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.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00721266
First received: July 4, 2008
Last updated: August 4, 2014
Last verified: August 2014
  Purpose

This study will evaluate the pharmacokinetics, maximum tolerated dose and anti-t umor activity of RO5083945 in patients with metastatic and/or locally advanced m alignant EGFR+ solid tumors. In the first part of the study, groups of patients will be sequentially enrolled to receive ascending doses of RO5083945 administer ed 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 enroll ed, and will receive RO5083945 at the recommended dose and regimen identified in Part 1. The anticipated time on study treatment is until disease progression, a nd the target sample size is <100 individuals.


Condition Intervention Phase
Neoplasms
Drug: RO5083945
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
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.

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Pharmacokinetic parameters, and maximum tolerated dose (Part 1) [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Tumor growth control rate (CR, PR, SD) (Part 2) [ Time Frame: Event driven ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • AEs and laboratory parameters, pharmacodynamic parameters (Parts 1 and 2) [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Anti-tumor activity (ORR, DR, PFS) (Part 2) [ Time Frame: Event driven ] [ Designated as safety issue: No ]

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided by Hoffmann-La Roche

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00721266     History of Changes
Other Study ID Numbers: BO21495, 2007-005939-28
Study First Received: July 4, 2008
Last Updated: August 4, 2014
Health Authority: Spain: Agency for Medicines and Health Products

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on August 27, 2014