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

NCT00882674 | Completed Phase 1

• 2 other identifiers: NP220022008-004128-22
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Percent reduction in IGF-1R expression

  From initial diagnosis to tumor excision

Secondary Outcomes (2)

• Correlation of R1507 pharmacokinetic parameters with biological changes in tumor tissue

  Days 1, 8 and 31

• Adverse events, laboratory parameters

  Throughout study

Study Arms (1)

1

EXPERIMENTAL

Drug: RG1507

Interventions

RG1507 DRUG

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

1

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (1)

Unknown Facility

Edinburgh, EH4 2XU, United Kingdom

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

RG-1507 monoclonal antibody

Condition Hierarchy (Ancestors)

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

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2009
• First Posted: April 16, 2009
• Study Start: July 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: November 2, 2016

Record last verified: 2016-11

Locations

GB (1)