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

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00560560

First Posted: November 19, 2007

Last Update Posted: May 20, 2013

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by (Responsible Party):

Pfizer

Results First Submitted: January 18, 2013

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition:	Colorectal Neoplasm
Intervention:	Biological: CP-751, 871

Participant Flow

Hide Participant Flow

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

Baseline Characteristics

Hide Baseline Characteristics

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

Outcome Measures

Show All Outcome Measures

1. Primary:

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

Show Outcome Measure 1

2. Secondary:

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

Show Outcome Measure 2

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. ]

Show Outcome Measure 3

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 ]

Show Outcome Measure 4

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 ]

Show Outcome Measure 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) ]

Show Outcome Measure 6

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 ]

Show Outcome Measure 7

8. Secondary:

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

Show Outcome Measure 8

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

Show Other Adverse Events

Limitations and Caveats

Hide Limitations and Caveats

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.

More Information

Hide More Information

Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: 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.

Results Point of Contact:

Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com

Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT00560560 History of Changes
Other Study ID Numbers:	A4021006
First Submitted:	November 15, 2007
First Posted:	November 19, 2007
Results First Submitted:	January 18, 2013
Results First Posted:	May 9, 2013
Last Update Posted:	May 20, 2013

To Top