NCT01480583

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

A Phase II, Multi-center, Open-label Study Evaluating GRN1005 Alone or in Combination With Trastuzumab in Breast Cancer Patients With Brain Metastases

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 85 (actual)
• Sponsor: Angiochem Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

Please see Brief Summary section.

Conditions

• Breast Cancer
• Brain Metastases

Interventions

Type	Name	Description
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

Timeline

• Start date: 2011-10-01
• Primary completion: 2015-06-01
• Completion: 2015-10-01
• First posted: 2011-11-29
• Last updated: 2016-07-13

Locations

2 sites across 1 country: United States