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See termination reason in detailed description.
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This is a Phase 1 study investigating the safety and tolerability of Figitumumab plus Pegvisomant for treatment of advanced solid tumors.
This study was closed to enrollment on 18 April 2011 due to inability to recruit patients on a timely basis as well as business reasons. Study closure was not related to any safety concerns.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| figitumumab | Drug | IGF-1R antibody, 20 mg/kg, IV every 3 weeks for up to 1 year |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. AEs were graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 3.0 (Grade [Gr] 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death). Relatedness to [study drug] was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category. | From Screening to the follow-up visit (90 days after last dose of figitimumab) |
| Number of Participants With Dose Limiting Toxicities (DLT) | DLT was defined as any of the following events occurring during DLT period and considered related to study medication: Grade (Gr) 4 neutropenia lasting >=7 days, febrile neutropenia (Gr 3 or 4 neutropenia, fever >=38.5 degrees Celsius, lasting over 24 hours), neutropenic infection (Gr >=3 neutropenia, infection); Gr 3 or 4 thrombocytopenia associated with bleeding or Gr 4 thrombocytopenia >=7 days; Gr 3 or 4 lymphopeniab accompanied by an opportunistic infection; other non-hematologic Grade 4 toxicities or symptomatic Gr 3 toxicities that require medical intervention and 14 days to resolve. | From Cycle 2, Day 1 to Cycle 3, Day 8; from Cycle 1, Day 15 to end of Cycle 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Circulating Insulin-like Growth Factor (IGF-1) Levels | The effect of the combined therapy with figitumumab and pegvisomant on circulating concentrations of total IGF-1 was assessed. | Days 1 and 15 of Cycle 1 (Baseline); Day 1 of subsequent cycles starting from Cycle 2 to Cycle 27; end of treatment (21 days after last dose of figitumumab); follow-up visit (90 days after last dose of figitumumab) |
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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 | Minneapolis | Minnesota | 55455 | United States | ||
| Pfizer Investigational Site |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Figitumumab 20mg/kg + Pegvisomant 10 mg | Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 10 mg subcutaneously once daily, up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days. |
| FG001 | Figitumumab 20mg/kg + Pegvisomant 20 mg | Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 20 mg subcutaneously once daily, up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Figitumumab 20 mg/kg +Pegvisomant 10 mg | Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 10 mg subcutaneously once daily, up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days. |
| 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 | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. AEs were graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 3.0 (Grade [Gr] 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death). Relatedness to [study drug] was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category. | Safety analysis set: all enrolled participants who received at least 1 dose of either of the study medications. | Posted | Number | Participants | From Screening to the follow-up visit (90 days after last dose of figitimumab) |
|
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 | Figitumumab 20 mg/kg + Pegvisomant 10 mg | Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 10 mg subcutaneously once daily up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastrointestinal haemorrhage | 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 |
The study was terminated prematurely due to lack of operational feasibility and the halt of figitumumab development.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
Not provided
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D008175 | Lung Neoplasms |
| D001943 | Breast Neoplasms |
| D011471 | Prostatic Neoplasms |
| D012509 | Sarcoma |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
Not provided
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| ID | Term |
|---|---|
| C525021 | figitumumab |
| C406545 | pegvisomant |
Not provided
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| pegvisomant | Drug | growth hormone antagonist, 10, 20 or 30 mg per day via subcutaneous injection for up to 1 year |
|
|
| Cycle 1: Maximum Observed Plasma Concentration (Cmax) of Figitumumab | Cycle 1: Day 1 (within 2 hours before figitumumab infusion), Day 2 (1 hour post figitumumab infusion), Day 8 and Day 15 |
| Maximum Observed Plasma Concentration (Cmax) of Figitumumab | Cycle 2: Day 1 (within 2 hours before and 1 hour after figitumumab infusion); Cycle 3 to Cycle 17: Day 1 (within 2 hours before figitumumab infusion); end of treatment; 90-day follow-up visit |
| Cycle 1: Plasma Concentration at the Last Quantifiable Time Point (Clast) of Figitumumab | Cycle 1: Day 1 (within 2 hours before figitumumab infusion), Day 2 (1 hour post figitumumab infusion), Day 8 and Day 15 |
| Plasma Concentration at the Last Quantifiable Time Point (Clast) of Figitumumab | Plasma Concentration at the Last Quantifiable Time Point (Clast) of Figitumumab from Cycle 2 to the end of treatment. | Cycle 2: Day 1 (within 2 hours before and 1 hour after figitumumab infusion); Cycle 3 to Cycle 17: Day 1 (within 2 hours before figitumumab infusion); end of treatment; 90-day follow-up visit |
| Cycle 1: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Figitumumab | Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) of figitumumab in cycle 1. | Days 1, 2, 8 and 15 of Cycle 1; Day 1 of subsequent cycle starting from Cycle 2 (up to Cycle 17); end of treatment ( 21 days after last dose of figitumumab); follow-up visit (90 days after last dose of figitumumab) |
| Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)of Figitumumab | Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)of figitumumab after Cycle 1 | Cycle 2: Day 1 (within 2 hours before and 1 hour after figitumumab infusion); Cycle 3 to Cycle 17: Day 1 (within 2 hours before figitumumab infusion); end of treatment; 90-day follow-up visit |
| Area Under the Trough Concentrations (AUCtrough) | The trough concentration-time profile (AUCtrough) of pegvisomant was to be analyzed by noncompartmental methods. | Cycle 1: Day 15 (within 2 hours before loading dose), Day 16 (within 2 hours pre-SC dose); Cycle 2: Days 1, 8 and 15 (within 2 hours pre-SC dose); Cycle 3 up to Cycle 17: Day 1 (within 2 hours pre-SC dose); end of treatment; 90-day follow-up visit |
| Mean Change in Glucose Levels Between Fasting and Post Glucose Load | The effect of combining figitumumab with pegvisomant was analyzed to assess whether pegvisomant reverses figitumumab-induced glucose intolerance at various pegvisomant dose levels. The change in glucose load was assessed by Glucose Tolerance Testing (GTT) at baseline (fasting), during Cycle 1 following administration of figitumumab alone (post load), and near the end of Cycle 2 (post load) following combined therapy with figitumumab and pegvisomant. | Screening; Day 8 of Cycle 1; Day 15 of Cycle 2 |
| Percentage of Participants Reporting Positive Anti-Drug Antibodies (ADA) Response for Figitumumab | Percentage of participants with positive total or neutralizing ADA for figitumumab. | Day 1 of Cycles 1 and 4; end of treatment (21 days after last dose of figitumumab); follow-up visit (90 days after last dose of figitumumab) |
| 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 Response Evaluation Criteria in Solid Tumors (RECIST)version 1.1. 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 version 1.1. Confirmed responses are those that persist on repeat imaging study ≥4 weeks after initial documentation of response. | From Screening, odd numbered cycles (predose, Cycle 3, 5, 7 etc.) up to Cycle 27 or end of treatment visit (21 days after last dose of figitumumab) |
| Rochester |
| Minnesota |
| 55905 |
| United States |
| Pfizer Investigational Site | Montreal | Quebec | H3T 1E2 | Canada |
| Pfizer Investigational Site | Helsinki | 00290 | Finland |
| Pfizer Investigational Site | Münster | 48149 | Germany |
| Withdrawal by Subject |
|
| Disease Progression |
|
| Subject Enrolled in Hospice |
|
| Terminated by the Sponsor |
|
| BG001 | Figitumumab 20 mg/kg + Pegvisomant 20 mg | Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 20 mg subcutaneously once daily, up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 10 mg subcutaneously once daily, up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.
| OG001 | Figitumumab 20mg/kg + Pegvisomant 20 mg | Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 20 mg subcutaneously once daily up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days. |
|
|
| Primary | Number of Participants With Dose Limiting Toxicities (DLT) | DLT was defined as any of the following events occurring during DLT period and considered related to study medication: Grade (Gr) 4 neutropenia lasting >=7 days, febrile neutropenia (Gr 3 or 4 neutropenia, fever >=38.5 degrees Celsius, lasting over 24 hours), neutropenic infection (Gr >=3 neutropenia, infection); Gr 3 or 4 thrombocytopenia associated with bleeding or Gr 4 thrombocytopenia >=7 days; Gr 3 or 4 lymphopeniab accompanied by an opportunistic infection; other non-hematologic Grade 4 toxicities or symptomatic Gr 3 toxicities that require medical intervention and 14 days to resolve. | Safety analysis set: all enrolled participants who received at least 1 dose of either of the study medications. N=number of participants remained on treatment throughout the required DLT period and included as analyzed for DLT based on the defined DLT evaluability specifications. | Posted | Number | participants | From Cycle 2, Day 1 to Cycle 3, Day 8; from Cycle 1, Day 15 to end of Cycle 2 |
|
|
|
| Secondary | Serum Circulating Insulin-like Growth Factor (IGF-1) Levels | The effect of the combined therapy with figitumumab and pegvisomant on circulating concentrations of total IGF-1 was assessed. | Biomarker analysis set: all enrolled participants who had at least 1 baseline or on-study sample submitted. N=number of participants who were evaluable for IGF-1 Levels at prespecified time points. | Posted | Mean | Standard Deviation | nanogram/milliliter (ng/mL) | Days 1 and 15 of Cycle 1 (Baseline); Day 1 of subsequent cycles starting from Cycle 2 to Cycle 27; end of treatment (21 days after last dose of figitumumab); follow-up visit (90 days after last dose of figitumumab) |
|
|
|
| Secondary | Cycle 1: Maximum Observed Plasma Concentration (Cmax) of Figitumumab | PK samples were not analyzed as the study was terminated prematurely due to lack of operational feasibility and the halt of figitumumab development. | Posted | Cycle 1: Day 1 (within 2 hours before figitumumab infusion), Day 2 (1 hour post figitumumab infusion), Day 8 and Day 15 |
|
|
| Secondary | Maximum Observed Plasma Concentration (Cmax) of Figitumumab | PK samples were not analyzed as the study was terminated prematurely due to lack of operational feasibility and the halt of figitumumab development. | Posted | Cycle 2: Day 1 (within 2 hours before and 1 hour after figitumumab infusion); Cycle 3 to Cycle 17: Day 1 (within 2 hours before figitumumab infusion); end of treatment; 90-day follow-up visit |
|
|
| Secondary | Cycle 1: Plasma Concentration at the Last Quantifiable Time Point (Clast) of Figitumumab | PK samples were not analyzed as the study was terminated prematurely due to lack of operational feasibility and the halt of figitumumab development. | Posted | Cycle 1: Day 1 (within 2 hours before figitumumab infusion), Day 2 (1 hour post figitumumab infusion), Day 8 and Day 15 |
|
|
| Secondary | Plasma Concentration at the Last Quantifiable Time Point (Clast) of Figitumumab | Plasma Concentration at the Last Quantifiable Time Point (Clast) of Figitumumab from Cycle 2 to the end of treatment. | PK samples were not analyzed as the study was terminated prematurely due to lack of operational feasibility and the halt of figitumumab development. | Posted | Cycle 2: Day 1 (within 2 hours before and 1 hour after figitumumab infusion); Cycle 3 to Cycle 17: Day 1 (within 2 hours before figitumumab infusion); end of treatment; 90-day follow-up visit |
|
|
| Secondary | Cycle 1: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Figitumumab | Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) of figitumumab in cycle 1. | PK samples were not analyzed as the study was terminated prematurely due to lack of operational feasibility and the halt of figitumumab development. | Posted | Days 1, 2, 8 and 15 of Cycle 1; Day 1 of subsequent cycle starting from Cycle 2 (up to Cycle 17); end of treatment ( 21 days after last dose of figitumumab); follow-up visit (90 days after last dose of figitumumab) |
|
|
| Secondary | Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)of Figitumumab | Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)of figitumumab after Cycle 1 | PK samples were not analyzed as the study was terminated prematurely due to lack of operational feasibility and the halt of figitumumab development. | Posted | Cycle 2: Day 1 (within 2 hours before and 1 hour after figitumumab infusion); Cycle 3 to Cycle 17: Day 1 (within 2 hours before figitumumab infusion); end of treatment; 90-day follow-up visit |
|
|
| Secondary | Area Under the Trough Concentrations (AUCtrough) | The trough concentration-time profile (AUCtrough) of pegvisomant was to be analyzed by noncompartmental methods. | PK samples were not analyzed as the study was terminated prematurely due to lack of operational feasibility and the halt of figitumumab development. | Posted | Cycle 1: Day 15 (within 2 hours before loading dose), Day 16 (within 2 hours pre-SC dose); Cycle 2: Days 1, 8 and 15 (within 2 hours pre-SC dose); Cycle 3 up to Cycle 17: Day 1 (within 2 hours pre-SC dose); end of treatment; 90-day follow-up visit |
|
|
| Secondary | Mean Change in Glucose Levels Between Fasting and Post Glucose Load | The effect of combining figitumumab with pegvisomant was analyzed to assess whether pegvisomant reverses figitumumab-induced glucose intolerance at various pegvisomant dose levels. The change in glucose load was assessed by Glucose Tolerance Testing (GTT) at baseline (fasting), during Cycle 1 following administration of figitumumab alone (post load), and near the end of Cycle 2 (post load) following combined therapy with figitumumab and pegvisomant. | Glucose tolerance set: All enrolled participants who started treatment and who had at least one baseline or on-study sample submitted. N=number of participants with analyable data for this outcome measure. | Posted | Mean | Standard Deviation | milligram/deciliter (mg/dL) | Screening; Day 8 of Cycle 1; Day 15 of Cycle 2 |
|
|
|
| Secondary | Percentage of Participants Reporting Positive Anti-Drug Antibodies (ADA) Response for Figitumumab | Percentage of participants with positive total or neutralizing ADA for figitumumab. | ADA samples were not analyzed as the study was terminated prematurely due to lack of operational feasibility and the halt of figitumumab development. | Posted | Day 1 of Cycles 1 and 4; end of treatment (21 days after last dose of figitumumab); follow-up visit (90 days after last dose of figitumumab) |
|
|
| 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 Response Evaluation Criteria in Solid Tumors (RECIST)version 1.1. 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 version 1.1. Confirmed responses are those that persist on repeat imaging study ≥4 weeks after initial documentation of response. | Response-evaluable set: All participants who started Cycle 1 with an adequate baseline tumor assessment and at least 1 follow up tumor assessment. | Posted | Number | participants | From Screening, odd numbered cycles (predose, Cycle 3, 5, 7 etc.) up to Cycle 27 or end of treatment visit (21 days after last dose of figitumumab) |
|
|
|
| 9 |
| 17 |
| 17 |
| 17 |
| EG001 | Figitumumab 20 mg/kg + Pegvisomant 20 mg | Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles (up to total duration of 27 cycles). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 20 mg subcutaneously once daily up to total duration of 27 cycles. Each cycle was of 21 days. | 4 | 6 | 6 | 6 |
| Death | General disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Disease progression | General disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| General physical health deterioration | General disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Medical device complication | General disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Pain | General disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Pelvic infection | Infections and infestations | MedDRA v14.1 | Non-systematic Assessment |
|
| Blood uric acid increased | Investigations | MedDRA v14.1 | Non-systematic Assessment |
|
| C-reactive protein increased | Investigations | MedDRA v14.1 | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Cauda equina syndrome | Nervous system disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Ear discomfort | Ear and labyrinth disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Hearing impaired | Ear and labyrinth disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Sudden hearing loss | Ear and labyrinth disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Dry eye | Eye disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Ocular hyperaemia | Eye disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal 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 |
|
| Abdominal pain upper | 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 |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Erosive oesophagitis | Gastrointestinal disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Eructation | Gastrointestinal disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Gastric ulcer | Gastrointestinal disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Hiatus hernia | Gastrointestinal disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Impaired gastric emptying | Gastrointestinal disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Proctalgia | Gastrointestinal disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Stomatitis | 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 |
|
| Chest pain | General disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Chills | General disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Disease progression | General disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Exercise tolerance decreased | General disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| General physical health deterioration | General disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Injection site induration | General disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Injection site reaction | General disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Medical device pain | General disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Mucosal inflammation | General disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Necrosis | 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 |
|
| Pyrexia | General disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Thirst | General disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Cholangitis | Hepatobiliary disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Contrast media allergy | Immune system disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Fungal infection | Infections and infestations | MedDRA v14.1 | Non-systematic Assessment |
|
| Lung infection | Infections and infestations | MedDRA v14.1 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA v14.1 | Non-systematic Assessment |
|
| Paronychia | Infections and infestations | MedDRA v14.1 | Non-systematic Assessment |
|
| Pelvic infection | Infections and infestations | MedDRA v14.1 | Non-systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA v14.1 | Non-systematic Assessment |
|
| Sinusitis | 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 |
|
| Wound infection | Infections and infestations | MedDRA v14.1 | Non-systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA v14.1 | Non-systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA v14.1 | Non-systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA v14.1 | Non-systematic Assessment |
|
| Thermal burn | Injury, poisoning and procedural complications | 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 albumin decreased | 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 uric acid increased | Investigations | MedDRA v14.1 | Non-systematic Assessment |
|
| C-reactive protein increased | Investigations | MedDRA v14.1 | Non-systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA v14.1 | Non-systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA v14.1 | Non-systematic Assessment |
|
| Insulin-like growth factor increased | Investigations | MedDRA v14.1 | Non-systematic Assessment |
|
| International normalised ratio increased | Investigations | MedDRA v14.1 | Non-systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA v14.1 | Non-systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA v14.1 | Non-systematic Assessment |
|
| Weight decreased | Investigations | MedDRA v14.1 | Non-systematic Assessment |
|
| Weight increased | Investigations | MedDRA v14.1 | Non-systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Hypermagnesaemia | Metabolism and nutrition disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Hypernatraemia | Metabolism and nutrition disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Bone swelling | Musculoskeletal and connective tissue disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Muscular weakness | 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 |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Myalgia | 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 |
|
| Vaginal neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v14.1 | Non-systematic Assessment |
|
| Convulsion | Nervous system disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Dyskinesia | Nervous system disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Facial nerve disorder | Nervous system disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Hemiparesis | Nervous system disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Intracranial pressure increased | Nervous system disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Paraesthesia mucosal | Nervous system disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Sensory disturbance | Nervous system disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Spinal cord compression | Nervous system disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Atrophic vulvovaginitis | Reproductive system and breast disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Vaginal ulceration | Reproductive system and breast disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Pulmonary congestion | Respiratory, thoracic and mediastinal disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Nail disorder | Skin and subcutaneous tissue disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Pruritus generalised | Skin and subcutaneous tissue disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Skin disorder | Skin and subcutaneous tissue disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Pelvic venous thrombosis | 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.
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| Cycle 3 (n = 6, 5) |
|
| Cycle 4 (n = 5, 3) |
|
| Cycle 5 (n = 3, 4) |
|
| Cycle 6 (n = 2, 2) |
|
| Cycle 7 (n = 1, 2) |
|
| Cycle 8 (n = 0, 2) |
|
| Cycle 9 (n = 0, 2) |
|
| Cycle 10 (n = 0, 2) |
|
| Cycle 11 (n = 0, 2) |
|
| Cycle 12 (n = 0, 2) |
|
| Cycle 13 (n = 0, 2) |
|
| Cycle 14 (n = 0, 2) |
|
| Cycle 15 (n = 0, 2) |
|
| Cycle 16 (n = 0, 2) |
|
| Cycle 17 (n = 0, 2) |
|
| Cycle 18 (n = 0, 2) |
|
| Cycle 19 (n = 0, 1) |
|
| Cycle 20 (n = 0, 2) |
|
| Cycle 21 (n = 0, 2) |
|
| Cycle 22 (n = 0, 1) |
|
| Cycle 23 (n = 0, 1) |
|
| Cycle 24 (n = 0, 1) |
|
| Cycle 25 (n = 0, 1) |
|
| Cycle 26 (n = 0, 1) |
|
| Cycle 27 (n = 0, 0) |
|
| Follow-Up (n = 2, 1) |
|
| Cycle 2 Day 15 (n = 4, 5) |
|