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

NCT ID: NCT01480583

Last Updated: 2016-07-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 85 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2015-10-31

Brief 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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

GRN1005

GRN1005 alone in HER2- MBC patients with brain mets. 18F-FLT may also be administered to this arm (if patient enrolled at NCI)

Group Type: EXPERIMENTAL

GRN1005

Intervention Type: DRUG

550 mg/m2 IV every 3 weeks

18F-FLT

Intervention Type: DRUG

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

GRN1005 with trastuzumab

GRN1005 in combination with trastuzumab in MBC patients with brain mets 18F-FLT may also be administered to this arm (if patient enrolled at NCI)

Group Type: EXPERIMENTAL

GRN1005

Intervention Type: DRUG

550 mg/m2 IV every 3 weeks

Trastuzumab

Intervention Type: DRUG

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

18F-FLT

Intervention Type: DRUG

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

Interventions

GRN1005

550 mg/m2 IV every 3 weeks

Intervention Type: DRUG

Trastuzumab

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

Intervention Type: DRUG

18F-FLT

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

Intervention Type: DRUG

Other Intervention Names

ANG1005; Herceptin; 18F-fluorothymidine

Eligibility Criteria

Inclusion Criteria

1. Age ≥ 18 years

2. Histologically or cytologically-documented breast cancer (HER2 status and ER/PgR status must be known)

3. Brain metastasis from breast cancer with or without prior WBRT

4. At least one radiologically-confirmed and measurable metastatic brain lesion (≥ 1.0 cm in the longest diameter) by Gd-MRI of the brain < 14 days prior to first dose (Metastatic brain lesions previously treated with SRS may not be target or non-target lesions)

5. Patients must be neurologically stable: On stable doses of corticosteroids and anticonvulsants (not EIAEDs, including phenytoin, phenobarbitol, carbamazepine, fosphenytoin, primidone, oxcarbazepine) for ≥ 5 days prior to obtaining the baseline Gd-MRI of the brain and ≥ 5 days prior to first dose

6. KPS ≥ 70%

7. Completed WBRT for intra-cranial lesions ≥ 28 days prior to first dose

Exclusion Criteria

1. NCI CTCAE v4.0 Grade ≥ 2 neuropathy

2. CNS disease requiring immediate neurosurgical intervention (e.g., resection, shunt placement, etc.)

3. Known leptomeningeal disease

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Angiochem Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Betty Lawrence

Role: STUDY_DIRECTOR

Angiochem Inc

Nancy Lin, MD

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Susan Bates, MD

Role: PRINCIPAL_INVESTIGATOR

National Cancer Institute (NCI)

Locations

Ingalls Memorial Hospital

Harvey, Illinois, United States

NCI

Rockville, Maryland, United States

Countries

United States

Other Identifiers

CP1005B016

Identifier Type: -

Identifier Source: org_study_id