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GRN1005 Alone or in Combination With Trastuzumab in Breast Cancer Patients With Brain Metastases (GRABM-B)

Primary Purpose

Breast Cancer, Brain Metastases

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

GRN1005

Trastuzumab

18F-FLT

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring GRN1005, ANG1005, Peptide-Drug Conjugate (PDC), LRP-1, Targeted Therapy, Breast Cancer, Brain Metastases, Brain Tumor, Blood Brain Barrier, Trastuzumab, Herceptin, Paclitaxel, Taxol, Breast cancer with brain metastases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

Age ≥ 18 years
Histologically or cytologically-documented breast cancer (HER2 status and ER/PgR status must be known)
Brain metastasis from breast cancer with or without prior WBRT
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)
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
KPS ≥ 70%
Completed WBRT for intra-cranial lesions ≥ 28 days prior to first dose

Key Exclusion Criteria:

NCI CTCAE v4.0 Grade ≥ 2 neuropathy
CNS disease requiring immediate neurosurgical intervention (e.g., resection, shunt placement, etc.)
Known leptomeningeal disease

Sites / Locations

Ingalls Memorial Hospital
NCI

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

GRN1005

GRN1005 with trastuzumab

Arm Description

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

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)

Outcomes

Primary Outcome Measures

Intra-cranial objective response rate in breast cancer patients with brain metastasis

Secondary Outcome Measures

Number of patients with adverse events as a measure of safety and tolerability of GRN1005 alone or in combination with Trastuzumab

Intra-cranial objective response duration

3-month intra-cranial progression-free survival

Six month overall survival (OS)

Full Information

NCT ID

NCT01480583

First Posted

November 16, 2011

Last Updated

July 11, 2016

Sponsor

Angiochem Inc

1. Study Identification

Unique Protocol Identification Number

NCT01480583

Brief Title

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

Acronym

GRABM-B

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2016

Overall Recruitment Status

Completed

Study Start Date

October 2011 (undefined)

Primary Completion Date

June 2015 (Actual)

Study Completion Date

October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Angiochem Inc

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer, Brain Metastases

Keywords

GRN1005, ANG1005, Peptide-Drug Conjugate (PDC), LRP-1, Targeted Therapy, Breast Cancer, Brain Metastases, Brain Tumor, Blood Brain Barrier, Trastuzumab, Herceptin, Paclitaxel, Taxol, Breast cancer with brain metastases

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

85 (Actual)

8. Arms, Groups, and Interventions

Arm Title

GRN1005

Arm Type

Experimental

Arm Description

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

Arm Title

GRN1005 with trastuzumab

Arm Type

Experimental

Arm Description

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)

Intervention Type

Drug

Intervention Name(s)

GRN1005

Other Intervention Name(s)

ANG1005

Intervention Description

550 mg/m2 IV every 3 weeks

Intervention Type

Drug

Intervention Name(s)

Trastuzumab

Other Intervention Name(s)

Herceptin

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

18F-FLT

Other Intervention Name(s)

18F-fluorothymidine

Intervention Description

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

Primary Outcome Measure Information:

Title

Intra-cranial objective response rate in breast cancer patients with brain metastasis

Time Frame