GRN1005 Alone or in Combination With Trastuzumab in Breast Cancer Patients With Brain Metastases - Full Text View

Sponsor:	Geron Corporation
Information provided by (Responsible Party):	Geron Corporation
ClinicalTrials.gov Identifier:	NCT01480583

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:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

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 ]

Estimated Enrollment:	100
Study Start Date:	October 2011
Estimated Study Completion Date:	September 2013
Estimated Primary Completion Date:	March 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: GRN1005 alone for HER2- MBC patients GRN1005 alone for HER2 - metastatic breast cancer patients	Drug: GRN1005 650 mg/m2 IV every 3 weeks Other Name: ANG1005
Experimental: GRN1005 + Trastuzumab for HER2+ MBC patients GRN1005 in combination with Trastuzumab for HER2 + metastatic breast cancer patients	Drug: GRN1005 650 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

Eligibility

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

Criteria

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 ≥ 80% (=ECOG of 0 or 1)
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

Contacts and Locations

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

Contacts

Contact: Roya Nawabi		info@geron.com
Contact: Maria Schaefer		info@geron.com

Locations

United States, California
Univ. of California at San Diego	Recruiting
La Jolla, California, United States, 92093
Contact: Bradley Brown 858-822-5377 bdbrown@ucsd.edu
Principal Investigator: Santosh Kesari, MD
University of Southern California	Recruiting
Los Angeles, California, United States, 90033
Contact: Kristy Watkins 323-865-0452 watkins_k@med.usc.edu
Principal Investigator: Debasish Tripathy, MD
United States, Florida
Northwest Hematology and Oncology Associates	Recruiting
Coral Springs, Florida, United States, 33065
Contact: Lesley Thompson 954-755-1901 lthompson@crninc.org
Principal Investigator: Steve Weiss, MD
Moffitt Cancer Center	Recruiting
Tampa, Florida, United States, 33612
Contact: Mira Lacevic 813-745-8304 mensura.lacevic@moffitt.org
Principal Investigator: Susan Minton, MD
United States, Georgia
Northeast Georgia Cancer, LLC	Recruiting
Athens, Georgia, United States, 30607
Contact: Jamie Hodgson 706-353-2990 ext 279 jhodgson@negacancer.com
Principal Investigator: Petros Nikolinakos, MD
United States, Illinois
Ingalls Memorial Hospital	Recruiting
Harvey, Illinois, United States, 60426
Contact: Margaret Marriott 708-915-6119 mmarriot@ingalls.org
United States, Indiana
Indiana University	Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Jessica Sollars 317-278-5117 jlsherma@iupui.edu
Principal Investigator: Kathy Miller, MD
United States, Kansas
Cancer Center of Kansas	Recruiting
Witchita, Kansas, United States, 67214
Contact: Susan Stockton 316-613-4318 susan.stockton@cancercenterofkansas.com
Principal Investigator: Shaker Dakhil, MD
United States, Massachusetts
Dana Farber Cancer Institute	Recruiting
Boston, Massachusetts, United States, 02215
Contact: Nancy Lin, MD 617-632-2335 Nancy_Lin@dfci.harvard.edu
Principal Investigator: Nancy Lin, MD
United States, Michigan
Henry Ford Hospital	Recruiting
Detroit, Michigan, United States, 48202
Contact: Nichell Fowlkes 313-916-7231 nfowlke1@hfhs.org
Principal Investigator: Ding Wang, MD
United States, North Carolina
Univ. of North Carolina	Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Rachel Phipps 919-966-4432 rachel_phipps@med.unc.edu
Principal Investigator: Carey Anders, MD
United States, Ohio
University Hospitals Seidman Cancer Center	Recruiting
Cleveland, Ohio, United States, 44106
Contact: Dawn Diorio 216-844-1845 dawn.diorio@uhhospitals.org
Principal Investigator: Paula Silverman, MD
University Hospitals Seidman Cancer Center	Not yet recruiting
Cleveland, Ohio, United States, 44106
Contact: Karen Manias 216-844-4722 karen.manias@uhhospitals.org
Principal Investigator: Paula Silverman, MD
United States, Tennessee
The West Clinic	Recruiting
Memphis, Tennessee, United States, 38120
Contact: Tracy Stewart 901-683-0055 ext 1236 tstewart@westclinic.com
Principal Investigator: Lee Schwartzberg, MD
Tennessee Oncology	Recruiting
Nashville, Tennessee, United States, 37203
Contact: Marsha Dunn 615-329-7274 marsha.dunn@scresearch.net
Principal Investigator: Denise Yardley, MD
United States, Texas
MD Anderson	Not yet recruiting
Houston, Texas, United States, 77030
Contact: Aurora Madrigal 713-792-2817 agmadrig@mdanderson.org
Principal Investigator: Nuhad Ibrahim, MD
Canada, Ontario
London Regional Cancer Center	Not yet recruiting
London, Ontario, Canada, N6A 4L6
Contact: Ted Vandenberg, MD Ted.vandenberg@lhsc.on.ca
Principal Investigator: Ted Vandenberg, MD
Sunnybrook	Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Tammy Taite 416-480-5000 ext 79 tammy.taite@sunnybrook.ca
Principal Investigator: Sunil Verma, MD

Sponsors and Collaborators

Geron Corporation

Investigators

Study Director:	Mona Shing, 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 15, 2012
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, 2012