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GRN1005 Alone or in Combination With Trastuzumab in Breast Cancer Patients With Brain Metastases

NCT01480583 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 85

Last updated 2016-07-13

No results posted yet for this study

Summary

The purpose of this study is to assess the efficacy, safety, and tolerability of GRN1005 in patients with brain metastases from breast cancer. For patients with HER2 positive metastatic breast cancer, GRN1005 will be assessed in combination with Trastuzumab (Herceptin®) as per standard-of-care practice.

In addition, this study will evaluate the ability of 18F-FLT to determine if the amount of change in the uptake in the brain metastases from breast cancer after GRN1005 treatment, correlates with intra-cranial response (for patients enrolled at NCI).

Conditions

Interventions

DRUG

GRN1005

550 mg/m2 IV every 3 weeks

DRUG

Trastuzumab

2 mg/kg IV every week or 6 mg/kg IV every 3 weeks per investigator choice

DRUG

18F-FLT

5 mCi of 18F-FLT IV during Screening and during Cycle 1

Sponsors & Collaborators

  • Angiochem Inc

    lead INDUSTRY

Principal Investigators

  • Betty Lawrence · Angiochem Inc

  • Nancy Lin, MD · Dana-Farber Cancer Institute

  • Susan Bates, MD · National Cancer Institute (NCI)

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2015-06-30
Completion
2015-10-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01480583 on ClinicalTrials.gov