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

This study is currently recruiting participants.
Verified October 2013 by Angiochem Inc
Sponsor:
Information provided by (Responsible Party):
Angiochem Inc
ClinicalTrials.gov Identifier:
NCT01480583
First received: November 16, 2011
Last updated: October 4, 2013
Last verified: October 2013

November 16, 2011
October 4, 2013
October 2011
June 2014   (final data collection date for primary outcome measure)
Intra-cranial objective response rate in breast cancer patients with brain metastasis [ Time Frame: Upon enrollment through end of study period (1 year after last patient is enrolled) ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01480583 on ClinicalTrials.gov Archive Site
  • Number of patients with adverse events as a measure of safety and tolerability of GRN1005 alone or in combination with Trastuzumab [ Time Frame: Upon enrollment through end of study period (1 year after last patient is enrolled) ] [ Designated as safety issue: Yes ]
  • Intra-cranial objective response duration [ Time Frame: Upon enrollment through end of study period (1 year after last patient is enrolled) ] [ Designated as safety issue: No ]
  • 3-month intra-cranial progression-free survival [ Time Frame: Upon enrollment through end of study period (1 year after last patient is enrolled) ] [ Designated as safety issue: No ]
  • Six month overall survival (OS) [ Time Frame: Upon enrollment through end of study period (1 year after last patient is enrolled) ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

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).

Please see Brief Summary section.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Breast Cancer
  • Brain Metastases
  • Drug: GRN1005
    550 mg/m2 IV every 3 weeks
    Other Name: ANG1005
  • Drug: Trastuzumab
    2 mg/kg IV every week or 6 mg/kg IV every 3 weeks per investigator choice
    Other Name: Herceptin
  • Drug: 18F-FLT
    5 mCi of 18F-FLT IV during Screening and during Cycle 1
    Other Name: 18F-fluorothymidine
  • Experimental: GRN1005
    GRN1005 alone in HER2- MBC patients with brain mets. 18F-FLT may also be administered to this arm (if patient enrolled at NCI)
    Interventions:
    • Drug: GRN1005
    • Drug: 18F-FLT
  • Experimental: 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)
    Interventions:
    • Drug: GRN1005
    • Drug: Trastuzumab
    • Drug: 18F-FLT
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
80
June 2014
June 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Robin Frye 301-402-5958 and 301-451-7868 fryer@mail.nih.gov
Contact: Betty Lawrence 514-788-7800 blawrence@angiochem.com
United States
 
NCT01480583
CP1005B016
No
Angiochem Inc
Angiochem Inc
Not Provided
Study Director: Jean-Paul Castaigne, MD Angiochem Inc
Principal Investigator: Nancy Lin, MD Dana-Farber Cancer Institute
Principal Investigator: Susan Bates, MD National Cancer Institute (NCI)
Angiochem Inc
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP