Breast CancerPhase 2NCT02048059
ANG1005 in Breast Cancer Patients With Recurrent Brain Metastases
A Phase 2 study testing ANG1005 in people with Breast Cancer and Brain Metastases, run by Angiochem Inc at 19 sites in United States.
Trial summary
This is a Phase 2 study to see if an investigational drug, ANG1005, can shrink tumor cells in breast cancer patients with recurrent brain metastases. 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?
- ANG1005
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 19 sitesUnited States
- Study dates
- Apr 2014to Sep 2017
- 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
- ≥ 18 years old
- Breast cancer
- Recurrent brain metastases from breast cancer
- At least one radiologically-confirmed and measurable metastatic brain lesion ( ≥ 0.5 cm)
- Neurologically stable
- Karnofsky Performance Status (KPS) score ≥ 70
- Adequate hematology and serum chemistry laboratory test results
- Expected survival of ≥ 3 months
Who cannot join
- Prior treatment with ANG1005/GRN1005
- Evidence of symptomatic intracranial hemorrhage
- Pregnancy or lactation
- Inadequate bone marrow reserve
- Any evidence of severe or uncontrolled diseases
- Patients with the presence of an infection including abscess or fistulae, or known infection with hepatitis B or C or HIV
Show all 10Show fewer
- History of interstitial lung disease or evidence of clinically significant interstitial lung disease
- Severe cardiac conduction disturbance
- Central nervous system (CNS) disease requiring immediate neurosurgery intervention
- Known severe hypersensitivity or allergy to paclitaxel or any of its components
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
United States19 sites
University of New Mexico
Albuquerque, New Mexico, 87106
GRU Cancer Center - Georgia Regents University
Augusta, Georgia, 30912
University of Colorado Cancer Center
Aurora, Colorado, 80045
University of Maryland - Greenebaum Cancer Center
Baltimore, Maryland, 21201
National Cancer Institute
Bethesda, Maryland, 20892-1903
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599-7295
Northwestern University
Chicago, Illinois, 60611
Cleveland Clinic
Cleveland, Ohio, 44195
The Long Islan Brain Tumor Center at Neurological Surgery P.C.
Commack, New York, 11725
Cancer & Hematology Centers of Western Michigan
Grand Rapids, Michigan, 49503
MD Anderson Cancer Center
Houston, Texas, 77030
UC San Diego Moores Cancer Center
La Jolla, California, 92093-0698
University of California - LAC Medical Center
Los Angeles, California, 90033
University of Southern California - Norris Comprehensive Cancer Center
Los Angeles, California, 90033
UC - Irvine Chao Family Comprehensive Cancer Center
Orange, California, 92868
Magee Womens Hospital
Pittsburgh, Pennsylvania, 15213
UPMC Cancer Center
Pittsburgh, Pennsylvania, 15232
Univeristy of Texas Health Science Center in San Antonio
San Antonio, Texas, 78229
University of Arizona Cancer Center
Tucson, Arizona, 85719
About this study
Official title: A Phase II, Open-Label, Multi-Center Study of ANG1005 in Breast Cancer Patients With Recurrent Brain Metastases
This is a Phase 2 study to see if an investigational drug, ANG1005, can shrink tumor cells in breast cancer patients with recurrent brain metastases.
- Conditions
- Breast Cancer, Brain Metastases
- Being tested
- ANG1005
- Keywords
- ANG1005, GRN1005, Low-density lipoprotein receptor-related protein (LRP-1), Targeted therapy, Breast cancer, Brain metastases, Brain tumor, Blood-brain barrier, Trastuzumab, Herceptin, Paclitaxel, Taxol, Breast cancer with brain metastases, Triple Negative, Triple negative breast cancer (TNBC), Herceptin 2 (HER2)-positive, HER2-negative, Metastatic brain tumors
- Medical subject headings
- Breast Neoplasms, Brain Neoplasms, Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ANG1005Drug
| Study group | Role | What they receive |
|---|---|---|
| ANG1005 | Experimental | Participants received ANG1005 intravenously (IV) at a dose of 600 mg/m^2 on Day 1 of each 21-day cycle. ANG1005 will be administered for up to a maximum of one year, or until disease progression or adverse events (AE) that are not tolerated. Receives: Drug: ANG1005 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intracranial objective response rate (iORR)
Measured: Upon enrollment through end of study period (1 year after last patient is enrolled)
Secondary outcomes (10)
Duration of intracranial objective response
Measured: Upon enrollment through end of study period (1 year after last patient is enrolled)
Median intracranial progression-free survival (PFS)
Measured: Upon enrollment through end of study period (1 year after last patient is enrolled)
Intracranial PFS rates at 3, 6 and 12 months
Measured: Upon enrollment through end of study period (1 year after last patient is enrolled)
6-month overall survival (OS) rate
Measured: Upon enrollment through end of study period (1 year after last patient is enrolled
Extracranial objective response rate (eORR) and duration of response
Measured: Upon enrollment through end of study period (1 year after last patient is enrolled
Number of Patients with adverse events
Measured: Upon enrollment through end of study period (1 year after last patient is enrolled
Plasma pharmacokinetics of ANG1005
To determine the drug concentration and distribution in the plasma. (AUC, Cmax, T1/2)
Measured: On Day 1 of Cycles 1 and 3
Intracranial ORR by modified Response Assessment in Neuro-Oncology (RANO) criteria
Measured: Upon enrollment through end of study period (1 year after last patient is enrolled)
Intracranial clinical benefit rate (iCBR) at 3 and 6 months
Measured: Upon enrollment through end of study period (1 year after last patient is enrolled)
Potential immunogenicity of ANG1005
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 Jan 2014 (estimated)
- Study startApr 2014
- Primary completionMar 2016
- Study completionSep 2017
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Angiochem Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Betty Lawrence, Study director, Angiochem Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02048059
- Sponsor's protocol ID
- ANG1005-CLN-04
- Status last verified
- Feb 2020
- First submitted
- 21 Jan 2014
- Last updated
- 25 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Open-Label, Multi-Center Study of ANG1005 in Breast Cancer Patients With Recurrent Brain Metastases
- ClinicalTrials.gov ID
- NCT02048059
- Acronym / sponsor ID
- ANG1005-CLN-04
- Conditions
- Breast Cancer, Brain Metastases
- Keywords
- ANG1005, GRN1005, Low-density lipoprotein receptor-related protein (LRP-1), Targeted therapy, Breast cancer, Brain metastases, Brain tumor, Blood-brain barrier
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Angiochem IncIndustry (pharma, biotech, devices)
- Study start
- Apr 2014 (actual)
- Primary completion
- Mar 2016 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 29 Jan 2014 (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.
This is a Phase 2 study to see if an investigational drug, ANG1005, can shrink tumor cells in breast cancer patients with recurrent brain metastases.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ANG1005 | Experimental | Drug: ANG1005Participants received ANG1005 intravenously (IV) at a dose of 600 mg/m^2 on Day 1 of each 21-day cycle. ANG1005 will be administered for up to a maximum of one year, or until disease progression or adverse events (AE) that are not tolerated. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- ≥ 18 years old
- Breast cancer
- Recurrent brain metastases from breast cancer
- At least one radiologically-confirmed and measurable metastatic brain lesion ( ≥ 0.5 cm)
- Neurologically stable
Key exclusion criteria (10 listed)
- Prior treatment with ANG1005/GRN1005
- Evidence of symptomatic intracranial hemorrhage
- Pregnancy or lactation
- Inadequate bone marrow reserve
- Any evidence of severe or uncontrolled diseases
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 |
|---|---|---|
| ANG1005 | Drug | ANG1005 |
Primary outcome
Intracranial objective response rate (iORR)
Time frame: Upon enrollment through end of study period (1 year after last patient is enrolled)
10 secondary outcomes
Duration of intracranial objective response
Time frame: Upon enrollment through end of study period (1 year after last patient is enrolled)
Median intracranial progression-free survival (PFS)
Time frame: Upon enrollment through end of study period (1 year after last patient is enrolled)
Intracranial PFS rates at 3, 6 and 12 months
Time frame: Upon enrollment through end of study period (1 year after last patient is enrolled)
6-month overall survival (OS) rate
Time frame: Upon enrollment through end of study period (1 year after last patient is enrolled
Extracranial objective response rate (eORR) and duration of response
Time frame: Upon enrollment through end of study period (1 year after last patient is enrolled
Number of Patients with adverse events
Time frame: Upon enrollment through end of study period (1 year after last patient is enrolled
Plasma pharmacokinetics of ANG1005
Time frame: On Day 1 of Cycles 1 and 3
Intracranial ORR by modified Response Assessment in Neuro-Oncology (RANO) criteria
Time frame: Upon enrollment through end of study period (1 year after last patient is enrolled)
Intracranial clinical benefit rate (iCBR) at 3 and 6 months
Time frame: Upon enrollment through end of study period (1 year after last patient is enrolled)
Potential immunogenicity of ANG1005
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 25 Feb 2020.
- Safety, pharmacokinetics, and activity of GRN1005, a novel conjugate of angiopep-2, a peptide facilitating brain penetration, and paclitaxel, in patients with advanced solid tumorsLink provided by the sponsor.
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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
19 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 ANG1005 in people with Breast Cancer and Brain Metastases, run by Angiochem Inc at 19 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 8 inclusion and 10 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 25 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 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?
Intracranial objective response rate (iORR) (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 25 Feb 2020.