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See termination reason in detailed description.
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This is the first study using PF-03758309, an oral compound, in patients with advanced solid tumors. In this study different doses of PF-03758309 will be administered to different groups of patients. The study will assess the compound's safety, the blood levels of PF-03758309 during the treatment and the effect of the compound on the tumor cells.
The study was prematurely terminated on 26Jul2011 due to the undesirable PK characteristics of PF-03758309 and the lack of an observed dose-response relationship. There were no safety concerns that contributed to the study termination.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-03758309 | Drug | Oral PF-03758309 will be administered in capsules (once or twice daily) until toxicity, progressive disease, or patient refusal to continue on therapy. The starting dose is 1 mg once daily. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Cycle 1 Dose-limiting Toxicities (DLT) | DLT includes: Grade (GR) 4 neutropenia (NP) that persisted for >7 consecutive days; Febrile NP; GR3 NP infection; GR4 thrombocytopenia (TP); GR3 TP with bleeding; Any other GR>=3 toxicity not classified under Common Terminology Criteria for Adverse Events (CTCAE) blood or bone marrow (exception of nausea, vomiting, or diarrhea in subjects who received optimal treatment with antiemetics or anti-diarrheals); Failure to recover to an adequate condition to recommence study treatment after a 2-week delay; Failure to receive >= 80% of planned PF-03758309 dose due to study drug related toxicity | Baseline (up to 30 days prior to first study drug administration) till 28 days after the last treatment administration (end of Cycle 1 [28 days]) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Objective Response | Number of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST. Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as ≥30% decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat imaging study ≥4 weeks after initial documentation of response. |
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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 | Santa Monica | California | 90404 | United States | ||
| Pfizer Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34253597 | Derived | Mpilla GB, Uddin MH, Al-Hallak MN, Aboukameel A, Li Y, Kim SH, Beydoun R, Dyson G, Baloglu E, Senapedis WT, Landesman Y, Wagner KU, Viola NT, El-Rayes BF, Philip PA, Mohammad RM, Azmi AS. PAK4-NAMPT Dual Inhibition Sensitizes Pancreatic Neuroendocrine Tumors to Everolimus. Mol Cancer Ther. 2021 Oct;20(10):1836-1845. doi: 10.1158/1535-7163.MCT-20-1105. Epub 2021 Jul 12. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | PF-03758309, 1 Milligram (mg) Once Daily (QD) | PF-03758309 1 mg administered orally once daily |
| FG001 | PF-03758309, 1 mg Twice Daily (BID) | PF-03758309 1 mg administered orally twice daily |
| FG002 | PF-03758309, 2 mg BID | PF-03758309 2 mg administered orally twice daily |
| FG003 | PF-03758309, 10 mg BID | PF-03758309 10 mg administered orally twice daily |
| FG004 | PF-03758309, 20 mg BID | PF-03758309 20 mg administered orally twice daily |
| FG005 | PF-03758309, 40 mg BID | PF-03758309 40 mg administered orally twice daily |
| FG006 | PF-03758309, 50 mg BID | PF-03758309 50 mg administered orally twice daily |
| FG007 | PF-03758309, 60 mg BID | PF-03758309 60 mg administered orally twice dailly |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | PF-03758309 | Participants who received: 1 mg QD, 1 mg BID, 2 mg BID, 10 mg BID, 20 mg BID, 40 mg BID, 50 mg BID and 60 mg BID |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 Cycle 1 Dose-limiting Toxicities (DLT) | DLT includes: Grade (GR) 4 neutropenia (NP) that persisted for >7 consecutive days; Febrile NP; GR3 NP infection; GR4 thrombocytopenia (TP); GR3 TP with bleeding; Any other GR>=3 toxicity not classified under Common Terminology Criteria for Adverse Events (CTCAE) blood or bone marrow (exception of nausea, vomiting, or diarrhea in subjects who received optimal treatment with antiemetics or anti-diarrheals); Failure to recover to an adequate condition to recommence study treatment after a 2-week delay; Failure to receive >= 80% of planned PF-03758309 dose due to study drug related toxicity | Safety analysis set: All participants enrolled in the study that received at least 1 dose of PF-03758309 (including the lead in dose). | Posted | Number | participants | Baseline (up to 30 days prior to first study drug administration) till 28 days after the last treatment administration (end of Cycle 1 [28 days]) |
|
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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-03758309, 1 mg QD | PF-03758309, 1 mg administered orally once daily |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Asthenia | General disorders | MedDRA 14.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 14.1 | Non-systematic Assessment |
The study was closed due to pharmacokinetic (PK) issues observed from initial PK data. Individual plasma concentration versus time were listed but final PK analysis and pharmacodynamic analyses were not conducted.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| Baseline until the date of first documented progression or discontinuation from the study due to any cause, assessed every 2 months until when the last participant was discontinued due to disease progression in Month 27 of the study |
| Time to Tumor Progression (TTP) | Time in weeks from start of study treatment to first documentation of objective tumor progression or death due to cancer, whichever comes first. TTP was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]) | Baseline until the date of first documented progression or discontinuation from the study due to any cause, assessed every 2 months until when the last participant was discontinued due to disease progression in Month 27 of the study |
| Duration of Response | Time in weeks from the first documentation of objective tumor response to objective tumor progression or death due to any cancer. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 7. DR was calculated for the subgroup of participants with a confirmed objective tumor response. | Baseline until the date of first documented progression or discontinuation from the study due to any cause, assessed every 2 months until when the last participant was discontinued due to disease progression in Month 27 of the study |
| Maximum Observed Plasma Concentration (Cmax) | predose, 0.5, 1, 2, 3, 5, 8, 10, 24 and 48 hours post dose, on Cycle 1 Day 8 and Cycle 2-4 Day 1 at pre-dose and 2 hours post morning dose, and on Cycle 1 Day 15 at predose, 0.5, 1, 2, 3, 5, 8 and 10 hours post morning dose |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) | predose, 0.5, 1, 2, 3, 5, 8, 10, 24 and 48 hours post dose, on Cycle 1 Day 8 and Cycle 2-4 Day 1 at pre-dose and 2 hours post morning dose, and on Cycle 1 Day 15 at predose, 0.5, 1, 2, 3, 5, 8 and 10 hours post morning dose |
| Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) | Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) | predose, 0.5, 1, 2, 3, 5, 8, 10, 24 and 48 hours post dose, on Cycle 1 Day 8 and Cycle 2-4 Day 1 at pre-dose and 2 hours post morning dose, and on Cycle 1 Day 15 at predose, 0.5, 1, 2, 3, 5, 8 and 10 hours post morning dose |
| Area Under the Concentration-Time Curve From Time 0 to 12 Hours Post Morning Dose [AUC(0-12)] | pre-dose and 12 hours post morning dose |
| Minimum Observed Plasma Trough Concentration (Cmin) | predose, 0.5, 1, 2, 3, 5, 8, 10, 24 and 48 hours post dose, and on Cycle 1 Day 15 at predose, 0.5, 1, 2, 3, 5, 8 and 10 hours post morning dose |
| Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) | predose, 0.5, 1, 2, 3, 5, 8, 10, 24 and 48 hours post dose, and on Cycle 1 Day 15 at predose, 0.5, 1, 2, 3, 5, 8 and 10 hours post morning dose |
| PAK (p21 Activated Kinase)-Related Pathway Molecule Expression Modulation by PF-03758309 in Tumor and Surrogate Tissue | Screening, 0, 2, 4, and 72 hours post dose Cycle 2 Day 8. A 6th sample of hair follicle could be requested at 6 or 8 hours post-dose if necessary. For fresh tumor tissue, baseline and between Day 8 and 22 of Cycle 1 in participants with accessible tumors |
| Baseline Tumor Expression of PAK-related Pathway Molecules and Other Known Biomarkers | Baseline |
| Aurora |
| Colorado |
| 80045 |
| United States |
| Pfizer Investigational Site | East Melbourne | Victoria | 3002 | Australia |
| Protocol Violation |
|
| Withdrawal by Subject |
|
| Objective progression or relapse |
|
| Other |
|
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
PF-03758309 1 mg administered orally once daily |
| OG001 | PF-03758309, 1 mg BID | PF-03758309 1 mg administered orally twice daily |
| OG002 | PF-03758309, 2 mg BID | PF-03758309 2 mg administered orally twice daily |
| OG003 | PF-03758309, 10 mg BID | PF-03758309 10 mg administered orally twice daily |
| OG004 | PF-03758309, 20 mg BID | PF-03758309 20 mg administered orally twice daily |
| OG005 | PF-03758309, 40 mg BID | PF-03758309 40 mg administered orally twice daily |
| OG006 | PF-03758309, 50 mg BID | PF-03758309 50 mg administered orally twice daily |
| OG007 | PF-03758309, 60 mg BID | PF-03758309 60 mg administered orally twice daily |
|
|
| Secondary | Number of Participants With Objective Response | Number of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST. Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as ≥30% decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat imaging study ≥4 weeks after initial documentation of response. | Per protocol analysis set: all participants who have received a minimum of 1 cycle of study treatment (at least 80% of planned dose), had baseline assessments and at least 1 on-study tumor assessment were considered evaluable for response. | Posted | Number | participants | Baseline until the date of first documented progression or discontinuation from the study due to any cause, assessed every 2 months until when the last participant was discontinued due to disease progression in Month 27 of the study |
|
|
|
| Secondary | Time to Tumor Progression (TTP) | Time in weeks from start of study treatment to first documentation of objective tumor progression or death due to cancer, whichever comes first. TTP was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]) | Data not analyzed due to early termination of the study. | Posted | Baseline until the date of first documented progression or discontinuation from the study due to any cause, assessed every 2 months until when the last participant was discontinued due to disease progression in Month 27 of the study |
|
|
| Secondary | Duration of Response | Time in weeks from the first documentation of objective tumor response to objective tumor progression or death due to any cancer. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 7. DR was calculated for the subgroup of participants with a confirmed objective tumor response. | Data not analyzed due to early termination of the study. | Posted | Baseline until the date of first documented progression or discontinuation from the study due to any cause, assessed every 2 months until when the last participant was discontinued due to disease progression in Month 27 of the study |
|
|
| Secondary | Maximum Observed Plasma Concentration (Cmax) | Data not analyzed due to early termination of the study. | Posted | predose, 0.5, 1, 2, 3, 5, 8, 10, 24 and 48 hours post dose, on Cycle 1 Day 8 and Cycle 2-4 Day 1 at pre-dose and 2 hours post morning dose, and on Cycle 1 Day 15 at predose, 0.5, 1, 2, 3, 5, 8 and 10 hours post morning dose |
|
|
| Secondary | Time to Reach Maximum Observed Plasma Concentration (Tmax) | Data not analyzed due to early termination of the study. | Posted | predose, 0.5, 1, 2, 3, 5, 8, 10, 24 and 48 hours post dose, on Cycle 1 Day 8 and Cycle 2-4 Day 1 at pre-dose and 2 hours post morning dose, and on Cycle 1 Day 15 at predose, 0.5, 1, 2, 3, 5, 8 and 10 hours post morning dose |
|
|
| Secondary | Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) | Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) | Data not analyzed due to early termination of the study. | Posted | predose, 0.5, 1, 2, 3, 5, 8, 10, 24 and 48 hours post dose, on Cycle 1 Day 8 and Cycle 2-4 Day 1 at pre-dose and 2 hours post morning dose, and on Cycle 1 Day 15 at predose, 0.5, 1, 2, 3, 5, 8 and 10 hours post morning dose |
|
|
| Secondary | Area Under the Concentration-Time Curve From Time 0 to 12 Hours Post Morning Dose [AUC(0-12)] | Data not analyzed due to early termination of the study. | Posted | pre-dose and 12 hours post morning dose |
|
|
| Secondary | Minimum Observed Plasma Trough Concentration (Cmin) | Data not analyzed due to early termination of the study. | Posted | predose, 0.5, 1, 2, 3, 5, 8, 10, 24 and 48 hours post dose, and on Cycle 1 Day 15 at predose, 0.5, 1, 2, 3, 5, 8 and 10 hours post morning dose |
|
|
| Secondary | Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) | Data not analyzed due to early termination of the study. | Posted | predose, 0.5, 1, 2, 3, 5, 8, 10, 24 and 48 hours post dose, and on Cycle 1 Day 15 at predose, 0.5, 1, 2, 3, 5, 8 and 10 hours post morning dose |
|
|
| Secondary | PAK (p21 Activated Kinase)-Related Pathway Molecule Expression Modulation by PF-03758309 in Tumor and Surrogate Tissue | Data not analyzed due to early study termination. | Posted | Screening, 0, 2, 4, and 72 hours post dose Cycle 2 Day 8. A 6th sample of hair follicle could be requested at 6 or 8 hours post-dose if necessary. For fresh tumor tissue, baseline and between Day 8 and 22 of Cycle 1 in participants with accessible tumors |
|
|
| Secondary | Baseline Tumor Expression of PAK-related Pathway Molecules and Other Known Biomarkers | Data not analyzed due to early study termination. | Posted | Baseline |
|
|
| 0 |
| 3 |
| 3 |
| 3 |
| EG001 | PF-03758309, 1 mg BID | PF-03758309 1 mg administered orally twice daily | 0 | 3 | 3 | 3 |
| EG002 | PF-03758309, 2 mg BID | PF-03758309 2 mg administered orally twice daily | 0 | 3 | 3 | 3 |
| EG003 | PF-03758309, 10 mg BID | PF-03758309 10 mg administered orally twice daily | 0 | 3 | 3 | 3 |
| EG004 | PF-03758309, 20 mg BID | PF-03758309 20 mg administered orally twice daily | 1 | 5 | 5 | 5 |
| EG005 | PF-03758309, 40 mg BID | PF-03758309 40 mg administered orally twice daily | 0 | 3 | 3 | 3 |
| EG006 | PF-03758309, 50 mg BID | PF-03758309 50 mg administered orally twice daily | 1 | 5 | 5 | 5 |
| EG007 | PF-03758309, 60 mg BID | PF-03758309 60 mg administered orally twice daily | 2 | 10 | 10 | 10 |
| Abdominal Pain | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Disease Progression | General disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Anorectal discomfort | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Colitis | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Defaecation urgency0 | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Frequent bowel movements | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Gastroesophageal reflux disease | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Haematochezia | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Proctalgia | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Retching | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Catheter site pain | General disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Chest pain | General disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Chills | General disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Early satiety | General disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Mucosal inflammation | General disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Pain | General disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Temperature intolerance | General disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Seasonal allergy | Immune system disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Candidiasis | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
|
| Localised infection | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
|
| Oral candidiasis | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
|
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 14.1 | Non-systematic Assessment |
|
| Wound | Injury, poisoning and procedural complications | MedDRA 14.1 | Non-systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA 14.1 | Non-systematic Assessment |
|
| Breath sounds abnormal | Investigations | MedDRA 14.1 | Non-systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 14.1 | Non-systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Iron deficiency | Metabolism and nutrition disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Vitamin B12 deficiency | Metabolism and nutrition disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Vitamin D deficiency | Metabolism and nutrition disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Arthalgia | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Post herpetic neuralgia | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Sinus headache | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Mental status changes | Psychiatric disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Mood altered | Psychiatric disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Urinary hesitation | Renal and urinary disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Amenorrhoea | Reproductive system and breast disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Perineal pain | Reproductive system and breast disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Rales | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Throat tightness | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Dermal cyst | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Skin irritation | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Flushing | Vascular disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Haemorrhage | Vascular disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 14.1 | Non-systematic Assessment |
|
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.
| confirmed partial response (PR) |
|