MedDataX Logo

A Dose-Escalation Study of RO5083945 in Patients With Metastatic and/or Locally Advanced Malignant Epidermal Growth Factor Receptor (EGFR)+ Solid Tumors.

NCT ID: NCT00721266

Last Updated: 2016-11-02

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2011-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study will evaluate the pharmacokinetics, maximum tolerated dose and anti-tumor activity of RO5083945 in patients with metastatic and/or locally advanced malignant EGFR+ solid tumors. In the first part of the study, groups of patients will be sequentially enrolled to receive ascending doses of RO5083945 administered weekly, every 2 weeks or every 3 weeks. The starting dose of 50mg weekly will be escalated in subsequent groups of patients after a successful assessment of the safety, tolerability and pharmacokinetics of the previous dose. In Part 2 of the study, patients with EGFR+ and mutant KRAS colorectal cancer will be enrolled, and will receive RO5083945 at the recommended dose and regimen identified in Part 1. The anticipated time on study treatment is until disease progression, and the target sample size is \<100 individuals.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Neoplasms

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Group Type EXPERIMENTAL

RO5083945

Intervention Type DRUG

Administered iv, either weekly, every 2 weeks or every 3 weeks, at escalating doses (with a starting dose of 50mg weekly (Part 1)). Recommended dose administered iv, either weekly, every 2 weeks or every 3 weeks (Part 2).

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

RO5083945

Administered iv, either weekly, every 2 weeks or every 3 weeks, at escalating doses (with a starting dose of 50mg weekly (Part 1)). Recommended dose administered iv, either weekly, every 2 weeks or every 3 weeks (Part 2).

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* adult patients, \>=18 years of age;
* centrally confirmed EGFR expression in tumor tissue;
* radiologically measurable or clinically evaluable disease;
* last dose of systemic anti-neoplastic therapy or radiotherapy \>=28 days prior to start of study;
* histologically or cytologically confirmed advanced stage, primary or metastatic EGFR+ solid tumors (Part 1);
* histologically or cytologically confirmed advanced stage, primary or metastatic EGFR+ and mutant KRAS colorectal cancer (Part 2);
* not more than 2 previous cytotoxic regimens for metastatic disease (Part 2).

Exclusion Criteria

* history of grade 3-4 toxicity resulting from previous anti-EGFR treatment;
* known or suspected CNS metastases;
* wild type KRAS colorectal cancer (Part 2).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Toulouse, , France

Site Status

Villejuif, , France

Site Status

Barcelona, Barcelona, Spain

Site Status

Seville, Sevilla, Spain

Site Status

Valencia, Valencia, Spain

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom France Spain

References

Explore related publications, articles, or registry entries linked to this study.

Paz-Ares LG, Gomez-Roca C, Delord JP, Cervantes A, Markman B, Corral J, Soria JC, Berge Y, Roda D, Russell-Yarde F, Hollingsworth S, Baselga J, Umana P, Manenti L, Tabernero J. Phase I pharmacokinetic and pharmacodynamic dose-escalation study of RG7160 (GA201), the first glycoengineered monoclonal antibody against the epidermal growth factor receptor, in patients with advanced solid tumors. J Clin Oncol. 2011 Oct 1;29(28):3783-90. doi: 10.1200/JCO.2011.34.8888. Epub 2011 Sep 6.

Reference Type DERIVED
PMID: 21900113 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2007-005939-28

Identifier Type: -

Identifier Source: secondary_id

BO21495

Identifier Type: -

Identifier Source: org_study_id