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Clinical Trials/CTRI/2010/091/000170
CTRI/2010/091/000170
Recruiting
Phase 4

An Observational Study to evaluate the safety and efficacy of Cetuximab in combination with platinum-based chemotherapy, in the first-line therapy of recurrent/ metastatic Squamous Cell Carcinoma of Head and Neck (SCCHN)

Merck Specialities Pvt Ltd5th Floor Shiv Sagar Estate, Dr. Aniie Besant Road, WorliMumbai 4000180 sites100 target enrollmentTBD

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Not specified
Sponsor
Merck Specialities Pvt Ltd5th Floor Shiv Sagar Estate, Dr. Aniie Besant Road, WorliMumbai 400018
Enrollment
100
Status
Recruiting
Last Updated
4 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
4 years ago
Study Type
Observational

Investigators

Sponsor
Merck Specialities Pvt Ltd5th Floor Shiv Sagar Estate, Dr. Aniie Besant Road, WorliMumbai 400018

Eligibility Criteria

Inclusion Criteria

  • The study inclusion criteria is as per the local SPC: ?Cetuximab is indicated for the treatment of patients with squamous cell cancer of the head and neck in combination with platinum\-based chemotherapy for recurrent and/or metastatic disease.?
  • For each platinum\-based chemotherapy, the related product labels approved by India Health Authorities should also be followed strictly in terms of patient eligibility.

Exclusion Criteria

  • Patients with known severe (grade 3 or 4; NCI\-CTC) hypersensitivity reactions to
  • Cetuximab are contraindicated for Cetuximab

Outcomes

Primary Outcomes

Not specified

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