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NCT Number: NCT00882674

A Study to Evaluate the Biological Activity of R1507 in Women With Operable Breast Cancer

This 2 part study will explore the pharmacodynamic effects of R1507 in breast cancer tumor cells in female patients with operable breast cancer. In the first part of the study, patients will receive a single dose of R1507, 16mg/kg iv, on day 1; pre-and post-treatment (at breast surgery on day 8) breast tissue samples will be obtained for measurement of IGF-1R expression. If sufficient biological activity is demonstrated, 3 additional cohorts of patients will be entered into Part 2 of the study, to receive a single dose of 9mg, 3mg/kg or 1mg/kg iv R1507, respectively. The anticipated time on study treatment is < 3 months, and the target sample size is <100 individuals.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Edinburgh, EH4 2XU, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • female patients, >=18 years of age;
  • invasive, and operable, breast cancer;
  • ECOG Performance Status of 0 or 1.

Exclusion criteria

  • evidence of metastatic disease;
  • inflammatory breast cancer;
  • prior hormonal or systemic therapy for breast cancer;
  • prior treatment with an agent targetting the IGF-1R pathway;
  • patients receiving concurrent radiotherapy, or who have received radiotherapy within 28 days prior to receipt of study drug.

Treatment and study plan

RG1507

Drug

16mg/kg, 9mg/kg, 3mg/kg or 1mg/kg iv on Day 1 in one of 4 cohorts of patients

Primary outcomes

  1. Percent reduction in IGF-1R expression

    Time frame: From initial diagnosis to tumor excision

Secondary outcomes

  1. Correlation of R1507 pharmacokinetic parameters with biological changes in tumor tissue

    Time frame: Days 1, 8 and 31

  2. Adverse events, laboratory parameters

    Time frame: Throughout study

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

An Exploratory Study to Evaluate the Biological Activity of R1507, a Human Monoclonal Antibody Antagonist of the Insulin-like Growth Factor Receptor (IGF-1R) in Women With Operable Breast Cancer

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Apr 16, 2009
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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