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| ID | Type | Description | Link |
|---|---|---|---|
| CP13-0501 | Other Identifier | ImClone, LLC | |
| I5A-IE-JAEH | Other Identifier | Eli Lilly and Company |
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The purpose of this study is to determine if IMC-A12 is safe for participants, and also to determine the best dose of IMC-A12 to give to participants.
The purpose of this study is to establish the safety profile and maximum tolerated dose (MTD) of the anti-IGF-IR monoclonal antibody IMC-A12 administered weekly in participants with advanced solid tumors who no longer respond to standard therapy or for whom no standard therapy is available
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IMC-A12 | Experimental | All participants will receive intravenous (I.V.) infusions of IMC-A12, with the dose depending on which cohort they are enrolled into. A minimum of three participants will be enrolled in each cohort. When all participants complete a cohort, dose escalation to the next cohort will occur. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IMC-A12 | Biological | Cohort 1 3 milligrams/kilogram (mg/kg), I.V. once a week, for 4 weeks, followed by a 2-week observation period. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AEs) or Deaths | Data presented are the number of participants who experienced serious adverse events (SAEs), other non-serious AEs and deaths during the study including the 30-day follow-up. A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Event module. | Enrollment to study completion up to 215 weeks |
| Maximum Tolerated Dose (MTD) | The MTD was defined as the dose preceding the dose level at which 2 participants experienced a dose-limiting toxicity (DLT). A DLT was defined as any Grade 3 or 4 hematologic or nonhematologic toxicity based on Common Terminology Criteria for AE (CTCAE), excluding alopecia, which was considered by the investigator to be definitely, probably, or possibly related to IMC-A12. | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Concentration (Cmax) of IMC-A12 Following Multiple Doses | Predose, 0.5, 1, 2, 4, 8, 24, 48, 96, 168, 264 and 336 hours after the infusion of Cycle 1 | |
| Observed Serum Concentration of IMC-A12 at 168 Hour Post End of Infusion Following Multiple Doses |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ImClone Investigational Site | Scottsdale | Arizona | 85258 | United States | ||
| ImClone Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25749986 | Derived | Higano CS, Berlin J, Gordon M, LoRusso P, Tang S, Dontabhaktuni A, Schwartz JD, Cosaert J, Mehnert JM. Safety, tolerability, and pharmacokinetics of single and multiple doses of intravenous cixutumumab (IMC-A12), an inhibitor of the insulin-like growth factor-I receptor, administered weekly or every 2 weeks in patients with advanced solid tumors. Invest New Drugs. 2015 Apr;33(2):450-62. doi: 10.1007/s10637-015-0217-7. Epub 2015 Mar 7. |
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After completion of the 10 milligrams/kilogram (mg/kg) cohort, PK data were obtained that established a recommended dose for Phase 2 studies. Enrollment and dose escalation beyond 15 mg/kg was stopped. Participants with progressive disease (PD) or death were considered to have completed the study.
For participants enrolled under Protocol Versions 1.0 and 2.0, there was a 2-week pharmacokinetic (PK) period prior to Cycle 1.
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| ID | Title | Description |
|---|---|---|
| FG000 | 3 mg/kg | 3 mg/kg IMC-A12 administered intravenously (I.V.) on Day 1 of a 2-week PK period prior to Cycle 1. 3 mg/kg IMC-A12 administered I.V. once a week for 4 weeks, for a total of 4 doses per cycle. Cycle 1 was followed by a 2-week observation. Participants with an objective response after Cycle 1 could have received additional treatment cycles at the same dose and schedule until disease progression or withdrawal criteria were met. Participants with stable disease (SD) could have received up to 2 additional 4-week treatment cycles at the same dose and schedule. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| PK Period |
|
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| IMC-A12 | Biological | Cohort 2 6 mg/kg, I.V. once a week, for 4 weeks, followed by a 2-week observation period. |
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| IMC-A12 | Biological | Cohort 3 10 mg/kg, I.V. once a week, for 4 weeks, followed by a 2-week observation period. |
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| IMC-A12 | Biological | Cohort 4 15 mg/kg, I.V. once a week, for 4 weeks, followed by a 2-week observation period. |
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| IMC-A12 | Biological | Cohort 5 21 mg/kg, I.V. once a week, for 4 weeks, followed by a 2-week observation period. |
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| IMC-A12 | Biological | Cohort 6 27 mg/kg, I.V. once a week, for 4 weeks, followed by a 2-week observation period. |
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| Predose, 0.5, 1, 2, 4, 8, 24, 48, 96, 168, 264 and 336 hours after the infusion of Cycle 1 |
| Area Under the Serum Concentration Versus Time Curve of IMC-A12 During One Dosing Interval (AUCÏ„) Following Multiple Doses | Predose, 0.5, 1, 2, 4, 8, 24, 48, 96, 168, 264 and 336 hours after the infusion of Cycle 1 |
| Half-Life (t1/2) of IMC-A12 Following Multiple Doses | Half-Life (t1/2) is the time measured for the plasma concentration of the drug to decrease by one half. The analysis was not performed for the 6 mg/kg and 10 mg/kg dosing groups due to insufficient PK data. | Predose, 0.5, 1, 2, 4, 8, 24, 48, 96, 168, 264 and 336 hours after the infusion of Cycle 1 |
| Clearance Rate of IMC-A12 at Steady State (CLss) Following Multiple Doses | CLss is the volume of plasma (or blood) from which the drug is completely removed, or cleared, in a given time at steady-state. | Predose, 0.5, 1, 2, 4, 8, 24, 48, 96, 168, 264 and 336 hours after the infusion of Cycle 1 |
| Volume of Distribution of IMC-A12 at Steady State (Vss) Following Multiple Doses | Vss 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 at steady-state. The analysis was not performed for the 6 mg/kg and 10 mg/kg dosing groups due to insufficient PK data. | Predose, 0.5, 1, 2, 4, 8, 24, 48, 96, 168, 264 and 336 hours after the infusion of Cycle 1 |
| Serum Anti-IMC-A12 Antibody Assessment (Immunogenicity) | Analysis was not performed due to lack of available assay. | Before the last infusion of each treatment cycle |
| Number of Participants With Best Overall Response | Stable Disease (SD) is neither sufficient shrinkage to qualify for partial response (PR) nor sufficient increase to qualify for progressive disease (PD). PR and PD were assessed by investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.0. PR is ≥30% decrease in sum of longest diameter of target lesions. PD is ≥20% increase in sum of longest diameter of target lesions and/or a new lesion. Participants with a global deterioration of their health status requiring discontinuation of treatment without objective evidence of disease progression at that time were to be reported as "symptomatic deterioration" | Enrollment to study completion up to 215 weeks |
| Detroit |
| Michigan |
| 48201 |
| United States |
| ImClone Investigational Site | Seattle | Washington | 98109 | United States |
| FG001 | 6 mg/kg | 6 mg/kg IMC-A12 administered I.V. on Day 1 of a 2-week PK period prior to Cycle 1. 6 mg/kg IMC-A12 administered I.V. once a week for 4 weeks, for a total of 4 doses per cycle. Cycle 1 was followed by a 2-week observation. Participants with an objective response after Cycle 1 could have received additional treatment cycles at the same dose and schedule until disease progression or withdrawal criteria were met. Participants with SD could have received up to 2 additional 4-week treatment cycles at the same dose and schedule. |
| FG002 | 10 mg/kg | 10 mg/kg IMC-A12 administered I.V. on Day 1 of a 2-week PK period prior to Cycle 1. 10 mg/kg IMC-A12 administered I.V. once a week for 4 weeks, for a total of 4 doses per cycle. Cycle 1 was followed by a 2-week observation. Participants with an objective response after Cycle 1 could have received additional treatment cycles at the same dose and schedule until disease progression or withdrawal criteria were met. Participants with SD could have received up to 2 additional 4-week treatment cycles at the same dose and schedule. |
| FG003 | 15 mg/kg | 15 mg/kg IMC-A12 administered I.V. once a week for 4 weeks, for a total of 4 doses per cycle. Cycle 1 was followed by a 2-week observation. Participants with an objective response after Cycle 1 could have received additional treatment cycles at the same dose and schedule until disease progression or withdrawal criteria were met. Participants with SD could have received up to 2 additional 4-week treatment cycles at the same dose and schedule. |
| COMPLETED |
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| NOT COMPLETED |
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| Treatment Period |
|
|
All enrolled participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | 3 mg/kg | 3 mg/kg IMC-A12 administered I.V. on Day 1 of a 2-week PK period prior to Cycle 1. 3 mg/kg IMC-A12 administered I.V. once a week for 4 weeks, for a total of 4 doses per cycle. Cycle 1 was followed by a 2-week observation. Participants with an objective response after Cycle 1 could have received additional treatment cycles at the same dose and schedule until disease progression or withdrawal criteria were met. Participants with SD could have received up to 2 additional 4-week treatment cycles at the same dose and schedule. |
| BG001 | 6 mg/kg | 6 mg/kg IMC-A12 administered I.V. on Day 1 of a 2-week PK period prior to Cycle 1. 6 mg/kg IMC-A12 administered I.V. once a week for 4 weeks, for a total of 4 doses per cycle. Cycle 1 was followed by a 2-week observation. Participants with an objective response after Cycle 1 could have received additional treatment cycles at the same dose and schedule until disease progression or withdrawal criteria were met. Participants with SD could have received up to 2 additional 4-week treatment cycles at the same dose and schedule. |
| BG002 | 10 mg/kg | 10 mg/kg IMC-A12 administered I.V. on Day 1 of a 2-week PK period prior to Cycle 1. 10 mg/kg IMC-A12 administered I.V. once a week for 4 weeks, for a total of 4 doses per cycle. Cycle 1 was followed by a 2-week observation. Participants with an objective response after Cycle 1 could have received additional treatment cycles at the same dose and schedule until disease progression or withdrawal criteria were met. Participants with SD could have received up to 2 additional 4-week treatment cycles at the same dose and schedule. |
| BG003 | 15 mg/kg | 15 mg/kg IMC-A12 administered I.V. once a week for 4 weeks, for a total of 4 doses per cycle. Cycle 1 was followed by a 2-week observation. Participants with an objective response after Cycle 1 could have received additional treatment cycles at the same dose and schedule until disease progression or withdrawal criteria were met. Participants with SD could have received up to 2 additional 4-week treatment cycles at the same dose and schedule. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
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| 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) or Deaths | Data presented are the number of participants who experienced serious adverse events (SAEs), other non-serious AEs and deaths during the study including the 30-day follow-up. A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Event module. | All enrolled participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | No | Enrollment to study completion up to 215 weeks |
|
|
| ||||||||||||||||||||||||||||||||||
| Primary | Maximum Tolerated Dose (MTD) | The MTD was defined as the dose preceding the dose level at which 2 participants experienced a dose-limiting toxicity (DLT). A DLT was defined as any Grade 3 or 4 hematologic or nonhematologic toxicity based on Common Terminology Criteria for AE (CTCAE), excluding alopecia, which was considered by the investigator to be definitely, probably, or possibly related to IMC-A12. | All participants who received at least 1 dose of study drug and completed Cycle 1 and 2-week observation or discontinued treatment for an IMC-A12-related toxicity. | Posted | Number | mg/kg | 6 weeks |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Maximum Concentration (Cmax) of IMC-A12 Following Multiple Doses | All participants who received study drug and had PK data available to calculate Cmax. | Posted | Geometric Mean | Geometric Coefficient of Variation | micrograms/milliliter (µg/mL) | Predose, 0.5, 1, 2, 4, 8, 24, 48, 96, 168, 264 and 336 hours after the infusion of Cycle 1 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Observed Serum Concentration of IMC-A12 at 168 Hour Post End of Infusion Following Multiple Doses | All participants who received study drug and had PK data available to calculate Cmin. | Posted | Geometric Mean | Geometric Coefficient of Variation | µg/mL | Predose, 0.5, 1, 2, 4, 8, 24, 48, 96, 168, 264 and 336 hours after the infusion of Cycle 1 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Area Under the Serum Concentration Versus Time Curve of IMC-A12 During One Dosing Interval (AUCτ) Following Multiple Doses | All participants who received study drug and had PK data available to calculate AUCτ. | Posted | Geometric Mean | Geometric Coefficient of Variation | micrograms*hour/milliliter (µg*h/mL | Predose, 0.5, 1, 2, 4, 8, 24, 48, 96, 168, 264 and 336 hours after the infusion of Cycle 1 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Half-Life (t1/2) of IMC-A12 Following Multiple Doses | Half-Life (t1/2) is the time measured for the plasma concentration of the drug to decrease by one half. The analysis was not performed for the 6 mg/kg and 10 mg/kg dosing groups due to insufficient PK data. | All participants who received study drug and had PK data available to calculate t1/2. Zero participants were analyzed for the 6 mg/kg and 10 mg/kg dosing groups due to insufficient PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | days | Predose, 0.5, 1, 2, 4, 8, 24, 48, 96, 168, 264 and 336 hours after the infusion of Cycle 1 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Clearance Rate of IMC-A12 at Steady State (CLss) Following Multiple Doses | CLss is the volume of plasma (or blood) from which the drug is completely removed, or cleared, in a given time at steady-state. | All participants who received study drug and had PK data available to calculate CLss. | Posted | Geometric Mean | Geometric Coefficient of Variation | Liters/hour (L/h) | Predose, 0.5, 1, 2, 4, 8, 24, 48, 96, 168, 264 and 336 hours after the infusion of Cycle 1 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Volume of Distribution of IMC-A12 at Steady State (Vss) Following Multiple Doses | Vss 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 at steady-state. The analysis was not performed for the 6 mg/kg and 10 mg/kg dosing groups due to insufficient PK data. | All participants who received study drug and had PK data available to calculate Vss. Zero participants were analyzed for the 6 mg/kg and 10 mg/kg dosing groups due to insufficient PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | Liters (L) | Predose, 0.5, 1, 2, 4, 8, 24, 48, 96, 168, 264 and 336 hours after the infusion of Cycle 1 |
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| Secondary | Serum Anti-IMC-A12 Antibody Assessment (Immunogenicity) | Analysis was not performed due to lack of available assay. | Zero participants were analyzed due to lack of available assay. | Posted | Before the last infusion of each treatment cycle |
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| Secondary | Number of Participants With Best Overall Response | Stable Disease (SD) is neither sufficient shrinkage to qualify for partial response (PR) nor sufficient increase to qualify for progressive disease (PD). PR and PD were assessed by investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.0. PR is ≥30% decrease in sum of longest diameter of target lesions. PD is ≥20% increase in sum of longest diameter of target lesions and/or a new lesion. Participants with a global deterioration of their health status requiring discontinuation of treatment without objective evidence of disease progression at that time were to be reported as "symptomatic deterioration" | All enrolled participants. | Posted | Count of Participants | Participants | No | Enrollment to study completion up to 215 weeks |
|
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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 | 3 mg/kg | 3 mg/kg IMC-A12 administered I.V. on Day 1 of a 2-week PK period prior to Cycle 1. 3 mg/kg IMC-A12 administered I.V. once a week for 4 weeks, for a total of 4 doses per cycle. Cycle 1 was followed by a 2-week observation. Participants with an objective response after Cycle 1 could have received additional treatment cycles at the same dose and schedule until disease progression or withdrawal criteria were met. Participants with SD could have received up to 2 additional 4-week treatment cycles at the same dose and schedule. | 2 | 7 | 7 | 7 | ||
| EG001 | 6 mg/kg | 6 mg/kg IMC-A12 administered I.V. on Day 1 of a 2-week PK period prior to Cycle 1. 6 mg/kg IMC-A12 administered I.V. once a week for 4 weeks, for a total of 4 doses per cycle. Cycle 1 was followed by a 2-week observation. Participants with an objective response after Cycle 1 could have received additional treatment cycles at the same dose and schedule until disease progression or withdrawal criteria were met. Participants with SD could have received up to 2 additional 4-week treatment cycles at the same dose and schedule. | 3 | 9 | 8 | 9 | ||
| EG002 | 10 mg/kg | 10 mg/kg IMC-A12 administered I.V. on Day 1 of a 2-week PK period prior to Cycle 1. 10 mg/kg IMC-A12 administered I.V. once a week for 4 weeks, for a total of 4 doses per cycle. Cycle 1 was followed by a 2-week observation. Participants with an objective response after Cycle 1 could have received additional treatment cycles at the same dose and schedule until disease progression or withdrawal criteria were met. Participants with SD could have received up to 2 additional 4-week treatment cycles at the same dose and schedule. | 2 | 6 | 6 | 6 | ||
| EG003 | 15 mg/kg | 15 mg/kg IMC-A12 administered I.V. once a week for 4 weeks, for a total of 4 doses per cycle. Cycle 1 was followed by a 2-week observation. Participants with an objective response after Cycle 1 could have received additional treatment cycles at the same dose and schedule until disease progression or withdrawal criteria were met. Participants with SD could have received up to 2 additional 4-week treatment cycles at the same dose and schedule. | 0 | 2 | 2 | 2 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| DIARRHOEA | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
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| DUODENAL ULCER HAEMORRHAGE | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
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| NAUSEA | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
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| VOMITING | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
| |
| ASTHENIA | General disorders | MedDRA 8.0 | Systematic Assessment |
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| DISEASE PROGRESSION | General disorders | MedDRA 8.0 | Systematic Assessment |
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| NON-CARDIAC CHEST PAIN | General disorders | MedDRA 8.0 | Systematic Assessment |
| |
| BACTERAEMIA | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
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| PNEUMONIA | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
| |
| DEHYDRATION | Metabolism and nutrition disorders | MedDRA 8.0 | Systematic Assessment |
| |
| CANCER PAIN | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 8.0 | Systematic Assessment |
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| PELVIC PAIN | Reproductive system and breast disorders | MedDRA 8.0 | Systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | Systematic Assessment |
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| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | Systematic Assessment |
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| HAEMOPTYSIS | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | Systematic Assessment |
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| PNEUMONIA ASPIRATION | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | Systematic Assessment |
| |
| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 8.0 | Systematic Assessment |
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| IRON DEFICIENCY ANAEMIA | Blood and lymphatic system disorders | MedDRA 8.0 | Systematic Assessment |
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| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 8.0 | Systematic Assessment |
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| BRADYCARDIA | Cardiac disorders | MedDRA 8.0 | Systematic Assessment |
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| DIASTOLIC DYSFUNCTION | Cardiac disorders | MedDRA 8.0 | Systematic Assessment |
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| TACHYCARDIA | Cardiac disorders | MedDRA 8.0 | Systematic Assessment |
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| VISUAL DISTURBANCE | Eye disorders | MedDRA 8.0 | Systematic Assessment |
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| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
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| ASCITES | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
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| CONSTIPATION | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
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| DIARRHOEA | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
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| DYSPEPSIA | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
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| FAECES DISCOLOURED | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
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| FOOD POISONING | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
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| GASTROOESOPHAGEAL REFLUX DISEASE | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
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| GINGIVAL PAIN | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
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| NAUSEA | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
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| ORAL PAIN | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
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| RECTAL PROLAPSE | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
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| TOOTHACHE | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
| |
| UPPER GASTROINTESTINAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
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| VOMITING | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
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| ASTHENIA | General disorders | MedDRA 8.0 | Systematic Assessment |
| |
| CHEST DISCOMFORT | General disorders | MedDRA 8.0 | Systematic Assessment |
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| CHILLS | General disorders | MedDRA 8.0 | Systematic Assessment |
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| EARLY SATIETY | General disorders | MedDRA 8.0 | Systematic Assessment |
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| FATIGUE | General disorders | MedDRA 8.0 | Systematic Assessment |
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| GAIT DISTURBANCE | General disorders | MedDRA 8.0 | Systematic Assessment |
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| INFUSION RELATED REACTION | General disorders | MedDRA 8.0 | Systematic Assessment |
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| NODULE | General disorders | MedDRA 8.0 | Systematic Assessment |
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| NON-CARDIAC CHEST PAIN | General disorders | MedDRA 8.0 | Systematic Assessment |
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| OEDEMA PERIPHERAL | General disorders | MedDRA 8.0 | Systematic Assessment |
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| PAIN | General disorders | MedDRA 8.0 | Systematic Assessment |
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| HEPATIC PAIN | Hepatobiliary disorders | MedDRA 8.0 | Systematic Assessment |
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| FUNGAL INFECTION | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
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| GASTROENTERITIS VIRAL | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
| |
| HELICOBACTER INFECTION | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
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| INFLUENZA | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
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| RESPIRATORY TRACT INFECTION VIRAL | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
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| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
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| URINARY TRACT INFECTION | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
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| VIRAL INFECTION | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
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| INCISION SITE COMPLICATION | Injury, poisoning and procedural complications | MedDRA 8.0 | Systematic Assessment |
| |
| THERMAL BURN | Injury, poisoning and procedural complications | MedDRA 8.0 | Systematic Assessment |
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| DENTAL EXAMINATION ABNORMAL | Investigations | MedDRA 8.0 | Systematic Assessment |
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| SPUTUM ABNORMAL | Investigations | MedDRA 8.0 | Systematic Assessment |
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| WEIGHT DECREASED | Investigations | MedDRA 8.0 | Systematic Assessment |
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| WEIGHT INCREASED | Investigations | MedDRA 8.0 | Systematic Assessment |
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| ANOREXIA | Metabolism and nutrition disorders | MedDRA 8.0 | Systematic Assessment |
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| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA 8.0 | Systematic Assessment |
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| DEHYDRATION | Metabolism and nutrition disorders | MedDRA 8.0 | Systematic Assessment |
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| HYPERGLYCAEMIA | Metabolism and nutrition disorders | MedDRA 8.0 | Systematic Assessment |
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| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 8.0 | Systematic Assessment |
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| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 8.0 | Systematic Assessment |
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| BONE PAIN | Musculoskeletal and connective tissue disorders | MedDRA 8.0 | Systematic Assessment |
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| CHEST WALL PAIN | Musculoskeletal and connective tissue disorders | MedDRA 8.0 | Systematic Assessment |
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| COSTOCHONDRITIS | Musculoskeletal and connective tissue disorders | MedDRA 8.0 | Systematic Assessment |
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| FLANK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 8.0 | Systematic Assessment |
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| MUSCLE SPASMS | Musculoskeletal and connective tissue disorders | MedDRA 8.0 | Systematic Assessment |
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| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA 8.0 | Systematic Assessment |
| |
| OSTEONECROSIS | Musculoskeletal and connective tissue disorders | MedDRA 8.0 | Systematic Assessment |
| |
| OSTEOPENIA | Musculoskeletal and connective tissue disorders | MedDRA 8.0 | Systematic Assessment |
| |
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA 8.0 | Systematic Assessment |
| |
| SHOULDER PAIN | Musculoskeletal and connective tissue disorders | MedDRA 8.0 | Systematic Assessment |
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| DIZZINESS | Nervous system disorders | MedDRA 8.0 | Systematic Assessment |
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| HEADACHE | Nervous system disorders | MedDRA 8.0 | Systematic Assessment |
| |
| SENSORY DISTURBANCE | Nervous system disorders | MedDRA 8.0 | Systematic Assessment |
| |
| INSOMNIA | Psychiatric disorders | MedDRA 8.0 | Systematic Assessment |
| |
| MICTURITION URGENCY | Renal and urinary disorders | MedDRA 8.0 | Systematic Assessment |
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| NEPHROPATHY TOXIC | Renal and urinary disorders | MedDRA 8.0 | Systematic Assessment |
| |
| URINARY INCONTINENCE | Renal and urinary disorders | MedDRA 8.0 | Systematic Assessment |
| |
| PELVIC PAIN | Reproductive system and breast disorders | MedDRA 8.0 | Systematic Assessment |
| |
| TESTICULAR PAIN | Reproductive system and breast disorders | MedDRA 8.0 | Systematic Assessment |
| |
| VAGINAL DISCHARGE | Reproductive system and breast disorders | MedDRA 8.0 | Systematic Assessment |
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| BREATH SOUNDS DECREASED | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | Systematic Assessment |
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| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | Systematic Assessment |
| |
| CRACKLES LUNG | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | Systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | Systematic Assessment |
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| DYSPNOEA EXERTIONAL | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | Systematic Assessment |
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| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | Systematic Assessment |
| |
| HAEMOPTYSIS | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | Systematic Assessment |
| |
| NASAL CONGESTION | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | Systematic Assessment |
| |
| PHARYNGOLARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | Systematic Assessment |
| |
| POSTNASAL DRIP | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | Systematic Assessment |
| |
| RHINORRHOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | Systematic Assessment |
| |
| WHEEZING | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | Systematic Assessment |
| |
| ACNE | Skin and subcutaneous tissue disorders | MedDRA 8.0 | Systematic Assessment |
| |
| DRY SKIN | Skin and subcutaneous tissue disorders | MedDRA 8.0 | Systematic Assessment |
| |
| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA 8.0 | Systematic Assessment |
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| PSORIASIS | Skin and subcutaneous tissue disorders | MedDRA 8.0 | Systematic Assessment |
| |
| RASH | Skin and subcutaneous tissue disorders | MedDRA 8.0 | Systematic Assessment |
| |
| URTICARIA | Skin and subcutaneous tissue disorders | MedDRA 8.0 | Systematic Assessment |
| |
| VARICOSE VEIN | Vascular disorders | MedDRA 8.0 | Systematic Assessment |
|
Investigators agreed to delay independently publishing or disclosing data, findings or conclusions from the study except as part of a multi-center publication. Upon study publication or if the draft publication is not produced within approximately 6 months of the final report of the study results, investigators may independently publish, subject to confidential information review/redaction by sponsor. The sponsor may request publication delay up to 90 days to seek patent protection.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| C557414 | cixutumumab |
Not provided
Not provided
Not provided
| Withdrawal by Subject |
|
| Male |
|
| Black |
|
| Asian |
|
| Hispanic |
|
| Unknown |
|
| AEs |
|
| Death due to PD |
|
| OG002 | 10 mg/kg | 10 mg/kg IMC-A12 administered I.V. on Day 1 of a 2-week PK period prior to Cycle 1. 10 mg/kg IMC-A12 administered I.V. once a week for 4 weeks, for a total of 4 doses per cycle. Cycle 1 was followed by a 2-week observation. Participants with an objective response after Cycle 1 could have received additional treatment cycles at the same dose and schedule until disease progression or withdrawal criteria were met. Participants with SD could have received up to 2 additional 4-week treatment cycles at the same dose and schedule. |
| OG003 | 15 mg/kg | 15 mg/kg IMC-A12 administered I.V. once a week for 4 weeks, for a total of 4 doses per cycle. Cycle 1 was followed by a 2-week observation. Participants with an objective response after Cycle 1 could have received additional treatment cycles at the same dose and schedule until disease progression or withdrawal criteria were met. Participants with SD could have received up to 2 additional 4-week treatment cycles at the same dose and schedule. |
|
|
| OG002 |
| 10 mg/kg |
10 mg/kg IMC-A12 administered I.V. on Day 1 of a 2-week PK period prior to Cycle 1. 10 mg/kg IMC-A12 administered I.V. once a week for 4 weeks, for a total of 4 doses per cycle. Cycle 1 was followed by a 2-week observation. Participants with an objective response after Cycle 1 could have received additional treatment cycles at the same dose and schedule until disease progression or withdrawal criteria were met. Participants with SD could have received up to 2 additional 4-week treatment cycles at the same dose and schedule. |
| OG003 | 15 mg/kg | 15 mg/kg IMC-A12 administered I.V. once a week for 4 weeks, for a total of 4 doses per cycle. Cycle 1 was followed by a 2-week observation. Participants with an objective response after Cycle 1 could have received additional treatment cycles at the same dose and schedule until disease progression or withdrawal criteria were met. Participants with SD could have received up to 2 additional 4-week treatment cycles at the same dose and schedule. |
|
|
| OG002 | 10 mg/kg | 10 mg/kg IMC-A12 administered I.V. on Day 1 of a 2-week PK period prior to Cycle 1. 10 mg/kg IMC-A12 administered I.V. once a week for 4 weeks, for a total of 4 doses per cycle. Cycle 1 was followed by a 2-week observation. Participants with an objective response after Cycle 1 could have received additional treatment cycles at the same dose and schedule until disease progression or withdrawal criteria were met. Participants with SD could have received up to 2 additional 4-week treatment cycles at the same dose and schedule. |
| OG003 | 15 mg/kg | 15 mg/kg IMC-A12 administered I.V. once a week for 4 weeks, for a total of 4 doses per cycle. Cycle 1 was followed by a 2-week observation. Participants with an objective response after Cycle 1 could have received additional treatment cycles at the same dose and schedule until disease progression or withdrawal criteria were met. Participants with SD could have received up to 2 additional 4-week treatment cycles at the same dose and schedule. |
|
|
| OG002 | 10 mg/kg | 10 mg/kg IMC-A12 administered I.V. on Day 1 of a 2-week PK period prior to Cycle 1. 10 mg/kg IMC-A12 administered I.V. once a week for 4 weeks, for a total of 4 doses per cycle. Cycle 1 was followed by a 2-week observation. Participants with an objective response after Cycle 1 could have received additional treatment cycles at the same dose and schedule until disease progression or withdrawal criteria were met. Participants with SD could have received up to 2 additional 4-week treatment cycles at the same dose and schedule. |
| OG003 | 15 mg/kg | 15 mg/kg IMC-A12 administered I.V. once a week for 4 weeks, for a total of 4 doses per cycle. Cycle 1 was followed by a 2-week observation. Participants with an objective response after Cycle 1 could have received additional treatment cycles at the same dose and schedule until disease progression or withdrawal criteria were met. Participants with SD could have received up to 2 additional 4-week treatment cycles at the same dose and schedule. |
|
|
| OG002 | 10 mg/kg | 10 mg/kg IMC-A12 administered I.V. on Day 1 of a 2-week PK period prior to Cycle 1. 10 mg/kg IMC-A12 administered I.V. once a week for 4 weeks, for a total of 4 doses per cycle. Cycle 1 was followed by a 2-week observation. Participants with an objective response after Cycle 1 could have received additional treatment cycles at the same dose and schedule until disease progression or withdrawal criteria were met. Participants with SD could have received up to 2 additional 4-week treatment cycles at the same dose and schedule. |
| OG003 | 15 mg/kg | 15 mg/kg IMC-A12 administered I.V. once a week for 4 weeks, for a total of 4 doses per cycle. Cycle 1 was followed by a 2-week observation. Participants with an objective response after Cycle 1 could have received additional treatment cycles at the same dose and schedule until disease progression or withdrawal criteria were met. Participants with SD could have received up to 2 additional 4-week treatment cycles at the same dose and schedule. |
|
|
| OG002 | 10 mg/kg | 10 mg/kg IMC-A12 administered I.V. on Day 1 of a 2-week PK period prior to Cycle 1. 10 mg/kg IMC-A12 administered I.V. once a week for 4 weeks, for a total of 4 doses per cycle. Cycle 1 was followed by a 2-week observation. Participants with an objective response after Cycle 1 could have received additional treatment cycles at the same dose and schedule until disease progression or withdrawal criteria were met. Participants with SD could have received up to 2 additional 4-week treatment cycles at the same dose and schedule. |
| OG003 | 15 mg/kg | 15 mg/kg IMC-A12 administered I.V. once a week for 4 weeks, for a total of 4 doses per cycle. Cycle 1 was followed by a 2-week observation. Participants with an objective response after Cycle 1 could have received additional treatment cycles at the same dose and schedule until disease progression or withdrawal criteria were met. Participants with SD could have received up to 2 additional 4-week treatment cycles at the same dose and schedule. |
|
|
| OG002 | 10 mg/kg | 10 mg/kg IMC-A12 administered I.V. on Day 1 of a 2-week PK period prior to Cycle 1. 10 mg/kg IMC-A12 administered I.V. once a week for 4 weeks, for a total of 4 doses per cycle. Cycle 1 was followed by a 2-week observation. Participants with an objective response after Cycle 1 could have received additional treatment cycles at the same dose and schedule until disease progression or withdrawal criteria were met. Participants with SD could have received up to 2 additional 4-week treatment cycles at the same dose and schedule. |
| OG003 | 15 mg/kg | 15 mg/kg IMC-A12 administered I.V. once a week for 4 weeks, for a total of 4 doses per cycle. Cycle 1 was followed by a 2-week observation. Participants with an objective response after Cycle 1 could have received additional treatment cycles at the same dose and schedule until disease progression or withdrawal criteria were met. Participants with SD could have received up to 2 additional 4-week treatment cycles at the same dose and schedule. |
|
|
| 10 mg/kg |
10 mg/kg IMC-A12 administered I.V. on Day 1 of a 2-week PK period prior to Cycle 1. 10 mg/kg IMC-A12 administered I.V. once a week for 4 weeks, for a total of 4 doses per cycle. Cycle 1 was followed by a 2-week observation. Participants with an objective response after Cycle 1 could have received additional treatment cycles at the same dose and schedule until disease progression or withdrawal criteria were met. Participants with SD could have received up to 2 additional 4-week treatment cycles at the same dose and schedule. |
| OG003 | 15 mg/kg | 15 mg/kg IMC-A12 administered I.V. once a week for 4 weeks, for a total of 4 doses per cycle. Cycle 1 was followed by a 2-week observation. Participants with an objective response after Cycle 1 could have received additional treatment cycles at the same dose and schedule until disease progression or withdrawal criteria were met. Participants with SD could have received up to 2 additional 4-week treatment cycles at the same dose and schedule. |
|
| OG002 | 10 mg/kg | 10 mg/kg IMC-A12 administered I.V. on Day 1 of a 2-week PK period prior to Cycle 1. 10 mg/kg IMC-A12 administered I.V. once a week for 4 weeks, for a total of 4 doses per cycle. Cycle 1 was followed by a 2-week observation. Participants with an objective response after Cycle 1 could have received additional treatment cycles at the same dose and schedule until disease progression or withdrawal criteria were met. Participants with SD could have received up to 2 additional 4-week treatment cycles at the same dose and schedule. |
| OG003 | 15 mg/kg | 15 mg/kg IMC-A12 administered I.V. once a week for 4 weeks, for a total of 4 doses per cycle. Cycle 1 was followed by a 2-week observation. Participants with an objective response after Cycle 1 could have received additional treatment cycles at the same dose and schedule until disease progression or withdrawal criteria were met. Participants with SD could have received up to 2 additional 4-week treatment cycles at the same dose and schedule. |
|
|