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A Study in Head and Neck Cancer

Primary Purpose

Head and Neck Cancer

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Cetuximab

Cisplatin

Carboplatin

5-Fluorouracil

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:

Head and neck cancer that was confirmed by tissue biopsy or cytology
Disease not suitable for local therapy
Measurable or evaluable disease
Karnofsky performance status (KPS) score of at least 70
Organs are functioning well (bone marrow reserve, liver and kidney)
Life expectancy of at least 12 weeks
Signed informed consent document

Exclusion Criteria:

Receiving another investigational medication within the last 30 days
Prior chemotherapy, except if given as part of a multimodal treatment for locally advanced head and neck cancer that was completed more than 4 months prior to study entry.
Nasopharyngeal carcinoma
Previous treatment with monoclonal antibody therapy or other signal transduction inhibitors or epidermal growth factor receptor (EGFR) targeting therapy except for prior cetuximab treatment given as part of a multimodal treatment for locally advanced head and neck cancer that was completed more than 4 months prior to study entry.
Uncontrolled high blood pressure
Heart disease or had a heart attack within the last year
Currently have an infection that requires for you to take an IV antibiotic
Currently receiving other therapies for your cancer, such as chemotherapy, radiation therapy, immunotherapy, and hormonal therapy
Medical or psychological condition that would not permit the participant to complete the study or sign informed consent
Known drug abuse (with the exception of alcohol abuse)
Known allergic reaction against any of the components of the study treatment
Second primary malignancy that is clinically detectable at the time of consideration for study enrollment
Have had another type of cancer within the last 2 years
You are currently pregnant or breastfeeding
You are considering becoming pregnant or fathering a child

Sites / Locations

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Safety Lead-In (cetuximab manufactured by ImClone)

Cetuximab manufactured by ImClone

Cetuximab manufactured by Boehringer Ingelheim

Arm Description

Cycle 1: Week 1 - Cetuximab 400 milligrams per square meter (mg/m^2) on Day 1; Cisplatin 100 mg/m^2 on Day 1 or carboplatin area under the curve (AUC) 5 on Day 1; 5-FU 1000 mg/m^2 on Days 1-4 Week 2 - Cetuximab 250 mg/m^2 on Day 1 Week 3 - Cetuximab 250 mg/m^2 on Day 1 Cycle 2-6: Week 1 - Cetuximab 250 mg/m^2 on Day 1; Cisplatin 100 mg/m^2 on Day 1 or carboplatin AUC 5 on Day 1; 5-FU 1000 mg/m^2 on Days 1-4 Week 2 - Cetuximab 250 mg/m^2 on Day 1 Week 3 - Cetuximab 250 mg/m^2 on Day 1 After 6 cycles, participants may then receive weekly cetuximab monotherapy 250 mg/m^2 until progression of disease, unacceptable toxicity, or another withdrawal criteria is met.

Cycle 1: Week 1 - Cetuximab 400 mg/m^2 on Day 1; Cisplatin 100 mg/m^2 on Day 1 or carboplatin AUC 5 on Day 1; 5-FU 1000 mg/m^2 on Days 1-4 Week 2 - Cetuximab 250 mg/m^2 on Day 1 Week 3 - Cetuximab 250 mg/m^2 on Day 1 Cycle 2-6: Week 1 - Cetuximab 250 mg/m^2 on Day 1; Cisplatin 100 mg/m^2 on Day 1 or carboplatin AUC 5 on Day 1; 5-FU 1000 mg/m^2 on Days 1-4 Week 2 - Cetuximab 250 mg/m^2 on Day 1 Week 3 - Cetuximab 250 mg/m^2 on Day 1 After 6 cycles, participants may then receive weekly cetuximab monotherapy 250 mg/m^2 until progression of disease, unacceptable toxicity, or another withdrawal criteria is met.

Outcomes

Primary Outcome Measures

Number of Participants Who Had Treatment-Emergent Adverse Events (TEAEs); Data Analysis Cut-Off: September 27, 2013

September 27, 2013 is the date when data was last collected for the primary endpoint. Prior to this date, the manufacturing process for the BI-manufactured cetuximab was changed necessitating the need to switch participants to US commercial cetuximab. All other components of their treatment regimen remained unchanged and participants stayed in their original reporting group. Therefore, the number of participants in the BI-manufactured cetuximab treatment arm who had TEAEs includes TEAEs while participants received BI-manufactured and US-commercial cetuximab. Using September 27 cut-off, the analysis of TEAEs is confounded by the switch from BI-manufactured to US commercial cetuximab. TEAEs were defined as serious and other non-serious AEs that occurred or worsened after study treatment (regardless of causality). TEAE information for Safety Lead-In group available in Reported Adverse Events module which is summary of serious and other non-serious AEs regardless of causality.

Number of Participants Who Had TEAEs; Data Analysis Cut-Off: January 23, 2013

January 23, 2013 is the date when the first participant in the BI-manufactured cetuximab treatment arm switched to US commercial cetuximab due to changes in the manufacturing process for the BI-manufactured cetuximab necessitating the need to switch participants to US commercial cetuximab. Each participant who switched treatments received at least 2 cycles of BI-manufactured cetuximab before switching. All other components of their treatment regimen remained unchanged. The number of participants who had TEAEs during combination therapy is reported. Using January 23 cut-off, data is un-confounded by lack of BI-manufactured cetuximab. TEAEs were defined as serious and other non-serious adverse events (AEs) that occurred or worsened after study treatment (regardless of causality). TEAE information for Safety Lead-in group available in Reported Adverse Event module which is summary of serious and other non-serious AEs regardless of causality.

Secondary Outcome Measures

Overall Survival (OS)

OS was defined as duration from the date of randomization to the date of death from any cause. For each participant not known to have died as of the 23 October 2014 data cutoff date for the analysis, OS was censored at the date last known to be alive. In addition, any participants on Arm B who was switched from BI-manufactured cetuximab to ImClone-manufactured cetuximab was censored at the time of the switch.

Progression-Free Survival (PFS)

PFS was defined as duration from the date of randomization to the first date of objective progressive disease (PD) or death from any cause. For each participant who was not known to have died or to have had objective PD as of the 23 October 2014 data cutoff date for the analysis, PFS was censored at the date of the participant's last complete tumor assessment prior to that cutoff date. In addition, any participant in Arm B who was switched from BI-manufactured cetuximab to ImClone-manufactured cetuximab was censored at the time of the switch.

Percentage of Participants Having a Confirmed Best Response of Complete Response (CR) or Partial Response (PR) (Overall Response Rate [ORR])

Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST, version [v]1.0) criteria. CR was defined as the disappearance of all target lesions. PR was defined as having at least a 30% decrease in sum of longest diameter of target lesions. Percentage of participants with a confirmed CR or PR=(number of participants whose best overall response was CR or PR)/(number of participants treated)*100.

Number of Participants With Anti-Cetuximab Antibodies

Percentage of Participants Having a Best Response of CR, PR, or Stable Disease (SD) - Disease Control Rate (DCR)

Response was defined using RECIST, v1.0 criteria. CR was defined as the disappearance of all target lesions. PR was defined as having at least a 30% decrease in sum of longest diameter of target lesions. Progressive Disease (PD) was defined as having at least a 20% increase in the sum of the longest diameter of target lesions. Stable Disease (SD) was defined as small changes that did not meet the above criteria.

Maximum Serum Concentration (Cmax) of Cetuximab Following 400 mg/m² Cetuximab Dosing

The Cmax of cetuximab following 400 mg/m² cetuximab dosing during Part 2 of the study is reported. As specified in the protocol, pharmacokinetics (PK) samples were not collected during Part 1 of the study, Safety Lead-In or during Part 2 monotherapy.

Cmax of Cetuximab at Steady State

A total of 4 samples were collected at various times during combination therapy, from the third dose of 250 mg/m^2 cetuximab in Cycle 1 (Week 3) through the final dose in Cycle 3 (Week 3) and used to report Cmax of cetuximab at steady state during Part 2 of the study. As specified in the protocol, PK samples were not collected during Part 1 of the study, Safety Lead-In, or during Part 2 monotherapy.

Area Under the Concentration Curve (AUC) of Cetuximab at Steady State

A total of 4 samples were collected during combination therapy, from the first dose of 250 mg/m^2 cetuximab in Cycle 1 (Day 1) through the final dose in Cycle 3 (Week 3) and used to report AUC of cetuximab at steady state during Part 2 of the study. As specified in the protocol, PK samples were not collected during Part 1 of the study, Safety Lead-In, or during Part 2 monotherapy.

Full Information

NCT ID

NCT01081041

First Posted

March 3, 2010

Last Updated

September 10, 2019

Sponsor

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT01081041

Brief Title

A Study in Head and Neck Cancer

Official Title

A Randomized, Double-Blind, Phase 2 Safety Study of Cetuximab, Using ImClone Versus Boehringer Ingelheim Manufacturing Processes, in Combination With Cisplatin or Carboplatin and 5-Fluorouracil in the First-Line Treatment of Patients With Locoregionally Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck

Study Type

Interventional

2. Study Status

Record Verification Date

September 2019

Overall Recruitment Status

Completed

Study Start Date

June 2010 (undefined)

Primary Completion Date

August 2013 (Actual)

Study Completion Date

September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Eli Lilly and Company

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This study will begin with a 30 participant lead-in part: these 30 participants will receive cetuximab manufactured by ImClone on a weekly basis in combination with other chemotherapy drugs [cisplatin or carboplatin plus 5-fluorouracil (5-FU)] administered every 3 weeks. After 18 weeks, participants who benefit from this treatment may continue to receive cetuximab once-weekly until progression of the disease, an unacceptable side effect occurs, participants withdraw consent, or the study is closed. In the second part of this study, 200 participants will be randomized in 2 arms: 100 participants will receive commercial cetuximab manufactured by ImClone (Group A) 100 participants will receive cetuximab manufactured by Boehringer Ingelheim (Group B). All these 200 participants will receive other chemotherapy drugs (cisplatin or carboplatin plus 5-FU) administered every 3 weeks. After 18 weeks, participants who benefit from this treatment may continue to receive cetuximab once-weekly until progression of the disease, an unacceptable side effect occurs, participants withdraw consent, or the study is closed.

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

ParticipantInvestigator

Allocation

Randomized

Enrollment

187 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Safety Lead-In (cetuximab manufactured by ImClone)

Arm Type

Experimental

Arm Description

Arm Title

Cetuximab manufactured by ImClone

Arm Type

Experimental

Arm Description

Arm Title

Cetuximab manufactured by Boehringer Ingelheim

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Cetuximab

Other Intervention Name(s)

Erbitux, LY2939777

Intervention Description

Administered intravenously

Intervention Type

Drug

Intervention Name(s)

Cisplatin

Intervention Description

Administered intravenously

Intervention Type

Drug

Intervention Name(s)

Carboplatin

Intervention Description

Administered intravenously

Intervention Type

Drug

Intervention Name(s)

5-Fluorouracil

Other Intervention Name(s)

5-FU

Intervention Description

Administered intravenously

Primary Outcome Measure Information:

Title

Number of Participants Who Had Treatment-Emergent Adverse Events (TEAEs); Data Analysis Cut-Off: September 27, 2013

Description

Time Frame

Part 2: Baseline to end of combination therapy (up to 18 weeks)

Title

Number of Participants Who Had TEAEs; Data Analysis Cut-Off: January 23, 2013

Description

Time Frame

Part 2: Baseline to end of combination therapy or date first participant switched to US commercial cetuximab (up to 18 weeks)

Secondary Outcome Measure Information:

Title

Overall Survival (OS)

Description

Time Frame

Parts 1 and 2: Randomization to Date of Death from any Cause (Up to 36.3 Months)

Title

Progression-Free Survival (PFS)

Description

Time Frame

Parts 1 and 2: Randomization to Progression of Disease or Death from any Cause (Up to 32.7 Months)

Title

Percentage of Participants Having a Confirmed Best Response of Complete Response (CR) or Partial Response (PR) (Overall Response Rate [ORR])

Description

Time Frame

Parts 1 and 2: Randomization to Progression of Disease (Up to 32.7 Months)

Title

Number of Participants With Anti-Cetuximab Antibodies

Time Frame

Day 1, Week 1 of Cycles 3 and 5 (postbaseline samples were collected prior to infusion).

Title

Percentage of Participants Having a Best Response of CR, PR, or Stable Disease (SD) - Disease Control Rate (DCR)

Description

Time Frame

Parts 1 and 2: Randomization to Progression of Disease (Up to 32.7 Months)

Title

Maximum Serum Concentration (Cmax) of Cetuximab Following 400 mg/m² Cetuximab Dosing

Description

Time Frame

Part 2: Cycle 1, Day 1: 0 hours [(h); immediately postdose], 1 h, 2 h, and 24 h postdose

Title

Cmax of Cetuximab at Steady State

Description

Time Frame

Part 2: Weekly from Cycle 1, Week 3 through Cycle 3, Week 3: 0 h (immediately postdose), 24 h, 96 h, and 168 h postdose

Title

Area Under the Concentration Curve (AUC) of Cetuximab at Steady State

Description

Time Frame

Part 2: Weekly from Cycle 1, Day 1 through Cycle 3, Week 3: 0 h (immediately postdose), 24 h, 96 h, and 168 h postdose

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Head and neck cancer that was confirmed by tissue biopsy or cytology Disease not suitable for local therapy Measurable or evaluable disease Karnofsky performance status (KPS) score of at least 70 Organs are functioning well (bone marrow reserve, liver and kidney) Life expectancy of at least 12 weeks Signed informed consent document Exclusion Criteria: Receiving another investigational medication within the last 30 days Prior chemotherapy, except if given as part of a multimodal treatment for locally advanced head and neck cancer that was completed more than 4 months prior to study entry. Nasopharyngeal carcinoma Previous treatment with monoclonal antibody therapy or other signal transduction inhibitors or epidermal growth factor receptor (EGFR) targeting therapy except for prior cetuximab treatment given as part of a multimodal treatment for locally advanced head and neck cancer that was completed more than 4 months prior to study entry. Uncontrolled high blood pressure Heart disease or had a heart attack within the last year Currently have an infection that requires for you to take an IV antibiotic Currently receiving other therapies for your cancer, such as chemotherapy, radiation therapy, immunotherapy, and hormonal therapy Medical or psychological condition that would not permit the participant to complete the study or sign informed consent Known drug abuse (with the exception of alcohol abuse) Known allergic reaction against any of the components of the study treatment Second primary malignancy that is clinically detectable at the time of consideration for study enrollment Have had another type of cancer within the last 2 years You are currently pregnant or breastfeeding You are considering becoming pregnant or fathering a child

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Organizational Affiliation

Eli Lilly and Company

Official's Role

Study Director

Facility Information:

Facility Name

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85715

Country

United States

Facility Name

City

Fullerton

State/Province

California

ZIP/Postal Code

92835

Country

United States

Facility Name

City

Long Beach

State/Province

California

ZIP/Postal Code

90813

Country

United States

Facility Name

City

Grand Junction

State/Province

Colorado

ZIP/Postal Code

81501

Country

United States

Facility Name

City

Weston

State/Province

Florida

ZIP/Postal Code

33331

Country

United States

Facility Name

City

Albany

State/Province

Georgia

ZIP/Postal Code

31701

Country

United States

Facility Name

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60612

Country

United States

Facility Name

City

Springfield

State/Province

Illinois

ZIP/Postal Code

62703

Country

United States

Facility Name

City

New Albany

State/Province

Indiana

ZIP/Postal Code

47150

Country

United States

Facility Name

City

Wichita

State/Province

Kansas

ZIP/Postal Code

67214

Country

United States

Facility Name

City

Albany

State/Province

New York

ZIP/Postal Code

12208

Country

United States

Facility Name

City

New York

State/Province

New York

ZIP/Postal Code

10029

Country

United States

Facility Name

City

Portland

State/Province

Oregon

ZIP/Postal Code

97207

Country

United States

Facility Name

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29425

Country

United States

Facility Name

City

Abilene

State/Province

Texas

ZIP/Postal Code

79606

Country

United States

Facility Name

City

Calgary

State/Province

Alberta

ZIP/Postal Code

T2N 4N2

Country

Canada

Facility Name

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T6G 1Z2

Country

Canada

Facility Name

City

London

State/Province

Ontario

ZIP/Postal Code

N6A 4L6

Country

Canada

Facility Name

City

Ottawa

State/Province

Ontario

ZIP/Postal Code

K1H 8L6

Country

Canada

Facility Name

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 2M9

Country

Canada

Facility Name

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H2L 4M1

Country

Canada

Facility Name

City

Chihuahua

ZIP/Postal Code

31000

Country

Mexico

Facility Name

City

Guadalajara

ZIP/Postal Code

44200

Country

Mexico

Facility Name

City

Merida

ZIP/Postal Code

97000

Country

Mexico

Facility Name

City

Mexico City

ZIP/Postal Code

14000

Country

Mexico

Facility Name

City

Monterrey

ZIP/Postal Code

64320

Country

Mexico

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

IPD Sharing Time Frame

Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.

IPD Sharing Access Criteria

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

IPD Sharing URL

https://vivli.org/

Citations:

PubMed Identifier

26768732

Citation

Soulieres D, Aguilar JL, Chen E, Misiukiewicz K, Ernst S, Lee HJ, Bryant K, He S, Obasaju CK, Chang SC, Chin S, Adkins D. Cetuximab plus platinum-based chemotherapy in head and neck squamous cell carcinoma: a randomized, double-blind safety study comparing cetuximab produced from two manufacturing processes using the EXTREME study regimen. BMC Cancer. 2016 Jan 14;16:19. doi: 10.1186/s12885-016-2064-0.

Results Reference

derived

Learn more about this trial

A Study in Head and Neck Cancer

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