A Study of Pharmacodynamics of RO5083945 in Patients With Head and Neck Squamous Cell Carcinoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2012-06-30

Brief Summary

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This open-label study will assess the pharmacodynamics, safety and efficacy of RO5083945 as compared to cetuximab in patients with head and neck squamous cell carcinoma. Patients will receive at least 2 infusions of either RO5083945 or cetuximab. Anticipated time on study treatment is up to 3 months, and target sample size is \<50.

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Detailed Description

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Conditions

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Head and Neck Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

Group Type EXPERIMENTAL

RO5083945

Intervention Type DRUG

700mg iv weekly

B

Group Type ACTIVE_COMPARATOR

cetuximab

Intervention Type DRUG

400mg/m2 iv 1st dose, 250mg/m2 iv subsequent weekly doses

Interventions

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RO5083945

700mg iv weekly

Intervention Type DRUG

cetuximab

400mg/m2 iv 1st dose, 250mg/m2 iv subsequent weekly doses

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* adult patients, \>/=18 years of age
* squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx

Exclusion Criteria

* carcinoma of nasal cavity, paranasal sinus and nasopharynx
* recurrent squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx
* known positivity for HIV, hepatitis B and/or hepatitis C infection

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No