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A Study of MEHD7945A Versus Cetuximab in Patients With Recurrent/Metastatic Squamous Cell Carcinoma of The Head And Neck

Primary Purpose

Head and Neck Cancer

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
MEHD7945A
cetuximab
Sponsored by
Genentech, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • Histologically confirmed Stage III or IV recurrent/metastatic squamous cell carcinoma of the head and neck (R/M SCCHN)
  • Progressive disease on or after first-line platinum-based chemotherapy regimen for R/M SCCHN (maximum of 6 cycles)
  • No more than one platinum-based chemotherapy regimen for R/M SCCHN is allowed
  • Prior platinum-based treatment as definitive chemo/radiotherapy for locally advanced disease is allowed if completed/terminated >/= 6 months before the platinum-based regimen for R/M SCCHN
  • Consent to provide archival tumor tissue for biomarker testing
  • Measurable disease per RECIST v1.1
  • ECOG performance status of 0, 1 or 2
  • Adequate hematologic, renal and liver function

Exclusion Criteria:

  • Nasopharyngeal cancer
  • Prior treatment with an investigational or approved agent for the purpose of inhibiting HER family members
  • This includes but is not limited to cetuximab, panitumumab, erlotinib, geftinib, and lapatinib
  • Prior treatment with an EGFR inhibitor is allowed if it was administered as part of definitive therapy for locally advanced disease and completed >/=1 year before study enrollment
  • Leptomeningeal disease as the only manifestation of the current malignancy
  • Active infection requiring iv antibiotics
  • Active autoimmune disease that is not controlled by non-steroidal anti-inflammatory drugs
  • Current severe, uncontrolled systemic disease (e.g. clinically significant cardiovascular, pulmonary, or metabolic disease; wound healing disorders; ulcers; bone fractures)
  • History of heart failure or serious cardiac arrhythmia
  • History of myocardial infarction within 6 months of Cycle 1, Day 1
  • Clinically significant liver disease, including active viral, alcoholic or other hepatitis, cirrhosis, or current alcohol abuse
  • HIV infection
  • Primary central nervous system (CNS) malignancy or untreated/active CNS metastases (progressing or requiring anticonvulsants or corticosteroids for symptomatic control)
  • Pregnant or lactating women
  • Malignancies other than SCCHN within 5 years prior to randomization, with the exception of adequately treated basal or squamous cell skin cancer and carcinoma in situ of the cervix

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

A: MEHD7945A

B: Cetuximab

Arm Description

Outcomes

Primary Outcome Measures

Progression-free survival (tumor assessments according to RECIST criteria)

Secondary Outcome Measures

Objective response: complete response or partial response
Disease control: complete response, partial response or stable disease
Duration of objective response
Time to disease progression
Overall survival
Safety: Incidence of adverse events
Pharmacokinetics: Cmax/Cmin
Immunogenicity: anti-MEHD7945A levels

Full Information

First Posted
April 11, 2012
Last Updated
November 1, 2016
Sponsor
Genentech, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01577173
Brief Title
A Study of MEHD7945A Versus Cetuximab in Patients With Recurrent/Metastatic Squamous Cell Carcinoma of The Head And Neck
Official Title
A Phase II, Open-Label, Randomized Study of MEDH7945A Versus Cetuximab in Patients With Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck Who Have Progressed During or Following Platinum-based Chemotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genentech, Inc.

4. Oversight

5. Study Description

Brief Summary
This phase II, open-label, randomized study will evaluate the efficacy and safety of MEHD7945A versus cetuximab in patients with recurrent/metastatic squamous cell carcinoma of the head and neck who have progressed during or following platinum-based chemotherapy. Patients will be randomized to receive either MEHD7945A 1100 mg intravenously (iv) every 2 weeks or cetuximab 400 mg/m2 iv loading dose followed by 250 mg/m2 iv weekly. Patients treated with cetuximab (Arm B) may cross-over to MEHD7945A (Arm A) upon central confirmation of progressive disease and upon meeting eligibility criteria. Anticipated time on study treatment is until disease progression or intolerable toxicity occurs.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
122 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A: MEHD7945A
Arm Type
Experimental
Arm Title
B: Cetuximab
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
MEHD7945A
Intervention Description
1100 mg iv every 2 weeks
Intervention Type
Drug
Intervention Name(s)
cetuximab
Intervention Description
400 mg/m2 iv loading dose, followed by 250 mg/m2 weekly
Primary Outcome Measure Information:
Title
Progression-free survival (tumor assessments according to RECIST criteria)
Time Frame
approximately 24 months
Secondary Outcome Measure Information:
Title
Objective response: complete response or partial response
Time Frame
approximately 24 months
Title
Disease control: complete response, partial response or stable disease
Time Frame
approximately 24 months
Title
Duration of objective response
Time Frame
approximately 24 months
Title
Time to disease progression
Time Frame
approximately 24 months
Title
Overall survival
Time Frame
approximately 24 months
Title
Safety: Incidence of adverse events
Time Frame
approximately 24 months
Title
Pharmacokinetics: Cmax/Cmin
Time Frame
Pre-dose and 30 min after end of infusion on Day 1 of Cycles 1, 2, 3, and 4, and at treatment completion
Title
Immunogenicity: anti-MEHD7945A levels
Time Frame
Pre-dose on Day 1 of Cycles 1 and 4, and at treatment completion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult patients, >/= 18 years of age Histologically confirmed Stage III or IV recurrent/metastatic squamous cell carcinoma of the head and neck (R/M SCCHN) Progressive disease on or after first-line platinum-based chemotherapy regimen for R/M SCCHN (maximum of 6 cycles) No more than one platinum-based chemotherapy regimen for R/M SCCHN is allowed Prior platinum-based treatment as definitive chemo/radiotherapy for locally advanced disease is allowed if completed/terminated >/= 6 months before the platinum-based regimen for R/M SCCHN Consent to provide archival tumor tissue for biomarker testing Measurable disease per RECIST v1.1 ECOG performance status of 0, 1 or 2 Adequate hematologic, renal and liver function Exclusion Criteria: Nasopharyngeal cancer Prior treatment with an investigational or approved agent for the purpose of inhibiting HER family members This includes but is not limited to cetuximab, panitumumab, erlotinib, geftinib, and lapatinib Prior treatment with an EGFR inhibitor is allowed if it was administered as part of definitive therapy for locally advanced disease and completed >/=1 year before study enrollment Leptomeningeal disease as the only manifestation of the current malignancy Active infection requiring iv antibiotics Active autoimmune disease that is not controlled by non-steroidal anti-inflammatory drugs Current severe, uncontrolled systemic disease (e.g. clinically significant cardiovascular, pulmonary, or metabolic disease; wound healing disorders; ulcers; bone fractures) History of heart failure or serious cardiac arrhythmia History of myocardial infarction within 6 months of Cycle 1, Day 1 Clinically significant liver disease, including active viral, alcoholic or other hepatitis, cirrhosis, or current alcohol abuse HIV infection Primary central nervous system (CNS) malignancy or untreated/active CNS metastases (progressing or requiring anticonvulsants or corticosteroids for symptomatic control) Pregnant or lactating women Malignancies other than SCCHN within 5 years prior to randomization, with the exception of adequately treated basal or squamous cell skin cancer and carcinoma in situ of the cervix
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Genentech, Inc.
Official's Role
Study Director
Facility Information:
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
City
Paducah
State/Province
Kentucky
ZIP/Postal Code
42003
Country
United States
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
City
St Joseph
State/Province
Missouri
ZIP/Postal Code
64507
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10011
Country
United States
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7295
Country
United States
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37909
Country
United States
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705-2275
Country
United States
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
City
Waratah
State/Province
New South Wales
ZIP/Postal Code
2298
Country
Australia
City
Wollongong
State/Province
New South Wales
ZIP/Postal Code
2500
Country
Australia
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
City
Kurralta Park
State/Province
South Australia
ZIP/Postal Code
5037
Country
Australia
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3002
Country
Australia
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
City
Namur
ZIP/Postal Code
5000
Country
Belgium
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
City
Ruse
ZIP/Postal Code
7000
Country
Bulgaria
City
Sofia
ZIP/Postal Code
1303
Country
Bulgaria
City
Clichy
ZIP/Postal Code
92118
Country
France
City
Lyon
ZIP/Postal Code
69373
Country
France
City
Villejuif
ZIP/Postal Code
94805
Country
France
City
Berlin
ZIP/Postal Code
12200
Country
Germany
City
Essen
ZIP/Postal Code
45122
Country
Germany
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
City
Gyor
ZIP/Postal Code
9024
Country
Hungary
City
Szolnok
ZIP/Postal Code
5004
Country
Hungary
City
Udine
State/Province
Friuli-Venezia Giulia
ZIP/Postal Code
33100
Country
Italy
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20133
Country
Italy
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20162
Country
Italy
City
Orbassano
State/Province
Piemonte
ZIP/Postal Code
10043
Country
Italy
City
Torino
State/Province
Piemonte
ZIP/Postal Code
10126
Country
Italy
City
Brasov
ZIP/Postal Code
500019
Country
Romania
City
Cluj-Napoca
ZIP/Postal Code
400015
Country
Romania
City
Cluj-Napoca
ZIP/Postal Code
400058
Country
Romania
City
Timisoara
ZIP/Postal Code
300239
Country
Romania
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
City
Madrid
ZIP/Postal Code
28041
Country
Spain
City
Madrid
ZIP/Postal Code
28050
Country
Spain
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
City
Valencia
ZIP/Postal Code
46010
Country
Spain
City
Coventry
ZIP/Postal Code
CV2 2DX
Country
United Kingdom
City
Glasgow
ZIP/Postal Code
G12 0YN
Country
United Kingdom
City
London
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
City
Sutton
ZIP/Postal Code
SM2 5PT
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

A Study of MEHD7945A Versus Cetuximab in Patients With Recurrent/Metastatic Squamous Cell Carcinoma of The Head And Neck

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