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:

Information provided by (Responsible Party):

Pfizer

ClinicalTrials.gov Identifier:

NCT00560560

First received: November 15, 2007

Last updated: May 16, 2013

Last verified: May 2013

History of Changes

Results First Received: January 18, 2013

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Colorectal Neoplasm
Intervention:	Biological: CP-751, 871

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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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

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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
Number of Participants [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

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1. Primary:

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

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2. Secondary:

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

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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. ]

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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 ]

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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 ]

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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) ]

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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 ]

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8. Secondary:

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

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Serious Adverse Events

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Other Adverse Events

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More Information

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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.

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
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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

No publications provided

Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT00560560 History of Changes
Other Study ID Numbers:	A4021006
Study First Received:	November 15, 2007
Results First Received:	January 18, 2013
Last Updated:	May 16, 2013
Health Authority:	United States: Food and Drug Administration

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