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See termination reason in detailed description.
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PF-04217903 may work in cancer by blocking the cell growth, migration and invasion of tumor cells. PF-04217903 is a new member in a class of drugs called c-Met/hepatocyte growth factor receptor tyrosine kinase inhibitors. This research study is the first time PF-04217903 will be given to patients. PF-04217903 is taken by mouth daily.
The study was prematurely discontinued due to a strategic development decision by Pfizer on 10FEB2012. The decision to terminate was not based on any safety concerns.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-04217903 | Drug | Escalating doses of PF-04217903 will be administered orally on a continuous dosing schedule. Doses to be evaluated will range from 50 mg BID to 1000 mg BID. A cycle is considered to be 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Tolerated Dose (MTD) | MTD: dose level at which 1 of 6 participants experienced dose-limiting toxicity (DLT) after 21 days of treatment (Cycle 1). DLT: grade (Gr) 2 elevated creatinine, acute renal failure, Gr 3 thrombocytopenia with bleeding, hypertension (if unmanageable),Gr >=3 non-hematological non-disease-related (NDR) toxicities (except alopecia,Gr 3/4 hypophosphatemia, hyperuricemia), Gr 3/4 nausea, vomiting, diarrhea, Gr 4 neutropenia, thrombocytopenia lasting for >=7 days, febrile neutropenia, neutropenic infection, inability to deliver 80 percent of planned dose during Cycle 1 due to NDR toxicities. | Baseline up to 21 days after the start of each increased treatment dose |
| Recommended Phase 2 Dose (RP2D) | Baseline up to 21 days after the start of each increased treatment dose | |
| Number of Participants With Dose-Limiting Toxicities (DLTs) | DLT includes Gr 2 elevated creatinine and acute renal failure, Gr 3 thrombocytopenia with bleeding, hypertension (if unmanageable), Gr >= 3 non-hematological non-disease-related (NDR) toxicities (except alopecia, Gr 3/4 hypophosphatemia, hyperuricemia), Gr 3/4 nausea, vomiting, diarrhea, Gr 4 neutropenia, thrombocytopenia lasting for >= 7 days, febrile neutropenia, neutropenic infection, inability to deliver at least 80 percent of planned dose during Cycle 1 due to NDR adverse events. | Baseline up to 21 days after the start of each increased treatment dose |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) for PF-04217903 and PF-04217903 Metabolite (PF-04328029) | 0 (pre-dose), 1, 2, 4, 6, 8 and 12 hours (hrs) (just prior to evening dosing) post dose on Cycle (C) 1 Day (D) 1 and C2 D1 | |
| Minimum Observed Plasma Trough Concentration (Cmin) for PF-04217903 and PF-04217903 Metabolite (PF-04328029) |
Not provided
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 | Aurora | Colorado | 80045 | United States | ||
| Pfizer Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23610116 | Derived | Diamond JR, Salgia R, Varella-Garcia M, Kanteti R, LoRusso PM, Clark JW, Xu LG, Wilner K, Eckhardt SG, Ching KA, Lira ME, Schoenmakers EF, Christensen JG, Camidge DR. Initial clinical sensitivity and acquired resistance to MET inhibition in MET-mutated papillary renal cell carcinoma. J Clin Oncol. 2013 Jun 1;31(16):e254-8. doi: 10.1200/JCO.2012.46.4289. Epub 2013 Apr 22. No abstract available. |
| 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-04217903 50 mg | Two tablets 25 milligram (mg) PF-04217903 administered orally twice a day in continuous 21-day cycles. |
| FG001 | PF-04217903 100 mg | Four tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles. |
| FG002 | PF-04217903 200 mg | One tablet 125 mg and 3 tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles. |
| FG003 | PF-04217903 150 mg | One tablet 125 mg and 1 tablet 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1: PF-04217903 50 mg |
|
| ||||||||||||||||||
| Period 2: PF-04217903 100 mg |
| |||||||||||||||||||
| Period 3: PF-04217903 200 mg |
| |||||||||||||||||||
| Period 4: PF-04217903 150 mg |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | PF-04217903 50 mg | Two tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles. |
| BG001 | PF-04217903 100 mg | Four tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| 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 | Maximum Tolerated Dose (MTD) | MTD: dose level at which 1 of 6 participants experienced dose-limiting toxicity (DLT) after 21 days of treatment (Cycle 1). DLT: grade (Gr) 2 elevated creatinine, acute renal failure, Gr 3 thrombocytopenia with bleeding, hypertension (if unmanageable),Gr >=3 non-hematological non-disease-related (NDR) toxicities (except alopecia,Gr 3/4 hypophosphatemia, hyperuricemia), Gr 3/4 nausea, vomiting, diarrhea, Gr 4 neutropenia, thrombocytopenia lasting for >=7 days, febrile neutropenia, neutropenic infection, inability to deliver 80 percent of planned dose during Cycle 1 due to NDR toxicities. | Analysis population included all enrolled participants who received at least 1 dose of the study treatment. | Posted | Number | mg | Baseline up to 21 days after the start of each increased treatment dose |
|
Not provided
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-04217903 50 mg | Two tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA v14.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA v14.1 | Non-systematic Assessment |
Insufficient number of participants had been enrolled in the study due to a strategic development decision; therefore some of the objectives for this study were either not investigated or not fully investigated.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
Not provided
| ID | Term |
|---|---|
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| C558663 | 2-(4-(3-quinolin-6-ylmethyl-3H-(1,2,3)triazolo(4,5-b)pyrazin-5-yl)pyrazol-1-yl)ethanol |
Not provided
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Participants did not receive 200 mg twice a day dose of study treatment for this specific measure. |
| 0 (pre-dose), 1, 2, 4, 6, 8 and 12 hrs (just prior to evening dosing) post dose on C2 D1 |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-04217903 and PF-04217903 Metabolite (PF-04328029) | 0 (pre-dose), 1, 2, 4, 6, 8 and 12 hrs (just prior to evening dosing) post dose on C1 D1 and C2 D1 |
| Pre-dose Plasma Concentration (Ctrough) for PF-04217903 and PF-04217903 Metabolite (PF-04328029) | Participants did not receive 200 mg twice a day dose of study treatment for this specific measure. | 0 (pre-dose), 1, 2, 4, 6, 8 and 12 hrs (just prior to evening dosing) post dose on C1 D1 and C2 D1 |
| Area Under the Plasma Concentration Time-curve From Zero to the Last Measured Concentration [AUC(0-last)] for PF-04217903 and PF-04217903 Metabolite (PF-04328029) | Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). | 0 (pre-dose), 1, 2, 4, 6, 8 and 12 hrs (just prior to evening dosing) post dose on C1 D1 and C2 D1 |
| Area Under the Curve From Time Zero to End of Dosing Interval [AUC(0-tau)] for PF-04217903 and PF-04217903 Metabolite (PF-04328029) | Area under the concentration-time profile from time zero to time tau (dosing interval), where tau is equal to 12 hours. | 0 (pre-dose), 1, 2, 4, 6, 8 and 12 hrs (just prior to evening dosing) post dose on C1 D1 and C2 D1 |
| Accumulation Ratio (Rac) for PF-04217903 and PF-04217903 Metabolite (PF-04328029) | Rac is obtained from AUCtau (Cycle 2 Day 1) divided by AUCtau (Cycle 1 Day 1). Participants did not receive 200 mg twice a day dose of study treatment for this specific measure. | 0 (pre-dose), 1, 2, 4, 6, 8 and 12 hrs (just prior to evening dosing) post dose on C2 D1 |
| Metabolite to Parent Ratio Area Under the Curve From Time Zero to End of Dosing Interval (MRAUCtau) | Molar ratio of metabolite to parent area under the plasma concentration time-curve from zero (pre-dose) to end of dosing interval (MRAUCtau). | 0 (pre-dose), 1, 2, 4, 6, 8 and 12 hrs (just prior to evening dosing) post dose on C1 D1 and C2 D1 |
| Apparent Oral Clearance (CL/F) for PF-04217903 | Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. Participants did not receive 200 mg twice a day dose of study treatment for this specific measure. | 0 (pre-dose), 1, 2, 4, 6, 8 and 12 hrs (just prior to evening dosing) post dose on C2 D1 |
| Change From Baseline in Tumor Proliferation Using F-Fluoro-3'-Deoxy-3'-L-Fluorothymidine Positron Emission Tomography (FLT-PET) Imaging at Day 1 of Cycle 2 | F-fluoro-3'-deoxy-3'-L-fluorothymidine positron emission tomography (FLT-PET) imaging was used to assess the tumor proliferation in RP2D cohorts. Results of the FLT-PET were scored according to the methods developed by the American College of Radiology Imaging Network (ACRIN). | Cycle 2 Day 1 |
| Percentage of Participants With Objective Response (OR) | Percentage of participants with OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed response were those that persisted on repeat imaging study at least 4 weeks after initial documentation of response. CR was defined as disappearance of all lesions (target and/or non target). PR were those with at least 30 percent decrease in sum of the longest dimensions of target lesions taking as a reference the baseline sum longest dimensions, with non target lesions not increased or absent. | Baseline until disease progression up to C2 D1 |
| Chicago |
| Illinois |
| 60637 |
| United States |
| Pfizer Investigational Site | Boston | Massachusetts | 02114 | United States |
| Pfizer Investigational Site | Boston | Massachusetts | 02115 | United States |
| Pfizer Investigational Site | Boston | Massachusetts | 02215 | United States |
| Pfizer Investigational Site | Detroit | Michigan | 48201 | United States |
| Objective progression or relapse |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| BG002 | PF-04217903 200 mg | One tablet 125 mg and 3 tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles. |
| BG003 | PF-04217903 150 mg | One tablet 125 mg and 1 tablet 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles. |
| BG004 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Primary | Recommended Phase 2 Dose (RP2D) | Data was not analyzed due to insufficient number of participants enrolled. | Posted | Number | mg | Baseline up to 21 days after the start of each increased treatment dose |
|
|
| Primary | Number of Participants With Dose-Limiting Toxicities (DLTs) | DLT includes Gr 2 elevated creatinine and acute renal failure, Gr 3 thrombocytopenia with bleeding, hypertension (if unmanageable), Gr >= 3 non-hematological non-disease-related (NDR) toxicities (except alopecia, Gr 3/4 hypophosphatemia, hyperuricemia), Gr 3/4 nausea, vomiting, diarrhea, Gr 4 neutropenia, thrombocytopenia lasting for >= 7 days, febrile neutropenia, neutropenic infection, inability to deliver at least 80 percent of planned dose during Cycle 1 due to NDR adverse events. | DLT analysis set: participants who received first cycle of study medication and did not temporarily or permanently discontinue from study medication or missed more than 3 consecutive days of PF-04217903 dosing for reasons other than DLTs within first cycle. | Posted | Number | Participants | Baseline up to 21 days after the start of each increased treatment dose |
|
|
|
| Secondary | Maximum Observed Plasma Concentration (Cmax) for PF-04217903 and PF-04217903 Metabolite (PF-04328029) | The pharmacokinetic (PK) parameter analysis population included all enrolled participants who received the study medication and had at least 1 of the PK parameters of interest. 'n' signifies those participants evaluated for this measure at specific time point for each arm group respectively. | Posted | Geometric Mean | Standard Deviation | Nanogram per milliliter (ng/mL) | 0 (pre-dose), 1, 2, 4, 6, 8 and 12 hours (hrs) (just prior to evening dosing) post dose on Cycle (C) 1 Day (D) 1 and C2 D1 |
|
|
|
| Secondary | Minimum Observed Plasma Trough Concentration (Cmin) for PF-04217903 and PF-04217903 Metabolite (PF-04328029) | Participants did not receive 200 mg twice a day dose of study treatment for this specific measure. | The PK parameter analysis population included all enrolled participants who received the study medication and had at least 1 of the PK parameters of interest. 'n' signifies those participants evaluated for this measure at specific time point for each arm group respectively. | Posted | Geometric Mean | Standard Deviation | ng/mL | 0 (pre-dose), 1, 2, 4, 6, 8 and 12 hrs (just prior to evening dosing) post dose on C2 D1 |
|
|
|
| Secondary | Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-04217903 and PF-04217903 Metabolite (PF-04328029) | The PK parameter analysis population included all enrolled participants who received the study medication and had at least 1 of the PK parameters of interest. 'n' signifies those participants evaluated for this measure at specific time point for each arm group respectively. | Posted | Median | Full Range | hr | 0 (pre-dose), 1, 2, 4, 6, 8 and 12 hrs (just prior to evening dosing) post dose on C1 D1 and C2 D1 |
|
|
|
| Secondary | Pre-dose Plasma Concentration (Ctrough) for PF-04217903 and PF-04217903 Metabolite (PF-04328029) | Participants did not receive 200 mg twice a day dose of study treatment for this specific measure. | The PK parameter analysis population included all enrolled participants who received the study medication and had at least 1 of the PK parameters of interest. 'n' signifies those participants evaluable for this measure. | Posted | Geometric Mean | Standard Deviation | ng/mL | 0 (pre-dose), 1, 2, 4, 6, 8 and 12 hrs (just prior to evening dosing) post dose on C1 D1 and C2 D1 |
|
|
|
| Secondary | Area Under the Plasma Concentration Time-curve From Zero to the Last Measured Concentration [AUC(0-last)] for PF-04217903 and PF-04217903 Metabolite (PF-04328029) | Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). | The PK parameter analysis population included all enrolled participants who received the study medication and had at least 1 of the PK parameters of interest. 'n' signifies those participants evaluated for this measure at specific time point for each arm group respectively. | Posted | Geometric Mean | Standard Deviation | ng*hr/mL | 0 (pre-dose), 1, 2, 4, 6, 8 and 12 hrs (just prior to evening dosing) post dose on C1 D1 and C2 D1 |
|
|
|
| Secondary | Area Under the Curve From Time Zero to End of Dosing Interval [AUC(0-tau)] for PF-04217903 and PF-04217903 Metabolite (PF-04328029) | Area under the concentration-time profile from time zero to time tau (dosing interval), where tau is equal to 12 hours. | The PK parameter analysis population included all enrolled participants who received the study medication and had at least 1 of the PK parameters of interest. 'n' signifies those participants evaluated for this measure at specific time point for each arm group respectively. | Posted | Geometric Mean | Standard Deviation | ng*hr/mL | 0 (pre-dose), 1, 2, 4, 6, 8 and 12 hrs (just prior to evening dosing) post dose on C1 D1 and C2 D1 |
|
|
|
| Secondary | Accumulation Ratio (Rac) for PF-04217903 and PF-04217903 Metabolite (PF-04328029) | Rac is obtained from AUCtau (Cycle 2 Day 1) divided by AUCtau (Cycle 1 Day 1). Participants did not receive 200 mg twice a day dose of study treatment for this specific measure. | The PK parameter analysis population included all enrolled participants who received the study medication and had at least 1 of the PK parameters of interest. 'n' signifies those participants evaluated for this measure at specific time point for each arm group respectively. | Posted | Mean | Standard Deviation | Ratio | 0 (pre-dose), 1, 2, 4, 6, 8 and 12 hrs (just prior to evening dosing) post dose on C2 D1 |
|
|
|
| Secondary | Metabolite to Parent Ratio Area Under the Curve From Time Zero to End of Dosing Interval (MRAUCtau) | Molar ratio of metabolite to parent area under the plasma concentration time-curve from zero (pre-dose) to end of dosing interval (MRAUCtau). | The PK parameter analysis population included all enrolled participants who received the study medication and had at least 1 of the PK parameters of interest. 'n' signifies those participants evaluated for this measure at specific time point for each arm group respectively. | Posted | Mean | Standard Deviation | Ratio | 0 (pre-dose), 1, 2, 4, 6, 8 and 12 hrs (just prior to evening dosing) post dose on C1 D1 and C2 D1 |
|
|
|
| Secondary | Apparent Oral Clearance (CL/F) for PF-04217903 | Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. Participants did not receive 200 mg twice a day dose of study treatment for this specific measure. | The PK parameter analysis population included all enrolled participants who received the study medication and had at least 1 of the PK parameters of interest. 'N' (number of participants analyzed) signifies those participants evaluable for this measure. | Posted | Geometric Mean | Standard Deviation | Liter/hr (L/hr) | 0 (pre-dose), 1, 2, 4, 6, 8 and 12 hrs (just prior to evening dosing) post dose on C2 D1 |
|
|
|
| Secondary | Change From Baseline in Tumor Proliferation Using F-Fluoro-3'-Deoxy-3'-L-Fluorothymidine Positron Emission Tomography (FLT-PET) Imaging at Day 1 of Cycle 2 | F-fluoro-3'-deoxy-3'-L-fluorothymidine positron emission tomography (FLT-PET) imaging was used to assess the tumor proliferation in RP2D cohorts. Results of the FLT-PET were scored according to the methods developed by the American College of Radiology Imaging Network (ACRIN). | Data was not analyzed due to insufficient number of participants enrolled. | Posted | Mean | Standard Deviation | Standardized Uptake Value (SUV) | Cycle 2 Day 1 |
|
|
| Secondary | Percentage of Participants With Objective Response (OR) | Percentage of participants with OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed response were those that persisted on repeat imaging study at least 4 weeks after initial documentation of response. CR was defined as disappearance of all lesions (target and/or non target). PR were those with at least 30 percent decrease in sum of the longest dimensions of target lesions taking as a reference the baseline sum longest dimensions, with non target lesions not increased or absent. | Efficacy analysis set included all enrolled participants who received the study treatment and had measurable disease at baseline. | Posted | Number | 95% Confidence Interval | Percentage of participants | Baseline until disease progression up to C2 D1 |
|
|
|
| 0 |
| 3 |
| 3 |
| 3 |
| EG001 | PF-04217903 100 mg | Four tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles. | 3 | 7 | 7 | 7 |
| EG002 | PF-04217903 200 mg | One tablet 125 mg and 3 tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles. | 1 | 2 | 2 | 2 |
| EG003 | PF-04217903 150 mg | One tablet 125 mg and 1 tablet 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles. | 2 | 4 | 4 | 4 |
| Disease progression | General disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA v14.1 | Non-systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA v14.1 | Non-systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA v14.1 | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Abdominal pain lower | Gastrointestinal disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Retching | Gastrointestinal disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Asthenia | General disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Atrophy | General disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Catheter site related reaction | General disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Chest pain | General disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Local swelling | General disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Pain | General disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Performance status decreased | General disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Bile duct obstruction | Hepatobiliary disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA v14.1 | Non-systematic Assessment |
|
| Herpes virus infection | Infections and infestations | MedDRA v14.1 | Non-systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA v14.1 | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA v14.1 | Non-systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA v14.1 | Non-systematic Assessment |
|
| Skin infection | Infections and infestations | MedDRA v14.1 | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA v14.1 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA v14.1 | Non-systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA v14.1 | Non-systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA v14.1 | Non-systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA v14.1 | Non-systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA v14.1 | Non-systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA v14.1 | Non-systematic Assessment |
|
| Blood glucose increased | Investigations | MedDRA v14.1 | Non-systematic Assessment |
|
| Blood lactate dehydrogenase increased | Investigations | MedDRA v14.1 | Non-systematic Assessment |
|
| Blood pressure increased | Investigations | MedDRA v14.1 | Non-systematic Assessment |
|
| Blood urea increased | Investigations | MedDRA v14.1 | Non-systematic Assessment |
|
| Electrocardiogram ST segment depression | Investigations | MedDRA v14.1 | Non-systematic Assessment |
|
| Eosinophil count increased | Investigations | MedDRA v14.1 | Non-systematic Assessment |
|
| Glucose urine present | Investigations | MedDRA v14.1 | Non-systematic Assessment |
|
| Transaminases increased | Investigations | MedDRA v14.1 | Non-systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Hyperphosphataemia | Metabolism and nutrition disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Coccydynia | Musculoskeletal and connective tissue disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Disturbance in attention | Nervous system disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Hallucination | Psychiatric disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Mental status changes | Psychiatric disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Nail disorder | Skin and subcutaneous tissue disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA v14.1 | 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.
| PF-04217903 (C2 D1) (n=2, 4, 0, 2) |
|
| PF-04328029 (C1 D1) (n=3, 7, 2, 4) |
|
| PF-04328029 (C2 D1) (n=2, 4, 0, 2) |
|
|
| PF-04217903 (C2 D1) (n=2, 4, 0, 2) |
|
| PF-04328029 (C1 D1) (n=3, 7, 2, 4) |
|
| PF-04328029 (C2 D1) (n=2, 4, 0, 2) |
|
|
| PF-04328029 (C1 D1) (n=3, 7, 4) |
|
| PF-04328029 (C2 D1) (n=3, 6, 3) |
|
| PF-04217903 (C2 D1) (n=2, 4, 0, 2) |
|
| PF-04328029 (C1 D1) (n=3, 7, 2, 4) |
|
| PF-04328029 (C2 D1) (n=2, 4, 0, 2) |
|
| PF-04217903 (C2 D1) (n=2, 4, 0, 1) |
|
| PF-04328029 (C1 D1) (n=3, 7, 2, 4) |
|
| PF-04328029 (C2 D1) (n=2, 4, 0, 1) |
|
| PF-04328029 (n=2, 4, 1) |
|
| C2 D1 (n=2, 4, 0, 1) |
|