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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Angiochem Inc
Sponsor:
Information provided by (Responsible Party):
Angiochem Inc
ClinicalTrials.gov Identifier:
NCT01480583
First received: November 16, 2011
Last updated: September 3, 2014
Last verified: September 2014
  Purpose

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).


Condition Intervention Phase
Breast Cancer
Brain Metastases
Drug: GRN1005
Drug: Trastuzumab
Drug: 18F-FLT
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Angiochem Inc:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 80
Study Start Date: October 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)
Drug: GRN1005
550 mg/m2 IV every 3 weeks
Other Name: ANG1005
Drug: 18F-FLT
5 mCi of 18F-FLT IV during Screening and during Cycle 1
Other Name: 18F-fluorothymidine
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)
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

Detailed Description:

Please see Brief Summary section.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01480583

Contacts
Contact: Christine Bryla, RN, MSN 301-451-7868 brylacm@mail.nih.gov
Contact: Betty Lawrence 514-788-7800 blawrence@angiochem.com

Locations
United States, Illinois
Ingalls Memorial Hospital Completed
Harvey, Illinois, United States, 60426
United States, Maryland
NCI Recruiting
Rockville, Maryland, United States, 20892
Contact: Christine Bryla, RN, MSN    301-451-7868    brylacm@mail.nih.gov   
Principal Investigator: Susan Bates, MD         
Sponsors and Collaborators
Angiochem Inc
Investigators
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)
  More Information

No publications provided

Responsible Party: Angiochem Inc
ClinicalTrials.gov Identifier: NCT01480583     History of Changes
Other Study ID Numbers: CP1005B016
Study First Received: November 16, 2011
Last Updated: September 3, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Angiochem Inc:
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

Additional relevant MeSH terms:
Brain Neoplasms
Breast Neoplasms
Neoplasm Metastasis
Neoplasms, Second Primary
Brain Diseases
Breast Diseases
Central Nervous System Diseases
Central Nervous System Neoplasms
Neoplasms
Neoplasms by Site
Neoplastic Processes
Nervous System Diseases
Nervous System Neoplasms
Pathologic Processes
Skin Diseases
Trastuzumab
Antineoplastic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 30, 2014