Not provided
Not provided
Not provided
Not provided
Not provided
See termination reason in detailed description.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study is primarily to evaluate the single dose pharmacokinetics of CP-751,871 and its effect on QT interval prolongation.
This study was terminated on October 30th, 2009. While the study was terminated due to adverse events and altered benefit/risk ratio in healthy subjects, the findings in healthy volunteers are not considered to alter the benefit/risk evaluation of figitumumab in cancer patients. No changes due to the termination of this study are anticipated in the conduct of the ongoing cancer patient studies with figitumumab at this time.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 10 mg/kg cohort | Experimental |
| |
| 20 mg/kg cohort | Experimental |
| |
| 20/20 mg/kg cohort | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CP-751,871 | Biological | single dose, 1-hr IV infusion |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) | Day 1 pre-dose and 1 hour post-dose, Day 2 (24 hours post-dose), 8, 15, 22, 29, 43, 57, 71 and 85 | |
| Area Under the Curve From Time Zero to the Last Time Point With Quantifiable Concentration (AUClast) | Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) | Day 1 pre-dose and 1 hour post-dose, Day 2 (24 hours post-dose), 8, 15, 22, 29, 43, 57, 71 and 85 |
| Plasma Clearance (CL) | Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. | Day 1 pre-dose and 1 hour post-dose, Day 2 (24 hours post-dose), 8, 15, 22, 29, 43, 57, 71 and 85 |
| Apparent Volume of Distribution (Vz) | Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. | Day 1 pre-dose and 1 hour post-dose, Day 2 (24 hours post-dose), 8, 15, 22, 29, 43, 57, 71 and 85 |
| Plasma Decay Half-Life (t1/2) | Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. | Day 1 pre-dose and 1 hour post-dose, Day 2 (24 hours post-dose), 8, 15, 22, 29, 43, 57, 71 and 85 |
| QTc Using Fridericia's Correction Method (QTcF) After Receiving CP-751,871 at the 20/20 mg/kg Dose Level | QTcF is the time from electrocardiogram Q wave to the end of the T wave corresponding to electrical systole, corrected for heart rate using Fridericia's correction |
| Measure | Description | Time Frame |
|---|---|---|
| QTcF After Receiving Moxifloxacin at the Historical Moxifloxacin Median Tmax of 3 Hours | baseline, 3 hours postdose | |
| Serum Concentration of Insulin-like Growth Factor 1 (IGF-1) | IGF-1 is one of the IGF-axis related biomarkers. Part of the secondary objectives of the study was to explore the relationships of plasma CP-751,871 concentrations to such biomarkers. Cmax is the mean ± standard deviation (SD) concentration observed at the time of maximal change from baseline. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | New Haven | Connecticut | 06511-5473 | United States |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
Not provided
Study participants were planned to be assigned to 1 of 3 sequential dosing cohorts: CP-751,871 at 10 mg/kg; at 20 mg/kg; 2 doses of 20 mg/kg on consecutive days. Dosing was via intravenous (IV) administration. The third dosing cohort (2 doses of 20 mg/kg on consecutive days) did not enroll participants due to early termination of the study.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | CP-751,871 10 mg/kg | A single dose of CP-751,871 at 10 mg/kg following an 8 hour fast, administered via 1-hour IV infusion. |
| FG001 | CP-751,871 20 mg/kg | A single dose of CP-751,871 at 20 mg/kg following an 8 hour fast, administered via 1-hour IV infusion. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | CP-751,871 10 mg/kg | A single dose of CP-751,871 at 10 mg/kg following an 8 hour fast, administered via 1-hour IV infusion. |
| BG001 | CP-751,871 20 mg/kg | A single dose of CP-751,871 at 20 mg/kg following an 8 hour fast, administered via 1-hour IV infusion. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Maximum Observed Plasma Concentration (Cmax) | All treated participants. | Posted | Mean | Standard Deviation | mg/L | Day 1 pre-dose and 1 hour post-dose, Day 2 (24 hours post-dose), 8, 15, 22, 29, 43, 57, 71 and 85 |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CP-751,871 10 mg/kg | A single dose of CP-751,871 at 10 mg/kg following an 8 hour fast, administered via 1-hour IV infusion. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphadenitis | Blood and lymphatic system disorders | MedDRA v13.0 | Non-systematic Assessment |
This study was terminated prior to enrollment of participants into Cohort 3 (2 doses of 20 mg/kg on consecutive days). Therefore, endpoints relating to that cohort were not assessed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| C525021 | figitumumab |
| D000077266 | Moxifloxacin |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| CP-751,871 |
| Biological |
single dose, 1-hr IV infusion |
|
| CP-751,871, moxifloxacin, saline | Biological | Two doses at 20 mg/kg each on two consecutive days, each administered via 1-hr IV infusion |
|
| Day 1 at 1 and 24 hours post-dose, Day 7, 28 |
| Day 1 pre-dose (Baseline), 1 hour post dose, Day 2 (24 hours post-dose), Day 8, 15, 22, 29, 43, 57, 71, 85 |
| Serum Concentration of Free Insulin-like Growth Factor 1 (IGF-1) | IGF-1 is one of the IGF-axis related biomarkers. Part of the secondary objectives of the study was to explore the relationships of plasma CP-751,871 concentrations to such biomarkers. Cmax is the mean ± standard deviation (SD) concentration observed at the time of maximal change from baseline. | Day 1 pre-dose, 1 hour post dose, Day 2 (24 hours post-dose), Day 8, 15, 22, 29, 43, 57, 71, 85 |
| Serum Concentration of Insulin-like Growth Factor 2 (IGF-2) | IGF-2 is one of the IGF-axis related biomarkers. Part of the secondary objectives of the study was to explore the relationships of plasma CP-751,871 concentrations to such biomarkers. Cmax is the mean ± standard deviation (SD) concentration observed at the time of maximal change from baseline. | Day 1 pre-dose, 1 hour post dose, Day 2 (24 hours post-dose), Day 8, 15, 22, 29, 43, 57, 71, 85 |
| Serum Concentration of Insulin-like Growth Factor Binding Protein 3 (IGFBP-3) | IGFBP-3 is one of the IGF-axis related biomarkers. Part of the secondary objectives of the study was to explore the relationships of plasma CP-751,871 concentrations to such biomarkers. Cmax is the mean ± standard deviation (SD) concentration observed at the time of maximal change from baseline. | Day 1 pre-dose, 1 hour post dose, Day 2 (24 hours post-dose), Day 8, 15, 22, 29, 43, 57, 71, 85 |
| Serum Concentration of Insulin | Insulin is one of the IGF-axis related biomarkers. Part of the secondary objectives of the study was to explore the relationships of plasma CP-751,871 concentrations to such biomarkers. Cmax is the mean ± standard deviation (SD) concentration observed at the time of maximal change from baseline. | Day 1 pre-dose, 1 hour post dose, Day 2 (24 hours post-dose), Day 8, 15, 22, 29, 43, 57, 71, 85 |
| Serum Concentration of Fasting Glucose | Glucose is one of the IGF-axis related biomarkers. Part of the secondary objectives of the study was to explore the relationships of plasma CP-751,871 concentrations to such biomarkers. Cmax is the mean ± standard deviation (SD) concentration observed at the time of maximal change from baseline. | Day 1 pre-dose, 1 hour post dose, Day 2 (24 hours post-dose), Day 8, 15, 22, 29, 43, 57, 71, 85 |
| Anti-drug Antibodies (ADA) Against CP-751,871 in Serum Samples | Number of participants who tested positive for ADA | Day 1 pre-dose, Day 15, 29, 57, 85 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Primary | Area Under the Curve From Time Zero to the Last Time Point With Quantifiable Concentration (AUClast) | Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) | All treated participants. | Posted | Mean | Standard Deviation | mg*h/L | Day 1 pre-dose and 1 hour post-dose, Day 2 (24 hours post-dose), 8, 15, 22, 29, 43, 57, 71 and 85 |
|
|
|
| Primary | Plasma Clearance (CL) | Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. | All treated and evaluable participants (had measurements related to the PK parameter stated above). | Posted | Mean | Standard Deviation | mL/day/kg | Day 1 pre-dose and 1 hour post-dose, Day 2 (24 hours post-dose), 8, 15, 22, 29, 43, 57, 71 and 85 |
|
|
|
| Primary | Apparent Volume of Distribution (Vz) | Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. | All treated and evaluable participants (had measurements related to the PK parameter stated above). | Posted | Mean | Standard Deviation | mL/kg | Day 1 pre-dose and 1 hour post-dose, Day 2 (24 hours post-dose), 8, 15, 22, 29, 43, 57, 71 and 85 |
|
|
|
| Primary | Plasma Decay Half-Life (t1/2) | Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. | All treated and evaluable participants (had measurements related to the PK parameter stated above). | Posted | Mean | Standard Deviation | days | Day 1 pre-dose and 1 hour post-dose, Day 2 (24 hours post-dose), 8, 15, 22, 29, 43, 57, 71 and 85 |
|
|
|
| Primary | QTc Using Fridericia's Correction Method (QTcF) After Receiving CP-751,871 at the 20/20 mg/kg Dose Level | QTcF is the time from electrocardiogram Q wave to the end of the T wave corresponding to electrical systole, corrected for heart rate using Fridericia's correction | Data not obtained due to early termination of the study. | Posted | Day 1 at 1 and 24 hours post-dose, Day 7, 28 |
|
|
| Secondary | QTcF After Receiving Moxifloxacin at the Historical Moxifloxacin Median Tmax of 3 Hours | Data not obtained due to early termination of the study. | Posted | baseline, 3 hours postdose |
|
|
| Secondary | Serum Concentration of Insulin-like Growth Factor 1 (IGF-1) | IGF-1 is one of the IGF-axis related biomarkers. Part of the secondary objectives of the study was to explore the relationships of plasma CP-751,871 concentrations to such biomarkers. Cmax is the mean ± standard deviation (SD) concentration observed at the time of maximal change from baseline. | All treated participants who had at least 1 postdose concentration measurement. | Posted | Mean | Standard Deviation | ng/mL | Day 1 pre-dose (Baseline), 1 hour post dose, Day 2 (24 hours post-dose), Day 8, 15, 22, 29, 43, 57, 71, 85 |
|
|
|
| Secondary | Serum Concentration of Free Insulin-like Growth Factor 1 (IGF-1) | IGF-1 is one of the IGF-axis related biomarkers. Part of the secondary objectives of the study was to explore the relationships of plasma CP-751,871 concentrations to such biomarkers. Cmax is the mean ± standard deviation (SD) concentration observed at the time of maximal change from baseline. | All treated participants who had at least 1 postdose concentration measurement. | Posted | Mean | Standard Deviation | ng/mL | Day 1 pre-dose, 1 hour post dose, Day 2 (24 hours post-dose), Day 8, 15, 22, 29, 43, 57, 71, 85 |
|
|
|
| Secondary | Serum Concentration of Insulin-like Growth Factor 2 (IGF-2) | IGF-2 is one of the IGF-axis related biomarkers. Part of the secondary objectives of the study was to explore the relationships of plasma CP-751,871 concentrations to such biomarkers. Cmax is the mean ± standard deviation (SD) concentration observed at the time of maximal change from baseline. | All treated participants who had at least 1 postdose concentration measurement. | Posted | Mean | Standard Deviation | ng/mL | Day 1 pre-dose, 1 hour post dose, Day 2 (24 hours post-dose), Day 8, 15, 22, 29, 43, 57, 71, 85 |
|
|
|
| Secondary | Serum Concentration of Insulin-like Growth Factor Binding Protein 3 (IGFBP-3) | IGFBP-3 is one of the IGF-axis related biomarkers. Part of the secondary objectives of the study was to explore the relationships of plasma CP-751,871 concentrations to such biomarkers. Cmax is the mean ± standard deviation (SD) concentration observed at the time of maximal change from baseline. | All treated participants who had at least 1 postdose concentration measurement. | Posted | Mean | Standard Deviation | ng/mL | Day 1 pre-dose, 1 hour post dose, Day 2 (24 hours post-dose), Day 8, 15, 22, 29, 43, 57, 71, 85 |
|
|
|
| Secondary | Serum Concentration of Insulin | Insulin is one of the IGF-axis related biomarkers. Part of the secondary objectives of the study was to explore the relationships of plasma CP-751,871 concentrations to such biomarkers. Cmax is the mean ± standard deviation (SD) concentration observed at the time of maximal change from baseline. | All treated participants who had at least 1 postdose concentration measurement. | Posted | Mean | Standard Deviation | mIU/mL | Day 1 pre-dose, 1 hour post dose, Day 2 (24 hours post-dose), Day 8, 15, 22, 29, 43, 57, 71, 85 |
|
|
|
| Secondary | Serum Concentration of Fasting Glucose | Glucose is one of the IGF-axis related biomarkers. Part of the secondary objectives of the study was to explore the relationships of plasma CP-751,871 concentrations to such biomarkers. Cmax is the mean ± standard deviation (SD) concentration observed at the time of maximal change from baseline. | All treated participants who had at least 1 postdose concentration measurement. | Posted | Mean | Standard Deviation | mg/dL | Day 1 pre-dose, 1 hour post dose, Day 2 (24 hours post-dose), Day 8, 15, 22, 29, 43, 57, 71, 85 |
|
|
|
| Secondary | Anti-drug Antibodies (ADA) Against CP-751,871 in Serum Samples | Number of participants who tested positive for ADA | All treated participants. | Posted | Number | number of participants | Day 1 pre-dose, Day 15, 29, 57, 85 |
|
|
|
| 0 |
| 16 |
| 9 |
| 16 |
| EG001 | CP-751,871 20 mg/kg | A single dose of CP-751,871 at 20 mg/kg following an 8 hour fast, administered via 1-hour IV infusion. | 0 | 12 | 12 | 12 |
| Cerumen impaction | Ear and labyrinth disorders | MedDRA v13.0 | Non-systematic Assessment |
|
| Ear discomfort | Ear and labyrinth disorders | MedDRA v13.0 | Non-systematic Assessment |
|
| Hypoacusis | Ear and labyrinth disorders | MedDRA v13.0 | Non-systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | MedDRA v13.0 | Non-systematic Assessment |
|
| Conjunctivitis allergic | Eye disorders | MedDRA v13.0 | Non-systematic Assessment |
|
| Dry eye | Eye disorders | MedDRA v13.0 | Non-systematic Assessment |
|
| Keratoconjunctivitis sicca | Eye disorders | MedDRA v13.0 | Non-systematic Assessment |
|
| Ocular hyperaemia | Eye disorders | MedDRA v13.0 | Non-systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA v13.0 | Non-systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA v13.0 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA v13.0 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA v13.0 | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA v13.0 | Non-systematic Assessment |
|
| Gingival pain | Gastrointestinal disorders | MedDRA v13.0 | Non-systematic Assessment |
|
| Hyperchlorhydria | Gastrointestinal disorders | MedDRA v13.0 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA v13.0 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA v13.0 | Non-systematic Assessment |
|
| Asthenia | General disorders | MedDRA v13.0 | Non-systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA v13.0 | Non-systematic Assessment |
|
| Chest pain | General disorders | MedDRA v13.0 | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA v13.0 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA v13.0 | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA v13.0 | Non-systematic Assessment |
|
| Chlamydial infection | Infections and infestations | MedDRA v13.0 | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA v13.0 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA v13.0 | Non-systematic Assessment |
|
| Periorbital cellulitis | Infections and infestations | MedDRA v13.0 | Non-systematic Assessment |
|
| Respiratory tract infection viral | Infections and infestations | MedDRA v13.0 | Non-systematic Assessment |
|
| Viral upper respiratory tract infection | Infections and infestations | MedDRA v13.0 | Non-systematic Assessment |
|
| Head injury | Injury, poisoning and procedural complications | MedDRA v13.0 | Non-systematic Assessment |
|
| Multiple injuries | Injury, poisoning and procedural complications | MedDRA v13.0 | Non-systematic Assessment |
|
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA v13.0 | Non-systematic Assessment |
|
| Thermal burn | Injury, poisoning and procedural complications | MedDRA v13.0 | Non-systematic Assessment |
|
| Audiogram abnormal | Investigations | MedDRA v13.0 | Non-systematic Assessment |
|
| Echocardiogram abnormal | Investigations | MedDRA v13.0 | Non-systematic Assessment |
|
| Heart rate irregular | Investigations | MedDRA v13.0 | Non-systematic Assessment |
|
| Schirmer's test abnormal | Investigations | MedDRA v13.0 | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v13.0 | Non-systematic Assessment |
|
| Muscle twitching | Musculoskeletal and connective tissue disorders | MedDRA v13.0 | Non-systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA v13.0 | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA v13.0 | Non-systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA v13.0 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA v13.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA v13.0 | Non-systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA v13.0 | Non-systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA v13.0 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v13.0 | Non-systematic Assessment |
|
| Dry throat | Respiratory, thoracic and mediastinal disorders | MedDRA v13.0 | Non-systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA v13.0 | Non-systematic Assessment |
|
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA v13.0 | Non-systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA v13.0 | Non-systematic Assessment |
|
| Hair growth abnormal | Skin and subcutaneous tissue disorders | MedDRA v13.0 | Non-systematic Assessment |
|
| Nail discolouration | Skin and subcutaneous tissue disorders | MedDRA v13.0 | 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.
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| Nominal Day 29 |
|
| Nominal Day 57 |
|
| Nominal Day 85 |
|