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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.

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ClinicalTrials.gov Identifier: NCT00721266
Recruitment Status : Completed
First Posted : July 24, 2008
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Neoplasms Drug: RO5083945 Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 102 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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.
Study Start Date : June 2008
Primary Completion Date : June 2011
Study Completion Date : June 2011
Arms and Interventions

Arm Intervention/treatment
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).


Outcome Measures

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

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

Eligibility Criteria

Information from the National Library of Medicine

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00721266


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