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

Sponsor

Hoffmann-La Roche (Industry)

Overall Status

Completed

CT.gov ID

NCT00882674

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Drug: RG1507	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

8 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official 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

Study Start Date :

Jul 1, 2009

Actual Primary Completion Date :

Dec 1, 2010

Actual Study Completion Date :

Dec 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Drug: RG1507 16mg/kg, 9mg/kg, 3mg/kg or 1mg/kg iv on Day 1 in one of 4 cohorts of patients

Arm

Intervention/Treatment

Experimental: 1

Drug: RG1507

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

Outcome Measures

Primary Outcome Measures

Percent reduction in IGF-1R expression [From initial diagnosis to tumor excision]

Secondary Outcome Measures

Correlation of R1507 pharmacokinetic parameters with biological changes in tumor tissue [Days 1, 8 and 31]
Adverse events, laboratory parameters [Throughout study]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Edinburgh		United Kingdom	EH4 2XU

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director: Clinical Trials, Hoffmann-La Roche

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hoffmann-La Roche

ClinicalTrials.gov Identifier:

NCT00882674

Other Study ID Numbers:

NP22002
2008-004128-22

First Posted:

Apr 16, 2009

Last Update Posted:

Nov 2, 2016

Last Verified:

Nov 1, 2016

Additional relevant MeSH terms:

Breast Neoplasms

Study Results

No Results Posted as of Nov 2, 2016