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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Geron Corporation
ClinicalTrials.gov Identifier:
NCT01480583
First received: November 16, 2011
Last updated: May 13, 2013
Last verified: May 2013
History of Changes
  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.


Condition Intervention Phase
Breast Cancer
Brain Metastases
 Drug: GRN1005
Drug: Trastuzumab
 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:

Drug Information available for: Trastuzumab
U.S. FDA Resources

Further study details as provided by Geron Corporation:

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 ]

Enrollment: 80
Study Start Date: October 2011
Estimated Study Completion Date: June 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GRN1005 alone for HER2- MBC patients
Please see above.
 Drug: GRN1005
550 mg/m2 IV every 3 weeks
Other Name: ANG1005
Experimental: GRN1005 with trastuzumab
GRN1005 in combination with trastuzumab in MBC patients with brain mets
 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

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

  Show 32 Study Locations
Sponsors and Collaborators
Geron Corporation
Investigators
Study Director: Steve Sagar, MD Geron Corporation
Principal Investigator: Nancy Lin, MD Dana-Farber Cancer Institute
  More Information

No publications provided

Responsible Party: Geron Corporation
ClinicalTrials.gov Identifier: NCT01480583     History of Changes
Other Study ID Numbers: CP1005B016
Study First Received: November 16, 2011
Last Updated: May 13, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Geron Corporation:
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:
Breast Neoplasms
Neoplasm Metastasis
Neoplasms, Second Primary
Brain Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Neoplastic Processes
Pathologic Processes
 Central Nervous System Neoplasms
Nervous System Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Trastuzumab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013