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

NCT ID: NCT00882674

Last Updated: 2016-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2010-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

RG1507

Intervention Type DRUG

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

Interventions

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RG1507

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Edinburgh, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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2008-004128-22

Identifier Type: -

Identifier Source: secondary_id

NP22002

Identifier Type: -

Identifier Source: org_study_id