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

This study has been completed.
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: July 4, 2008
Last updated: November 1, 2016
Last verified: November 2016
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.

Condition Intervention Phase
Drug: RO5083945
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label, Dose-escalation Study to Evaluate Safety, Pharmacokinetics and Tumor Growth Control Rate of RO5083945, a Glycoengineered Antibody Against EGFR, in Patients With Metastatic and/or Locally Advanced Malignant EGFR+ Solid Tumors.

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Pharmacokinetic parameters, and maximum tolerated dose (Part 1) [ Time Frame: Throughout study ]
  • Tumor growth control rate (CR, PR, SD) (Part 2) [ Time Frame: Event driven ]

Secondary Outcome Measures:
  • AEs and laboratory parameters, pharmacodynamic parameters (Parts 1 and 2) [ Time Frame: Throughout study ]
  • Anti-tumor activity (ORR, DR, PFS) (Part 2) [ Time Frame: Event driven ]

Enrollment: 102
Study Start Date: June 2008
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: 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).


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).
  Contacts and Locations
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Please refer to this study by its identifier: NCT00721266

Toulouse, France, 31059
Villejuif, France, 94805
Barcelona, Spain, 08035
Sevilla, Spain, 41013
Valencia, Spain, 46010
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Hoffmann-La Roche Identifier: NCT00721266     History of Changes
Other Study ID Numbers: BO21495
Study First Received: July 4, 2008
Last Updated: November 1, 2016 processed this record on May 24, 2017