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

Breast Cancer Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01480583
• Other study ID #: CP1005B016
• Status: Completed
• Phase: Phase 2
• First received: November 16, 2011
• Last updated: July 11, 2016
• Start date: October 2011
• Est. completion date: October 2015

Study information

• Verified date: July 2016
• Source: Angiochem Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Description:

Please see Brief Summary section.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: October 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Key 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

Key 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Metastases
• Brain Neoplasms
• Breast Cancer
• Breast Neoplasms
• Neoplasm Metastasis
• Neoplasms, Second Primary

Intervention

Drug:
• GRN1005
550 mg/m2 IV every 3 weeks
• Trastuzumab
2 mg/kg IV every week or 6 mg/kg IV every 3 weeks per investigator choice
• 18F-FLT
5 mCi of 18F-FLT IV during Screening and during Cycle 1

Locations

Country	Name	City	State
United States	Ingalls Memorial Hospital	Harvey	Illinois
United States	NCI	Rockville	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Angiochem Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intra-cranial objective response rate in breast cancer patients with brain metastasis		Upon enrollment through end of study period (1 year after last patient is enrolled)	No
Secondary	Number of patients with adverse events as a measure of safety and tolerability of GRN1005 alone or in combination with Trastuzumab		Upon enrollment through end of study period (1 year after last patient is enrolled)	Yes
Secondary	Intra-cranial objective response duration		Upon enrollment through end of study period (1 year after last patient is enrolled)	No
Secondary	3-month intra-cranial progression-free survival		Upon enrollment through end of study period (1 year after last patient is enrolled)	No
Secondary	Six month overall survival (OS)		Upon enrollment through end of study period (1 year after last patient is enrolled)	No