkers in Biopsied Tumor Tissue at Week 2 and 6: Phase 2 | Change from baseline in following pharmacodynamic parameters were planned to be calculated: expression and/or phosphorylation of Phosphoinositide-3-kinase (PI3K) pathway proteins in biopsied tumor tissue and markers of cell cycle and survival. | Phase 2: Baseline, Week 2, 6 |
| Number of Participants With Genetic Alterations: Phase 2 | Following genetic alterations were planned to be analyzed: mutations in Phosphoinositide 3-kinase, catalytic, alpha (PIK3CA), amplification of PIK3CA, Phosphate and tensin homolog (PTEN) deficiency, and changes in other genes or proteins in, or impacting V-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS), Insulin-like Growth Factor 1 Receptor (IGF-1R), phosphatidylinositol 3-kinase (PI3K)/ mammalian target of rapamycin (mTOR) pathway. | Phase 2: Baseline, Week 2, 6 |
| Milan |
| 20132 |
| Italy |
| Pfizer Investigational Site | Barcelona | Barcelona | 08035 | Spain |
| Pfizer Investigational Site | Gothenburg | 413 45 | Sweden |
| Pfizer Investigational Site | Stockholm | 171 76 | Sweden |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | PF-04691502 + Letrozole (Phase 1B) | Letrozole 2.5 milligram (mg) tablet orally on Day 1 followed by PF-04691502 8 mg tablet orally once daily from Day 2 until Day 11 and then a combination of PF-04691502 8 mg tablet and letrozole 2.5 mg tablet orally once daily from Day 12 until progression of disease, occurrence of unacceptable toxicity or withdrawal of consent. Dose of PF-04691502 was reduced to 6 mg orally once daily based on preliminary safety analysis conducted in the first 7 participants evaluable for safety. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs): Phase 1B | An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. SAE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study treatment and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. | Safety analysis set included all enrolled participants who started study treatment. | Posted | Number | participants | Phase 1B: Baseline up to 28 days after last administration of study treatment |
|
|
| |||||||||||||||||||||||||||||||||
| Primary | Change From Baseline in Ki-67 Percent Positive Tumor Cells in Biopsied Tumor Tissue at Week 6: Phase 2 | Nuclear proliferation marker Ki-67 was to be assessed by immunohistochemistry technique in all specimens. | Data was not analyzed due to premature termination of the study. No participant was enrolled in phase 2 of the study. | Posted | Phase 2: Baseline, Week 6 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs): Phase 2 | An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. SAE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study treatment and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. | Data was not analyzed due to premature termination of the study. No participant was enrolled in phase 2 of the study. | Posted | Phase 2: Baseline up to 28 days after last administration of study treatment |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Clinically Significant Laboratory Tests Abnormalities: Phase 1B and 2 | Laboratory analysis planned to include blood chemistry, hematology and urinalysis. | Data was not analyzed due to premature termination of the study. No participant was enrolled in phase 2 of the study. | Posted | Phase 1B: Baseline up to end of treatment (Week 34); Phase 2: Baseline up to Week 16 or early termination (ET) |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Clinically Significant Abnormalities in Vital Signs: Phase 1B and 2 | Vital signs assessments planned to include measurement of blood pressure and heart rate. | Data was not analyzed due to premature termination of the study. No participant was enrolled in phase 2 of the study. | Posted | Phase 1B: Baseline up to 28 days after last dose of study treatment (Week 34); Phase 2: Baseline up to Week 16 or ET |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Clinically Significant Abnormalities in Corrected QT (QTc) Interval: Phase 1B | Data was not analyzed due to premature termination of the study. | Posted | Phase 1B: Baseline up to end of treatment (Week 34) |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Objective Response (OR): Phase 1B and 2 | Number of participants with objective response based on assessment of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as complete disappearance of all target lesions and non-target lesions, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis less than [<] 10 millimeter [mm]). No appearance of new lesions and normalization of tumor marker levels. PR was defined as greater than or equal to (>=) 30 percent (%) decrease from baseline of the sum of diameters of all target lesions, using the short diameter in the sum for target nodes and the longest diameter in the sum for all other target lesions. | Data for phase 1B was reported in individual participant listings but not statistically summarized for analysis due to premature termination of the study. No participant was enrolled in phase 2 of the study. | Posted | Phase 1B: Baseline, Week 12, end of treatment (Week 34); Phase 2: Baseline, Week 6, 16 or ET |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Pharmacokinetic (PK) Parameters of PF-04691502 and Letrozole: Phase 1B and 2 | Phase 1B: Following PK parameters were planned to be calculated from the plasma concentration time data using standard non-compartmental methods. For PF-04691502: area under the curve from time zero to last quantifiable concentration (AUClast), area under the curve from time zero to end of dosing interval (AUCtau), maximum observed plasma concentration (Cmax), minimum observed plasma trough concentration (Cmin), average plasma concentration (Cavg), time to reach maximum observed plasma concentration (Tmax), observed accumulation ratio (Rac [obs]); for letrozole: AUClast, Cmax. Phase 2: Following PK parameters were planned to be calculated for PF-04691502 from the plasma concentration time data using standard non-compartmental methods- AUClast, Cmax and Tmax. | Data for phase 1B was reported in individual participant listings but not statistically summarized for analysis due to premature termination of the study. No participant was enrolled in phase 2 of the study. | Posted | Phase 1B: 0 (pre-dose), 1, 2, 4, 6, 24 hours on Day 1 (letrozole alone), Day 2 (PF-0491502 alone), Day 12, Week 5 (PF-0491502 and letrozole in combination); Phase 2: 0 (pre-dose), 1, 2, 4, 6, 24 hours on Day 1, pre-dose on Week 2, 6 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Pharmacodynamic, Cell Proliferation and Survival Biomarkers in Biopsied Tumor Tissue at Week 2 and 6: Phase 2 | Change from baseline in following pharmacodynamic parameters were planned to be calculated: expression and/or phosphorylation of Phosphoinositide-3-kinase (PI3K) pathway proteins in biopsied tumor tissue and markers of cell cycle and survival. | Data was not analyzed due to premature termination of the study. No participant was enrolled in phase 2 of the study. | Posted | Phase 2: Baseline, Week 2, 6 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Genetic Alterations: Phase 2 | Following genetic alterations were planned to be analyzed: mutations in Phosphoinositide 3-kinase, catalytic, alpha (PIK3CA), amplification of PIK3CA, Phosphate and tensin homolog (PTEN) deficiency, and changes in other genes or proteins in, or impacting V-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS), Insulin-like Growth Factor 1 Receptor (IGF-1R), phosphatidylinositol 3-kinase (PI3K)/ mammalian target of rapamycin (mTOR) pathway. | Data was not analyzed due to premature termination of the study. No participant was enrolled in phase 2 of the study. | Posted | Phase 2: Baseline, Week 2, 6 |
|
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The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
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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 | PF-04691502 + Letrozole (Phase 1B) | Letrozole 2.5 milligram (mg) tablet orally on Day 1 followed by PF-04691502 8 mg tablet orally once daily from Day 2 until Day 11 and then a combination of PF-04691502 8 mg tablet and letrozole 2.5 mg tablet orally once daily from Day 12 until progression of disease, occurrence of unacceptable toxicity or withdrawal of consent. Dose of PF-04691502 was reduced to 6 mg orally once daily based on preliminary safety analysis conducted in the first 7 participants evaluable for safety. | 7 | 14 | 14 | 14 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Rash maculo | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Toxic skin eruption | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Death | General disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Disease progression | General disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Pneumocystis jiroveci pneumonia | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Oral discomfort | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Catheter site related reaction | General disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Early satiety | General disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Blister | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Hair texture abnormal | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Onychoclasis | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Rash papular | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Toxic skin eruption | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Fluid retention | Metabolism and nutrition disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Folate deficiency | Metabolism and nutrition disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Hypermagnesaemia | Metabolism and nutrition disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Vitamin D deficiency | Metabolism and nutrition disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Asymptomatic bacteriuria | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Escherichia urinary tract infection | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Oesophageal candidiasis | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Oral fungal infection | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Blood insulin increased | Investigations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Blood urine present | Investigations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Lymphoedema | Vascular disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Thrombophlebitis | Vascular disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Varicose vein | Vascular disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Polycythaemia | Blood and lymphatic system disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Oliguria | Renal and urinary disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Conjunctivitis | Eye disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
|
Study was prematurely terminated due to PF-04691502 tolerability findings that prompted Sponsor to re-evaluate strategic goals of program. Unexpected frequency of severe skin toxicity was observed and no participant was enrolled in phase 2 of study.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C570662 | 2-amino-8-(4-(2-hydroxyethoxy)cyclohexyl)-6-(6-methoxypyridin-3-yl)-4-methylpyrido(2,3-d)pyrimidin-7(8H)-one |
| D000077289 | Letrozole |
| ID | Term |
|---|---|
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Counts |
|---|
| Participants |
|
| OG002 |
| Letrozole (Phase 2) |
Letrozole 2.5 mg tablet orally once daily up to Week 6 or 16 as per investigator's discretion. |
|
Combination of PF-04691502 6 mg tablet and letrozole 2.5 mg tablet orally once daily up to Week 6 or 16 as per investigator's discretion. |
| OG003 | Letrozole (Phase 2) | Letrozole 2.5 mg tablet orally once daily up to Week 6 or 16 as per investigator's discretion. |
|
Combination of PF-04691502 6 mg tablet and letrozole 2.5 mg tablet orally once daily up to Week 6 or 16 as per investigator's discretion. |
| OG003 | Letrozole (Phase 2) | Letrozole 2.5 mg tablet orally once daily up to Week 6 or 16 as per investigator's discretion. |
|
| OG001 | PF-04691502, Then PF-04691502 + Letrozole (Phase 2) | PF-04691502 6 mg tablet orally once daily up to Week 2 followed by combination of PF-04691502 6 mg tablet and letrozole 2.5 mg tablet orally once daily up to Week 6 or 16 as per investigator's discretion. |
| OG002 | PF-04691502 + Letrozole (Phase 2) | Combination of PF-04691502 6 mg tablet and letrozole 2.5 mg tablet orally once daily up to Week 6 or 16 as per investigator's discretion. |
| OG003 | Letrozole (Phase 2) | Letrozole 2.5 mg tablet orally once daily up to Week 6 or 16 as per investigator's discretion. |
|
| OG001 | PF-04691502, Then PF-04691502 + Letrozole (Phase 2) | PF-04691502 6 mg tablet orally once daily up to Week 2 followed by combination of PF-04691502 6 mg tablet and letrozole 2.5 mg tablet orally once daily up to Week 6 or 16 as per investigator's discretion. |
| OG002 | PF-04691502 + Letrozole (Phase 2) | Combination of PF-04691502 6 mg tablet and letrozole 2.5 mg tablet orally once daily up to Week 6 or 16 as per investigator's discretion. |
| OG003 | Letrozole (Phase 2) | Letrozole 2.5 mg tablet orally once daily up to Week 6 or 16 as per investigator's discretion. |
|
| Units | Counts |
|---|---|
| Participants |
|
|