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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-002286-30 | EudraCT Number |
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The study was terminated on June 24th, 2015 due to change in strategy of PF-03084014 development. There were no safety/efficacy concerns behind the decision.
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This study is designed to evaluate the preliminary anti-tumor activity and tolerability of PF-03084014 when administered as a single agent in the treatment of patients with advanced triple receptor-negative breast cancer (mTNBC) harboring genomic alterations in Notch receptors (NA+), and in a smaller subset of mTNBC patients whose tumor tests negative for genomic alterations in Notch receptors (NA-)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PF-03084014 | Experimental | PF-03084014 will be administered orally, continuously, twice daily at 150 mg, but the dose can be reduced to 100 mg or 80 mg. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-03084014 | Drug | Tablet, 10 mg, twice a day. |
| |
| PF-03084014 |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response (OR) Rate in Participants With Advanced Triple Receptor-Negative Breast Cancer (mTNBC) Harboring Activating Genomic Alterations in Notch Receptors (NA+) | OR status based on assessment of confirmed complete remission (CR) or confirmed partial remission (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1). CR: Complete disappearance of all target lesions with the exception of nodal disease and all target nodes decreased to normal size (short axis less than [<]10 millimeter [mm]). PR: Greater than or equal to (>=)30% decrease under baseline of the sum of diameters of all target measurable lesions. OR=CR+PR. | Cycle 3 Day 1, Cycle 5 Day 1, and every 6 weeks for subsequent cycles ntil disease progression, patient refusal for further follow up, or start of another anti-cancer treatment, whichever occurred first. |
| Measure | Description | Time Frame |
|---|---|---|
| OR Rate in Participants With mTNBC Whose Tumors Tested Negative for Eenomic Alterations in Notch Receptor (NA-) | OR status based on assessment of confirmed CR or confirmed PR according to RECIST 1.1. CR: Complete disappearance of all target lesions with the exception of nodal disease and all target nodes decreased to normal size (short axis <10 mm). PR: >=30% decrease under baseline of the sum of diameters of all target measurable lesions. OR=CR+PR. |
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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 |
|---|---|---|---|---|---|---|
| Stanford Cancer Institute | Stanford | California | 94305 | United States | ||
| Stanford Hospital and Clinics |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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| ID | Title | Description |
|---|---|---|
| FG000 | PF-03084014 | PF-03084014 at the starting dose of 150 mg twice daily (BID) (in the form of one 100-mg and one 50-mg tablet) was administered orally BID continuously in 21-day cycles until disease progression, patient refusal of further treatment, or unacceptable toxicity, whichever occurred first. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
Tablet, 50 mg, twice a day |
|
| PF-03084014 | Drug | Tablet, 100 mg, twice a day |
|
| Cycle 3 Day 1, Cycle 5 Day 1, and every 6 weeks for subsequent cycles ntil disease progression, patient refusal for further follow up, or start of another anti-cancer treatment, whichever occurred first. |
| Progression-Free Survival (PFS) in Participants With NA+ or NA mTNBC | The period from study entry until disease progression, death, whichever occurred first as per RECIST version 1.1. | 2 years |
| Duration of Response (DR) in Participants With NA+ or NA mTNBC | Time from the first documentation of objective tumor response to objective tumor progression or death due to any cause. DR was calculated for the subgroup of patients with a confirmed objective tumor response. Objective Progression (PD): 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy), with a minimum absolute increase of 5 mm. | 2 years |
| One-Year Survival Probability in Participants With NA+ or NA mTNBC | Overall survival (OS) status (alive or not) at 1 year after study entry. The the survival probability at 1 year was summarized as a product limit estimator based on the Kaplan-Meier method to account for censored events. | 1 year |
| Overall Survival (OS) in Participants With NA+ or NA mTNBC | OS was the duration from enrollment to death. For participants who are alive, overall survival was censored at the last contact. | 2 years |
| Type of Notch Genomic Alterations in Participants With NA+ mTNBC | Type of notch genomic alterations identified by NGS assay in patients with NA+ mTNBC | 2 years |
| Pre-dose Serum Concentration (Ctrough) for PF-03084014 | Day 1 of Cycle 1, 2, 3, and 5 |
| Pharmacodynamic (PD) Effects of PF-03084014 in Tumor Specimens and Peripheral Blood | Original diagnostic tumor tissue or the most recent metastatic tumor (archival or de novo biopsy), plasma, and peripheral blood samples were collected for biomarker assessments of circulating analytes, immunohistochemistry for notch receptors expression, expression of notch pathway components and modulators, mutational analysis of pathway and disease associated genes. | Day 1 of Cycle 1, 2, 3, and 5 |
| Alterations in Genes, Proteins, and RNAs Relevant to the Notch Signaling Pathway, to TNBC Biology, and to Sensitivity/Resistance to PF-03084014 in Tumor Specimens and Peripheral Blood. | Original diagnostic tumor tissue or the most recent metastatic tumor (archival or de novo biopsy), plasma, and peripheral blood samples were collected for biomarker assessments of circulating analytes, immunohistochemistry for notch receptors expression, expression of notch pathway components and modulators, mutational analysis of pathway and disease associated genes. | Day 1 of Cycle 1, 2, 3, and 5 |
| Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | An AE was any untoward medical occurrence without regard to causality in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs were defined as all deaths, regardless of cause, from treatment start until 28 days after the last dose and non-fatal events occurring after treatment start regardless of cause, up until 28 days after the last dose or until start of new anti-cancer treatment, whichever was first. | 2 years |
| Number of Participants With Treatment-Emergent AEs by CTCAE Grade | An AE was any untoward medical occurrence without regard to causality in a participant who received study drug. AEs were defined according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. | 2 years |
| Number of Participants With Laboratory Test (Hematology) Abnormalities | Number of participants with CTCAE version 4.03 grade 1 to 4 hematological test abnormalities. | Day 1 of Cycles 1, 2, 3, 4, 5, and subsequent cycles. |
| Number of Participants With Laboratory Test (Chemistry) Abnormalities | Number of participants with CTCAE version 4.03 grade 1 to 4 chemistry test abnormalities | Day 1 and Day 15 of Cycles 1, 2, 3, 4, 5, and subsequent cycles up to Cycle 8 and Day 8 of Cycle 1 |
| Number of Participants With Laboratory Test (Urinalysis) Abnormalities | Number of participants with CTCAE version 4.03 grade 1 to 4 urinalysis test abnormalities for urine protein. | Day 1 of Cycle 1 |
| Number of Notch Genomic Alterations in Participants With NA+ mTNBC | Number of notch genomic alterations identified by NGS assay in patients with NA+ mTNBC | 2 years |
| Stanford |
| California |
| 94305 |
| United States |
| Stanford Women's Cancer Center | Stanford | California | 94305 | United States |
| The University of Chicago Medical Center | Chicago | Illinois | 60637 | United States |
| University of Chicago Medical Center | Chicago | Illinois | 60637 | United States |
| University of Chicago Comprehensive Cancer Center at Silver Cross Hospital | New Lenox | Illinois | 60451 | United States |
| Midwestern Regional Medical Center | Zion | Illinois | 60099 | United States |
| Brigham and Women's Hospital (BWH) | Boston | Massachusetts | 02115 | United States |
| Dana-Farber Cancer Institute (DFCI) | Boston | Massachusetts | 02215 | United States |
| Memorial Sloan Kettering Cancer Center Basking Ridge | Basking Ridge | New Jersey | 07920 | United States |
| The Valley Hospital - Luckow Pavilion | Paramus | New Jersey | 07652 | United States |
| Valley Medical Group | Paramus | New Jersey | 07652 | United States |
| Valley Medical Group | Westwood | New Jersey | 07675 | United States |
| Memorial Sloan Kettering Cancer Center Commack | Commack | New York | 11725 | United States |
| Memorial Sloan Kettering Cancer Center West Harrison | Harrison | New York | 10604 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| Memorial Sloan Kettering Cancer Center Rockville Centre | Rockville Centre | New York | 11570 | United States |
| Memorial Sloan Kettering Cancer Center Sleepy Hollow | Sleepy Hollow | New York | 10591 | United States |
| Debreceni Egyetem, Klinikai Kozpont, Onkologiai Intezet | Debrecen | 4032 | Hungary |
| Presidio Ospedaliero Vito Fazzi | Lecce | 73100 | Italy |
| Istitutio Europeo di Oncologia | Milan | 20141 | Italy |
| Vesalius | Krakow | 31108 | Poland |
| Vesalius Poradnia Onkologiczna i Hematologiczna | Krakow | 31216 | Poland |
| Szpital Kliniczny Przemienienia Panskiego, Uniwersutetu Medycznego im. Karola Marcinkowskiego | Poznan | 60-569 | Poland |
| Complejo Hospitalario Universitario A Coruna (Hospital Teresa Herrera) | A Coruña | 15006 | Spain |
| Hospital Universitari Vall d'Hebron | Barcelona | 08035 | Spain |
| Hospital Clinic de Barcelona | Barcelona | 08036 | Spain |
| Hospital de la Santa Creu i Sant Pau | Barcelona | 08041 | Spain |
| Instituto Catalan de Oncologia de L'Hospitalet de Llobregat (ICO) | Barcelona | 08908 | Spain |
| Hospital General Universitario Gregorio Maranon | Madrid | 28007 | Spain |
| Hospital Universitario 12 de Octubre | Madrid | 28041 | Spain |
| Hospital Universitario Virgen del Rocio | Seville | 41013 | Spain |
| Hospital ClÃnico Universitario de Valencia | Valencia | 46010 | Spain |
| Beatson West of Scotland Cancer Centre | Glasgow | Scotland | G12 0YN | United Kingdom |
| Ross Hall Hospital | Glasgow | Scotland | G52 3NQ | United Kingdom |
| The Royal Marsden NHS Foundation Trust | London | SW3 6JJ | United Kingdom |
| The Royal Marsden NHS Foundation Trust | Surrey | SM2 5PT | United Kingdom |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | PF-03084014 | PF-03084014 at the starting dose of 150 mg twice daily (BID) (in the form of one 100-mg and one 50-mg tablet) was administered orally BID continuously in 21-day cycles until disease progression, patient refusal of further treatment, or unacceptable toxicity, whichever occurred first. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | 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 | Objective Response (OR) Rate in Participants With Advanced Triple Receptor-Negative Breast Cancer (mTNBC) Harboring Activating Genomic Alterations in Notch Receptors (NA+) | OR status based on assessment of confirmed complete remission (CR) or confirmed partial remission (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1). CR: Complete disappearance of all target lesions with the exception of nodal disease and all target nodes decreased to normal size (short axis less than [<]10 millimeter [mm]). PR: Greater than or equal to (>=)30% decrease under baseline of the sum of diameters of all target measurable lesions. OR=CR+PR. | Data for this outcome measure was not collected due to early termination of this study. | Posted | Cycle 3 Day 1, Cycle 5 Day 1, and every 6 weeks for subsequent cycles ntil disease progression, patient refusal for further follow up, or start of another anti-cancer treatment, whichever occurred first. |
|
| |||||||||||||||||||
| Secondary | OR Rate in Participants With mTNBC Whose Tumors Tested Negative for Eenomic Alterations in Notch Receptor (NA-) | OR status based on assessment of confirmed CR or confirmed PR according to RECIST 1.1. CR: Complete disappearance of all target lesions with the exception of nodal disease and all target nodes decreased to normal size (short axis <10 mm). PR: >=30% decrease under baseline of the sum of diameters of all target measurable lesions. OR=CR+PR. | Data for this outcome measure was not collected due to early termination of this study. | Posted | Cycle 3 Day 1, Cycle 5 Day 1, and every 6 weeks for subsequent cycles ntil disease progression, patient refusal for further follow up, or start of another anti-cancer treatment, whichever occurred first. |
|
| |||||||||||||||||||
| Secondary | Progression-Free Survival (PFS) in Participants With NA+ or NA mTNBC | The period from study entry until disease progression, death, whichever occurred first as per RECIST version 1.1. | Data for this outcome measure was not collected due to early termination of this study. | Posted | 2 years |
|
| |||||||||||||||||||
| Secondary | Duration of Response (DR) in Participants With NA+ or NA mTNBC | Time from the first documentation of objective tumor response to objective tumor progression or death due to any cause. DR was calculated for the subgroup of patients with a confirmed objective tumor response. Objective Progression (PD): 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy), with a minimum absolute increase of 5 mm. | Data for this outcome measure was not collected due to early termination of this study. | Posted | 2 years |
|
| |||||||||||||||||||
| Secondary | One-Year Survival Probability in Participants With NA+ or NA mTNBC | Overall survival (OS) status (alive or not) at 1 year after study entry. The the survival probability at 1 year was summarized as a product limit estimator based on the Kaplan-Meier method to account for censored events. | Data for this outcome measure was not collected due to early termination of this study. | Posted | 1 year |
|
| |||||||||||||||||||
| Secondary | Overall Survival (OS) in Participants With NA+ or NA mTNBC | OS was the duration from enrollment to death. For participants who are alive, overall survival was censored at the last contact. | Data for this outcome measure was not collected due to early termination of this study. | Posted | 2 years |
|
| |||||||||||||||||||
| Secondary | Type of Notch Genomic Alterations in Participants With NA+ mTNBC | Type of notch genomic alterations identified by NGS assay in patients with NA+ mTNBC | Data for this outcome measure was not collected due to early termination of this study. | Posted | 2 years |
|
| |||||||||||||||||||
| Secondary | Pre-dose Serum Concentration (Ctrough) for PF-03084014 | Due to study termination, no PK analyses were performed for this study. | Posted | Day 1 of Cycle 1, 2, 3, and 5 |
|
| ||||||||||||||||||||
| Secondary | Pharmacodynamic (PD) Effects of PF-03084014 in Tumor Specimens and Peripheral Blood | Original diagnostic tumor tissue or the most recent metastatic tumor (archival or de novo biopsy), plasma, and peripheral blood samples were collected for biomarker assessments of circulating analytes, immunohistochemistry for notch receptors expression, expression of notch pathway components and modulators, mutational analysis of pathway and disease associated genes. | Due to study termination, no PD analyses were performed for this study. | Posted | Day 1 of Cycle 1, 2, 3, and 5 |
|
| |||||||||||||||||||
| Secondary | Alterations in Genes, Proteins, and RNAs Relevant to the Notch Signaling Pathway, to TNBC Biology, and to Sensitivity/Resistance to PF-03084014 in Tumor Specimens and Peripheral Blood. | Original diagnostic tumor tissue or the most recent metastatic tumor (archival or de novo biopsy), plasma, and peripheral blood samples were collected for biomarker assessments of circulating analytes, immunohistochemistry for notch receptors expression, expression of notch pathway components and modulators, mutational analysis of pathway and disease associated genes. | Due to study termination, no PD analyses were performed for this study. | Posted | Day 1 of Cycle 1, 2, 3, and 5 |
|
| |||||||||||||||||||
| Secondary | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | An AE was any untoward medical occurrence without regard to causality in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs were defined as all deaths, regardless of cause, from treatment start until 28 days after the last dose and non-fatal events occurring after treatment start regardless of cause, up until 28 days after the last dose or until start of new anti-cancer treatment, whichever was first. | The safety analysis set included all enrolled participants who received at least one dose of study medication. | Posted | Number | participants | 2 years |
|
| |||||||||||||||||
| Secondary | Number of Participants With Treatment-Emergent AEs by CTCAE Grade | An AE was any untoward medical occurrence without regard to causality in a participant who received study drug. AEs were defined according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. | The safety analysis set included all enrolled participants who received at least one dose of study medication. | Posted | Number | participants | 2 years |
|
| |||||||||||||||||
| Secondary | Number of Participants With Laboratory Test (Hematology) Abnormalities | Number of participants with CTCAE version 4.03 grade 1 to 4 hematological test abnormalities. | The safety analysis set included all enrolled participants who received at least one dose of study medication. | Posted | Number | participants | Day 1 of Cycles 1, 2, 3, 4, 5, and subsequent cycles. |
|
| |||||||||||||||||
| Secondary | Number of Participants With Laboratory Test (Chemistry) Abnormalities | Number of participants with CTCAE version 4.03 grade 1 to 4 chemistry test abnormalities | The safety analysis set included all enrolled participants who received at least one dose of study medication. | Posted | Number | participants | Day 1 and Day 15 of Cycles 1, 2, 3, 4, 5, and subsequent cycles up to Cycle 8 and Day 8 of Cycle 1 |
|
| |||||||||||||||||
| Secondary | Number of Participants With Laboratory Test (Urinalysis) Abnormalities | Number of participants with CTCAE version 4.03 grade 1 to 4 urinalysis test abnormalities for urine protein. | The safety analysis set included all enrolled participants who received at least one dose of study medication. | Posted | Number | participants | Day 1 of Cycle 1 |
|
| |||||||||||||||||
| Secondary | Number of Notch Genomic Alterations in Participants With NA+ mTNBC | Number of notch genomic alterations identified by NGS assay in patients with NA+ mTNBC | Data for this outcome measure was not collected due to early termination of this study. | Posted | 2 years |
|
|
2 years
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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-03084014 | PF-03084014 at the starting dose of 150 mg twice daily (BID) (in the form of one 100-mg and one 50-mg tablet) was administered orally BID continuously in 21-day cycles until disease progression, patient refusal of further treatment, or unacceptable toxicity, whichever occurred first. | 6 | 19 | 18 | 19 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Disease progression | General disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Non-systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Eye discharge | Eye disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Photopsia | Eye disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Vitreous floaters | Eye disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Blood chloride decreased | Investigations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Carbon dioxide increased | Investigations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Glomerular filtration rate decreased | Investigations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Protein total increased | Investigations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Hypouricaemia | Metabolism and nutrition disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Tumour exudation | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Non-systematic Assessment |
| |
| Tumour haemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Non-systematic Assessment |
| |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Non-systematic Assessment |
| |
| Balance disorder | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Peripheral motor neuropathy | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Nail dystrophy | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Rash macular | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
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This study was terminated prematurely based on project re-prioritization by the Sponsor and was not due to any safety concerns or regulatory actions.
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 |
|---|---|
| D064726 | Triple Negative Breast Neoplasms |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C550722 | nirogacestat |
Not provided
Not provided
Not provided
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