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

March 8, 2007
January 20, 2011
May 2007
December 2010   (final data collection date for primary outcome measure)
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 ]
To estimate the effect of panitumumab on objective response rate by end of treatment period
Complete list of historical versions of study NCT00446446 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Time to response
  • Duration of response
  • Rate of disease control
  • Time to progression (TTP)
  • Progression free survival (PFS)
  • Overall survival (OS)
  • Safety
Not Provided
Not Provided
 
PRISM (Panitumumab Regimen In Second-line Monotherapy of Head and Neck Cancer)
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

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.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Cancer
  • Carcinoma
  • Head and Neck Cancer
  • Metastases
  • Metastatic Cancer
  • Metastatic or Recurrent Squamous Cell Carcinoma of Head and Neck
  • Oncology
  • Squamous Cell Carcinoma
  • Tumors
Drug: Panitumumab
Single Arm Monotherapy Study
Experimental: panitumumab
Single Arm Monotherapy Study
Intervention: Drug: Panitumumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
52
July 2011
December 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00446446
20062088
Not Provided
Global Development Leader, Amgen Inc.
Amgen
Not Provided
Study Director: MD Amgen
Amgen
January 2011

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