Breast CancerPhase 2GRABM-BNCT01480583
GRN1005 Alone or in Combination With Trastuzumab in Breast Cancer Patients With Brain Metastases
A Phase 2 study testing GRN1005, Trastuzumab and 18F-FLT in people with Breast Cancer and Brain Metastases, run by Angiochem Inc at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Brain Metastases
- What is being tested?
- GRN1005, Trastuzumab and 18F-FLT
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2011to Oct 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- NCI CTCAE v4.0 Grade ≥ 2 neuropathy
- CNS disease requiring immediate neurosurgical intervention (e.g., resection, shunt placement, etc.)
- Known leptomeningeal disease
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Ingalls Memorial Hospital
Harvey, Illinois, 60426
NCI
Rockville, Maryland, 20892
About this study
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
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).
Read the detailed description
Please see Brief Summary section.
- Conditions
- Breast Cancer, Brain Metastases
- Being tested
- GRN1005, Trastuzumab, 18F-FLT
- Keywords
- 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
- Medical subject headings
- Breast Neoplasms, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GRN1005Drug
Also called ANG1005
550 mg/m2 IV every 3 weeks
TrastuzumabDrug
Also called Herceptin
2 mg/kg IV every week or 6 mg/kg IV every 3 weeks per investigator choice
18F-FLTDrug
Also called 18F-fluorothymidine
5 mCi of 18F-FLT IV during Screening and during Cycle 1
| Study group | Role | What they receive |
|---|---|---|
| GRN1005 | Experimental | GRN1005 alone in HER2- MBC patients with brain mets. 18F-FLT may also be administered to this arm (if patient enrolled at NCI) Receives: Drug: GRN1005; Drug: 18F-FLT |
| GRN1005 with trastuzumab | Experimental | 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) Receives: Drug: GRN1005; Drug: Trastuzumab; Drug: 18F-FLT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intra-cranial objective response rate in breast cancer patients with brain metastasis
Measured: Upon enrollment through end of study period (1 year after last patient is enrolled)
Secondary outcomes (4)
Number of patients with adverse events as a measure of safety and tolerability of GRN1005 alone or in combination with Trastuzumab
Measured: Upon enrollment through end of study period (1 year after last patient is enrolled)
Intra-cranial objective response duration
Measured: Upon enrollment through end of study period (1 year after last patient is enrolled)
3-month intra-cranial progression-free survival
Measured: Upon enrollment through end of study period (1 year after last patient is enrolled)
Six month overall survival (OS)
Measured: Upon enrollment through end of study period (1 year after last patient is enrolled)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2011 (estimated)
- Study startOct 2011
- Primary completionJun 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Angiochem Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Betty Lawrence, Study director, Angiochem IncNancy Lin, MD, Principal investigator, Dana-Farber Cancer InstituteSusan Bates, MD, Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01480583
- Sponsor's protocol ID
- CP1005B016
- Acronym
- GRABM-B
- Status last verified
- Jul 2016
- First submitted
- 16 Nov 2011
- Last updated
- 13 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01480583
- Acronym / sponsor ID
- GRABM-B / CP1005B016
- Conditions
- Breast Cancer, Brain Metastases
- Keywords
- GRN1005, ANG1005, Peptide-Drug Conjugate (PDC), LRP-1, Targeted Therapy, Breast Cancer, Brain Metastases, Brain Tumor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Angiochem IncIndustry (pharma, biotech, devices)
- Study start
- Oct 2011
- Primary completion
- Jun 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 29 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Please see Brief Summary section.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GRN1005 | Experimental | Drug: GRN1005, Drug: 18F-FLTGRN1005 alone in HER2- MBC patients with brain mets. 18F-FLT may also be administered to this arm (if patient enrolled at NCI) |
| GRN1005 with trastuzumab | Experimental | Drug: GRN1005, Drug: Trastuzumab, Drug: 18F-FLTGRN1005 in combination with trastuzumab in MBC patients with brain mets 18F-FLT may also be administered to this arm (if patient enrolled at NCI) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- NCI CTCAE v4.0 Grade ≥ 2 neuropathy
- CNS disease requiring immediate neurosurgical intervention (e.g., resection, shunt placement, etc.)
- Known leptomeningeal disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GRN1005Also: ANG1005550 mg/m2 IV every 3 weeks | Drug | GRN1005, GRN1005 with trastuzumab |
| TrastuzumabAlso: Herceptin2 mg/kg IV every week or 6 mg/kg IV every 3 weeks per investigator choice | Drug | GRN1005 with trastuzumab |
| 18F-FLTAlso: 18F-fluorothymidine5 mCi of 18F-FLT IV during Screening and during Cycle 1 | Drug | GRN1005, GRN1005 with trastuzumab |
Primary outcome
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)
4 secondary outcomes
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Betty Lawrence study director
Angiochem Inc
Nancy Lin, MD principal investigator
Dana-Farber Cancer Institute
Susan Bates, MD principal investigator
National Cancer Institute (NCI)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GRN1005, Trastuzumab and 18F-FLT in people with Breast Cancer and Brain Metastases, run by Angiochem Inc at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2016.