Does Acne Rash During Adolescence Predict Skin Reaction t... | NCT01382407

Studies
Does Acne Rash During Adolescence Predict Skin Reaction to Cetuximab

NCT01382407

Sponsor

Rambam Health Care Campus

Status

Completed

Last Update Posted

Apr 27, 2017Actual

Enrollment

100Actual

Phase

Not provided

Conditions

Colorectal Cancer Metastatic

Interventions

Cetuximab

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2011

Primary Completion Date

Apr 1, 2017Actual

Completion Date

Apr 1, 2017Actual

First Submitted Date

Jun 23, 2011

First Submission Date that Met QC Criteria

Jun 24, 2011

First Posted Date

Jun 27, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 26, 2017

Last Update Posted Date

Apr 27, 2017Actual

Name	Class
Merck KGaA, Darmstadt, Germany	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The hypothesis of this study is that patients who suffered from acne vulgaris during adolescence are at greater risk of developing acneiform skin rash due to cetuximab.

Detailed Description

The hypothesis of this study is that patients who suffered from acne vulgaris during adolescence are at greater risk of developing acneiform skin rash due to cetuximab

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cetuximab		All patients who started treatment with ERBITUX® (cetuximab), as a single agent or in combination with chemotherapy.	Drug: Cetuximab

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cetuximab	Drug	Once a week:Loading dose-400 mg/m2;subsequent-250 mg/m2 on days 8,15, 22,29,36 if administered as a single agent, or together with Irinotecan 125 mg/m2 on days 1,8,15,29 followed by administration every 42 days.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Relationship between acne and skin rash	To determine whether there is a relationship between acne during adolescence and skin rash during cetuximab treatment?	Within Erbitux treatment period (upto 12 months)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age above 18 years.
Histology or cytology proven KRAS-WT mCRC.
Performance status ≤3 (Eastern Cooperative Oncology Group [ECOG] classification)
Life expectancy of more than 12 weeks.
Written informed consent.
In women of childbearing potential, appropriate contraceptive measures must be used during treatment with cetuximab and for 6 months following the last dose of cetuximab.

Exclusion Criteria:

Past systemic immune therapy for disease other than cancer.
Past immune or other target therapy for cancer (not including bevacizumab).
Presence of acne or acneiform rash prior to starting treatment with cetuximab.
Patients with treatment plan of cetuximab and capecitabine combination.
For female patients: the patient is pregnant or lactating.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

All patients above the age of 18 years, who have been diagnosed with confirmed KRAS-WT mCRC, and are starting treatment with cetuximab, will be informed of the study.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gil Bar-Sela, M.D.	Rambam Health Care Campus	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Oncology Institute, Rambam Health Care Campus		Haifa		31096	Israel
Rambam Health Care Campus

Condition Browse Module

MeSH Terms

ID	Term
D000152	Acne Vulgaris

Ancestor Terms

ID	Term
D017486	Acneiform Eruptions
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D012625	Sebaceous Gland Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000068818	Cetuximab

Ancestor Terms

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins

Browse Leaves

Not provided

Browse Branches

Not provided