NCT01046266

Brief Summary

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P75+ for phase_1 head-and-neck-cancer

Timeline
Completed

Started Nov 2009

Shorter than P25 for phase_1 head-and-neck-cancer

Geographic Reach
5 countries

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

November 16, 2009

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 11, 2010

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

September 14, 2016

Status Verified

September 1, 2016

Enrollment Period

2.6 years

First QC Date

November 16, 2009

Last Update Submit

September 12, 2016

Conditions

Head and Neck Cancer

Outcome Measures

Primary Outcomes (1)

  • immune cell infiltration head and neck squamous cell cancer (HNSCC)

    through study completion or early study discontinuation

Secondary Outcomes (2)

  • pharmacodynamics: T lymphocytes, B lymphocytes, NK cells, plasma cytokine levels

    through study completion or early study discontinuation

  • safety and efficacy: AEs, laboratory parameters, tumour assessments

    through study completion or early study discontinuation

Study Arms (2)

A

EXPERIMENTAL
Drug: RO5083945

B

ACTIVE COMPARATOR
Drug: cetuximab

Interventions

RO5083945DRUG

700mg iv weekly

A
cetuximabDRUG

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

B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Unknown Facility

Toulouse, 31059, France

Location

Unknown Facility

Villejuif, 94805, France

Location

Unknown Facility

Milan, Lombardy, 20162, Italy

Location

Unknown Facility

Nijmegen, 6525 GA, Netherlands

Location

Unknown Facility

Barcelona, Barcelona, 08035, Spain

Location

Unknown Facility

Seville, Sevilla, 41013, Spain

Location

Unknown Facility

London, SE1 9RT, United Kingdom

Location

Related Publications (1)

  • Temam S, Spicer J, Farzaneh F, Soria JC, Oppenheim D, McGurk M, Hollebecque A, Sarini J, Hussain K, Soehrman Brossard S, Manenti L, Evers S, Delmar P, Di Scala L, Mancao C, Feuerhake F, Andries L, Ott MG, Passioukov A, Delord JP. An exploratory, open-label, randomized, multicenter study to investigate the pharmacodynamics of a glycoengineered antibody (imgatuzumab) and cetuximab in patients with operable head and neck squamous cell carcinoma. Ann Oncol. 2017 Nov 1;28(11):2827-2835. doi: 10.1093/annonc/mdx489.

    PMID: 28950289DERIVED

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

imgatuzumabCetuximab

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2009

First Posted

January 11, 2010

Study Start

November 1, 2009

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

September 14, 2016

Record last verified: 2016-09

Locations

GB(1)FR(2)IT(1)NL(1)ES(2)