Study Using CP-751,871 In Patients With Stage IV Colorectal Cancer That Has Not Responded To Previous Anti-Cancer Treatments

Study Overview
=================
Brief Summary
-----------------
This study will test if there is any survival benefit in patients with refractory metastatic colorectal cancer that receive CP-751, 871.

Official Title
-----------------
A Phase II, Single Arm Study Of CP-751,871 In Patients With Refractory Metastatic Adenocarcinoma Of The Colon Or Rectum

Conditions
-----------------
Colorectal Neoplasm

Intervention / Treatment
-----------------
* Biological: CP-751, 871


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who have stage IV colorectal cancer Patients whose disease has worsened despite prior anti-cancer therapy Patients who have satisfactory bonemarrow, kidney and liver function Exclusion Criteria: Patients who are being simultaneously treated with another anti-cancer therapy. Patients who have previously received anti-cancer therapy that works like CP-751, 871 (targets insulin-like growth factor receptor) Patients that are pregnant or breast-feeding

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Single arm study | Biological: CP-751, 871<br>* Human IgG2 Monoclonal Antibody. 20mg/kg or 30 mg/kg every 3 weeks for 17 cycles, until progression or unacceptable toxicity develops.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estimate of the 6 Month Survival Probability | The 6 month survival probability was defined as the probability of survival at 6 months based on the Kaplan-Meier estimate. The time was from date of enrollment to date of death due to any cause. For participants who were last known to be alive, overall survival was censored at the last contact date. | Baseline up to Month 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival | The time from date of enrollment to date of death due to any cause. For participants who were last known to be alive, overall survival was censored at the last contact date. | From date of enrollment until death or censorship, up to 33 months | 
| Progression-Free Survival (PFS) | The period from study entry until disease progression. Participants without progression or death were censored at time of last disease assessment. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as 20% increase in the sum of longest diameters of target measurable lesions, or a clear increase in a non-target lesion, or the apprearance of new lesions. | Baseline until tumor progression or censorship, up to 33 months. The frequency of tumor assessments was screening, every cycle, end of treatment (within 28 days of last dose of study drug), and follow-up. | 
| Percentage of Participants With Objective Response | Percentage of participants with OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as complete disappearance of all target and non-target disease. PR applied only to participants with at least one measurable lesion. Greater than or equal to 30 % decrease under baseline of the sum of longest diameters of all target measurable lesions. | Baseline, every cycle (Day 15-21 or according to local standard), end of treatment (within 28 days of last dose of study drug) and follow-up (150 days after last dose of study drug), up to 33 months | 
| Descriptive Summary of Figitumumab Concentration Versus Time | The measurement of mean plasma concentration of figitumumab in Day 1 of Cycle 1,2,3,4,5 | Pre-dose on Day 1, 1 hour after end of infusion (post-dose) on Day 2 in Cycle 1, pre-dose on Day 1 in Cycles 2,3,4, 1 hour post-dose on Day 1 in Cycle 5 | 
| Participants Reporting Positive for Total Anti-drug Antibodies (ADA) | The immunogenicity of figitumumab in terms of producing an antidrug antibody (ADA) response were monitored. | Up to 2 hours prior to infusion in Cycles 1 and 4, at the end of treatment, and at the 4th scheduled follow-up visit ( 150 days after the last infusion) | 
| Counts of Circulating Tumor Cells (CTCs) Expressing Positive Insulin-like Growth Factor 1 Receptor (IGF-1R) | The quantification of circulating tumor cells (CTCs) expressing the IGF-1R in this patient population. Blood samples were collected, and were measured using an automated microscope system. | Cycle 1 pre-dosing and Cycle 4 pre-dosing | 
| Counts of Circulating Tumor Cells (CTCs) | The quantification of circulating tumor cells (CTCs)in this patient population. Blood samples were collected, and were measured using an automated microscope system. | Cycle 1 pre-dosing and Cycle 4 pre-dosing | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Phase 2, Refractory Colorectal, Single arm