Non-small Cell Lung Cancer (NSCLC) With Brain MetastasesPhase 2GRABM-LNCT01497665
GRN1005 in Non-Small Cell Lung Cancer (NSCLC) Patients With Brain Metastases (GRABM-L)
A Phase 2 study testing GRN1005 in people with Non-small Cell Lung Cancer (NSCLC) With Brain Metastases, run by Angiochem Inc at 10 sites in 2 countries.
Trial summary
The purpose of this study is to assess the efficacy, safety, and tolerability of GRN1005 in patients with brain metastases from non-small cell lung cancer (NSCLC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer (NSCLC) With Brain Metastases
- What is being tested?
- GRN1005
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 10 sitesin 2 countries
- Study dates
- Nov 2011to Feb 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Adult patients (≥ 18 years)
- Histologically or cytologically-documented NSCLC (EGFR mutation status must be known)
- Brain metastases from NSCLC, which:
- have radiologically-progressed after WBRT or are present without prior WBRT
- At least one radiologically-confirmed and measurable lesion (≥ 1.0 cm in the longest diameter) within14 days prior to the first dose of GRN1005 (Cycle 1, Day 1), as follows: an intra-cranial disease lesion (≥ 1.0 cm in the longest diameter) confirmed by Gd-MRI, or an extra-cranial disease lesion (≥ 1.0 cm in the longest diameter) confirmed by MRI or CT scan with contrast Prior stereotactic radiosurgery (SRS) is allowed; however, metastatic brain lesions previously treated with SRS are not allowed as target or as non-target lesions.
- Patients must be neurologically stable, defined as being 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 of GRN1005 (Cycle 1, Day 1).
- Karnofsky Performance Score (KPS) ≥ 80%
- Completed WBRT for intra-cranial lesions ≥ 28 days prior to first dose of GRN1005 (with the exception of local radiation therapy for palliation to extra-cranial sites, i.e., bone). All clinically significant toxicities must have resolved to ≤ NCI CTCAE v4.0 Grade 1.0.
Who cannot join
- NCI CTCAE v4.0 Grade ≥ 2 neuropathy
- CNS disease requiring immediate neurosurgical intervention (e.g., resection, shunt placement, etc.)
- Known intra-cranial hemorrhage
- Known leptomeningeal disease
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
United States9 sites
Univ. Coloardo at Denver
Aurora, Colorado, 80045
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Northwestern Univ.
Chicago, Illinois, 60611
Karmanos Cancer Institute
Detroit, Michigan, 48201
Ingalls Memorial Hospital
Harvey, Illinois, 60426
Univ. of California San Diego
La Jolla, California, 92093
Tennessee Oncology
Nashville, Tennessee, 37203
Univ. of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15232
H. Lee Moffitt Cancer Center
Tampa, Florida, 33612
About this study
Official title: A Phase II, Multi-center, Open-label Study Evaluating the Efficacy and Safety of GRN1005 in Non-Small Cell Lung 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 non-small cell lung cancer (NSCLC).
- Being tested
- GRN1005
- Keywords
- GRN1005, ANG1005, LRP-1, Targeted Therapy, Brain Tumor, Blood Brain Barrier, Peptide-Drug Conjugate (PDC), Brain Metastases, Paclitaxel, Taxol, NSCLC, Non-Small Cell Lung Cancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, 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
650 mg/m2 IV every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| GRN1005 alone | Experimental | GRN1005 alone Receives: Drug: GRN1005 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall (Intra-cranial and Extra-cranial) Objective Response Rate in Non-small Cell Lung Cancer (NSCLC) Patients With Brain Metastasis
Tumor response was assessed by Gd-MRI for intracranial lesions and CT/MRI with contrast of chest, abdomen, pelvis for extracranial lesions using modified OVERALL RECIST v1.1 as follows: Complete Response (CR), disappearance of all target and non-target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions and non-target lesions stable or decreased; Stable Disease (SD), < 30% decrease but <20% increase in target lesions and non-target lesions stable or decreased; Progressive disease (PD), >= 20% (>= 5 mm) increase in the sum of diameters of the target lesions, taking as reference the smallest sum on study, non-target lesions increased or appearance of a new lesion; Overall Response (OR) = CR + PR.
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
Measured: Upon enrollment through end of study period (1 year after last patient is enrolled)
Duration of Overall Objective Response
Measured: Upon enrollment through end of study period (1 year after last patient is enrolled)
Duration of Overall Progression Free Survival
Measured: Upon enrollment through end of study period (1 year after last patient is enrolled)
Six Month Overall Survival
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 posted22 Dec 2011 (estimated)
- Study startNov 2011
- Primary completionJan 2013
- Study completionFeb 2013
Why it stopped: Slow recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Non-small Cell Lung Cancer (NSCLC) With Brain MetastasesStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Angiochem Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Betty Lawrence, Study director, Angiochem IncPatrick Wen, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01497665
- Sponsor's protocol ID
- CP1005B017
- Acronym
- GRABM-L
- Status last verified
- Jan 2019
- First submitted
- 20 Dec 2011
- Last updated
- 22 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Multi-center, Open-label Study Evaluating the Efficacy and Safety of GRN1005 in Non-Small Cell Lung Cancer Patients With Brain Metastases
- ClinicalTrials.gov ID
- NCT01497665
- Acronym / sponsor ID
- GRABM-L / CP1005B017
- Keywords
- GRN1005, ANG1005, LRP-1, Targeted Therapy, Brain Tumor, Blood Brain Barrier, Peptide-Drug Conjugate (PDC), Brain Metastases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow recruitment
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Angiochem IncIndustry (pharma, biotech, devices)
- Study start
- Nov 2011
- Primary completion
- Jan 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 22 Dec 2011 (estimated)
- Results
- Posted 14 Dec 2015
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 non-small cell lung cancer (NSCLC).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GRN1005 alone | Experimental | Drug: GRN1005GRN1005 alone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Adult patients (≥ 18 years)
- Histologically or cytologically-documented NSCLC (EGFR mutation status must be known)
- Brain metastases from NSCLC, which:
- have radiologically-progressed after WBRT or are present without prior WBRT
- At least one radiologically-confirmed and measurable lesion (≥ 1.0 cm in the longest diameter) within14 days prior to the first dose of GRN1005 (Cycle 1, Day 1), as follows: an intra-cranial disease lesion (≥ 1.0 cm in the longest diameter) confirmed by Gd-MRI, or an extra-cranial disease lesion (≥ 1.0 cm in the longest diameter) confirmed by MRI or CT scan with contrast Prior stereotactic radiosurgery (SRS) is allowed; however, metastatic brain lesions previously treated with SRS are not allowed as target or as non-target lesions.
Key exclusion criteria (4 listed)
- NCI CTCAE v4.0 Grade ≥ 2 neuropathy
- CNS disease requiring immediate neurosurgical intervention (e.g., resection, shunt placement, etc.)
- Known intra-cranial hemorrhage
- 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: ANG1005650 mg/m2 IV every 3 weeks | Drug | GRN1005 alone |
Primary outcome
Overall (Intra-cranial and Extra-cranial) Objective Response Rate in Non-small Cell Lung Cancer (NSCLC) Patients With Brain Metastasis
Time frame: upon enrollment through end of study period (1 year after last patient is enrolled)
Tumor response was assessed by Gd-MRI for intracranial lesions and CT/MRI with contrast of chest, abdomen, pelvis for extracranial lesions using modified OVERALL RECIST v1.1 as follows: Complete Response (CR), disappearance of all target and non-target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions and non-target lesions stable or decreased; Stable Disease (SD), < 30% decrease but <20% increase in target lesions and non-target lesions stable or decreased; Progressive disease (PD), >= 20% (>= 5 mm) increase in the sum of diameters of the target lesions, taking as reference the smallest sum on study, non-target lesions increased or appearance of a new lesion; Overall Response (OR) = CR + PR.
4 secondary outcomes
Number of Patients With Adverse Events as a Measure of Safety and Tolerability
Time frame: Upon enrollment through end of study period (1 year after last patient is enrolled)
Duration of Overall Objective Response
Time frame: Upon enrollment through end of study period (1 year after last patient is enrolled)
Duration of Overall Progression Free Survival
Time frame: Upon enrollment through end of study period (1 year after last patient is enrolled)
Six Month Overall Survival
Time frame: Upon enrollment through end of study period (1 year after last patient is enrolled)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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
Patrick Wen, MD principal investigator
Dana-Farber Cancer Institute
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GRN1005 in people with Non-small Cell Lung Cancer (NSCLC) With Brain Metastases, run by Angiochem Inc at 10 sites in 2 countries.
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 8 inclusion and 4 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: stopped early, as of the sponsor's last update on 22 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, Canada. 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?
Yes. Results are posted in the registry (first posted 14 Dec 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Overall (Intra-cranial and Extra-cranial) Objective Response Rate in Non-small Cell Lung Cancer (NSCLC) 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 22 Jan 2019.