GRN1005 Alone or in Combination With Trastuzumab in Breast Cancer Patients With Brain Metastases (GRABM-B)
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| ClinicalTrials.gov Identifier: NCT01480583 |
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Recruitment Status :
Completed
First Posted : November 29, 2011
Last Update Posted : July 13, 2016
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Sponsor:
Angiochem Inc
Information provided by (Responsible Party):
Angiochem Inc
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Brief 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).
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Breast Cancer Brain Metastases | Drug: GRN1005 Drug: Trastuzumab Drug: 18F-FLT | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 85 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (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 |
| Study Start Date : | October 2011 |
| Actual Primary Completion Date : | June 2015 |
| Actual Study Completion Date : | October 2015 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Breast cancer
MedlinePlus related topics:
Breast Cancer
Drug Information available for:
Trastuzumab
| Arm | Intervention/treatment |
|---|---|
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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)
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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 |
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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)
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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 |
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) ]
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) ]
- Intra-cranial objective response duration [ Time Frame: Upon enrollment through end of study period (1 year after last patient is enrolled) ]
- 3-month intra-cranial progression-free survival [ Time Frame: Upon enrollment through end of study period (1 year after last patient is enrolled) ]
- Six month overall survival (OS) [ Time Frame: Upon enrollment through end of study period (1 year after last patient is enrolled) ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| 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 ≥ 70%
- 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01480583
Locations
| United States, Illinois | |
| Ingalls Memorial Hospital | |
| Harvey, Illinois, United States, 60426 | |
| United States, Maryland | |
| NCI | |
| Rockville, Maryland, United States, 20892 | |
Sponsors and Collaborators
Angiochem Inc
Investigators
| Study Director: | Betty Lawrence | Angiochem Inc | |
| Principal Investigator: | Nancy Lin, MD | Dana-Farber Cancer Institute | |
| Principal Investigator: | Susan Bates, MD | National Cancer Institute (NCI) |
| Responsible Party: | Angiochem Inc |
| ClinicalTrials.gov Identifier: | NCT01480583 |
| Other Study ID Numbers: |
CP1005B016 |
| First Posted: | November 29, 2011 Key Record Dates |
| Last Update Posted: | July 13, 2016 |
| Last Verified: | July 2016 |
Keywords provided by Angiochem Inc:
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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:
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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 Alovudine Trastuzumab Antineoplastic Agents, Immunological Antineoplastic Agents Antiviral Agents Anti-Infective Agents |