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

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
Figitumumab 20 mg/kg	Figitumumab (CP-751,871) was given in 3-week cycles for a total of up to 17 cycles. Participants can receive treatment beyond 17 cycles provided clinical benefit is being achieved. Figitumumab 20 milligram/kilogram (mg/kg) was administered as an intravenous (IV) infusion on Day 1 and 2 in Cycle 1 (loading dose), and on Day 1 of every cycle thereafter.
Figitumumab 30 mg/kg	Figitumumab (CP-751,871) was given in 3-week cycles for a total of up to 17 cycles. Participants can receive treatment beyond 17 cycles provided clinical benefit is being achieved. Figitumumab 30 milligram/kilogram (mg/kg) was administered as an IV infusion on Day 1 and 2 in Cycle 1 (loading dose), and on Day 1 of every cycle thereafter.

Participant Flow:   Overall Study

	Figitumumab 20 mg/kg	Figitumumab 30 mg/kg
STARTED	85	83
COMPLETED	0	0
NOT COMPLETED	85	83

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups

	Description
Figitumumab 20 mg/kg	Figitumumab (CP-751,871) was given in 3-week cycles for a total of up to 17 cycles. Participants can receive treatment beyond 17 cycles provided clinical benefit is being achieved. Figitumumab 20 milligram/kilogram (mg/kg) was administered as an intravenous (IV) infusion on Day 1 and 2 in Cycle 1 (loading dose), and on Day 1 of every cycle thereafter.
Figitumumab 30 mg/kg	Figitumumab (CP-751,871) was given in 3-week cycles for a total of up to 17 cycles. Participants can receive treatment beyond 17 cycles provided clinical benefit is being achieved. Figitumumab 30 milligram/kilogram (mg/kg) was administered as an IV infusion on Day 1 and 2 in Cycle 1 (loading dose), and on Day 1 of every cycle thereafter.
Total	Total of all reporting groups

Baseline Measures

	Figitumumab 20 mg/kg	Figitumumab 30 mg/kg	Total
Overall Participants Analyzed  [Units: Participants]	85	83	168
Age, Customized  [Units: Participants]
<65 years	56	59	115
>=65 years	29	24	53
Gender  [Units: Participants]
Female	39	35	74
Male	46	48	94

1.  Primary:

Estimate of the 6 Month Survival Probability   [ Time Frame: Baseline up to Month 6 ]

2.  Secondary:

Overall Survival   [ Time Frame: From date of enrollment until death or censorship, up to 33 months ]

3.  Secondary:

Progression-Free Survival (PFS)   [ Time Frame: 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. ]

4.  Secondary:

Percentage of Participants With Objective Response   [ Time Frame: 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 ]

5.  Secondary:

Descriptive Summary of Figitumumab Concentration Versus Time   [ Time Frame: 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 ]

6.  Secondary:

Participants Reporting Positive for Total Anti-drug Antibodies (ADA)   [ Time Frame: 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) ]

7.  Secondary:

Counts of Circulating Tumor Cells (CTCs) Expressing Positive Insulin-like Growth Factor 1 Receptor (IGF-1R)   [ Time Frame: Cycle 1 pre-dosing and Cycle 4 pre-dosing ]

8.  Secondary:

Counts of Circulating Tumor Cells (CTCs)   [ Time Frame: Cycle 1 pre-dosing and Cycle 4 pre-dosing ]

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.