PRISM (Panitumumab Regimen In Second-line Monotherapy of Head and Neck Cancer)

The recruitment status of this study is unknown because the information has not been verified recently.

Verified January 2011 by Amgen.
Recruitment status was Active, not recruiting

Sponsor:

Information provided by:

Amgen

ClinicalTrials.gov Identifier:

NCT00446446

First received: March 8, 2007

Last updated: January 20, 2011

Last verified: January 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

March 8, 2007

Last Updated Date

January 20, 2011

Start Date ^ICMJE

May 2007

Estimated Primary Completion Date

December 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

To estimate the effect of second-line panitumumab monotherapy on objective response rate in patients with metastatic or recurrent squamous cell carcinoma of the head and neck [ Time Frame: 70 days ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

To estimate the effect of panitumumab on objective response rate by end of treatment period

Change History

Complete list of historical versions of study NCT00446446 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Duration of response [ Time Frame: 70 days ] [ Designated as safety issue: No ]
Rate of disease control [ Time Frame: 70 days ] [ Designated as safety issue: No ]
Exploratory [ Time Frame: 70 days ] [ Designated as safety issue: No ]
Time to progression (TTP) [ Time Frame: 70 days ] [ Designated as safety issue: No ]
Progression free survival (PFS) [ Time Frame: 70 days ] [ Designated as safety issue: No ]
Overall survival (OS) [ Time Frame: 70 days ] [ Designated as safety issue: No ]
Safety [ Time Frame: 70 days ] [ Designated as safety issue: No ]
Time to response [ Time Frame: 70 days ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Time to response
Duration of response
Rate of disease control
Time to progression (TTP)
Progression free survival (PFS)
Overall survival (OS)
Safety

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

PRISM (Panitumumab Regimen In Second-line Monotherapy of Head and Neck Cancer)

Official Title ^ICMJE

Phase 2, Single-Arm, Open-Label, Multi-Center Trial of Second-Line Panitumumab Monotherapy in Patients With Metastatic or Recurrent Squamous Cell Carcinoma of the Head and Neck

Brief Summary

This is an open-label, single-arm, phase 2, multi-center, clinical trial of panitumumab monotherapy for second-line treatment of metastatic or recurrent squamous cell carcinoma of head and neck (SCCHN) subjects. This study will be conducted in North America. Approximately 50 subjects with histologically or cytologically confirmed metastatic and/or recurrent SCCHN will be enrolled into the trial.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Cancer
Carcinoma
Head and Neck Cancer
Metastases
Metastatic Cancer
Metastatic or Recurrent Squamous Cell Carcinoma of Head and Neck
Oncology
Squamous Cell Carcinoma
Tumors

Intervention ^ICMJE

Drug: Panitumumab

Single Arm Monotherapy Study

Study Arm (s)

Experimental: panitumumab

Single Arm Monotherapy Study

Intervention: Drug: Panitumumab

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Estimated Completion Date

July 2011

Estimated Primary Completion Date

December 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Histologically or cytologically confirmed squamous cell carcinoma of head and neck (SCCHN) of oropharynx, oral cavity, hypopharynx, or larynx with at least 1 measurable lesion using CT or MRI scan
Diagnosis of recurrent disease determined to be incurable by surgery or radiotherapy
Karnofsky Performance Status (KPS) score ≥ 60% at screening
Men or women age ≥18 years
Adequate hematologic, electrolyte and hepatic functions and negative pregnancy test

Exclusion Criteria:

Subject received > 1 chemotherapy regimen for the treatment of metastatic or recurrent disease
Concomitant chemotherapy for recurrent disease administered solely for the purpose of radiation sensitization during re-irradiation will not be counted towards this chemotherapy regimen
Nasopharyngeal carcinoma, salivary gland and primary skin SCCHN, or symptomatic central nervous system (CNS) metastases
History of interstitial lung disease, significant cardiovascular disease, or another primary cancer
Known positive test for human immunodeficiency virus (HIV) infection, hepatitis C virus, acute or chronic hepatitis B infection
Known allergy or hypersensitivity to any component of panitumumab
Prior anti-epidermal growth factor receptor (EGFr) antibody therapy (eg, panitumumab, cetuximab) or treatment with small molecule EGFr inhibitors (eg, gefitinib, erlotinib, lapatinib) for recurrent or metastatic disease with the following exceptions: - Prior EGFr inhibitor therapy is allowed if received as part of prior multimodality treatment (eg, as radiation sensitizer) and completed > 24 weeks prior to randomization
Subjects who received no more than one dose of cetuximab and discontinued prior to progression due to documented severe infusion reaction are eligible.
Significant thromboembolic event ≤ 8 weeks prior to enrollment
Subjects not recovered from all previous acute radiotherapy-related toxicities
History of severe skin disorder that in the opinion of the investigator may interfere with study conduct
History of any medical, or psychiatric condition, or laboratory abnormality that may interfere with the interpretation of study results
Subject is currently in a clinical trial ≤ 30 days prior to enrollment
Subjects requiring use of immunosuppressive agents however corticosteroids are allowed
Man or woman of child-bearing potential who do not consent to use adequate contraceptive precautions during the course of the study
Female subject who is pregnant or breast-feeding
Subject requiring major surgery using general/spinal anesthesia ≤ 28 days prior to enrollment, or minor surgery ≤ 14 days prior to enrollment.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00446446

Other Study ID Numbers ^ICMJE

20062088

Has Data Monitoring Committee

Not Provided

Responsible Party

Global Development Leader, Amgen Inc.

Study Sponsor ^ICMJE

Amgen

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Amgen

Information Provided By

Amgen

Verification Date

January 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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