All Drugs and Chemicals

Hypoglycemic Agents

Antibodies

Antibodies, Monoclonal

Insulin

Insulin, Globin Zinc

Immunoglobulins

Mitogens

Immunologic Factors

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.

Cohort 1

3 milligrams/kilogram (mg/kg), I.V. once a week, for 4 weeks, followed by a 2-week observation period.

IMC-A12

Cohort 2

6 mg/kg, I.V. once a week, for 4 weeks, followed by a 2-week observation period.

Cohort 3

10 mg/kg, I.V. once a week, for 4 weeks, followed by a 2-week observation period.

Cohort 4

15 mg/kg, I.V. once a week, for 4 weeks, followed by a 2-week observation period.

Cohort 5

21 mg/kg, I.V. once a week, for 4 weeks, followed by a 2-week observation period.

Cohort 6

27 mg/kg, I.V. once a week, for 4 weeks, followed by a 2-week observation period.

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)

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

A Study of IMC-A12 in Participants With Tumors Who No Longer Respond to Treatment or For Whom No Treatment is Available

Phase I Study of Anti-Insulin-Like Growth Factor-I Receptor (IGF-IR) Monoclonal Antibody IMC-A12 in Patients With Advanced Solid Tumors Who No Longer Respond to Standard Therapy or for Whom No Standard Therapy is Available

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.

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.

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.

CLss is the volume of plasma (or blood) from which the drug is completely removed, or cleared, in a given time at steady-state.

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.

Analysis was not performed due to lack of available assay.

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"

Eli Lilly and Company

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.

3 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.

6 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.

10 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.

15 mg/kg

Total

Age, Continuous

Sex: Female, Male

White

Black

Asian

Hispanic

Unknown

Race/Ethnicity, Customized

United States

Region of Enrollment

Chief Medical Officer

SAEs

Death due to PD

All enrolled participants who received at least 1 dose of study drug.

Number of Participants With Adverse Events (AEs) or Deaths

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.

Maximum Tolerated Dose (MTD)

All participants who received study drug and had PK data available to calculate Cmax.

Maximum Concentration (Cmax) of IMC-A12 Following Multiple Doses

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.

All participants who received study drug and had PK data available to calculate Cmin.

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 AUCτ.

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 t1/2. Zero participants were analyzed for the 6 mg/kg and 10 mg/kg dosing groups due to insufficient PK data.

Half-Life (t1/2) of IMC-A12 Following Multiple Doses

All participants who received study drug and had PK data available to calculate CLss.

Clearance Rate of IMC-A12 at Steady State (CLss) Following Multiple Doses

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.

Volume of Distribution of IMC-A12 at Steady State (Vss) Following Multiple Doses

Zero participants were analyzed due to lack of available assay.

Serum Anti-IMC-A12 Antibody Assessment (Immunogenicity)

Stable Disease (SD)

Progressive Disease (PD)

Symptomatic Deterioration

Not Evaluable

Partial Response (PR)

Number of Participants With Best Overall Response

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.

Spots Global Cancer Trial Database for A Study of IMC-A12 in Participants With Tumors Who No Longer Respond to Treatment or For Whom No Treatment is Available

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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