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This is a phase 1 study of anti-IGF-IR CP-751,871 in patients with solid tumors currently enrolling patients 9 years old and older with Ewing's sarcoma family of tumors (Ewing's, PNET and Askin's).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CP-751,871 | Drug | Currently dosing at 20 mg/kg, IV on day 1 of each 28 day cycle until progression or unacceptable toxicity |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 150 days after last dose that were absent before treatment or that worsened relative to pretreatment state. | Baseline up to 150 days after the last administration of study drug |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) in Cycle 1 | Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose | |
| Maximum Observed Plasma Concentration (Cmax) in Cycle 4 | Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose |
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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 | Ann Arbor | Michigan | 48109-0848 | United States | ||
| Pfizer Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22682017 | Derived | Asmane I, Watkin E, Alberti L, Duc A, Marec-Berard P, Ray-Coquard I, Cassier P, Decouvelaere AV, Ranchere D, Kurtz JE, Bergerat JP, Blay JY. Insulin-like growth factor type 1 receptor (IGF-1R) exclusive nuclear staining: a predictive biomarker for IGF-1R monoclonal antibody (Ab) therapy in sarcomas. Eur J Cancer. 2012 Nov;48(16):3027-35. doi: 10.1016/j.ejca.2012.05.009. Epub 2012 Jun 7. | |
| 20036194 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Figitumumab 3 mg/kg | Figitumumab 3 milligram/kilogram (mg/kg) was supplied as a liquid solution administered as an intravenous (IV) infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort. |
| FG001 | Figitumumab 6 mg/kg | Figitumumab 6 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort. |
| FG002 | Figitumumab 10 mg/kg | Figitumumab 10 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort. |
| FG003 | Figitumumab 20 mg/kg | Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort. |
| FG004 | Figitumumab 20 mg/kg RP2D | Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for recommended Phase 2 dose [RP2D] extension cohort. |
| FG005 | Figitumumab 20 mg/kg RP2D ACC+Sarcoma | Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D adrenocortical carcinoma [ACC] and sarcoma extension cohort. |
| FG006 | Figitumumab 20 mg/kg RP2D ESFT | Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (4 weeks in duration) for RP2D Ewing's sarcoma family of tumors [ESFT] extension cohort. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All enrolled participants
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| ID | Title | Description |
|---|---|---|
| BG000 | Figitumumab 3 mg/kg | Figitumumab 3 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort. |
| BG001 | Figitumumab 6 mg/kg |
| 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 Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 150 days after last dose that were absent before treatment or that worsened relative to pretreatment state. | All enrolled participants who started treatment. | Posted | Number | participants | Baseline up to 150 days after the last administration of study drug |
|
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The same event may appear as both an adverse event (AE) and a serious AE (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 3 mg/kg | Figitumumab 3 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA version 13.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA version 13.1 | Non-systematic Assessment |
The study was completed and 2 participants in figitumumab 20 mg/kg RP2D ESFT group were transitioned to compassionate figitumumab treatment as investigators judged they were receiving benefit from the protocol therapy.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| ID | Term |
|---|---|
| D012512 | Sarcoma, Ewing |
| ID | Term |
|---|---|
| D012516 | Osteosarcoma |
| D018213 | Neoplasms, Bone Tissue |
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
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| ID | Term |
|---|---|
| C525021 | figitumumab |
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| Time to Reach Maximum Observed Plasma Concentration (Tmax) in Cycle 1 | Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) in Cycle 4 | Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose |
| Plasma Decay Half-Life (t1/2) in Cycle 1 | Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. | Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose |
| Plasma Decay Half-Life (t1/2) in Cycle 4 | Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. | Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose |
| Time to Reach Last Quantifiable Concentration (Tlast) in Cycle 1 | Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose |
| Time to Reach Last Quantifiable Concentration (Tlast) in Cycle 4 | Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose |
| Systemic Clearance (CL) in Cycle 1 | CL is a quantitative measure of the rate at which a drug substance is removed from the body. | Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose |
| Systemic Clearance (CL) in Cycle 4 | CL is a quantitative measure of the rate at which a drug substance is removed from the body. | Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose |
| Concentration at End of Infusion (Cendinf) in Cycle 1 | Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose |
| Concentration at End of Infusion (Cendinf) in Cycle 4 | Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose |
| Volume of Distribution (Vz) in Cycle 1 | Vz is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. | Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose |
| Volume of Distribution (Vz) in Cycle 4 | Vz is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. | Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose |
| Volume of Distribution at Steady State (Vss) in Cycle 1 | Vz is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Vss is the Vz at steady-state. | Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose |
| Volume of Distribution at Steady State (Vss) in Cycle 4 | Vz is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Vss is the Vz at steady-state. | Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose |
| Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) in Cycle 1 | Area under the plasma concentration time-curve from zero to the last measured concentration | Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose |
| Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) in Cycle 4 | Area under the plasma concentration time-curve from zero to the last measured concentration | Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose |
| Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] in Cycle 1 | Area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (0 - ∞). | Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose |
| Area Under the Plasma Concentration-time Profile From Time 0 to 504 Hours (21 Days) (AUC504) in Cycle 1 | Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose |
| Area Under the Plasma Concentration-time Profile From Time 0 to 504 Hours (21 Days) (AUC504) in Cycle 4 | Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose |
| Area Under the Plasma Concentration-time Profile From Time 0 to 672 Hours (28 Days) (AUC672) in Cycle 1 | Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose |
| Area Under the Plasma Concentration-time Profile From Time 0 to 672 Hours (28 Days) (AUC672) in Cycle 4 | Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose |
| Human Anti-human Antibodies (HAHA) Levels | HAHA were indicators of immunogenicity to figitumumab. | 30 minutes predose in Cycles 1 up to 61, and last scheduled follow-up visit (up to 150 days from the last dose of study drug) |
| Number of Circulating Tumor Cells (CTCs) | Quantification of CTCs using an automated microscope system | 30 minutes predose in all cycles (up to 17); 1, 3, 7, and 14 days postdose in Cycle 1 for dose escalation and RP2D extension cohorts; and also 1 day postdose in Cycle 4 for RP2D extension cohort |
| Number of Insulin-like Growth Factor 1 Receptor (IGF-1R) Positive CTCs | Quantification of IGF-IR positive CTCs using an automated microscope system | 30 minutes predose in all cycles (up to 17); 1, 3, 7, and 14 days postdose in Cycle 1 for dose escalation and RP2D extension cohorts; and also 1 day postdose in Cycle 4 for RP2D extension cohort |
| Rochester |
| Minnesota |
| 55905 |
| United States |
| Pfizer Investigational Site | Sutton | Surrey | SM2 5PT | United Kingdom |
| Derived |
| Olmos D, Postel-Vinay S, Molife LR, Okuno SH, Schuetze SM, Paccagnella ML, Batzel GN, Yin D, Pritchard-Jones K, Judson I, Worden FP, Gualberto A, Scurr M, de Bono JS, Haluska P. Safety, pharmacokinetics, and preliminary activity of the anti-IGF-1R antibody figitumumab (CP-751,871) in patients with sarcoma and Ewing's sarcoma: a phase 1 expansion cohort study. Lancet Oncol. 2010 Feb;11(2):129-35. doi: 10.1016/S1470-2045(09)70354-7. Epub 2009 Dec 23. |
| Adverse Event |
|
| Laboratory abnormality |
|
| Withdrawal by Subject |
|
| Other |
|
| Progressive disease |
|
| Terminated by sponsor |
|
Figitumumab 6 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort. |
| BG002 | Figitumumab 10 mg/kg | Figitumumab 10 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort. |
| BG003 | Figitumumab 20 mg/kg | Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort. |
| BG004 | Figitumumab 20 mg/kg RP2D | Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D extension cohort. |
| BG005 | Figitumumab 20 mg/kg RP2D ACC+Sarcoma | Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D ACC and sarcoma extension cohort. |
| BG006 | Figitumumab 20 mg/kg RP2D ESFT | Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (4 weeks in duration) for RP2D ESFT extension cohort. |
| BG007 | Total | Total of all reporting groups |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Figitumumab 3 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
| OG001 | Figitumumab 6 mg/kg | Figitumumab 6 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort. |
| OG002 | Figitumumab 10 mg/kg | Figitumumab 10 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort. |
| OG003 | Figitumumab 20 mg/kg | Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort. |
| OG004 | Figitumumab 20 mg/kg RP2D | Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D extension cohort. |
| OG005 | Figitumumab 20 mg/kg RP2D ACC+Sarcoma | Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D ACC and sarcoma extension cohort. |
| OG006 | Figitumumab 20 mg/kg RP2D ESFT | Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (4 weeks in duration) for RP2D ESFT extension cohort. |
|
|
| Secondary | Maximum Observed Plasma Concentration (Cmax) in Cycle 1 | All participants treated who had at least 1 of the pharmacokinetic (PK) parameters of primary interest. N=number of participants evaluable for the outcome measure. Summaries for figitumumab 20 mg/kg RP2D, and figitumumab 20 mg/kg RP2D ACC and sarcoma extension cohorts were combined into 1 reporting group: figitumumab 20 mg/kg RP2D every 3 weeks. | Posted | Mean | Standard Deviation | milligram/liter (mg/L) | Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose |
|
|
|
| Secondary | Maximum Observed Plasma Concentration (Cmax) in Cycle 4 | All participants treated who had at least 1 of the PK parameters of primary interest in extension cohorts. N=number of participants evaluable for the outcome measure. Summaries for figitumumab 20 mg/kg RP2D, and figitumumab 20 mg/kg RP2D ACC and sarcoma extension cohorts were combined into 1 reporting group: figitumumab 20 mg/kg RP2D every 3 weeks. | Posted | Mean | Standard Deviation | mg/L | Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose |
|
|
|
| Secondary | Time to Reach Maximum Observed Plasma Concentration (Tmax) in Cycle 1 | All participants treated who had at least 1 of the PK parameters of primary interest. N=number of participants evaluable for the outcome measure. Summaries for figitumumab 20 mg/kg RP2D, and figitumumab 20 mg/kg RP2D ACC and sarcoma extension cohorts were combined into 1 reporting group: figitumumab 20 mg/kg RP2D every 3 weeks. | Posted | Mean | Standard Deviation | hours | Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose |
|
|
|
| Secondary | Time to Reach Maximum Observed Plasma Concentration (Tmax) in Cycle 4 | All participants treated who had at least 1 of the PK parameters of primary interest in extension cohorts. N=number of participants evaluable for the outcome measure. Summaries for figitumumab 20 mg/kg RP2D, and figitumumab 20 mg/kg RP2D ACC and sarcoma extension cohorts were combined into 1 reporting group: figitumumab 20 mg/kg RP2D every 3 weeks. | Posted | Mean | Standard Deviation | hours | Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose |
|
|
|
| Secondary | Plasma Decay Half-Life (t1/2) in Cycle 1 | Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. | All participants treated who had at least 1 of the PK parameters of primary interest. N=number of participants evaluable for the outcome measure. Summaries for figitumumab 20 mg/kg RP2D, and figitumumab 20 mg/kg RP2D ACC and sarcoma extension cohorts were combined into 1 reporting group: figitumumab 20 mg/kg RP2D every 3 weeks. | Posted | Mean | Standard Deviation | hours | Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose |
|
|
|
| Secondary | Plasma Decay Half-Life (t1/2) in Cycle 4 | Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. | All participants treated who had at least 1 of the PK parameters of primary interest in extension cohorts. N=number of participants evaluable for the outcome measure. Summaries for figitumumab 20 mg/kg RP2D, and figitumumab 20 mg/kg RP2D ACC and sarcoma extension cohorts were combined into 1 reporting group: figitumumab 20 mg/kg RP2D every 3 weeks. | Posted | Mean | Standard Deviation | hours | Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose |
|
|
|
| Secondary | Time to Reach Last Quantifiable Concentration (Tlast) in Cycle 1 | All participants treated who had at least 1 of the PK parameters of primary interest. N=number of participants evaluable for the outcome measure. Summaries for figitumumab 20 mg/kg RP2D, and figitumumab 20 mg/kg RP2D ACC and sarcoma extension cohorts were combined into 1 reporting group: figitumumab 20 mg/kg RP2D every 3 weeks. | Posted | Mean | Standard Deviation | hours | Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose |
|
|
|
| Secondary | Time to Reach Last Quantifiable Concentration (Tlast) in Cycle 4 | All participants treated who had at least 1 of the PK parameters of primary interest in extension cohorts. N=number of participants evaluable for the outcome measure. Summaries for figitumumab 20 mg/kg RP2D, and figitumumab 20 mg/kg RP2D ACC and sarcoma extension cohorts were combined into 1 reporting group: figitumumab 20 mg/kg RP2D every 3 weeks. | Posted | Mean | Standard Deviation | hours | Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose |
|
|
|
| Secondary | Systemic Clearance (CL) in Cycle 1 | CL is a quantitative measure of the rate at which a drug substance is removed from the body. | All participants treated who had at least 1 of the PK parameters of primary interest. N=number of participants evaluable for the outcome measure. Summaries for figitumumab 20 mg/kg RP2D, and figitumumab 20 mg/kg RP2D ACC and sarcoma extension cohorts were combined into 1 reporting group: figitumumab 20 mg/kg RP2D every 3 weeks. | Posted | Mean | Standard Deviation | milliliter/day/kilogram (mL/day/kg) | Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose |
|
|
|
| Secondary | Systemic Clearance (CL) in Cycle 4 | CL is a quantitative measure of the rate at which a drug substance is removed from the body. | All participants treated who had at least 1 of the PK parameters of primary interest in extension cohorts. N=number of participants evaluable for the outcome measure. Summaries for figitumumab 20 mg/kg RP2D, and figitumumab 20 mg/kg RP2D ACC and sarcoma extension cohorts were combined into 1 reporting group: figitumumab 20 mg/kg RP2D every 3 weeks. | Posted | Mean | Standard Deviation | mL/day/kg | Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose |
|
|
|
| Secondary | Concentration at End of Infusion (Cendinf) in Cycle 1 | All participants treated who had at least 1 of the PK parameters of primary interest. N=number of participants evaluable for the outcome measure. Summaries for figitumumab 20 mg/kg RP2D, and figitumumab 20 mg/kg RP2D ACC and sarcoma extension cohorts were combined into 1 reporting group: figitumumab 20 mg/kg RP2D every 3 weeks. | Posted | Mean | Standard Deviation | mg/L | Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose |
|
|
|
| Secondary | Concentration at End of Infusion (Cendinf) in Cycle 4 | All participants treated who had at least 1 of the PK parameters of primary interest in extension cohorts. N=number of participants evaluable for the outcome measure. Summaries for figitumumab 20 mg/kg RP2D, and figitumumab 20 mg/kg RP2D ACC and sarcoma extension cohorts were combined into 1 reporting group: figitumumab 20 mg/kg RP2D every 3 weeks. | Posted | Mean | Standard Deviation | mg/L | Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose |
|
|
|
| Secondary | Volume of Distribution (Vz) in Cycle 1 | Vz is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. | All participants treated who had at least 1 of the PK parameters of primary interest. N=number of participants evaluable for the outcome measure. Summaries for figitumumab 20 mg/kg RP2D, and figitumumab 20 mg/kg RP2D ACC and sarcoma extension cohorts were combined into 1 reporting group: figitumumab 20 mg/kg RP2D every 3 weeks. | Posted | Mean | Standard Deviation | milliliter/kilogram (mL/kg) | Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose |
|
|
|
| Secondary | Volume of Distribution (Vz) in Cycle 4 | Vz is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. | All participants treated who had at least 1 of the PK parameters of primary interest in extension cohorts. N=number of participants evaluable for the outcome measure. Summaries for figitumumab 20 mg/kg RP2D, and figitumumab 20 mg/kg RP2D ACC and sarcoma extension cohorts were combined into 1 reporting group: figitumumab 20 mg/kg RP2D every 3 weeks. | Posted | Mean | Standard Deviation | mL/kg | Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose |
|
|
|
| Secondary | Volume of Distribution at Steady State (Vss) in Cycle 1 | Vz is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Vss is the Vz at steady-state. | All participants treated who had at least 1 of the PK parameters of primary interest. N=number of participants evaluable for the outcome measure. Summaries for figitumumab 20 mg/kg RP2D, and figitumumab 20 mg/kg RP2D ACC and sarcoma extension cohorts were combined into 1 reporting group: figitumumab 20 mg/kg RP2D every 3 weeks. | Posted | Mean | Standard Deviation | mL/kg | Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose |
|
|
|
| Secondary | Volume of Distribution at Steady State (Vss) in Cycle 4 | Vz is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Vss is the Vz at steady-state. | All participants treated who had at least 1 of the PK parameters of primary interest in extension cohorts. N=number of participants evaluable for the outcome measure. Summaries for figitumumab 20 mg/kg RP2D, and figitumumab 20 mg/kg RP2D ACC and sarcoma extension cohorts were combined into 1 reporting group: figitumumab 20 mg/kg RP2D every 3 weeks. | Posted | Mean | Standard Deviation | mL/kg | Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose |
|
|
|
| Secondary | Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) in Cycle 1 | Area under the plasma concentration time-curve from zero to the last measured concentration | All participants treated who had at least 1 of the PK parameters of primary interest. N=number of participants evaluable for the outcome measure. Summaries for figitumumab 20 mg/kg RP2D, and figitumumab 20 mg/kg RP2D ACC and sarcoma extension cohorts were combined into 1 reporting group: figitumumab 20 mg/kg RP2D every 3 weeks. | Posted | Mean | Standard Deviation | milligram*hour/liter (mg*hr/L) | Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose |
|
|
|
| Secondary | Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) in Cycle 4 | Area under the plasma concentration time-curve from zero to the last measured concentration | All participants treated who had at least 1 of the PK parameters of primary interest in extension cohorts. N=number of participants evaluable for the outcome measure. Summaries for figitumumab 20 mg/kg RP2D, and figitumumab 20 mg/kg RP2D ACC and sarcoma extension cohorts were combined into 1 reporting group: figitumumab 20 mg/kg RP2D every 3 weeks. | Posted | Mean | Standard Deviation | mg*hr/L | Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose |
|
|
|
| Secondary | Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] in Cycle 1 | Area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (0 - ∞). | All participants treated who had at least 1 of the PK parameters of primary interest. N=number of participants evaluable for the outcome measure. Summaries for figitumumab 20 mg/kg RP2D, and figitumumab 20 mg/kg RP2D ACC and sarcoma extension cohorts were combined into 1 reporting group: figitumumab 20 mg/kg RP2D every 3 weeks. | Posted | Mean | Standard Deviation | mg*hr/L | Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose |
|
|
|
| Secondary | Area Under the Plasma Concentration-time Profile From Time 0 to 504 Hours (21 Days) (AUC504) in Cycle 1 | All participants treated who had at least 1 of the PK parameters of primary interest in all cohorts except ESFT extension cohort. N=number of participants evaluable for the outcome measure. Summaries for figitumumab 20 mg/kg RP2D, and RP2D ACC and sarcoma extension cohorts were combined into 1 reporting group: 20 mg/kg RP2D every 3 weeks. | Posted | Mean | Standard Deviation | mg*hr/L | Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose |
|
|
|
| Secondary | Area Under the Plasma Concentration-time Profile From Time 0 to 504 Hours (21 Days) (AUC504) in Cycle 4 | All participants treated who had at least 1 of the PK parameters of primary interest in all cohorts except ESFT extension cohort. N=number of participants evaluable for the outcome measure. Summaries for figitumumab 20 mg/kg RP2D, and RP2D ACC and sarcoma extension cohorts were combined into 1 reporting group: 20 mg/kg RP2D every 3 weeks. | Posted | Mean | Standard Deviation | mg*hr/L | Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose |
|
|
|
| Secondary | Area Under the Plasma Concentration-time Profile From Time 0 to 672 Hours (28 Days) (AUC672) in Cycle 1 | All participants treated who had at least 1 of the PK parameters of primary interest in RP2D ESFT extension cohort. N=number of participants evaluable for the outcome measure | Posted | Mean | Standard Deviation | mg*hr/L | Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose |
|
|
|
| Secondary | Area Under the Plasma Concentration-time Profile From Time 0 to 672 Hours (28 Days) (AUC672) in Cycle 4 | All participants treated who had at least 1 of the PK parameters of primary interest in RP2D ESFT extension cohort. N=number of participants evaluable for the outcome measure | Posted | Mean | Standard Deviation | mg*hr/L | Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose |
|
|
|
| Secondary | Human Anti-human Antibodies (HAHA) Levels | HAHA were indicators of immunogenicity to figitumumab. | Per protocol, the presence of HAHA would only be evaluated for those samples with plasma figitumumab concentrations below the limit of quantification (BLQ). Since none of the postdose samples in the study had figitumumab concentrations BLQ, therefore no sample was analyzed for HAHA. | Posted | 30 minutes predose in Cycles 1 up to 61, and last scheduled follow-up visit (up to 150 days from the last dose of study drug) |
|
|
| Secondary | Number of Circulating Tumor Cells (CTCs) | Quantification of CTCs using an automated microscope system | Pretreatment CTCs were detected in an insufficient number of participants to analyze for any treatment effect on this pharmacodynamic biomarker. | Posted | 30 minutes predose in all cycles (up to 17); 1, 3, 7, and 14 days postdose in Cycle 1 for dose escalation and RP2D extension cohorts; and also 1 day postdose in Cycle 4 for RP2D extension cohort |
|
|
| Secondary | Number of Insulin-like Growth Factor 1 Receptor (IGF-1R) Positive CTCs | Quantification of IGF-IR positive CTCs using an automated microscope system | Pretreatment IGF-1R positive CTCs were detected in an insufficient number of participants to analyze for any treatment effect on this pharmacodynamic biomarker. | Posted | 30 minutes predose in all cycles (up to 17); 1, 3, 7, and 14 days postdose in Cycle 1 for dose escalation and RP2D extension cohorts; and also 1 day postdose in Cycle 4 for RP2D extension cohort |
|
|
| 2 |
| 3 |
| 3 |
| 3 |
| EG001 | Figitumumab 6 mg/kg | Figitumumab 6 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort. | 1 | 3 | 3 | 3 |
| EG002 | Figitumumab 10 mg/kg | Figitumumab 10 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort. | 3 | 3 | 3 | 3 |
| EG003 | Figitumumab 20 mg/kg | Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort. | 1 | 3 | 3 | 3 |
| EG004 | Figitumumab 20 mg/kg RP2D | Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D extension cohort. | 5 | 13 | 13 | 13 |
| EG005 | Figitumumab 20 mg/kg RP2D ACC+Sarcoma | Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D ACC and sarcoma extension cohort. | 17 | 29 | 29 | 29 |
| EG006 | Figitumumab 20 mg/kg RP2D ESFT | Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (4 weeks in duration) for RP2D ESFT extension cohort. | 5 | 11 | 11 | 11 |
| Ascites | Gastrointestinal disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Ileus | Gastrointestinal disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Intestinal obstruction | Gastrointestinal disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Disease progression | General disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA version 13.1 | Non-systematic Assessment |
|
| Lower respiratory tract infection | Infections and infestations | MedDRA version 13.1 | Non-systematic Assessment |
|
| Lower respiratory tract infection viral | Infections and infestations | MedDRA version 13.1 | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA version 13.1 | Non-systematic Assessment |
|
| Staphylococcal infection | Infections and infestations | MedDRA version 13.1 | Non-systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA version 13.1 | Non-systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA version 13.1 | Non-systematic Assessment |
|
| Blood creatinine increased | Infections and infestations | MedDRA version 13.1 | Non-systematic Assessment |
|
| Blood culture positive | Investigations | MedDRA version 13.1 | Non-systematic Assessment |
|
| Blood uric acid increased | Investigations | MedDRA version 13.1 | Non-systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA version 13.1 | Non-systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA version 13.1 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Intracranial pressure increased | Nervous system disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Spinal cord compression | Nervous system disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Renal pain | Renal and urinary disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Female genital tract fistula | Reproductive system and breast disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Pneumomediastinum | Respiratory, thoracic and mediastinal disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Superior vena caval occlusion | Vascular disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Thrombosis | Vascular disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Lymphopenia | Blood and lymphatic system disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Ear congestion | Ear and labyrinth disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Ear pain | Ear and labyrinth disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Delayed puberty | Endocrine disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Goitre | Endocrine disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Conjunctivitis | Eye disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Dry eye | Eye disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Eye pain | Eye disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Eye pruritus | Eye disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Keratitis | Eye disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Miosis | Eye disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Ocular hyperaemia | Eye disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Cheilitis | Gastrointestinal disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Dental caries | Gastrointestinal disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Gingival bleeding | Gastrointestinal disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Haematochezia | Gastrointestinal disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Mouth haemorrhage | Gastrointestinal disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Oesophageal pain | Gastrointestinal disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Oral pain | Gastrointestinal disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Sensitivity of teeth | Gastrointestinal disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Tooth disorder | Gastrointestinal disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Catheter site pain | General disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Catheter site related reaction | General disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Chest pain | General disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Chills | General disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Crepitations | General disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Disease progression | General disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Feeling abnormal | General disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Gait disturbance | General disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Infusion related reaction | General disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Localised oedema | General disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Malaise | General disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Mass | General disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Mucosal inflammation | General disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Pain | General disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Graft versus host disease | Immune system disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Seasonal allergy | Immune system disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Eye infection | Infections and infestations | MedDRA version 13.1 | Non-systematic Assessment |
|
| Gastroenteritis viral | Infections and infestations | MedDRA version 13.1 | Non-systematic Assessment |
|
| Infection | Infections and infestations | MedDRA version 13.1 | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA version 13.1 | Non-systematic Assessment |
|
| Nail infection | Infections and infestations | MedDRA version 13.1 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA version 13.1 | Non-systematic Assessment |
|
| Oral candidiasis | Infections and infestations | MedDRA version 13.1 | Non-systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA version 13.1 | Non-systematic Assessment |
|
| Skin infection | Infections and infestations | MedDRA version 13.1 | Non-systematic Assessment |
|
| Staphylococcal infection | Infections and infestations | MedDRA version 13.1 | Non-systematic Assessment |
|
| Subcutaneous abscess | Infections and infestations | MedDRA version 13.1 | Non-systematic Assessment |
|
| Tinea pedis | Infections and infestations | MedDRA version 13.1 | Non-systematic Assessment |
|
| Tooth abscess | Infections and infestations | MedDRA version 13.1 | Non-systematic Assessment |
|
| Tooth infection | Infections and infestations | MedDRA version 13.1 | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA version 13.1 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA version 13.1 | Non-systematic Assessment |
|
| Vulvovaginal candidiasis | Infections and infestations | MedDRA version 13.1 | Non-systematic Assessment |
|
| Vulvovaginal mycotic infection | Infections and infestations | MedDRA version 13.1 | Non-systematic Assessment |
|
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA version 13.1 | Non-systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA version 13.1 | Non-systematic Assessment |
|
| Joint sprain | Injury, poisoning and procedural complications | MedDRA version 13.1 | Non-systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA version 13.1 | Non-systematic Assessment |
|
| Scratch | Injury, poisoning and procedural complications | MedDRA version 13.1 | Non-systematic Assessment |
|
| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA version 13.1 | Non-systematic Assessment |
|
| Activated partial thromboplastin time abnormal | Investigations | MedDRA version 13.1 | Non-systematic Assessment |
|
| Activated partial thromboplastin time prolonged | Investigations | MedDRA version 13.1 | Non-systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA version 13.1 | Non-systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA version 13.1 | Non-systematic Assessment |
|
| Bacterial test positive | Investigations | MedDRA version 13.1 | Non-systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA version 13.1 | Non-systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA version 13.1 | Non-systematic Assessment |
|
| Blood glucose increased | Investigations | MedDRA version 13.1 | Non-systematic Assessment |
|
| Blood magnesium increased | Investigations | MedDRA version 13.1 | Non-systematic Assessment |
|
| Blood phosphorus decreased | Investigations | MedDRA version 13.1 | Non-systematic Assessment |
|
| Blood potassium decreased | Investigations | MedDRA version 13.1 | Non-systematic Assessment |
|
| Blood potassium increased | Investigations | MedDRA version 13.1 | Non-systematic Assessment |
|
| Blood sodium decreased | Investigations | MedDRA version 13.1 | Non-systematic Assessment |
|
| Blood urea increased | Investigations | MedDRA version 13.1 | Non-systematic Assessment |
|
| Blood uric acid increased | Investigations | MedDRA version 13.1 | Non-systematic Assessment |
|
| Body temperature | Investigations | MedDRA version 13.1 | Non-systematic Assessment |
|
| Fungal test positive | Investigations | MedDRA version 13.1 | Non-systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA version 13.1 | Non-systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA version 13.1 | Non-systematic Assessment |
|
| International normalised ratio increased | Investigations | MedDRA version 13.1 | Non-systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA version 13.1 | Non-systematic Assessment |
|
| Neutrophil count increased | Investigations | MedDRA version 13.1 | Non-systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA version 13.1 | Non-systematic Assessment |
|
| Pulse abnormal | Investigations | MedDRA version 13.1 | Non-systematic Assessment |
|
| Urine leukocyte esterase positive | Investigations | MedDRA version 13.1 | Non-systematic Assessment |
|
| Weight decreased | Investigations | MedDRA version 13.1 | Non-systematic Assessment |
|
| Weight increased | Investigations | MedDRA version 13.1 | Non-systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA version 13.1 | Non-systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Hypermagnesaemia | Metabolism and nutrition disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Vitamin D deficiency | Metabolism and nutrition disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Limb discomfort | Musculoskeletal and connective tissue disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Trismus | Musculoskeletal and connective tissue disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Skin papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 13.1 | Non-systematic Assessment |
|
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 13.1 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Dizziness postural | Nervous system disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Hyporeflexia | Nervous system disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Lethargy | Nervous system disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Neuropathy peripheral | Nervous system disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Paralysis | Nervous system disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Phantom pain | Nervous system disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Sinus headache | Nervous system disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Adjustment disorder | Psychiatric disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Depressed mood | Psychiatric disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Azotaemia | Renal and urinary disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Microalbuminuria | Renal and urinary disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Renal impairment | Renal and urinary disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Urinary incontinence | Renal and urinary disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Erectile dysfunction | Reproductive system and breast disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Pelvic pain | Reproductive system and breast disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Scrotal pain | Reproductive system and breast disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Nasal discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Alopecia totalis | Skin and subcutaneous tissue disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Blister | Skin and subcutaneous tissue disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Blood blister | Skin and subcutaneous tissue disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Dermal cyst | Skin and subcutaneous tissue disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Nail disorder | Skin and subcutaneous tissue disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Onychoclasis | Skin and subcutaneous tissue disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Petechiae | Skin and subcutaneous tissue disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Skin discolouration | Skin and subcutaneous tissue disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Skin irritation | Skin and subcutaneous tissue disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Subcutaneous nodule | Skin and subcutaneous tissue disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Tooth extraction | Surgical and medical procedures | MedDRA version 13.1 | Non-systematic Assessment |
|
| Tooth repair | Surgical and medical procedures | MedDRA version 13.1 | Non-systematic Assessment |
|
| Flushing | Vascular disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Pallor | Vascular disorders | MedDRA version 13.1 | 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.
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D012509 | Sarcoma |