Evaluating ABX-EGF (Panitumumab) Monotherapy in Subjects With Metastatic Colorectal Cancer Following Treatment With Fluoropyrimidine, Irinotecan, and Oxaliplatin Chemotherapy

This study has been completed.

Study NCT00083616 Information provided by Amgen

First Received on May 26, 2004. Last Updated on June 30, 2011 History of Changes

Results First Received: August 6, 2010

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Conditions:	Colorectal Cancer Metastatic Cancer
Intervention:	Drug: ABX-EGF (panitumumab)

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
Participants were enrolled from 1 March 2004 through 19 Jul 2006

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
Panitumumab (ABX-EGF)	Open-label panitumumab administered by intravenous (IV) infusion at a dose of 6 mg/kg given once every 2 weeks until participants developed progressive disease, were unable to tolerate panitumumab, or discontinued treatment for other reasons.

Participant Flow: Overall Study

	Panitumumab (ABX-EGF)
STARTED	185
Received Study Medication	182
COMPLETED	154 ^[1]
NOT COMPLETED	31
Disease Progression	16
Lost to Follow-up	1
Physician Decision	2
Withdrawal by Subject	3
Ineligibility determined	2
Non-compliance	1
Other	6

[1]	Completed safety followup; participants who died on study were treated as having completed study

Baseline Characteristics

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Reporting Groups

	Description
Panitumumab	Open-label panitumumab administered by intravenous (IV) infusion at a dose of 6 mg/kg given once every 2 weeks until participants developed progressive disease, were unable to tolerate panitumumab, or discontinued treatment for other reasons.

Baseline Measures

	Panitumumab
Number of Participants [units: participants]	185
Age [units: Years] Mean ± Standard Deviation	59.6 ± 10.6
Gender [units: Participants]
Female	85
Male	100
Race/Ethnicity, Customized [units: Participants]
American Indian or Alaska Native	0
Asian	4
Black or African American	15
Hispanic or Latino	19
Japanese	0
Native Hawaiian or Other Pacific Islander	1
White or Caucasian	144
Other	2
Aborigine	0

Outcome Measures

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1. Primary:

Duration of Response [ Time Frame: Until disease progression (median 7 weeks) ]

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2. Primary:

Objective Tumor Response Through Week 16 [ Time Frame: 16 weeks ]

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3. Secondary:

Objective Tumor Response Throughout Study [ Time Frame: Until disease progression (median 7 weeks) ]

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4. Secondary:

Time to Response [ Time Frame: Until disease progression (median 7 weeks) ]

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5. Secondary:

Progression-free Survival Time [ Time Frame: Until disease progression (median 7 weeks) ]

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6. Secondary:

Time to Disease Progression [ Time Frame: Until disease progression (median 7 weeks) ]

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7. Secondary:

Time to Treatment Failure [ Time Frame: Until disease progression (median 7 weeks) ]

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8. Secondary:

Duration of Stable Disease [ Time Frame: Until disease progression (median 7 weeks) ]

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9. Secondary:

Overall Survival [ Time Frame: Until disease progression (median 7 weeks) ]

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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: The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multi-center studies, the investigator agrees not to publish any results before the first multi-center publication.

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: Study Director
Organization: Amgen Inc.
phone: 866-572-6436

No publications provided

Responsible Party:	Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier:	NCT00083616 History of Changes
Obsolete Identifiers:	NCT00087243
Other Study ID Numbers:	20030167
Study First Received:	May 26, 2004
Results First Received:	August 6, 2010
Last Updated:	June 30, 2011
Health Authority:	United States: Food and Drug Administration